A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy 9781553395317

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A Canadian Healthcare Innovation Agenda Policy, Governance, and Strategy

Edited by

Edited by

A. Scott Carson and Kim Richard Nossal A. Scott Carson and Kim Richard Nossal

Queen’s Policy Studies Series Queen’s Policy Studies Series School of Policy Studies, Queen’s University School of Policy Studies, Queen’s University McGill-Queen’s University Press McGill-Queen’s University Press Montréal & Kingston • London • Ithaca Montréal & Kingston | London | Ithaca

Copyright © 2018 School of Policy Studies, Queen’s University at Kingston, Canada

School of Policy Studies Publications Program Robert Sutherland Hall 138 Union Street Kingston, ON K7L 3N6 www.queensu.ca/sps/ All rights reserved. The use of any part of this publication for reproduction, transmission in any form, or by any means (electronic, mechanical, photocopying, recording, or otherwise), or storage in a retrieval system without the prior written consent of the publisher— or, in case of photocopying or other reprographic copying, a licence from the Canadian Copyright Licensing Agency—is an infringement of the copyright law. Enquiries concerning reproduction should be sent to the School of Policy Studies at the address above.

Library and Archives Canada Cataloguing in Publication

A Canadian healthcare innovation agenda : policy, governance, and strategy / edited by A. Scott Carson and Kim Richard Nossal.

(Queen’s policy studies series) Issued in print and electronic formats. ISBN 978-1-55339-529-4 (softcover).--ISBN 978-1-55339-530-0 (PDF).-ISBN 978-1-55339-531-7 (HTML)

1. Medical policy--Canada. 2. Health services administration--Canada. 3. Health care reform--Canada. I. Carson, A. Scott, editor II. Nossal, Kim Richard, editor III. Queen’s University (Kingston, Ont.). School of Policy Studies, issuing body IV. Series: Queen’s policy studies series

RA395.C3C2696 2018

362.10971

C2018-900867-9 C2018-900868-7

Contents

Contributors ................................................................................................ vii List of Abbreviations................................................................................. xiii Prologue Thawing Canadian Healthcare .............................................................. xvii C. David Naylor

Part 1: The Canadian Agenda Chapter 1 Innovation in Canadian Healthcare: An Essential Part of a System-Wide Strategy ............................................................................ 3 A. Scott Carson Chapter 2 Innovation in Canadian Healthcare: What Are We Talking About?.....................................................................................................21 Lynne Golding

Chapter 3 Reflections on the Naylor Report 2015: Fund, Agency, and Governance .................................................................................... 43 A. Scott Carson

Part 2: Innovation for Whom? Special Populations Chapter 4 Influencing Health Policy and Programming for Military and Veterans...........................................................................................65 Alice B. Aiken, Stéphanie A. H. Bélanger, and Julie Burch Chapter 5 Frail Seniors: Reorganizing the Healhcare System to Address the Needs of Some of Its Most Vulnerable Clients.................................. 73 John Muscedere Chapter 6 Innovation and Healthcare for Indigenous Peoples ..............................95 Michael E. Green

Part 3: Creating Innovation Chapter 7 The Role of Performance Data and Information in Driving and Supporting Health System Innovation ............................................105 Sara Allin, Mélanie Josée Davidson, Keith Denny, and David O’Toole Chapter 8 The Management of Innovation: Strengthening Patient Safety and Creating Value Though Supply Chain Transformation ......... 125 Anne Snowdon and Charles Alessi

Chapter 9 Health Profession Regulation: Improving the Prospects for Innovation ......................................................................................145 Jennifer Medves Chapter 10 Improving Healthcare Value by Unlocking Innovation: An Industry Perspective ........................................................................... 167 Neil Fraser Chapter 11 The Politics of Change: The Role of Medical Asociations in Innovation for Quality Care ..............................................................187 Christopher Simpson and Owen Adams Chapter 12 Educating for Innovation in Medicine ...................................................217 Eve Purdy and Richard Reznick

Contributors

Owen Adams is chief policy advisor at the Canadian Medical Association, based in Ottawa, Ontario. Since joining the CMA in 1990 he has contributed to the association’s research and policy development in areas such as physician human resources, health system financing, and health reform. Prior to joining the CMA he spent twelve years in the Health Division of Statistics Canada. He holds a BA and MA in Sociology from Western University and a PhD in Population Health from the University of Ottawa. Alice B. Aiken, PhD, CD is a professor and the vice president of research at Dalhousie University in Halifax, Nova Scotia. She does health services/health policy research in the area of veterans’ and military family health. She is a co-founder and the former scientific director of the Canadian Institute for Military and Veteran Health Research. Sara Allin is senior researcher with the Canadian Institute for Health Information and assistant professor, status only, at the Institute of Health Policy Management and Evaluation, University of Toronto. Sara has a PhD in Health Policy from the London School of Economics and Political Science. Stéphanie A. H. Bélanger is the associate scientific director of the Canadian Institute for Military and Veteran Health Research,

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and co-editor in chief of the Journal of Military, Veteran and Family Health. She is a professor in the Department of French, Literature, and Culture at the Royal Military College of Canada, where her research focuses on war testimony, soldier identity, and moral injuries. Julie Burch is the project manager at the Canadian Institute for Military and Veteran Health Research. A. Scott Carson, PhD is a professor of governance and strategy at Smith School of Business, Queen’s University, and previously the dean of two Canadian university business schools. He is co-editor, with Kim Richard Nossal and Jeffrey Dixon, of Toward a Healthcare Strategy for Canadians (2015) and co-editor with Kim Richard Nossal of Managing a Canadian Healthcare Strategy (2016).

Scott is past chair of the board of Kingston General Hospital, and has been a member of many other corporate and not-for-profit boards.

Mélanie Josée Davidson is a senior researcher with the Canadian Institute for Health Information. She first joined CIHI in 2004 and most recently held the position of special advisor to the president and CEO, working on health information and data use strategies. She has an MA from Queen’s University. Keith Denny is director, Clinical Data Standards and Quality, Canadian Institute for Health Information. He provides vision for CIHI’s data quality initiatives and for the development and application of clinical classifications and terminologies. He has held a number of leadership roles at CIHI and has more than twenty years of experience in the health sector. Lynne Golding leads the national Health Law Group at the law firm of Fasken Martineau DuMoulin LLP. From their Toronto office, she has an active corporate-commercial practice principally in the health industry, which involves transactions dealing with public and private corporations in both regulated and unregulated industries. Her own practice focuses on corporate law, particularly structuring contractual arrangements between hospitals and private sector service providers and providing governance advice. She has led large teams involved in the merger or inte-

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gration of large, medium, and small corporations involved in the delivery of healthcare. Lynne sits on a number of boards in the health sector. Michael E. Green, MD is Brian Hennen Chair and head of the Department of Family Medicine and professor of Family Medicine and Public Health Sciences at Queen’s University. He has extensive experience in Indigenous health as a family physician and public health medical officer as well as in Indigenous health research and education. Neil Fraser is the president of Medtronic Canada. He is chair of MEDEC and a board member of Baycrest Health Sciences, and was a member of the federal Advisory Panel on Healthcare Innovation and the Ontario Health Innovation Council. Neil is a frequent speaker on the topics of value-based procurement and outcomes-based healthcare. Jennifer Medves, PhD is the vice-dean (Faculty of Health Sciences) and director of the School of Nursing at Queen’s University. Dr. Medves’ research program, Nursing in Healthy Rural Workplaces, has a main focus on quality healthcare that enhances care, reduces episodes of patient safety incidences, and improves the healthcare environment for practitioners and Canadians. John Muscadere, MD, FRCPC is a professor of Critical Care Medicine at Queen’s University, Kingston. Dr. Muscedere has extensive experience in clinical research and is the scientific director for the Networks of Centres of Excellence (NCE) funded Canadian Frailty Network (CFN) whose mission is to improve the care of persons living with frailty across Canada. C. David Naylor is professor of medicine and president emeritus at the University of Toronto. Past medical dean and founding chief executive of the Institute for Clinical Evaluative Sciences, Naylor chaired Health Canada’s Advisory Panel on Healthcare Innovation in 2014–15. Kim Richard Nossal is a professor in the Department of Political Studies, Queen’s University. He was the director of the School

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of Policy Studies from 2013 to 2015, and co-editor, with A. Scott Carson and Jeffrey Dixon, of Toward a Healthcare Strategy for Canadians (2015) and co-editor with A. Scott Carson of Managing a Canadian Healthcare Strategy (2016). David O’Toole is president and CEO of the Canadian Institute for Health Information and current chair of the Board of the Kingston Health Sciences Centre. He graduated from Queen’s University and the Ivey School of Business (University of Western Ontario) prior to spending more than twenty years in the Ontario public sector. Eve Purdy, MD received her Bachelor of Health Sciences from McMaster University, followed by her medical degree from Queen’s University. She is currently a resident in emergency medicine at Queen’s while simultaneously completing a Master’s in Applied Anthropology through the University of North Texas. She is a champion of Free Open Access Medical Education, writing and editing for a number of online publications including CanadiEM and Academic Life in Emergency Medicine. She is fascinated by the transformations that take place during medical training and is keen to build a career dedicated to studying and improving medical and education cultures. Richard Reznick, MD received his medical degree from McGill University, followed by a general surgical residency at the University of Toronto. He spent two years in fellowship training, first obtaining a Masters’ degree in medical education, followed by a fellowship in colorectal surgery at the University of Texas. Dr. Reznick was the inaugural director of the University of Toronto Faculty of Medicine’s Centre for Research in Education at University Health Network, and in 1999 was appointed vice president of education at University Health Network. He served eight years as the R. S. McLaughlin Professor and chairman of the Department of Surgery at the University of Toronto. In 2010, Dr. Reznick assumed the position of dean, Faculty of Health Sciences at Queen’s University and chief executive officer of the Southeastern Ontario Academic Medical Organization (SEAMO). Christopher Simpson, MD is professor and head of cardiology at Queen’s University, medical director of the Cardiac Programs at Kings-

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ton General and Hotel Dieu hospitals, and the past-president of the Canadian Medical Association as well as current chair of the Canadian Wait Time Alliance. He received his MD from Dalhousie in 1992, and did post-graduate training at Queen’s and Western. His health policy interests include medical fitness to drive, patient flow, wait times, and seniors’ care. Anne Snowdon, PhD is a professor and academic chair of the World Health Innovation Network at the University of Windsor’s Odette School of Business. The World Health Innovation Network is the first Canadian health innovation centre with formal ties to the United States. She works to build collaborative partnerships between the two countries to advance the health of populations, accelerate health system innovation to achieve sustainability, economic value, and productivity by providing support for innovators and entrepreneurs to successfully bring their discoveries to the Canadian, US, and world markets.

List of Abbreviations APHI BGM CADTH CAF CAPR CaRMS CBHSSJB CBME C-Change CFPC CHA CIHI CIHR CIMVHR CMA CPAC CPG CPSI CSA CWC DND DRDC EIU EMP

Advisory Panel on Healthcare Innovation bicameral governance model Canadian Agency for Drugs and Technologies Canadian Armed Forces Canadian Alliance of Physiotherapy Regulators Canadian Resident Matching Service Cree Board of Health and Social Services of James Bay competency-based medical education Canadian Cardiovascular Harmonized Guidelines Endeavour College of Family Physicians of Canada Canada Health Act Canadian Institute for Health Information Canadian Institutes of Health Research Canadian Institute for Military and Veteran Health Research Canadian Medical Association Canadian Partnership Against Cancer clinical practice guideline Canadian Patient Safety Institute Canadian Securities Administrators Choosing Wisely Canada Department of National Defence Defence Research and Development Canada Economist Intelligence Unit extramural program

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List of Abbreviations

EMR EPA EQ-5D EQ-VAS FFS FNHA FNHC GPA HCIWG HIAC HIF HSMR HTA ICES ICHOM IOM IT Infoway JMVFH MCAT MOU MVF My NHS NAPAQH NICE OCHIS OECD OHIC P3 PCORI POEMS PPCP PREM

electronic medical record entrustable professional activity Euroqol-5D index Euroqol Visual Analogue Scale fee-for-service First Nations Health Authority First Nations Health Council grade point average Health Care Innovation Working Group Healthcare Innovation Agency of Canada Healthcare Innovation Fund hospital standardized mortality ratio health technology assessment Institute for Clinical Evaluative Sciences International Consortium for Health Outcomes Measurement Institute of Medicine information technology Canada Health Infoway Journal of Military, Veteran and Family Health Medical College Admission Test memorandum of understanding military veterans and their families My National Health Service National Partnership for Quality in Health National Institute for Health and Care Excellence Office of the Chief Health Innovation Strategist Organisation for Economic Co-operation and Development Ontario Health Innovation Council public private partnership Patient-Centered Outcomes Research Institute Patient-Oriented Evidence that Matters public private community partnership patient-reported experience measure

List of Abbreviations

PROM PSPP PTMAs PTSD PWGSW QMA RFP RMCC SDoH SPOR STARS TCFNH TRC VAC WCWL WTA

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patient-report outcome measure public social private partnership provincial-territorial medical associations post-traumatic stress disorder Public Works and Government Services Canada Québec Medical Association request for proposal Royal Military College of Canada social determinants of health Strategy for Patient Oriented Research Students and Trainees Advocating for Resource Stewardship Tripartite Committee on First Nations Health Truth and Reconciliation Commission of Canada Veterans Affairs Canada Western Canada Waiting List Wait Time Alliance

Prologue

Thawing Canadian Healthcare C. David Naylor

In 2017 the healthcare system in the United States found itself in a subacute crisis, as Republican lawmakers tried without success to forge a consensus around repealing and replacing the Affordable Care Act. Canada, meanwhile, remains the frozen north of healthcare policy—a system not so much in crisis, but in a chronically uncomfortable stasis. This obstipation is so extreme that it has already prompted publication of a detailed study evocatively entitled Paradigm Freeze: Why It Is So Hard to Reform Health Care in Canada (Lazar et al. 2013). In recent years, a group of scholars at Queen’s University have taken this unhappy situation as a positive challenge. They organized four conferences, held annually from 2013 to 2016, aptly entitled the Queen’s Health Policy Change Conference Series, and those conference proceedings in turn have led to three collections of essays—the last of which is in your hands or on your digital screen at the moment. All four conferences and the reports and publications related to them have focused carefully not just on strategies that would advance Canadian health policy, but how in concrete terms those policies might be implemented. It is true that the essays in the three volumes vary in the specificity of their action plans, and in their degree of optimism about whether policy makers in Canada’s notoriously dysfunctional federation will ever converge around an agenda of major reforms to the nation’s healthcare systems. But what they all reflect is the wide consensus that the modes of organizing and financing Canadian healthcare are outmoded, and that, despite some of the finest healthcare professionals and managers in the

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world, our performance measures are lagging and unlikely to improve unless serious changes are made. A second unusual aspect of the series is that its focus has been as much national as federal. This was a smart and pragmatic approach given Canada’s constitutional division of powers and the ongoing complexity of our federal/provincial/territorial interactions. A third and final differentiating feature of the series is its genesis in collaborations across Queen’s Faculty of Health Sciences, School of Policy Studies, and Smith School of Business. The inclusion of the Smith School, in turn, has catalyzed a focus on strategy, understood not as a generic concept, but as business educators see it, with an emphasis on delineating not just key objectives, but plans to achieve them, modes of implementing those plans, continuous assessment of progress towards the agreed objectives as the plans are executed, and recalibration of the plans as needed. Accordingly, the initial conference in 2013 and the volume of essays resulting from it focused on defining the need for, and potential shape of, a Canadian national healthcare strategy. The political backdrop made that focus particularly relevant. The Romanow and Kirby reports of 2002 marked the first major re-examinations of Canada’s healthcare arrangements since the 1964 Hall Commission report. Both reports punctuated and sought to guide a period of rebounding federal investment in healthcare, after sharp reductions in transfers to provinces and territories were made when the federal government attempted to eliminate its budgetary deficit in the 1990s. Alas, successive federal/provincial/territorial health accords and new federal spending by Liberal governments totaling tens of billions of dollars prompted only minimal reforms in the organization and finance of Canada’s thirteen provincial and territorial healthcare systems. It also became clear in those years that the dynamic of the negotiations was counter-productive. Provinces and territories repeatedly cited underfunding by Ottawa to rationalize local shortcomings in publicly insured healthcare services. Negotiations themselves were exercises in orchestrated outrage with thirteen against one at the table. There was no clarity about what the right federal share of total spending should be. And Ottawa had minimal ability to hold the provinces to account for increased transfers. Stephen Harper’s Conservative government took office in early 2006. The Conservatives inherited, and honoured, a ten-year agreement that had been reached with provinces and territories in 2004 by the Liberal

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government under Paul Martin, including its provision for a 6 percent annual escalator in the level of the federal transfer. In December 2011 the Conservatives announced a unilateral extension of that deal to fiscal 2016–17, but stipulated that the escalator would fall thereafter to 3 percent or the rate of nominal GDP growth, whichever was higher. The provisions of the Canada Health Act (1985) remained in force, along with the Act’s conditions on transfers relative to the provision of physician and general hospital services. However, the Conservatives placed no other conditions on the ongoing escalation of transfers. The signal of disengagement was clear: Provinces and territories would have clear authority for healthcare, and would thus bear unequivocal responsibility for the successes and failures of healthcare arrangements within their borders. One of the happy side-effects of the Conservative strategy was to galvanize greater provincial-territorial collaboration, including the creation of a pan-Canadian Pharmaceutical Alliance to augment purchasing power. Nonetheless, in areas such as healthcare innovation and policy reforms, collective efforts were hamstrung by the absence of a neutral broker or dedicated secretariat, by the usual centrifugal forces of a federation long bedevilled by an ideology of regional exceptionalism, and by the rapid turnover of health ministers. The first Queen’s conference and the accompanying book (Carson et al. 2015) accordingly swam directly against the then-prevailing federal currents. The issue addressed was not the absence of strategies; indeed, as A. Scott Carson observed, the country was “awash in them” (Carson 2015, 12). Nor was a top-down federal strategy the answer, given the decentralized administration of our thirteen (or more) healthcare systems. Rather, as Carson put it in a bracing final essay “Canadians do not have a vision and a plan for our system as a whole. What is needed is a system-wide strategy that links the provincial/territorial strategies so that they work more effectively together, connects the national institutions, and establishes pan-Canadian initiatives in health human resources, electronic health records, pharmacare, and seniors’ care” (Carson 2015, 259). He called for jurisdictions to agree on a vision and goals, principles, and commitments to move healthcare forward from coast to coast to coast. Out of that consensus would come a “balanced scorecard,” not dissimilar to the approach taken in the National Health Service of the United Kingdom at that time, albeit much more challenging to achieve in a federal jurisdiction. Carson also addressed a governance question that has troubled ob-

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servers for decades: the relentless politicization of Canadian healthcare, with its attendant blend of gaudy announcements, knee-jerk policy changes, public posturing by elected officials, and absence of substantive reforms to the organization and finance of any of our subnational systems. In this respect, optimists in the 1990s might have seen the widespread shift to regional governance of provincial healthcare systems as a countervailing action, fostering decentralization and de-politicization. It did neither (Naylor 1999). Regionalization eliminated the independent and voluntary boards of hundreds of hospitals and local agencies, and consolidated authority for various services under regional boards whose members were variously elected locally or appointed by government. Moreover, the motives were overtly political: devolving responsibility for tough local trade-offs in a period of fiscal restraint, while giving provinces a buffer against adverse public and stakeholder responses to budget cuts. Whether distracted by the recent regionalization phenomenon or sticking to their federal knitting, neither Romanow nor Kirby gave much attention to subnational governance in their 2002 reports. However, each supported the creation of non-politicized national bodies that would provide analysis and advice in support of healthcare reforms, with Romanow going further and suggesting that such a body might also act to forge inter-governmental agreement on where changes should and could be effected in Canada’s healthcare systems. Carson emphasized that Canada actually had considerable experience with jurisdictionally blended governance models in the healthcare realm, citing as precedents entities such as the Canadian Institute for Health Information and the Canadian Blood Service. Indeed, Sher in the same volume delineated how the Canadian Blood Service had created and executed a national strategy without undue friction by creating distinct boards for policy and operations (Sher 2015). Carson proposed a variant with a clearer division of authority—a true “bicameral” system. On the one side would be a national council with multi-jurisdictional representation to set the parameters of a balanced scorecard for shared federal/provincial/territorial accountability. On the other would be an operating service entity with a corporate governance structure to address pan-Canadian issues and meet objectives as agreed by the governing council. Provinces and territories would still have jurisdiction over their own healthcare arrangements. But in a rational universe, a steadily expanding set of services could migrate under the aegis of the new operating entity.

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In the winter of Harper-era disentangled federalism, these ideas had little chance of taking root. Proponents could perhaps be encouraged, however, by an essay in which a trio of Australian contributors showed that a national strategy for primary care reform emerged unexpectedly in their federation following a major change in political players (Beilby et al. 2015). Two further conferences in 2014 and 2015 substantially advanced the agenda, and yielded another powerful collection of essays—Managing a Canadian Healthcare Strategy. By then, the ground had been rendered more fertile by international affirmation that Canada’s healthcare systems were among the most expensive in the OECD, ranking in the top quartile on a per-capita basis, but ranking most often in the second or third quartile across a range of performance indicators. A particularly jarring wake-up call had been issued when the New York-based Commonwealth Fund produced a league table comparing healthcare performance in eleven jurisdictions with high per-capita GDP. Predictably, the United States was in last place, but Canada came second-last, having scored no better than mediocre on any single indicator. The ten essays in Managing a Canadian Healthcare Strategy accordingly emphasized that national coordination and improved service integration were not ends in themselves, but a means to raise the overall standard of Canadian healthcare back to a more internationally respectable level. Consistent with the emphasis of the series on strategy and action, measurement was a key theme. And in contrast to many tomes where policies are debated and proposed with scant attention to who will champion them or see to their implementation, the volume gave careful attention to the question of stimulating change, highlighting the role of extra-governmental leadership by healthcare professionals, the public, and the private sector. The final section was sobering, however, with two major essays asking whether and how “the jurisdictional realities of Canada’s political system” might “be managed to bring about strategic reform.” Neale Smith and Harvey Lazar reprised themes from the important Paradigm Freeze volume, of which Lazar was the lead editor. They saw little prospect of an early spring. They did not rule out the possibility that a newly-elected Liberal government might re-engage with the provinces and territories and drive forward with a national agenda, but were cautionary (Smith and Lazar 2016). Don Drummond and Talitha Calder took a more optimistic view. They argued that Harper-era disentanglement might have created a better prospect for a bottom-up process of reform. The changes would perforce be piecemeal

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and incremental, but something akin to a national strategy might gradually coalesce because the provinces and territories had begun working together and were more open to sharing best practices and forging a pan-Canadian consensus. They argued that better information-sharing—about policies, practices, and performance—could facilitate and accelerate this bottom-up trend. As to top-down or federally catalyzed initiatives, Drummond and Calder suggested that national stakeholder advocacy was generating momentum for changes in pharmaceutical pricing and might galvanize the creation of a seniors’ healthcare strategy (Drummond and Calder 2016). The fourth and final conference, in June 2016, summarized in the present volume, focused on innovation and its role in a national strategy that might galvanize improvements in our complex set of healthcare systems. The conference drew on multiple policy reports from different jurisdictions, including a lengthy report by Health Canada’s Advisory Panel on Healthcare Innovation (2015)—the first federal overview of the nation’s healthcare systems since the Kirby and Romanow reports in 2002. Carson’s introductory essay adroitly summarizes all the contributions. Thus, I will re-examine the context for the 2015 federal report of the Advisory Panel on Healthcare Innovation, briefly examine the latest the federal/provincial/territorial negotiations, and return to the key questions asked in the preceding volume: What are the chances of a breakthrough? And what role could the federal government play? It seems clear that the healthcare innovation mandate of the Panel arose from an opportunistic confluence of priorities. The minister of health in the Conservative government, Rona Ambrose, had rebuilt good relations with the provinces and territories. Minister Ambrose was wary of a return to the negotiations that had generated expensive and less-than-effective federal/provincial/territorial health accords under the Liberals, but she saw a role for selective federal action and targeted investment to improve healthcare for all citizens. While hard-liners in the Harper Cabinet were skeptical, they understood that the party was headed to the polls in October 2015, and vulnerable to criticism of its disengagement from the healthcare agenda—not least given the relatively low marks awarded Canadian healthcare by international assessors. The findings and conclusions of the Panel’s final report, released in July 2015, are widely known and readily accessible. Consistent with the thrust of the Queen’s conference series, it seems most efficient to focus

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here on how we foresaw that change might be driven by federal action. Given the failure to scale made-in-Canada innovations and adopt best practices from abroad, the Panel argued for two mutually reinforcing actions by Ottawa. One was a source of seed capital to spur innovation and “sustain momentum for change across jurisdictions.” This multiyear Healthcare Innovation Fund would be focused not on academic research, but on “support for activities that lead to scalable improvements in healthcare.” The other was to consolidate some of the existing health-related federal entities into a Healthcare Innovation Agency that would deploy these seeding and scaling resources, with a view to driving sustainable changes, and evaluating their impacts using pragmatic but rigorous methodologies (Advisory Panel 2015). Both the creation of an innovation fund and some consolidation of the array of small agencies in Ottawa had been recommended by a variety of national stakeholders. Both ideas in turn were clearly influenced by the experience of the United States Center for Medicare and Medicaid Innovation (CMMI). Created under the Patient Protection and Affordable Care Act (2010), CMMI had received a US$10 billion appropriation to be spent between 2011 and 2019, and had rapidly galvanized a variety of innovations in organization, finance, and delivery, evaluated them, and worked effectively to broaden the adoption of them (CMS Innovation Centre 2017). The experience was particularly relevant since American states have jurisdiction over Medicaid as a federally costshared program (unlike Medicare which is federally administered). The Prime Minister’s Office (PMO) reacted unfavourably to the report by the Advisory Panel on Healthcare Innovation, and the Conservative government accordingly proposed that the report be suppressed until after the fall election—a proposal rejected by the Panel. The PMO then demanded that specific revisions be made; these demands were also rejected unanimously by the panel members. Soon after, the report was released without any publicity on a Friday afternoon, and did not figure in the Conservative election platform. The Liberals in contrast signalled support for many of the ideas in the report. Their platform commitments were designed for voter appeal, emphasizing investments in homecare with an emphasis on seniors’ needs, mental health and addiction services, and enhanced services for Indigenous communities. However, collaborative innovation was a unifying theme, indicating that the Liberals had taken up the challenge of federal re-engagement and leadership in healthcare. On the other hand, the platform side-stepped the Panel’s detailed delineation of the futility of past na-

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tional health accords and instead promised that a new era of federal/ provincial/territorial comity would lead to yet another health accord! Unsurprisingly, after the electoral dust had settled, the latter platform promise sparked a recrudescence of all the adverse dynamics and laser-like focus on additional funds that had featured in past rounds of federal/provincial/territorial discussions. This unhappy process was in full swing when the last Queen’s conference took place in June 2016. Health Minister Jane Philpott and Finance Minister Bill Morneau eventually concluded that the only way forward was to create a public framework for consistency and fairness, and then negotiate the terms province by province. One by one, the provinces came aboard and a new national dispensation was reached piecemeal. The Conservative escalator to the core transfer was retained. One-time funds were added for home and community care ($6 billion over ten years starting in 2017–18) and for mental health and addiction services ($5 billion over ten years), all scaled on a per-capita basis like the core federal transfer. On the positive front, now that agreements have been reached, the federal/provincial/territorial interactions have calmed down and the interplay is cordial and constructive. In August 2017, for example, the ministers announced agreement to a set of common principles on “Shared Health Priorities.” The principles were designed to frame a set of bilateral agreements for transfer of the $11 billion in one-time-only funds for home and mental health services, and affirmed a common goal of enhancing the healthcare of Indigenous Canadians. Among the principles was a commitment to developing, evaluating, and sharing innovations, as well as measuring and reporting publicly on “progress on the collective and jurisdiction-specific goals under this Statement of Principles.” The agenda of objectives was encouragingly specific, exemplified by reference to “Spreading and scaling evidence-based models of home and community care that are more integrated and connected with primary health care,” or reference to improved home care infrastructure that included “digital connectivity” and “remote monitoring technology.” As usual, Quebec, which invoked the precedent of asymmetric federalism set in the 2004 Health Accord, was assigned its share, and went its own way. However, the prospect of $11 billion changing hands did prompt sufficient good will among the other provinces and territories that the ministers agreed to “ongoing collaboration.” This was to entail “ work on areas of mutual interest, specifically supporting health innovation and improving the affordability, accessibility and appropriate

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use of prescription drugs, including taking steps toward harmonization of drug plan formularies” (Health Canada 2017). Some will look at this outcome and lament another opportunity lost. It is certainly arguable that the momentum for change that will be unleashed by this federal investment of more than $1 billion a year for a decade would have been dwarfed had Ottawa proceeded with a national innovation fund on the same scale and with the type of machinery recommended by the Advisory Panel on Healthcare Innovation. However, our governments are at least talking thoughtfully with each other about healthcare issues, and finding some common ground. That this was achieved through bilateral as well as multilateral discussions, and with a sustainable infusion of funds, can be seen as steps taken in the right direction. One might also be encouraged by evidence of an economic resurgence in Canada, and by data showing that Canada’s provinces and territories have been very successful in the last few years at holding the line on healthcare spending. Thus, if the sun shines brightly enough, one can foresee that new tax revenues might be used in part to invest strategically in reform and thereby to incent change, rather than, as has so often been the case, to meet the pent-up income demands of providers and reinforce the status quo. Such optimism is perhaps an inevitable by-product of writing this prologue on a warm and bright fall day, when the Canadian winter seems a long way off, and thawing of our frozen healthcare system seems at least moderately imminent. However, if you are feeling less sunny, I encourage you to study not only the current fine volume of essays, but its two predecessors, where you will find both great food for thought, and fuel for optimism about our national healthcare prospects. References Advisory Panel on Healthcare Innovation. 2015. Unleashing Innovation: Excellent Healthcare for Canada (Ottawa), https://www.canada.ca/en/ health-canada/services/publications/health-system-services/report-adviso ry-panel-healthcare-innovation.html Beilby, Justin, Steve Hambleton, and Michael Reid. 2015. “System-wide healthcare reform: The Australian experience.” In Carson et al. 2015, 63–86. Carson, A. Scott, Jeffrey A. Dixon, and Kim Richard Nossal, eds. 2015. Toward a Healthcare Strategy for Canadians. Montréal and Kingston: Queen’s Policy Studies Series, McGill-Queen’s University Press.

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Carson, A. Scott, and Kim Richard Nossal, eds. 2016. Managing a Canadian Healthcare Strategy. Montréal and Kingston: Queen’s Policy Studies Series, McGill-Queen’s University Press. CMS Innovation Center. 2017. Centers for Medicare & Medicaid Services—Center for Medicare and Medicaid Innovation. Report to Congress, 2016. United States Department of Health and Human Services. Dated December 2016, released 5 January 2017, https://blog.cms. gov/2017/01/05/transforming-health-care-delivery-through-the-cms-inno vation-center/ Drummond, Don, and Talitha Calder. 2016. “An Action Plan for Reforming Healthcare in Canada.” In Carson and Nossal, 2016, 235–62. Health Canada. 2017. A Common Statement of Principles on Shared Health Priorities (21 August 2017), https://www.canada.ca/en/health-can ada/corporate/transparency/health-agreements/principles-shared-health-pri orities.html Lazar, Harvey, Pierre-Gerlier Forest, John N. Lavis, and John Church, eds. 2013. Paradigm Freeze: Why It Is So Hard to Reform Health Care in Canada. Montréal and Kingston: Queen’s Policy Studies, McGill-Queen’s University Press. Naylor, C. David. 1999. “Health Care in Canada: Incrementalism Under Fiscal Duress.” Health Affairs 18, no. 3: 9–26. Sher, Graham D. 2015. “Canadian Blood Services as an Example of a Canadian Healthcare Strategy.” In Carson et al., 2015, 39–62. Smith, Neale, and Harvey Lazar. 2016. “Clearing the Way: Beyond the Roadblocks to Healthcare Reform.” In Carson and Nossal, 2016, 205– 34.

Part 1

The Canadian Agenda

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Innovation in Canadian Healthcare: An Essential Part of a System-Wide Strategy A. Scott Carson

The Canadian healthcare system is a system-of-systems. It is the aggregation of fourteen loosely connected federal/provincial/territorial healthcare administrative and delivery systems. Some are centralized, some decentralized. However, there is no Canadian system-wide strategy that articulates over-arching healthcare goals and strategic objectives, much less a focused innovation strategy. Granted, our fourteen healthcare systems are not completely detached from one another. Canadians are justly proud of their universal health insurance by virtue of the Canada Health Act (1984) that sets out the principles underlying the pan-Canadian universal health insurance that must be provided by each province and territory. In addition, there are some sizable pan-Canadian programs for innovation that are sponsored by the federal government, such as Canada Health Infoway (technology), Canadian Institute of Health Information (data and information), Canadian Institutes for Health Research (research) and Canadian Foundation for Health Improvement (practice). However, Canada lacks a comprehensive system-wide strategic umbrella under which these federal programs, and the thirteen provincial/territorial healthcare delivery systems, could find coherence, coordination, and direction. Many Canadians are indifferent to the idea of a system-wide strategic approach. Perhaps this is because they are not aware of how unsustainably costly our system is. Or maybe they do not realize how A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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poorly Canada performs in terms of care processes, access, administrative efficiency, equity, and outcomes when compared with peer-group countries, despite what we spend (Commonwealth Fund 2017). And some Canadians oppose the idea of a Canadian strategy, particularly ideologues who think that a pan-Canadian strategy, even if it were established collaboratively among the federal, provincial, and territorial governments, would violate provincial/territorial rights. Others, however, are skeptics who doubt that gaining agreement would be possible given the regional differences in point of view. This book represents a more collectivist and optimistic view. A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy is a part of a broader exploration by Queen’s University of a Canadian system-wide healthcare strategy. Between 2013 and 2016, Queen’s hosted four high-level international conferences called the Queen’s Health Policy Change Conference Series. The conferences sought to address five questions: If Canada were to have a system-wide healthcare strategy that respected provincial/territorial rights, what form could such a strategy take? What would be the strategic goals? What areas of healthcare would be included? How would a pan-Canadian strategy be managed? How would the collaborative enterprise be governed? Each conference addressed different dimensions of a pan-Canadian strategy. The first three conferences addressed the structure of a Canadian strategy, processes of strategic change, and management issues associated with a pan-Canadian strategy. From these conferences came two edited volumes published by McGill-Queen’s University Press: Toward a Healthcare Strategy for Canadians in 2015 and Managing a Canadian Healthcare Strategy in 2016. The fourth conference in 2016 explored the prospects for a pan-Canadian healthcare innovation strategy. The conference’s themes were inspired by the report of the federally commissioned Advisory Panel on Healthcare Innovation, led by Dr. David Naylor (2015), which examined potential roles for the federal government in supporting healthcare innovation. The present collection focuses on national healthcare innovation. This book completes the trilogy of original essays by distinguished scholars and policy experts from Canada and around the world. While each book is self-contained, together the three books represent a coherent and cohesive study of the essential components of a pan-Canadian healthcare strategy. This book has three parts. In Part 1 we ask: What is meant by “innovation” when applied to healthcare policy? Because of the buzzword status of “innovation” in common parlance, it is not surprising that re-

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searchers, investors, patients, and the public may all have different conceptions of what defines innovation and the standards of quality and performance that must be met in order to qualify. Given this, political leaders and policy makers understandably have trouble establishing what innovations should be prioritized, who should be accountable, what barriers would need to be overcome, and how success should be measured. Building on the meaning of innovation is a central strategic question: What could a pan-Canadian innovation strategy look like? What would be its overall goals and strategic objectives? What specific strategies would come under these broad objectives? What institutional structures would be required for these strategies to be successfully pursued? How would strategic goals be implemented, and the institutions needed to administer them, managed? What form of governance of the institutions would most effectively promote the achievement of the strategic goals and objectives without political interference? The first two chapters deal with these issues. In a system-wide innovation strategy, we would expect to see familiar themes: system-wide pharmaceutical formularies and purchasing, adoption of common technologies for electronic health records, and harmonized policies for health human resources training and accreditation. But Part 2 of the book takes a less travelled path, asking: What about special populations, such as veterans, the frail elderly, and First Nations people? Where should they fit in a pan-Canadian innovation strategy? More specifically: because veterans have unique health needs given their past occupation, especially with respect to injury and patterns of mental health needs, the provincial/territorial systems may not be well equipped to provide adequate care. What innovations in patient-centred and evidence-based policy and strategy can be devised for them? Further, what about the transformative change needed in our healthcare system to deal with the increasing numbers of frail elderly populations whose chronic maladies and needs for care are significantly different and greater than previous generations? Finally, we often focus on the inequities in the care of First Nations peoples. But what about the successful models of innovative patient care and system administration that First Nations communities themselves have created? How can these be supported and leveraged? Part 3 concentrates on the need for creating innovation in the healthcare system as a whole. What is the role of data and information in creating opportunities for innovation across the system? What information do we need? How can we acquire and use it? How can inno-

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vations be introduced to the health supply chain to create value? How can waste be minimized? Finally, what is the cost to innovation of poor regulation of the healthcare professions? Is regulation to be regarded solely as a barrier to innovation? What can we do to restructure regulatory frameworks to promote innovation? If innovation is to be enhanced, we need to change. Three chapters in this section address aspects of change. The first assesses what a business perspective can offer to two key questions: What are the barriers to change and how can they be overcome? The second chapter examines the role that healthcare professions can play in promoting innovation. What has been their contribution in the past? Where have they been successful, and where have there been shortfalls? What can be contributed to innovation going forward? Finally, what about medical education? Do our current approaches to training doctors promote innovation? What should change? What would promote and encourage innovation in future generations of doctors? In sum, this collection represents a new way of thinking about Canadian innovation. While applauding and fully supporting the scientific and technological advancements in medical devices, pharmaceuticals, information technology, and the uses of technology in patient care, this book examines the over-arching strategies and institutions within which innovations can be supported, up-scaled, and promoted. The Agenda In the next chapter, Lynne Golding explains that to be successful, policy makers and proponents of innovation must have a common understanding, not only of what is meant by “innovation,” but also its obstacles and enablers. From an investor’s point of view, the purposes of the innovation, and its source of financing, must be clear. Innovators and policy makers must know who has the authority to decide whether the innovation will be adopted, who will be accountable for ensuring its success, and how the innovation fits with other public policy objectives. Golding starts with a survey of recent publications, searching for a common definition of innovation. As she no doubt expected, the term is variously applied—to devices, products, models of delivery, processes, and structures. Interestingly, and perhaps disappointingly for those concerned about our healthcare systems, despite the many uses of the word, Golding notes that “not a single publication addressed the topic of governance re-design or system-wide restructuring as a desirable in-

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novation in our healthcare system today.” What, then, are the main purposes of innovation? There are several categories: reduction in healthcare costs, sustainability of the system and improvements in clinical outcomes. But most striking to Golding is the way that healthcare innovation tends to be linked to economic development, especially competitiveness and productivity. Moreover, the innovation decisions, at least in Ontario, are top-down encouragement, but bottom-up innovation, e.g., from the Health Links. Golding notes that while the themes of accountability and integration are frequently articulated as public policy priorities across Canada, few of the publications she surveyed spoke to either. And on who should pay for innovation, Canadians seem firmly of the opinion that it should not be patients. And few publications have much to say about the private sector making investments in the healthcare sector. That said, there is significant conversation about the need for more direct government funding and tax credits to support research, innovator support and commercialization. Canadians, as Golding discovers, are culturally risk-averse. But she wonders whether our government-funded system is conducive to innovation “in an era of media and social media ‘outrage’ over apparent mismanagement, no matter how small the risk, or in an age of ‘gotcha’ politics and of risk mitigation in place of strategic planning?” As she asks, “Can a culture be developed in which health service providers consider not only how to mitigate or eliminate risk, but also how much risk (political, reputational and economic) they are willing to take on in order to innovate? Are they prepared to transfer the risk they are not willing to assume and to pay a price to be relieved of that risk?” While Golding finds little about the role that governance changes could play in supporting innovation, she does question how much gender diversity exists in the health sector’s many boards of directors. She goes on to point to research showing that productivity and innovation increase with diversity. On equally admonishing notes, Golding asks whether innovation is stymied by outdated collective agreements, threatened union political action, and political commitments to maintain the status quo. And is innovation constrained by the nature of the single-payer system, which limits the primary purchasers of innovation, the federal/provincial/territorial governments? In conclusion, Lynne Golding looks back to her starting point: given the wide diversity of patients, providers, and employees in the healthcare system, it is hardly surprising that there are so many uses for the

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term “innovation.” She ends by reiterating the importance to governments and healthcare providers of being clear about what counts as innovation before making significant investments in the hope they will be transformational. “There is much at stake,” she says. In the next chapter, I pick up Golding’s theme by reviewing certain aspects of the governance and strategic implications of the report of the Advisory Panel on Healthcare Innovation, chaired by David Naylor, a former president of the University of Toronto. The Panel was commissioned in 2014 by the Conservative government of Stephen Harper to recommend how the federal government could support healthcare innovation in a way that would slow the growth in healthcare spending while leading to improvements in quality and accessibility of care. After a year of Canada-wide meetings and deliberations, the Panel tabled its report, Unleashing Innovation: Excellent Healthcare for Canada (Naylor et al. 2015). The scale and scope of the recommendations were profoundly transformative. The five promising areas for fiscal and system performance improvement recommended by Naylor and his colleagues were: (1) patient engagement and empowerment, (2) health systems integration with workforce modernization, (3) technological transformation via digital health and precision medicine, (4) better value from procurement, reimbursement, and regulation, and (5) industry as a driver and innovation catalyst. Importantly, the recommendations as a whole hinged on two overarching proposals for the creation of federally led entities: a Healthcare Innovation Fund (HIF) and a Healthcare Innovation Agency of Canada (HIAC). The broad goal of the Fund is to affect sustainable and systematic changes to the delivery of health services; the Agency is to work with governments and stakeholders to set both long-term visions for the healthcare system, and innovation goals across the five key areas. I recommend that the Fund adopt as a part of its investment mandate, the establishment of “strategic alliances” with business. With respect to the Agency, I propose a governance structure based on what I call a “bicameral governance model.” The primary aspirational goals of the HIF are to improve the performance of the healthcare system, to enhance quality and value to Canadians, and to break down barriers to innovation. I focus on the third goal, showing that governments at all levels in Canada have a long history of working with business in mutually beneficial and innovative ways through public private partnerships (P3s). However, P3s

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typically involve financing that the private sector partners arrange, often made possible because of the commercial viability of the project. But there are many instances of hybrid partnerships among corporate and government partners, or in the developing world with respect to infrastructure and services, where the commercial value is less apparent or immanent. The HIF may be approached by entrepreneurs whose projects have public policy value, and a public-sector partner, but are less obviously commercial in the near term. HIF could have an important role in funding these. But I go further by explaining the potential value of strategic alliances between public and private sector entities. Whereas P3s tend to be project-oriented, alliances are more open-ended in terms of initiatives to be explored, and are less constrained by project end-points. Alliances generally have a higher risk appetite, but have a higher return potential, whether commercial or for the public good. The second building block of the Naylor report (2015) is the Agency (HIAC). Naylor and his colleagues faced an important challenge in the governance of this entity because of the overhanging specter of government interference. I suggest that the solution is to create an entity (HIAC) that has its own management and board of directors who are specifically responsible for the ongoing operation of the HIAC, which we might call the “Operating Board.” However, HIAC would be appointed and funded by the federal government, which would have an interest in ensuring its success. It would thus be reasonable for the government to want a governance oversight role for HIAC through a mechanism that we might call a “Policy Council.” If there were two governance bodies—an Operating Board and a Policy Council—how should authority be assigned to each governance body? What is the hierarchy between the two? The Bicameral Governance Model (BGM) keeps both the Operating Board and Policy Council on the same hierarchical level by assigning separate responsibilities to each. The responsibilities are assigned by an “Operating Agreement”—the body of documents that set out the bylaws, regulations, policies, and procedures that provide direction to the HIAC. In addition, the Operating Agreement would specify the policy objectives for HIAC as established by the government. It is the responsibility of the Operating Board to exercise the fiduciary duty expected of all directors and to act within the regulatory framework of the Operating Agreement. It is the corresponding duty of the Policy Council to ensure that the HIAC is being managed and governed in accordance with the Operating Agreement. The Operating Agreement must contain a mechanism for dispute resolution in the

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event that the Operating Board and Policy Council disagree over the proper application of the Operating Agreement’s terms and conditions. Of course, if agreement cannot be reached, and the breach is deemed to be severe and unresolvable, then more extensive remedies must be sought along a continuum from replacing the Operating Board to withdrawal of funding and/or dissolving the HIAC. While I provide a detailed discussion of other features of the BGM and its theoretical underpinnings, it is worth noting specifically the role of stakeholder advice, particularly at the operational level. In short, the Naylor report is a valuable document that introduces a fresh approach to re-engaging the federal government in Canadian healthcare. Most importantly, though, it presents a Canadian system-wide approach to healthcare innovation that is compatible with, and supportive of, the provincial systems. Innovation for Whom? Special Populations Whereas Part 1 looks at the meaning of innovation and the institutional entities that could be created to drive and support a Canadian system-wide innovation policy agenda, Part 2 considers the role and importance of innovative policy for three populations. Alice Aiken, Stéphanie Bélanger, and Julie Birch focus on military veterans, pointing out that the Naylor report did not deal with military personnel. While the Naylor Panel could hardly be faulted for not having sufficient time and space to address the interests every stakeholder group, Aiken et al. are surely correct in saying that veterans must be included in a comprehensive and coherent pan-Canadian healthcare strategy. They explain the role played by the Canadian Institute for Military and Veteran Health Research (CIMVHR), an independent research centre located at Queen’s University, in both promoting research and lobbying for the recognition of veterans and their families by provincial and territorial healthcare systems as a unique population. They argue that more robust data is needed to track veterans and their families, and of course, they make the case for more on-going funding for research for CIMVHR. This is hardly surprising because CIMVHR is a major provider of funds for university research on veterans across Canada and abroad. Since its establishment in 2010, the CIMVHR virtual network has grown to one thousand researchers from forty-two Canadian universities, with seven memorandums of understanding (MOUs) with international universities.

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The need for an entity such as CIMVHR arises from the complexity of military life and its effects on the social determinants of health of military service people and their families. The unlimited liability of participation in wars and critical missions keeps military personnel constantly exposed to injury and loss of life, and it creates work-family conflicts and lasting mental health problems. After service, life also can be emotionally difficult as veterans try to integrate into civilian life and seek employment. Providing for the healthcare needs of veterans requires a centralized focus, because 75 percent of the 650,000 veterans are clients of provincial healthcare services, and research shows that their unique needs are not well understood. To address these needs, CIMVHR has developed a dedicated staff, an active network of universities and multidisciplinary researchers, and funding support from Health Canada, Department of National Defence, Veterans Affairs Canada, The Royal Canadian Legion, Wounded Warriors, True Patriot Love, General Dynamics, and others. As well, CIMVHR has created a journal, Journal of Military, Veteran and Family Health, and supports conferences, collaborative projects (including sponsorship for the Queen’s Health Policy Change Conference Series), and other forms of knowledge diffusion. The second special population considered is frail seniors. It shares with veterans both a lack of any national strategy and a high level of misunderstanding by the healthcare system of the characteristics and needs of this segment of the population. John Muscedere points out that finding new ways to care for frail elderly will produce significant economic benefits to society, improve care for not only the frail but also their caregivers, and spur innovations in care and technologies, which in turn would create opportunities for Canadian competitiveness. The staggering cost to the healthcare system of care for the frail elderly contributes to a compelling case for policy innovation. The United Nations reports that globally over the next thirty years, the population over the age of 65 years will double, those over 85 will quadruple and 100-year-olds will increase ten-fold. While Canadians over the age of 65 years represent about 15 percent of the population, they account for 45 percent of all healthcare costs. The cost of caring for a patient over the age of 90 years is nearly 260 percent higher than a 65-year-old. Given these facts, despite the many calls for a national seniors’ strategy, there is none. Nor indeed is there any comprehensive strategy in any of the provinces or territories, beyond the patchwork of policies focusing on narrower populations such as older individuals requiring long term or

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palliative care. Part of the challenge to establishing an appropriate policy is that age and frailty as a health risk are not the same. Frailty, says Muscedere, is an under-recognized and underappreciated health condition. It is associated with declining health outcomes, increased mortality, decreased quality of life, and rising adverse events. Further, it comes with significantly increased costs and stresses on family and caregivers that vary with the number of chronic conditions and healthcare utilization— something that is not synonymous with age. Failure to distinguish age and frailty can lead to therapy that is ineffective and wastes health resources. Unfortunately, we lack enough research-based evidence. One reason is that most healthcare studies are conducted on those who are neither frail nor elderly. Muscedere provides many examples where properly distinguishing the two groups has led to more successful treatments. The siloed nature of modern Canadian healthcare reflects the historical reality of an age when life expectancy was in the 60s, and acute illnesses, usually associated with single organ dysfunction, was the focus. The awareness of multi-disease illness is still quite low, and care-plans reflect this lack of awareness or misunderstanding. So, policy changes are badly needed. To Muscedere, innovation needs to start with citizen engagement, and there must be more public education. Frailty screening, risk stratification and alternative care pathways, especially those including more care in the home, must be further developed: “Improving the care of the frail elderly will produce significant societal and economic benefits.” Michael Green gives us four inspiring stories of innovative change in First Nations communities. The First Nations Health Authority (FNHA) in British Columbia is an innovative agency that separates the care of patients from the politics of care by creating a governance structure that integrates federal, Aboriginal, and provincial governments as well as communities. The Tui’kn Partnership of Cape Breton, Nova Scotia was launched by the five First Nations communities to create a holistic model of primary care. The Cree Board of Health and Social Services of James Bay (CBHSSJB) in Quebec, servicing 19,000 residents in nine communities, is a mature health system that operates medical centres that deliver medical, dental, home care, and social services. It also operates a hospital, three youth facilities, public health services, and central liaison services to coordinate care outside of their region. The Southcentral Foundation in Alaska is Green’s fourth study. It has

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won international acclaim for its successes in the transformation of healthcare delivery through a model that is locally driven and committed to quality and family wellness, called the Nuka System of Care. It is a customer-owner model (with 60,000 customer-owners) that started in the mid 1980s as a $3 million per year organization, with twenty-five employees. It has since grown to $210 million with 1,500 employees that delivers comprehensive health, dental, mental and behavioural health services, primary care, and hospital care. It has developed rapid access and continuity of care through the use of advanced scheduling tools, telephone, telemedicine, and email. In each of these cases, we learn that despite the perception of herculean challenges, positive new approaches to patient care are possible if the healthcare system is prepared to make room for Indigenous leadership and meaningful engagement of the Indigenous communities and individuals as mutually responsible partners in health and service delivery agencies. Of central importance are locally informed and culturally relevant frameworks of health and wellness. Also required are accurate and timely data to support performance measurement, planning, and accountability. Green reminds us of the Calls to Action in the Truth and Reconciliation Commission’s report (2015, 18–25) for the healthcare sector to recognize Indigenous rights, improve the measurement of outcomes, establishment of clear targets to close identifiable gaps, enhance funding for integrated health and healing centres, engage and recognize the importance of elders and traditional healing practices, improve training for health professionals and prepare them to deliver culturally safe care, address racism, and seek the resolution of jurisdictional disputes as they relate to the funding and delivery of Aboriginal healthcare, and increase the participation of Aboriginal Canadians in the health workforce. What is striking about Green’s case studies is the reoccurrence of themes such as integration, partnership, collaboration, the importance of local/contextual knowledge, and respect for culture and local leadership. In each case, these factors have contributed to innovative solutions to problems. While each situation differs, the principles of innovation seem to be common to all. Management of Innovation To create innovative policy and processes, we need data and informa-

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tion. That is the key message from Sara Allin, Mélanie Josée Davidson, Keith Denny, and David O’Toole. They point out that data and information are critical enablers for innovation in health systems in Canada. Data helps us to identify opportunities by making comparisons and benchmarking possible. Further, in order to scale and spread innovations, we need to establish which ones are effective—this requires data. Equally, data and information enable us to evaluate interventions and to determine which are most likely to yield the greatest impact. Unfortunately, they also explain that there are many sectors where data are not either routinely collected or not made available in a format that promotes quality improvement and health system management. For instance, primary healthcare services represent the most encounters that Canadians have with the healthcare system, yet data recording this is, for the most part, absent from either provincial or pan-Canadian reporting. Similarly, despite our interest in improving the healthcare of vulnerable populations (as discussed above), we lack sound evidence. This is unfortunate because the rise of big data and digitizing of health records is raising expectations among Canadians, and the technologies are certainly creating opportunities, but we are not moving forward quickly enough. We need to be able, not just to capture the data in an electronic format, but also to structure, aggregate, and analyze it. Allin et al. provide insights into the intimate interconnection between innovation and performance improvement, especially with respect to the capacity of the health system to learn from information. They provide extensive accounts of how data can be used for innovation in quality and safety, efficiency, and improving care from the patient’s perspective. But they also highlight the importance of transformational leadership and change management in developing our use of data and information. To be successful, leaders need to create organizational environments that are conducive to the purposive use of performance information, requiring a shift in cultural norms. And sometimes we become so preoccupied with efficiency that we crowd out innovation by trying to eliminate “waste”—even the “good waste” that is part of experimentation. Anne Snowdon and Charles Alessi note that globally the fundamental goals of healthcare systems are quality and safety—key drivers of which are pharmaceuticals, medical devices, and new technologies. However, little progress has been made. Indeed, the Canadian and American systems lag other OECD comparator countries. The problem is inadequate system infrastructure, namely the ability to trace prod-

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ucts, care procedures, or outcomes to an individual patient. They set out the features of healthcare systems and infrastructure strategies that could lead to significant improvements in system performance. What they have in mind is the transformation of manual paper-based systems to strategic high performance digital supply chain systems to achieve cost savings and system sustainability that will lead to strengthening quality and safety. Snowdon and Alessi point to the strategic use of supply chain innovations in industries such as retail, grocery, and pharmaceuticals, showing how these innovations could be applied to healthcare systems, which currently have very limited ability to track any of their key business processes. The imperative for transformation and global supply chain collaboration is to embrace the opportunity for new product designs and innovation for significant cost reduction. They note that the technologies are commercially available, yet not integrated in many Canadian systems, and conclude by reiterating that the biggest impediment for Canadians is not the design of new technologies, but rather “creating the policy frameworks to hold health systems accountable for a strategic supply chain system.” The regulatory framework for health human resources in Canada, Jennifer Medves argues, needs a system-wide approach in the form of a federally regulated system. She suggests that it would promote the triple aim of “better health, better care, better value.” Medves points out that much Canadian regulation is a hold-over from traditional models that focus on protection of patients from harm. Unfortunately, these models have the effect of impeding innovative healthcare programs, place of care, and inter-professional practice. For instance, regulation has been used to give exclusive rights to provide certain care to certain professional groups (i.e., physicians), even if others (i.e., nurses, pharmacists) would be competent to provide that care at a much lower cost. Also, she explains that the structure of Canadian healthcare, in which provinces and territories are responsible for their own delivery systems, creates the unusual situation, compared to systems around the world, of multiple regulatory frameworks governing healthcare professionals even within a single country. A more progressive regulatory approach would be a Canada-wide, competency-based, “right-touch” model. A significant part of the problem, Medves argues, is the “self-regulatory” Canadian approach, which leaves provincial regulatory colleges in control of pre-licensure education, determining competency to

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practice, and dispute investigation. Around the world there has been a shift away from peer-to-peer forms of regulatory frameworks to more centralized government control. Medves is critical of Canada’s rigid and fragmented health workforce policies, and poses five key recommendations, including removing complaints from the regulatory college framework; encouraging “right touch” regulation of professionals; differentiating between colleges that are low risk to patients and those that are high risk; creating national regulatory frameworks to harmonize standards of practice; and encouraging one regulatory college for each profession at the federal level, with provincial/territorial colleges in support. In addition, Medves stresses that innovation in healthcare needs “a nimble, adaptable workforce that can take advantage of changes and expectations of patients”—and that the changes needed in regulation are “revolutionary and disruptive.” Creating Change: Practice, Politics, and Education What needs to be done to create positive change in Canada’s ability to be more innovative in healthcare? Neil Fraser provides a business point of view. Although he notes Canada’s healthcare systems have been allowed to congeal and harden, he is nonetheless optimistic that the decline can be reversed without sacrificing universal access to care. In his view, we have the necessary financial, organizational, and human resources to be able to lead the world again if we could shake free of the deeply entrenched barriers that have evolved over the years and constrained our ability to innovate. Fraser’s recommendations are based on a presumption that we all have the same fundamental objective of value-based health care, combined with fresh thinking and collaboration among government, health professionals, healthcare institutions, and industry. But it is governments who are key to enabling change because only they can remove the structural barriers. Since he was a member of the Naylor Panel, it is not surprising that Fraser would endorse the Naylor report’s recommendations for a new fund to invest $1 billion annually in high impact and scalable initiatives, and an agency to guide and stimulate the national healthcare innovation agenda. Fraser also believes that all provinces should establish a central clearinghouse for innovative ideas, such as Ontario’s Office of the Chief Health Innovation Strategist and that all provinces/territories should shift to strategic value-based procurement by hospitals and healthcare organizations. He suggests that we should adopt a more evidence-based

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approach to health technology assessment and to enable entrepreneurs to recoup their costs over time as an incentive and that funding should be reformed: hospitals should be moved toward activity-based funding and physicians should be transitioned from fee-for-service to bundled payments. Here the federal government could provide catalyzing or matching funding to aid in the transition. Fraser’s most dramatic comments focus on the role of industry. In his view, businesses need to go beyond thinking about simply delivering an innovative product or service. Instead, they should be more deeply involved in the process of delivering a successful patient outcome. He uses a model from the United States for hip or knee replacements as an illustration: since 40 percent of the cost is in post-operative care, the cost to the system and the suffering of the patient could be minimized if the company providing the artificial joint were to manage the patient’s care post-operatively (i.e., infections, pain management, and mobilization) by remote technology. Likewise, he argues that the healthcare sector and industry could work more closely together. With a more value-based approach, a concerted attempt to break down the barriers, and collaborative partnerships between government and business, Canada has the potential to be a leader among our OECD peer countries. Christopher Simpson and Owen Adams examine the role of medical associations in bringing about innovation. The Canadian Medical Association, in partnership with other professional associations, has been promoting innovation in the quality of care for over three decades. But Simpson and Adams also admit that there is still much work to do. They suggest that the medical community could likely make a significant contribution as an advocate for a patient and population outcomes agenda. But because only about half of the provinces have some form of health quality council, there should be a greater focus at the national level. That certainly is in keeping with many of the CMA’s policy positions that stress a pan-Canadian approach. What is striking about the story that Simpson and Adams have to tell is how much extensive collaboration has already taken place. Sometimes the CMA chooses to take supporting roles with partners; at other times, they lead. But changes have not always come as easily or gone as smoothly as they would have liked. While there is much for us to laud in the collaborative work of the CMA, without question the intricacies of the Canadian system create inertia. Previous chapters have pointed out how complex is the Canadian healthcare system (or, more appropriately, its systems), and the barriers to change that are created by this.

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Simpson and Adams demonstrate the urgency of effectively addressing Canada’s problems when they conclude their chapter by commenting on The Commonwealth Fund’s (2017) review of the healthcare systems of eleven comparator OECD countries. Each system is evaluated on five categories: care processes, access, administrative efficiency, equity, and healthcare outcomes. Simpson and Adams observe that Canada ranks no higher than sixth place, and on some we rank ninth or tenth. The Canadian Medical Association, Canadian Nurses Association and other professional associations have been long-standing proponents of pan-Canadian approaches to many aspects of health policy areas. Advocacy is one thing, but what about real change? If we want to climb the ranking ladder in the next Commonwealth Fund survey in a few years, we will need to get moving. Innovation in systems requires empowering the people who work in those systems. Eve Purdy and Richard Reznick examine the role of medical education in innovation. They note that medical schools need to graduate students who have the skills to engage creatively in issues of complexity, and who are prepared and willing to create change—in other words, we must graduate innovators. This is not an easy task, however, since while there have been significant advances in medical science and technology, medical education still looks as it did a century ago. In this chapter, they explore the medical education paradigm, the inertia associated with it, and what successful changes might entail. Purdy and Reznick walk us through the experience of a fictitious young medical student from the medical admissions process to graduation and residency. Purdy and Reznick argue that medical schools should add innovation potential to their admissions criteria; they recommend that medical schools should establish multiple paths for students who may start desiring medical school convinced they want to pursue one specialization only to discover later that want to change to something that better matches with their interests and abilities. They ask whether the undergraduate model of classroom-based pre-clerkship, followed by clinical clerkship, is still the best model. Perhaps making at least some room for autonomy and self-determination would better match the human desire for independence. The most important change, Reznick and Purdy suggest, is developing a culture of creativity. Doctors are not supposed to fail; but innovators do. They note that there is an understandable distaste for failure given the life-and-death consequences of their work, but it can also paralyze progress by creating an apprehensive mindset that tran-

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scends clinical and non-clinical domains. They finish on a positive note: if medical education does become better at cultivating innovators, the future workforce will be better able to handle unforeseen challenges, and engage complexity with confidence. Conclusion This collection of essays is at one level cautionary. It has a lot to say about the barriers to innovation. But on another level, it is positive and optimistic. It does not just treat innovation as a distant aspirational goal. Rather, the book points to what Canadians are capable of doing. Every chapter has concrete recommendations for how to move forward. Importantly, the theme that ties these essays together is a belief that there needs to be more “Canada” in our healthcare system—a greater recognition of unity of purpose and shared opportunity. Canadians need an overall strategic framework for innovation to guide our multiple systems toward common goals and strategic objectives. Other countries are leaving us behind, so we need to get going. These chapters explain what we need to do, and how. References Commonwealth Fund, The. 2017. Mirror, Mirror 2016, http://www. commonwealthfund.org/~/media/files/publications/fund-re port/2017/jul/schneider_mirror_mirror_2017.pdf Naylor, C. David, Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare Innovation. Ottawa: Health Canada. http://www.healthycanadians.gc.ca/ publications/health-system-systeme-sante/report-healthcare-inno vation-rapport-soins/alt/report-healthcare-innovation-rapport-soins-eng.pdf Truth and Reconciliation Commission of Canada: Calls to Action. 2015. Government of Canada, Ottawa.

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Innovation in Canadian Healthcare: What Are We Talking About? Lynne Golding

Innovation in healthcare is a popular topic in Canada. The word is used in the subject lines of thousands of reports, papers, speeches, newspaper articles, conference agendas, and white papers. We have statutes that embed the term in their names: the Alberta Research and Innovation Act, the Innovation Funding Act (Manitoba), Loi sur L’efficacité et L’innovation Énergétiques (Quebec), and the Innovation Corporation Act (Nova Scotia). We have cabinet ministers responsible for innovation, such as, for example, Navdeep Bains, current federal Minister of Innovation, Science and Economic Development. But when we talk about innovation in Canadian healthcare, what are we really talking about? Perhaps as importantly, what are we not talking about? The contention of this chapter is that to create coherent policies on innovation, policy makers and proponents of innovation must have a common understanding of what is to be innovated. To make effective innovation investments, decision makers must understand the purpose of the innovation, how it will be paid for, who will decide on its adoption and how its adoption aligns with other public policy imperatives. Finally, decision makers and policy makers need to understand and consider all obstacles to, and all enablers of, innovation—even those that are difficult to discuss. Accordingly, this chapter looks at how the term “innovation” was used in thirty-six publications relating to the Canadian healthcare system. After a brief discussion of the nature of A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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the publications reviewed, it will consider how broadly innovation was defined across them and what was stated to be the purpose of each innovation. It then considers what each publication said (and did not say) about the following topics, all of which should be relevant to policy makers: • • • • •

Who should make the decision to proceed with the innovation? Who is accountable for the success of the innovation? How will the innovation advance integration? Who will pay for the innovation? What is required to enable the innovation?

The exercise will show which topics related to innovation in healthcare within these thirty-six publications are most readily discussed and which are not. We contend that the failure to discuss some of these topics hampers the ability of policy makers to bring about the change so clearly required. What the Publications Addressed This chapter is based on a review of three dozen publications relating to the Canadian healthcare system, most of which were released in the past five years and each of which was gleaned from a website search of articles on “Canadian healthcare innovation.” The sample includes a variety of forms of publications (beyond scholarly papers) and a variety of authors or sponsoring entities (beyond government reports). The sample seeks to have some representation from across Canada. The word “innovation” appears in the title of each publication. The publications generally fell into three categories. They • proposed or advocated for the adoption of one or more innovations (21); • reported on innovations that had been tried or proposed (10); or • spoke to processes to explore existing or future innovations within the Canadian healthcare system (5). When a publication fell into more than one category, each was categorized based on its apparent primary purpose. Definition of Innovation Six publications included a definition of innovation. The definitions varied in length and meaning. Examples include:

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Innovation is “new or better ways of doing valued things. An ‘invention’ is not an innovation until it has been implemented to a meaningful extent. Innovating is not limited to products, but includes improved processes and new forms of business organization” (Expert Panel on Business Innovation, quoted in Snowdon, Shell, and Leitch 2010, 5). Innovation is “an openness on the part of people to new ways of thinking and doing that bring about improvements, whether to an individual business, an industry, government, the economy or society as a whole” (Government of Ontario 2015, 6). Innovation is “a new method, idea or device” (Collins English Dictionary, quoted in Shroff 2012, 2). Innovation is “something that adds value and provides a significant incremental (or more likely transformative) benefit over the current status quo (or standard of care, in the context of health)” (OBIO, CLEAR, and Innovation Cell 2013, 11). Innovation doesn’t have to be a brand new technology or process. It could be an enhancement of something that already exists” (Miller 2013)

After considering a number of definitions, the federal Advisory Panel on Healthcare Innovation (the Naylor Panel), in its report Unleashing Innovation: Excellent Healthcare for Canada, adopted the following definition: …activities that “generate value in terms of quality and safety of care, administrative efficiency, the patient experience, and patient outcomes.” (Health Canada, quoted in Naylor et al. 2015, 5)

The breadth of activities that fall within the term “innovation” is reflected in all of the definitions. The term is applied to devices, products, methods, processes, and structures. Two definitions specify that the technology, process, etc.—that is, the subject of the innovation—must be new. A third, while saying the opposite, likely means the same (i.e., the technology or process may not be new but the enhancement surely is). Three publications specify that an innovation must create value— although only one indicates that the value must be significant. Overall, the definitions set a fairly low threshold for how much value the change must generate in order to be considered innovative.

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While all improvements must be considered desirable and beneficial to be deemed “innovative,” presumably when policy makers speak of innovation in healthcare—especially when they speak about applying sizable financial resources to bring about those improvements—the change they are seeking is substantive change, meaningful change, transformational change (to use another overused term). But this goal may need to be made more explicit in the way we define innovation. Based on the definitions proffered above, this cannot be assumed. Subject of the Innovation Innovation was not only broadly defined; it was also broadly applied. What is it about the healthcare system that is to be innovated? A large number of publications—eighteen—spoke about innovations involving the application of information technology, particularly IT advancements in clinical service delivery and diagnostics, patient communication (including EMRs), appointment booking, and telemedicine, as well as the general need for the greater adoption of new technologies. Several publications spoke about the need for innovation in our healthcare delivery models and, in particular, innovations around patient-centred care. One publication mentioned the need for changes to the scopes of practice for pharmacists (Kirkey 2014), and another outlined a new care approach for those with chronic disease (Canadian Health Services Research Foundation 2012). Four publications discussed funding reform in the healthcare system: two proposed the end of fee-for-service funding (Frank 2012; Saunders et al. 2013); one referred to the move away from global budgets for hospitals towards activity-based funding (CFHI 2011); and one spoke about providing financial rewards for the achievement of quality and financial benchmarks (Snowdon et al. 2010). One publication stated that the single-payer healthcare system is financially unstable (University of Calgary 2015). Five publications focused on drugs and other life science innovations, including generic supplies, plan coverages, ethical processes, and further research and development in general (Health Care Innovation Working Group 2012; Nikidis 2015; Priest 2012; Sullivan 2015; Williams 2014). The topics discussed in four publications were too broad to be categorized. It may be a sign of the times that not a single publication addressed the topic of governance re-design or system-wide restructuring as a de-

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sirable innovation in our healthcare system today. Likely the subject would have been frequently raised in a similar search for innovation in healthcare conducted a decade or more ago. Whether a province’s regional structure is optimal; whether the number of health regions in a province is the the most efficient and effective; to what extent the government’s authority should be devolved to regional authorities; whether regional authorities should assume the powers of local hospital boards; whether authorities should have responsibility for other determinants of health (social services, for example, as in Quebec)— these would all have been ripe topics for discussions of innovation in healthcare a decade ago. Today, in the publications we sampled, they raise not a peep. It may be that today we do not have the fortitude to move those heavy governance pieces around the chess board that is our health system; the outlay of time, resources, and political will may be considered too great for the innovation that comes of it. But likely some restructuring is desirable, and some is required. Home care is one area that may require systemic innovation. In Ontario, the Ministry of Health and Long-Term Care has recently restructured the manner in which home care services are allocated and delivered. However, the changes (which involved moving the responsibility for the oversight of its delivery from fourteen Community Care Access Centres to fourteen Local Health Integration Networks) may not be sufficiently innovative. As policy makers consider alternative accountable care or hub-based delivery models, some deeper structural changes may have to be considered. Purpose of the Innovation Not all of the publications spoke to the purpose of the innovation, although in many cases the purpose could be inferred. Generally, the stated or inferred purposes fell into one or more of six categories. Seven innovations were proposed for their ability to reduce healthcare costs; eight were proposed for the way in which they would support the sustainability or increased efficiency of the healthcare system or an aspect of it.1 1 These two objectives may be one and the same. It is possible, though, that if innovators spoke more specifically about the limited nature of the cost reductions that would be realized by the adoption of their proposed innovation, greater trust— which is proposed by one publication as a key enabler to innovation—might be created. If an innovation intended to save costs performs the way it is proposed, then

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Eighteen publications identified improvement of clinical outcomes as the purpose of the innovation. Within this category, many spoke about improved outcomes for seniors (CMA 2014) or those with chronic conditions (Canadian Health Services Research Foundation 2012), and one described the potential for improvement of the health and wellness of an entire province (Alberta; Government of Alberta 2015). Eight publications stated that the innovation would improve the healthcare experience for patients or their families, including, specifically in one case, those suffering from dementia (Government of Canada 2015). Interestingly, six publications identified economic development— expressed also as increased competitiveness (Snowdon et al. 2010) or productivity (Kirkey 2014)—as being one of the purposes of the innovation. Who Makes the Innovation Decision? Few publications identified who would ultimately need to make the decision to adopt their innovation. The federal government was referred to most often, but this largely arose due to the number of publications that spoke about the $1.5 billion innovation fund proposed by the Naylor Panel (the Healthcare Innovation Fund; Naylor et al. 2015). One publication suggested (in reference to another innovation fund similar in purpose to the proposed Healthcare Innovation Fund) that funding proposals for healthcare innovation could be assessed through the use of a standard questionnaire and consideration by a diverse panel composed of scientific experts, entrepreneurs, and lay people—essentially an “innovation judging committee” (Priest 2012). Other publications referred to the need for the federal government to make changes in intellectual property laws (CFHI 2011; Williams 2014), to reduce trade barriers (Miller 2013), to refocus the National Research Council (Williams 2014), and to strengthen the Industrial Regional Assistance Program (Williams 2014). In sum, many publications focused on the federal role in creating a more dynamic innovation culture. At the same time, however, various proposals for tax reform, financial grants, changes in procurement laws, and attitudes towards innoit will result in a reduction in some healthcare costs. Unless healthcare funders are prepared to reduce healthcare funding by the amount of those savings, the cost of healthcare as a whole will not be reduced (since the savings will be used to meet one of many otherwise unmet needs). Our system may be no more sustainable. Nonetheless, it may be more efficient.

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vation make it clear that many publications view both federal and provincial governments as needing to have a decisive role in the adoption of innovations (e.g., Conference Board of Canada 2015; O’Hara 2015; Saunders et al. 2013; Sullivan 2015). Two provincial innovation agendas were referred to specifically: Ontario’s (Government of Ontario 2015) and Alberta’s (Government of Alberta 2015). Few publications spoke about how adoption decisions should be made. Some urged different or more effective procurement regimes for those purchasing healthcare innovations—i.e., regimes which would recognize more than just the short-term objective of lowest price (Conference Board of Canada 2015; Naylor et al. 2015; O’Hara 2015). Similarly, few publications addressed the differences between topdown innovation and bottom-up innovation, although Pitts (2015) spoke about innovation that could be realized on a day-to-day basis by doctors, nurses, “tech savants,” and administrators with an eye to the big picture. Increasingly, we see top-down efforts aimed at encouraging bottom-up innovation. For example, Ontario’s Health Links, launched in December 2012, were designed to improve the health of seniors and others with complex conditions by coordinating the care often received from multiple physicians, pharmacists, and other health service providers. Organizations were invited to submit plans on how they would meet those goals for a select number of patients within their catchment area. Initially twenty-six early adopter organizations were selected to proceed with modest amounts of funding. Eventually the number was increased to eighty-two. Each Health Link operated according to its own approved plan, with some having better success than others. With a better understanding now of which programs worked well, Ontario is beginning to standardize the programs under the nomenclature of “Advanced Health Links” (Ontario Ministry of Health and Long-Term Care 2016). Adopting a bottom-up or “fail cheap, fail early” process—as one publication advocates (Snowdon, Shell, and Leitch 2010)—seems to hold promise for encouraging innovation. Accountability and Integration Accountability and integration are frequently referred to as public policy priorities in the Canadian healthcare system, but few of the publications spoke to either. Addressing accountability would seem to require an articulation of what the innovation would accomplish, not only in

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generalities (i.e., saving money, improvement in patient experiences), but also in terms of specific measurable outcomes. Accountability would generally require identification of the objective of the innovation, the method by which the performance of the innovation would be measured, the numeric or other measurable goal that would indicate success, and the consequences of failure. None of the publications addressed all four aspects, although some spoke to at least one aspect: • One publication implied that the failure of a health service provider to meet stated benchmarks would result in a reduction or elimination of government funding (Snowdon et al. 2010); another suggested that savings realized against benchmarks would be reinvested in the service area that realized them (Frank 2012). • The Health Care Innovation Working Group (2012), under the leadership of then Saskatchewan Premier Brad Wall and former Prince Edward Island Premier Robert Ghiz, proposed the CASH reporting system adopted by the former NHS Institute for Innovation and Improvement. That system looks at five areas to determine the success of an innovation: completion; adoption/ awareness activities; spread (uptake of the innovation); impact (measured through evaluation based on the established objectives); and lessons learned. • One publication set a measurable objective with respect to its healthcare system performance goal: to bring Canada into the top five performing healthcare systems (HealthCareCAN 2016). • Another publication, the sponsor of which provided funding to an institute for healthcare innovation, identified criteria against which the program would be assessed five years later, including commercialization success, promotion and dissemination of knowledge, and training and development of future leaders in healthcare (Innovation, Science and Economic Development Canada 2014). • In evaluating an innovation, Canada Health Infoway suggested that success would be measured through the establishment of targets and performance indicators, including those related to use, solution quality, user adoption, and outcomes (Canada Health Infoway 2010). • In two publications promoting changes in physician compensation, the inference was clear: medical providers will not get paid unless they engage in healthcare team treatment programs and

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perform to benchmarks (Frank 2012; Saunders et al. 2013). • Ontario stated that it is developing an innovation scorecard that will focus on measuring investment impacts including, for example, wealth created per person and distribution of prosperity, the global share of knowledge-based firms, firm births and deaths, investment and public support for innovation, education and immigration, and trade balance for knowledge-based firms (Government of Ontario 2015). Even fewer publications addressed integration, another public policy objective in healthcare, although it is clear that some of the innovations require integration to succeed; for example, publications that dealt with the creation of electronic health records (e.g., Canada Health Infoway 2010) and with physician teams (e.g., Frank 2012). The publications that discussed innovations in chronic disease management contemplated better integration of ambulatory and community care providers (Canadian Health Services Research Foundation 2012), or, in one case, more integration among medical practitioner teams (Health Care Innovation Working Group 2012). The Naylor Panel considered many examples of projects involving integrated approaches. For example, it suggested implementing and developing projects involving bundled payments and shared financial incentives for hospitals, physicians, and community providers; delivery arrangements to address social needs and determinants of health, to protect and promote health, and to prevent disease; and optimizing scopes of practice among professionals in the healthcare sector (Naylor et al. 2015). Who Pays? Other than government publications that indicated innovations would be paid for out of tax dollars and publications discussing federal or provincial innovation funds, many publications were not forthcoming about how an innovation agenda would be paid for. One publication spoke to the amounts required to sustain drug coverage for employees being paid by employers (Sullivan 2015). One spoke to the use of federal and provincial infrastructure funds (Canadian Health Services Research Foundation 2012). Another spoke to the federal government assuming the costs of Phase 3 clinical trials (CFHI 2011). It can be inferred from at least four of the publications that the proponents concluded the innovation would pay for itself: that is, the savings to be realized by the adoption of the innovation would more than com-

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pensate for the cost of its adoption (Frank 2012; HIMSS 2015; Kirkey 2014; Snowdon et al. 2010). However, to the extent those innovations might require large, upfront investments to be made, there was little indication as to how our cash-strapped health service providers would obtain those initial funds. Few publications dealt with private sector “investment” in the healthcare sector—for example, arrangements in which the private sector pays the upfront costs of adoption, including the initial capital and operating costs (e.g., equipment, systems, or the construction and fitout of standalone ambulatory clinics), and then shares in the savings to be realized over time. See further discussion on this topic of risk transfer under “Changes in Culture” below. None of the publications spoke about patients paying any part of the cost of innovation, even though it may be perfectly legal for some fees to be charged under provincial health insurance laws, through block fees, or otherwise—such as the 1995 Professional Standard regarding Block Billing issued by the College of Physicians and Surgeons of Nova Scotia. This was true even in discussions about innovations aimed at “simply” improving the patient experience (booking appointments online; improved communication, etc.). None of the publications spoke about patients paying for medically necessary services more generally, and some absolutely reject the notion; this is presumably what is intended by Alex Drossos when he states that “the system can innovate without profit as the overriding priority” (as quoted in Pitts 2015). Presumably the publication that suggested that the single-payer system is not sustainable contemplated some degree of private pay (University of Calgary 2015), also discussed below under the “Single-Payer System.” Enablers of Innovation Many publications identified a number of enablers to overcome obstacles to innovation in the Canadian healthcare system. Research, Tax Credits, Federal Payments Eleven publications spoke to the need for greater research and funds to increase commercialization and adoption of innovations. Most of them supported the creation of federal or provincial innovation funds. Two publications spoke to the need for changes in intellectual property laws to advance innovation (CFHI 2011; Williams 2014). Some referred to tax

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credits and the reduction of trade barriers as methods to incentivize innovation (Miller 2013; Sullivan 2015). One publication proposed that the federal government assume the costs of Phase 3 clinical trials (CFHI 2011). Another spoke to potential changes to federally funded regional assistance programs and research councils (Williams 2014). Procurement Three studies (Conference Board of Canada 2015; O’Hara 2015; Saunders et al. 2013) discussed alternative procurement practices aimed at advancing innovation. It was argued that these innovative procurement practices will lead to greater innovation in the healthcare system. In comparing the Canadian system to the Swiss system, one publication noted that Canada has yet to recognize procurement as a tool for injecting innovation into the healthcare system (Saunders et al. 2013). Changes in Culture A number of publications spoke to the need for culture change as a means to encourage innovation. Measures referred to include those that would result in increased trust between government payers and providers of human health technology (OBIO, CLEAR, and Innovation Cell 2013), the application of ethical standards (Nikidis 2015), and the development of greater competition within the healthcare system (CFHI 2011). Two of these proposed innovations related to the pharmaceutical industry in particular. One suggested that entrepreneurs need to improve their marketing skills in order to provide better evidence and explain the improvements that would be derived from their proposed innovations (Pitts 2015). Three publications spoke to the risk-averse nature of Canadians or the healthcare system (Pitts 2015; Saunders et al. 2013; Snowdon et al. 2010). One publication spoke of the need to inculcate a culture of risk taking (Snowdon et al. 2010). Recognizing that we cannot innovate if we are not prepared to take risks, the publication promoted micro-innovations—small investments, commenced early, tested early—as a means to take responsible risk. The theory is that if the innovation is not going to be successful, it is best to identify that early and after a minimal investment has been made (fail early; fail cheap). This proposition begs this question, however: how much risk—and, by extension, how much innovation—can be taken in a healthcare system funded almost entirely by government?

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Is it possible for our government-funded healthcare system to take the risks that will lead to innovation in an era of media and social media “outrage” over apparent mismanagement, no matter how small the risk, or in an age of “gotcha” politics and of risk mitigation in place of strategic planning? Can a culture be developed in which health service providers consider not only how to mitigate or eliminate risk, but also how much risk (political, reputational, and economic) they are willing to take on in order to innovate? Are they prepared to transfer the risk they are not willing to assume and to pay a price to be relieved of that risk? Private sector entities are often more willing to take on the risks associated with innovation—for a price, of course. Acceding to such an arrangement is in itself an innovation. Can the sector embrace the notion that learning and improvement comes even from failure—that so long as the investment is limited, even a failure of an innovation can be a success? Regulatory Change A small number of publications spoke to the need for regulatory change to enable their proposed innovation. At least seven types of regulatory changes were identified: • increase regulatory harmonization (e.g., harmonize drug approval requirements with the U.S. Food and Drug Administration and European Medicines Agency; harmonize privacy legislation among the federal government and the provinces; Naylor et al. 2015); • optimize scopes of practice of health professionals (Kirkey 2014; Naylor et al. 2015); • change physician payment regimes (Frank 2012); • change patent laws (particularly in relation to length of patent terms; CFHI 2011; Williams 2014); • change procurement directives/laws (Conference Board of Canada 2015; O’Hara 2015; Saunders et al. 2013); • change health insurance laws to move away from the single-payer system (Arcus Consulting, n.d.); and • eliminate trade barriers (Miller 2013). Governance None of the publications discussed the potential for changes in the way

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our health system providers are governed as a means of encouraging innovation. Canada’s labour force, including those working in our healthcare system, is incredibly diverse. But how diverse is the board of directors of each health service provider? How diverse is its management team? Studies have shown that diversity is critical for an organization’s ability to innovate. For example, Hewlett, Marshall, and Sherbin’s 2013 article “How Diversity Can Drive Innovation” shows that companies with professionals who exhibit three inherent diversity traits (traits an individual was born with) and three acquired diversity traits (traits gained through experience) out-innovate and out-perform others. Rizy, Feil, Sniderman, and Egan’s (n.d.) report “Global Diversity and Inclusion: Fostering Innovation Through a Diverse Workforce,” based on oneon-one interviews with executives with direct responsibility for their company’s diversity and inclusion programs, found that diversity is a key driver of innovation and is a critical component of being successful on a global scale. Katherine W. Phillips’s (2014) “How Diversity Makes Us Smarter” demonstrated that building innovative teams or organizations requires diversity. For example, one of the mentioned studies was conducted by business professors Cristian Deszö of the University of Maryland and David Ross of Columbia University, who found that companies that prioritized innovation resulted in greater financial gains when women were part of top management. A number of initiatives are now in place to increase the representation of women on Canadian boards,2 but to truly innovate we will need 2 See, for example, the CSA Final Amendments to National Instrument—Disclosure of Corporate Governance Practices, OSC NI 58-101 (31 December 2014), which applies to TSX-listed and non-venture issuers. It mandates “Comply or Explain Disclosure Requirements” regarding quotas for women. See online at http://www.osc.gov.on.ca/en/ SecuritiesLaw_csa_20150928_58-307_staff-review-women-boards.htm. Also see the 2014 report of the Advisory Council for Promoting Women on Boards, delivered to the federal minister of labour and the minister of status of women, “Good for Business: A Plan to Promote the Participation of More Women on Canadian Boards.” Further, the Canada Bill 207 (S-207), An Act to modernize the composition of the boards of directors of certain corporations, financial institutions and parent Crown corporations, and in particular to ensure the balanced representation of women and men on those boards, was introduced on 8 December 2015 and was at second reading in the Senate until it was dropped from the Senate order paper on 25 October 2016. It should be noted that similar versions of this Act were introduced in 2011, 2013, and 2014, with little success. See: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8063360&File=19 and http://www.parl.gc.ca/LegisInfo/BillDetails.aspx-

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diversity of all sorts—demographic and experiential—throughout our boards and management teams. For another study on the effects of diversity on innovation, consider innovation-focused banks, where increases in racial diversity were clearly related to enhanced financial performance (Phillips 2014). Similarly, Walter in a 2014 article concluded that diversity is critical for an organization’s ability to innovate and adapt in a fast-changing environment. Diversity is essential to growth and prosperity of any company: diversity of perspectives, experiences, cultures, genders, and age. Why? Because diversity breeds innovation. And innovation breeds business success (Walter 2014). Labour and Human Resources None of the publications identified changes to Canada’s labour laws or government policies towards organized labour as being necessary or desirable enablers to greater innovation. Yet how often has innovation been stymied by outdated collective agreements, threatened union political action, and political commitments to maintain the status quo? Don’t we need to know? Don’t we need to consider how we can protect the legitimate interests of both the system’s healthcare employees and its patients? The status quo may not be the answer. Similarly, few publications identified the need for changes in compensation regimes for non-physicians as being an enabler of innovation. Query though whether the restraints on salaries and other compensation (including intellectual property rights) in the broader public sector are preventing the healthcare system from hiring and maintaining those best able to innovate and motivate those best able to create innovation.3 ?Language=E&Mode=1&billId=8063359. Finally, diversity on Canadian boards is addressed by proposed amendments in House of Commons of Canada Bill C-25, An Act to amend the Canada Business Corporations Act, the Canada Cooperatives Act, the Canada Not-for-profit Corporations Act and the Competition Act. If enacted, Bill C-25 will require certain federally incorporated corporations to provide shareholders with information regarding the diversity of directors and senior management and the diversity policies in place at the corporation. Bill C-25 has passed through the House of Commons and has passed second reading in the Senate. See: http://www.parl.ca/DocumentViewer/en/42-1/bill/C-25/third-reading and http://www. parl.ca/LegisInfo/BillDetails.aspx?Language=en&Mode=1&billId= 3 For example, for a number of years, the Ontario government has restrained executive compensation and performance pay in the broader public sector. The most recent iteration is the Broader Public Sector Executive Compensation Act (Ontario), which

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One publication suggested that financially rewarding compensation could overcome some current disincentives to innovation on the part of clinicians (Saunders et al. 2013). Single-Payer System Among the enablers of innovation, changes to our single-payer healthcare system were only hinted at (Arcus Consulting, n.d.; University of Calgary 2015). Is it possible to truly innovate our healthcare system as long as there are only fourteen primary purchasers of healthcare in Canada (ten provinces, three territories and the federal government); as long as the majority of our physicians have a single source of payment for the medically necessary services they perform; and as long as our hospitals and health systems receive nearly all of their operating revenue from the increasingly constrained resources of the government? Are there enough opportunities for innovators with system-wide solutions to command the attention of the small number of system-wide purchasers, or practice-specific solutions to find a practice with the means to purchase it? Do these limitations account for the great number of Canadian innovators who find their success outside of Canada? These are difficult questions that need to be considered. In its terms of reference, the Naylor Panel was charged with making recommendations to increase innovation in the Canadian healthcare system. The committee was given free rein subject to three caveats: (1) to respect the division of powers in the Canadian Constitution; (2) to fall within the existing parameters of the Canada Health Act; and (3) to avoid having its recommendations “result in increasing spending pressure on provincial and territorial budgets” or “imply either an increase or a decrease in the overall level of federal funding for current initiatives supporting innovation in healthcare” (Naylor et al. 2015, vii–viii). The committee was unable to comply with all caveats. It chose to disregard the third. Among others in its lengthy list of recommendations was the creation of the $1.5 billion national Healthcare Innovation Fund referred to above. It is understandable that the members of the Naylor Panel did not feel they could breach more than one condition. Some changes could nonetheless be made to our single-payer system for medically necescreates a concept of “executive frameworks” to restrain executive compensation, using a complex methodology. British Columbia also has policies to freeze or limit public sector compensation.

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sary procedures without violating the Canada Health Act, if the provincial governments were willing to ease restrictions, particularly in the realm of physician billing.4 This is not to suggest that a discussion of these matters at a provincial level would be an easy one. Conclusion A review of thirty-six publications showed the wide spectrum of topics discussed under the umbrella term “innovation” in healthcare in Canada. Given the breadth of the Canadian healthcare system—the numbers of its patients, service providers, and employees; its systems, processes, and physical structures; the technology used within it; the drugs administered and devices utilized; the professionals working within it—it is not surprising that the breadth of proposed innovations is similarly great. But, to be transformational, discussions about innovation also need to be specific. Before a government or a health service provider makes a significant investment in an innovation, the questions posed in this chapter need to be answered. There is much to discuss. There is much at stake. Note I would like to thank Kathryn Beck, Rosario Cartagena, Vanessa Mui, and Valerie Eisen for their assistance. References Part A—36 publications taken from Google searches on healthcare innovation in Canada Arcus Consulting Group. n.d. “Healthcare Innovation.” http://arcus group.ca/industries/healthcare-and-life-sciences/healthcare-inno vation/ Canada Health Infoway. 2010, 13 July. “Health Information Technology: Innovation to Improve Health Care Quality, Access and Availability.” Digital Canada 150. Government of Canada. https://www.ic.gc.ca/ eic/site/028.nsf/eng/00293.html 4 See “First, Do No Harm: How the Canada Health Act Obstructs Reform and Innovation” (Clemens and Esmail 2012). This is not to say that the Canada Health Act does not contain any constraints on private payment; its prohibitions on co-payments and extra-billing are clear limitations.

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Canadian Foundation for Healthcare Improvement (CFHI). 2011, 18 February. “Healthcare Innovation and Pharmaceutical Expenditures—Event.” http://www.cfhi-fcass.ca/NewsAndEvents/Events/ Event/11-02-10/e54943b9-8af7-48ac-ba2d-1941a1e2bddf.aspx Canadian Health Services Research Foundation. 2012, 15 February. “CEO Forum 2012—Driving Innovation: Reinventing Ambulatory and Community Care.” http://www.cfhi-fcass.ca/sf-docs/ default-source/ceo-forum-files/CEO-Forum-2012-Report-E.pdf?s fvrsn=0 Canadian Medical Association (CMA). 2014, 8 December. “Submission to Advisory Panel on Healthcare Innovation.” https://www.cma. ca/Assets/assets-library/document/en/advocacy/submissions/ CMA-Submission-Adv-Panel-on-HC-Innovation.pdf Chai, C. 2013. “5 Canadian Innovations That Could Change the Face of Global Health Care.” Global News, 21 November. http://global news.ca/news/982164/5-canadian-innovations-that-could-changethe-face-of-global-health-care/ Church, Elizabeth. 2015. “‘Zombie Report’ on Health-Care Innovation in Canada Gets New Life.” The Globe & Mail, 24 July. http://www. theglobeandmail.com/news/national/zombie-report-on-healthcare-innovation-in-canada-gets-new-life/article25657040/ Conference Board of Canada. 2015. “Opportunities for Improving Canada’s Health Care Systems: Strategic Procurement and Innovation— Conference Agenda.” 20–21 May, http://www.conferenceboard.ca/ Libraries/CONF_PDFS_PUBLIC/15-0096.sflb Folker, G. 2015. “Will Disruptive Technologies Lead to Healthcare Innovation?” ITAC Health. Healthcare Information Management and Communications Canada, 23 December. http://www.healthcareimc. com/main/will-disruptive-technologies-lead-to-healthcare-innova tion/ Frank, C. 2012. “Are Canada’s Premiers Serious About Innovation in Public Health Care?” University of Manitoba. http://umanitoba.ca/ outreach/evidencenetwork/archives/4513 Government of Alberta. 2015. “Alberta & 3M Canada Partner to Create New Opportunities for Healthcare Innovation, Diversification.” http://www.alberta.ca/release.cfm?xID=3871272FD278801C4-9B14-C97D00C9807DFBF5 Government of Canada. 2015. “Government of Canada Supports Innovative Healthcare Solutions Including a Focus on Dementia.” http:// news.gc.ca/web/article-en.do?nid=935699

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Government of Ontario. 2015. “Seizing Global Opportunities: Ontario’s Innovation Agenda.” https://www.ontario.ca/page/seizing-glob al-opportunities-ontarios-innovation-agenda Grant, K. 2015. “Health-Care Innovation Needs Politically Neutral Body, Panel Says.” The Globe and Mail, 17 July. http://www.theglobeand mail.com/news/national/health-care-innovation-needs-political ly-neutral-body-panel-says/article25568158/ Health Care Innovation Working Group. 2012. From Innovation to Action: The First Report of the Health Care Innovation Working Group. http://www.pmprovincesterritoires.ca/phocadownload/publica tions/health_innovation_report-e-web.pdf Healthcare Information and Management Systems Society (HIMSS). 2015. “National Healthcare Innovation Summit—Conference Agenda,” 15–17 June. http://www.healthcareinnovationsummit.org/ agenda.html HealthCareCAN. 2016. “Driving Innovation in Healthcare: An Engine for Economic Growth and Prosperity.” http://www.healthcare can.ca/wp-content/uploads/2015/09/HealthCareCAN-Pre-bud get-2016__FINAL.pdf Innovation, Science and Economic Development Canada. 2014. Evaluation of Industry Canada’s Contribution to the Ivey International Centre for Health Innovation. https://www.ic.gc.ca/eic/site/ae-ve. nsf/eng/03666.html Kirkey, S. 2014. “Innovation—Not More Dollars—The Cure for Canada’s Health-Care System’s Woes: Pharmaceutical Executive.” The National Post, 23 December. http://news.nationalpost.com/news/canada/ innovation-not-more-dollars-the-cure-for-canadas-health-care-sys tems-woes-pharmaceutical-executive Kirkup, K. 2015. “Federal Health Care Innovation Panel Finds Canada’s Medicare System Aging Badly.” Toronto Sun, 17 July. http://www. torontosun.com/2015/07/17/federal-health-care-innovation-pan el-finds-canadas-medicare-system-aging-badly McGill University Health Centre. 2014. “Conference Program—Institute for Strategic Analysis and Innovation,” 2–3 October. Canadian Foundation for Healthcare Improvement. http://www.cfhi-fcass. ca/sf-docs/default-source/documents/health_innovation_forum_ 2014_agenda_en.pdf?sfvrsn=2 Mendelsohn, Matthew. 2002. “Canadians’ Thoughts on Their Health Care System: Preserving the Canadian Model Through Innovation.” Commission on the Future of Health Care in Canada. Kingston:

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Queen’s University. http://www.queensu.ca/cora/_files/Mendel sohnEnglish.pdf Miller, A. 2013. “Healthcare and Innovation.” The Conference Board of Canada. http://www.conferenceboard.ca/commentaries/healthin novation/default/13-02-26/healthcare_and_innovation.aspx Naylor, C. David, Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare Innovation. Ottawa: Health Canada. http://www.healthycanadians.gc.ca/ publications/health-system-systeme-sante/report-healthcare-inno vation-rapport-soins/alt/report-healthcare-innovation-rapport-so ins-eng.pdf Nikidis, C. 2015. “Actions Based on Values: The Innovative Pharmaceutical Sector’s Path to Integrity.” Canadian Politics and Public Policy Magazine (September–October). http://policymagazine.ca/ pdf/15/PolicyMagazineSeptemberOctober-2015-WebReadyV2.pdf O’Hara, T. 2015. “Canada’s Healthcare Innovation Challenge.” HealthPRO Canada. http://portal.healthprocanada.com/documents /10180/412442/HPRO_InnovationFeature_FINALOCT2015.pdf Ontario Bioscience Innovation Organization (OBIO), Centre for Excellence in Economic Analysis Research (CLEAR), and Innovation Cell. 2013. Realizing the Promise of Healthcare Innovation in Ontario. http://static1.squarespace.com/static/55bbf3f3e4b08b36 22073685/t/562e7048e4b0f32b8b9e28ca/1445883976191/Innovation +Adoption+Report+for+Distribution.pdf Picard, André. 2013. “New Health Minister Says Public Health Care Must Innovate to Be Sustainable.” The Globe and Mail, 19 August. http://www.theglobeandmail.com/news/politics/ambrose-pro motes-health-innovation-at-cma-conference/article13840108/ Pitts, G. 2015. “Innovate or Decline: How Canada’s Healthcare System Needs to Change.” DeGroote School of Business, McMaster University. http://www.degroote.mcmaster.ca/articles/innovate-declinecanadas-healthcare-system-need-change/ Priest, L. 2012. “The Dragon’s Den of Health Care: Who Decides Which Innovations Get Funded?” The Globe and Mail, 14 May. http://www. theglobeandmail.com/news/national/the-dragons-den-of-healthcare-who-decides-which-innovations-get-funded/article2432798/ Research Money Inc., 2015. “New $1-Billion Healthcare Agency Would Help Unleash Innovation: Report.” HealthCareCAN. http://www. healthcarecan.ca/wp-content/uploads/2015/08/New-1-billion-

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healthcare-agency-would-help-unleash-innovation-Report-Vol-2912. pdf Saunders, C., J. Conly, W. Ghali, B. Baylis, D. Pittet, C. Ebell, G. Prada, et al. 2013. “Improving Canada’s Position in Healthcare Innovation: Learning from the Swiss Experience.” Working paper. W21C.org, International Innovation Forum. http://w21c.org/images/uploads/ documentation/W21C_International_Innovation_Forum_Paper_-_ Final_-_June_24.pdf Shroff, F. M. 2012. “Innovation and Transformation in Health Systems—A Primer for the BC Health Authorities’ Leadership Council.” Institute for Health System Transformation & Sustainability. http:// ihsts.ca/wp-content/uploads/2014/03/Health-System-Innovations -and-Transformations.pdf Snowdon, A., J. Shell, and K. K. Leitch. 2010. “Innovation Takes Leadership: Opportunities & Challenges for Canada’s Health Care System.” Centre for Health Innovation and Leadership, Richard Ivey School of Business. http://sites.ivey.ca/healthinnovation/files/2010/09/ White-Paper.pdf Sullivan, M. 2015. “Can an Innovative Tax Credit System Sustain Drug Plan Coverage in Canada?” Canadian Politics and Public Policy Magazine (September–October). http://policymagazine.ca/pdf/15/Pol icyMagazineSeptemberOctober-2015-WebReadyV2.pdf University of Calgary. 2015. “Symposium to Explore Ways to Unleash Health-Care Innovation in Canada.” UToday, 26 October. https:// www.ucalgary.ca/utoday/issue/2015-10-26/symposium-exploreways-unleash-health-care-innovation-canada Williams, R. 2014. “Canadians Have a Bright Future in Innovative Healthcare.” Huff Post Politics Canada, 14 May. http://www.huffing tonpost.ca/russell-williams/canada-healthcare_b_5323144.html Part B—Other sources referenced Advisory Council for Promoting Women on Boards. 2014. “Good for Business: A Plan to Promote the Participation of More Women on Canadian Boards.” http://www.swc-cfc.gc.ca/initiatives/wldp/wbca/wob-fca-eng.html Broader Public Sector Accountability Act. S. O. 2010. c. 25. Ottawa ON: Minister of Justice, Government of Canada. https://www.ontario. ca/laws/statute/10b25 Broader Public Sector Executive Compensation Act. S. O. 2014. c. 13. Ot-

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tawa, ON: Minister of Justice. https://www.ontario.ca/laws/statute /14b13 Canada Bill (S-207). 2015. An Act to modernize the composition of the boards of directors of certain corporations, financial institutions and parent Crown corporations, and in particular to ensure the balanced representation of women and men on those boards. 1st Sess., 42nd Parliament. Ottawa, ON: Minister of Justice. http://www.parl.gc.ca/ LegisInfo/BillDetails.aspx?Language=E&Mode=1&billId=8063359 Canadian Securities Administrators (CSA). 2015. Final Amendments to Disclosure of Corporate Governance Practices, OSC NI 58–101. 31 December 2014. Ottawa, ON: Minister of Justice, Government of Canada. http://www.osc.gov.on.ca/en/SecuritiesLaw_csa_20150928_58307_staff-review-women-boards.htm Clemens, J., and N. Esmail. 2012. “First, Do No Harm: How the Canada Health Act Obstructs Reform and Innovation.” Macdonald-Laurier Institute. http://www.macdonaldlaurier.ca/files/pdf/How-the-Cana da-Health-Act-Obstructs-Reform-and-Innovation-June-2012.pdf College of Physicians and Surgeons of Nova Scotia. 1995. “Professional Standard Regarding Block Billing.” https://www.cpsns.ns. ca/DesktopModules/Bring2mind/DMX/Download.aspx?Portal Id=0&TabId=129&EntryId=5 Expert Panel on Business Innovation. 2009. Innovation and Business Strategy: Why Canada Falls Short. Ottawa: Council of Canadian Academies. http://www.scienceadvice.ca/uploads/eng/assess ments%20and%20publications%20and%20news%20releases/inno/ (2009-06-11)%20innovation%20report.pdf Hewlett, S. A., M. Marshall, and L. Sherbin. 2013. “How Diversity Can Drive Innovation.” Harvard Business Review (December). https://hbr. org/2013/12/how-diversity-can-drive-innovation Ontario Ministry of Health and Long-Term Care. 2016. “Transforming Ontario’s Health Care System: Community Health Links Provide Coordinated, Efficient and Effective Care to Patients with Complex Needs. http://www.health.gov.on.ca/en/pro/programs/transfor mation/community.aspx Phillips, K. W. 2014. “How Diversity Makes Us Smarter.” Scientific American (1 October). http://www.scientificamerican.com/article/ how-diversity-makes-us-smarter/ Rizy, C., S. Feil, B. Sniderman, and M. E. Egan. n.d. “Global Diversity and Inclusion: Fostering Innovation Through a Diverse Workforce.” Forbes Insights. http://images.forbes.com/forbesinsights/

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StudyPDFs/Innovation_Through_Diversity.pdf Walter, E. 2014. “Reaping the Benefits of Diversity for Modern Business Innovation.” Forbes, 14 January. http://www.forbes.com/ sites/ekaterinawalter/2014/01/14/reaping-the-benefits-of-diversi ty-for-modern-business-innovation/#7720ab826476

3

Reflections on the Naylor Report 2015: Fund, Agency, and Governance A. Scott Carson

In June 2014, Rona Ambrose, the Canadian minister of health, commissioned the Advisory Panel on Healthcare Innovation, which was tasked with finding the five most promising areas of innovation. The hope was that the Panel would identify ways to slow the growth in healthcare spending and to lead to improvements in quality and accessibility of care. The Panel was then asked to address how the federal government could support innovation in each area. In July 2015, after a year of Canada-wide meetings and deliberations, the Panel, led by Dr. David Naylor, a former president of the University of Toronto, tabled Unleashing Innovation: Excellent Healthcare for Canada (Naylor et al. 2015). The Naylor report is pan-Canadian in scope, significant in its scale of initiatives, and bold in its recommended leadership role for the federal government in Canadian healthcare innovation. The five promising areas for fiscal and system performance improvement are (1) patient engagement and empowerment, (2) health systems integration with workforce modernization, (3) technological transformation via digital health and precision medicine, (4) better value from procurement, reimbursement and regulation, and (5) industry as a driver and innovation catalyst. The report proposed forty-three main recommendations and several other minor recommendations. Importantly, the recommendations as a whole are dependent upon two overarching proposals for the creation of federally led entities: a Healthcare Innovation Fund (HIF) A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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and a Healthcare Innovation Agency of Canada (HIAC). The broad goal of the Fund is to affect sustainable and systematic changes to the delivery of health services; the Agency is to work with governments and stakeholders to set both long-term visions for the healthcare system, and innovation goals across the five key areas. While the Fund and Agency are two powerful ideas, the report provides only conceptual sketches. Beyond the broad rationale and goals, much remains to be explained about how the Fund would establish and pursue its priorities and how the Agency should be governed. Thus in this chapter, I propose to extend the idea of the Fund in one of its suggested directions by exploring the Fund’s possible relationship to one of the priority themes, industry as a driver and an innovation catalyst. I show how the Fund could support strategic alliances between government and business and why this would be a catalyst for significant innovation. Next, I address the governance aspect of the Agency by suggesting a “bicameral governance model” that, among other things, could address the perennial problem of enabling governments to meet their accountability obligations without meddling in the operational strategies and decisions of the Agency. Environmental Conditions The Fund and Agency are two structural building blocks on which the proposed healthcare innovation program is constructed. This program arises not just from the current Canadian healthcare environment, but from what is expected to come in the future due to dynamic forces of change in the environment. The Naylor report pays considerable attention to the fiscal unsustainability of our healthcare system (our multiple federal/provincial/territorial systems). For instance, the report notes that the Canadian system is very costly compared to peer-group countries when measured both on a per capita basis and as a percentage of GDP (Canadian Institute for Health Information [CIHI] 2015). The Canadian system also has a mediocre peer-group performance record in terms of quality, access, efficiencies, equity, and healthy lives (Davis et al. 2014; also discussed in Carson 2015 and Drummond 2015). Further, Canadians are aging, especially in the Atlantic region, giving rise to the need for new models of provider-care, home care, and a shift in institutional focus from acute to chronic illness and injury (Canadian Medical Association [CMA] 2013). Finally, patients are demanding more from their healthcare system: greater participation in their own

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care; a responsive system focused on their needs rather than on provider and system manager preferences; system integration; and efficiency, especially in the form of better communication and reduced wait times. What Naylor and his colleagues learned is that innovation—management systems, diagnostic technologies, medical devices, and precision medicine—is crucial to the solution of these problems. But creative new ways of doing things will not be enough. They must be scaled-up so they have application across the country, rather than being limited to regions or institutions as exists today. At present, there are pockets of innovation across Canada, but they do not have sufficient scale to make a system-wide difference. However, innovation and scalability require funding to get them up and running. So the report proposes a major federally financed Fund for this purpose. Finally, the current federally supported initiatives in healthcare, such as Canada Health Infoway and the Canadian Foundation for Health Improvement, are significant to be sure. However, something needs to bring them together with the Fund. A central Agency could play this role. I proceed now to a discussion of the newly proposed Fund and Agency. The Naylor report says: “the Panel heard persistent calls from stakeholders across the country for a national strategy along with concrete action to support and accelerate innovation in Canada’s healthcare systems through creation of a catalytic fund.” Building on this, the report goes on to say that a “protected source of capital that dedicates funds toward innovation is not only desirable but essential to sustain momentum for change across jurisdictions” (Naylor et al. 2015, 39). In keeping with these statements, the Naylor report describes a fund (the HIF) that would have three main aspirational goals: improving performance of healthcare systems, enhancing quality and value to Canadians, and breaking down barriers to innovation. To meet these challenges, the HIF should be a strategic long-term investor in high impact initiatives and incent both adoption and scalability of innovations. More specifically, with an initial term of ten years, the HIF would promote development, testing, and evaluating new models of care, and identify its projects in collaboration with governments, patients, providers, and industry. The report makes it clear that the HIF is not intended to support academic research, because that is the role of the Canadian Institutes of Health Research (CIHR). The purpose of the Fund is to make investments, not provide grants. And it is to focus on promoting changes to the healthcare system, not on conducting basic research. As such, differ-

46 A. Scott Carson

ent skill-sets are required to manage the Fund than would be present in a granting agency such as the CIHR. Further, the HIF’s funding source is the federal government—in the amount of $1 billion per annum when fully operational. Importantly, the report indicated that this had to be new money, not a redirection of federal health transfers. Finally, while the report acknowledged that it was inevitable that cost-sharing with the provinces and territories would be needed to enhance the capacity of the HIF, it argued that this should not lead to a rigid formula-based funding program. The Naylor report provides a foundation for the HIF that needs yet to be fleshed out in detail. Table 3.1 provides a summary. While the report gives us a starting point for creating a fully developed Canadian healthcare innovation strategy, we need to establish specific, concrete, and measurable strategies following each strategic objective. In turn, for each strategy, we must identify the measures of success. Based on these measures, targets should then be developed for the planning period. Next, activities/tactics needed to execute the strategies should be identified. Following this would be the establishment of a process for assessing the outputs of our activities in relation to the strategic outcomes they were intended to achieve. Finally, the processes of learning from successes and failures would need to be established in order to move productively forward. In the next section, I build on one of the HIF’s themes: industry as an economic driver and innovation catalyst. The expected focus of the Fund would be on lending and investment opportunities with entrepreneurs, but I want to suggest a further type of funding opportunity. It involves promoting a specific form of public private partnership, namely the strategic alliance. Alliances can be a powerful vehicle for innovation, but they sometimes require funding that would not otherwise be available from commercial sources. This could be a role for the HIF. Let us start by describing an organizational form on which an alliance can be built, namely a public private partnership. Partnerships, Alliances, and the Healthcare Innovation Fund Public Private Partnerships A public private partnership (P3) is a joint venture among partners, one of which is a government, either directly through a ministry, agency, or controlled entity, and at least one is a private sector partner. Each contributes to the establishment of the partnership; usually the gov-

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Table 3.1 Healthcare Innovation Fund Summary Aspirational Goals

Themes

Strategic Objectives

Improve performance of the healthcare system

Patient engagement and empowerment

Long-term stra- Transparent tegic investment specification of goals

Enhance quality and value to Canadians

Health system integration

High impact innovation

Break down barriers to innovation

Technology transformation in precision medicine and digital healthcare

Promotion of Milestones with development, measurable testing and eval- outputs uation of new models of care

Better value from procurement, reimbursement and regulation

Collaboration with governments, patients and industry

Industry as economic driver and innovation catalyst

Operating Principles

Rigorous adjudication

Creation of economic and social value Sustainability of initiatives Commitment of stakeholders to continue to sustain initiatives Public assessment and reporting

Source: Author’s compilation.

ernment entity takes the lead in determining the fundamental goals of the relationship, which reflect its public policy objectives. In Canadian healthcare, a common form of P3 is a hospital infrastructure project. Typically, the government (or health ministry) engages a partner, or partners, to design, finance, build, operate, or maintain a hospital. Looked at from the point of risk appetite, a P3 allows a government and its business partners to allocate between them the risks associated with a project, based on which of the partners is best able to identify, assess, and manage particular risks. From the standpoint of innovation oppor-

48 A. Scott Carson

tunities, the government sets the public policy context for the project, and the private sector brings financing, resource capacity, and expertise. See Table 3.2 for a summary of how the functions are allocated to the private sector in current Canadian hospital P3 projects. How the partnership is structured depends in part on the strengths of the potential private sector partner(s). The key is to determine which partner has the best combination of resources in the functional areas required by the project in terms of financing, resource capacity, and expertise. In virtually all current Canadian healthcare P3s, the private sector arranges financing: project financing is usually provided by banks, and take-out financing is provided through long-term bank loans or private placements with pension funds or other institutional investors. The private sector can find creative ways of combining different forms of financing, which can bring value to the overall project. The government partner benefits because it avoids adding debt to the provincial balance sheet, and it keeps financial resources free for program and other forms of priority spending. The second resource category is operational capacity. Projects and other joint undertakings have non-financial resource requirements: human resources, technology, plant and equipment, business processes, and so on. Even limitations on time availability can be a capacity constraint. In some cases, a government partner may not possess the needed resources, or even if they do have the resources, the government may need to deploy them elsewhere. Consequently, partnering with the private sector can offer a ready solution to capacity issues. Third, a private partner may be able to contribute resources in the form of various types of expertise. This could come from its unique experience in executing tasks required for the project to be successful, or it could involve proprietary technologies or business processes that are valuable to the project, not readily available elsewhere and for which there are few viable substitutes. What, then, is the role for the Healthcare Innovation Fund? If the P3 model typically involves financing arranged by the private sector, then where is the funding capacity of the HIF needed? The answer is that financing is only available in P3s where the commercial opportunities are sufficient to compensate the private partners for the risks they are taking. Commercial attractiveness is not always evident in early stage projects. Let us look at two variants of the P3 that could be important to healthcare innovation, but that would not necessarily be able to raise commercial financing.

1

British Columbia

5

Quebec 1 35

Northwest Territories

Totals

3

1

1

1

DesignBuildFinanceOperate

5

1

4

DesignBuildFinance

3

3

BuildFinanceMaintain

31

31

BuildFinance

Source: Reproduced from Carson (2016a).

Note: As of June 2015, the numbers include projects at the stages of proposal, construction, or recent completion.

2

New Brunswick 7

16

1

Ontario 3

2

11

DesignBuildFinanceMaintain

Saskatchewan

Alberta

Design-BuildFinanceMaintainOperate

Models/ Provinces

Public Private Partnership Hospital Projects in Canada

Table 3.2

84

Totals

Reflections on the Naylor Report 2015: Fund, Agency, and Governance 49

50 A. Scott Carson

Hybrid Partnerships, Strategic Alliances, and the Healthcare Innovation Fund There is much that Canadians can learn and apply to healthcare innovation from organizational structures elsewhere in the world. For instance, there are derivative forms of P3 emerging from social movements in Europe and in developing countries that are not fundamentally commercial yet engage the private sector (Carson 2016b). For instance, a public social private partnership (PSPP) focuses on social services, such as helping the poor obtain housing or access to transportation, rather than infrastructure. But a PSPP depends upon private sector resources and expertise. It differs from the conventional P3 because it is usually driven by social enterprises or community groups. Similarly, a public private community partnership (PPCP) is commonly used for water and sanitation projects in developing countries such as India. The PPCP also builds on the P3 model of shared risk allocation and expertise, but includes community or municipal government participation. Both models are pertinent for our discussion about the HIF because each presents stakeholder-based opportunities for healthcare innovation, yet both face the problem of having to secure financing. Often the projects do not present commercially viable opportunities, at least in their nascent periods. If we were to consider adapting similar models to Canadian healthcare, the HIF could play a crucially important funding role. We would need to be convinced on a case by case basis that each partnership project demonstrated innovation potential—but this, after all, is precisely what the Naylor report prescribes for all funding opportunities coming to the HIF. Another option is a strategic alliance, which is a form of joint venture partnership. It is different than a P3 because it is more open-ended. A P3 is usually formed to complete a project, so it has a scheduled start and projected end date. The P3 begins when the partners enter into a contractual relationship with defined roles and responsibilities; it ends when the project or subsequent contract is finished. However, an alliance may start with a contractual relationship, but it does not depend upon the completion of a project to define the end of its life. For example, Star Alliance is the largest global airline alliance with twenty-seven members, and has been operating for nearly thirty years. A further point about alliances is that they have a purpose in going beyond existing projects (Carson 2015). They come together in order to explore new processes, technologies, or products that may not yet have

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been identified. That is, they seek opportunities for the future that are in pursuit of broader strategic goals (Doz and Hamel 1998). By way of illustration, General Electric’s healthcare unit and M+W Group created an alliance to overcome a lack of key pharmaceuticals in emerging nations. The alliance produces biopharmaceuticals such as vaccines, insulin, and biosimilars for those nations. GE’s major partnership contribution is technical expertise, and M+W contributes its global engineering, construction, and project management capability (GE Healthcare 2011). With P3s, resource capacity is the strength that businesses can bring to the government partner. However, strategic alliances have resources and more. Potentially, an alliance can bring opportunities for growth because of its longer-term orientation. Innovation is, after all, a strength of the private sector. Without being constrained by a contractually defined timeline and limited roles, there is an opportunity for institutional learning to develop as alliance partners come to understand each other’s perspectives and strengths, and to develop a working relationship based on mutual respect and trust. This is what can generate innovative solutions to long-term problems, and bring about growth. In this way, the resource capacity of the P3 can be combined with the growth capability of the strategic alliance. Herein lies an important role for the Healthcare Innovation Fund. Long-term strategic alliances that have innovation as their fundamental purpose could have a longer timeline and higher appetite for risk than would otherwise meet near term commercial thresholds. Funding support from the HIF could make these ventures feasible. In addition, this opens opportunities for participation by small entrepreneurs who on their own might not have access to investment capital. Rather than leaving those entrepreneurs to incubate their own, including them in an alliance with with strong partners, along with adequate HIF startup funding, could give them the kind of support of which disruptive innovations are made. In conclusion, there would be an opportunity for the HIF to support alliances with the private sector that would have the capacity to innovate, but where the venture’s outcomes would fall outside of either the payback time horizons or financial risk-appetites of the business partners. However, with appropriate HIF funding, these opportunities could become attractive to business and advance the public policy objectives of government.

52 A. Scott Carson

Healthcare Innovation Agency of Canada: Scope and Scale The second major foundational block on which the report’s recommendations are built is the proposed Healthcare Innovation Agency of Canada (HIAC). It is conceived as being pan-Canadian, and so would be broad in scope. It certainly would not be the only pan-Canadian entity. For instance, the Canadian Institute for Health Information (CIHI) and the Canadian Agency for Drugs and Technologies in Health (CADTH) both reflect federal/provincial/territorial funding partnerships and have shared multistakeholder governance that includes representation from provincial/territorial governments and the healthcare industry, academic, and business communities. Other entities, such as Canada Health Infoway (Infoway), Canadian Partnership Against Cancer (CPAC) and Canadian Patient Safety Institute (CPSI) are federally funded but have similar broadly representative governance structures. The mission of the HIAC would be to support on-the-ground efforts to enhance quality and system performance. To achieve this, the Agency’s main strategic objectives would be to establish a long-term vision for the healthcare system and innovation goals, and to improve Canada’s standing internationally on key metrics of system performance. HIAC would advance this through the twin goals of removing structural barriers to innovation, and spreading and scaling-up proven models and modalities of care. Importantly, the Agency would not only have a breadth of scope, but also, because of its $1 billion per annum funding base, it would have scale. In establishing the new HIAC, it would be important to avoid creating yet another piece of pan-Canadian administrative machinery. So, HIAC would consolidate and absorb, through an orderly wind-down, the functions of the CFHI and the CPSI. Canada Health Infoway would continue to complete its current mandate as a separate entity, or at least until HIF and HIAC are established, then fold its activities promoting e-health into the new entities. As well, the Agency would work closely with First Nations and with other pan-Canadian health agencies, including the academic granting agency, the Canadian Institute for Health Research, with which it would align priorities. The Healthcare Innovation Agency of Canada would be staffed so that it had resident expertise in the management of spreading and scaling innovation, quality improvement and patient safety, health data analytics, and digital health. To reflect the need for developing a culture of partnership with stakeholders, the staffing configuration would be

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multi-nodal so that staff could be located close to their partners and projects. As for the senior leadership of HIAC, recruitment would be internationally conducted to ensure the highest levels of expertise. International recruitment would also challenge the risk-averse ethos that is so dominant in Canada. The necessary legal structure for HIAC could be formed as a hybrid organization, somewhere between a federal government agency—at arm’s-length from the minister, but still under the administrative arm of the government—and a not-for-profit corporation with the federal government as the main funder. As the Naylor report explains, the agency model would bring the advantage of accountability, important given the substantial budget, but would suffer the perception of being too close to the federal government, yet too distant from the provinces and territories. The not-for-profit model would be more operationally nimble and make it easier to connect with stakeholder partners, but also subject to inter-jurisdictional politics around priorities and funding allocations. So, a structure that could capture the advantages of both while escaping some of the problems would be sought. The governance of this agency would be designed to ensure a standalone entity with independent oversight. Its board should be composed of eminent Canadians and, ideally, should include some international members. The board must be independent, well qualified, and non-partisan. In support, there would be one or more advisory committees with stakeholder representation that would include patients, providers, industry representatives, and provincial/territorial governments. A Bicameral Governance Model (BGM) The fundamental challenge for Naylor and his colleagues was to overcome the politicization of governance decision making on the one hand while recognizing the legitimate duty of governments to be accountable for the expenditure of public funds on the other. They were right to be concerned, and they were certainly not the first to address this issue. In 2002, the Romanow Commission’s report on The Future of Health Care in Canada and the Kirby Senate Standing Committee report on The Health of Canadians both recommended the creation of a system-wide, or national, independent body that would provide analysis, advice, and oversight to the system. Romanow recommended that the Health Council of Canada help achieve “an effective national health care system” (Romanow 2002, 54), by establishing common performance indi-

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cators and benchmarks, advising governments, and issuing public reports providing independent evaluations. It was to be an independent body “to drive reform and speed up the modernization of the health care system by ‘de-politicizing’ and streamlining some aspects of the existing intergovernmental process” (Romanow 2002, 55). However, in reality, the Council that later came into existence had little authority to make change or require compliance from the provinces and territories. Kirby proposed a similar standalone entity. During its hearings, the Senate committee received numerous recommendations for a depoliticized arm’s-length model. But in the end Kirby backed down: “The Committee agrees with the many witnesses who stressed the importance of taking measures to ‘depoliticize’ the management of the health care system. However, the Committee feels that this will be a long-term process, and that it is important to begin with the evaluation function only” (Kirby 2002, 1.3). Instead, the Kirby report opted for an advisory body, which resulted in a much weaker model without management or governance responsibility. Will the Naylor report recommendations suffer the same fate as others? In what follows, I propose a model that could meet the objectives of the HIAC.1 The Agency, Fund, and the BGM The governance structure for a Canadian system-wide innovation strategy must accommodate two basic needs. The first need is for a governance entity for the HIAC that can operate independently of government and be substantially free of political intervention in its normal course of business operations. The second is to enable government partners (federal, provincial, and territorial) not only to play their governing roles of establishing public policy in healthcare, but also to meet their accountability requirements to their respective electorates. A single entity is unlikely to be able to accommodate both. So, the HIAC should structure two governance bodies to accomplish the two separate sets of responsibilities. The key question remains: how to differentiate their mandates and, then, how to link them together? Let us begin by accepting the recommendation that the board of directors should comprise distinguished and well-qualified members, and that as a board they should be operationally independent from governments. For the purposes of the BGM, call this the Operating 1

This follows very closely the model presented in Carson (2015).

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Board. But since governments need to assure themselves that their policy mandate and public accountability for taxpayer’s money are discharged, the question becomes: Where does the political oversight reside? In the BGM, it is located in a parallel governance body, which we will call the Policy Council. The two parallel governance bodies in the model connect with each other through the Operating Agreement, which the Policy Council creates. Figure 3.1 sets out schematically the relationship between these components of the BGM. It is important to note that in the BGM, to reiterate the point above, the two governance bodies are on the same level. That is, the Policy Council is not structured as a supra oversight entity. Its role is different from the Operating Board, the mandate of which is contained in the Operating Agreement, which sets out how the governance bodies work with each other. Operating Board. The fundamental role of the Operating Board would be similar to that of a board of directors. A board of directors acts on behalf of a firm’s shareholders/stakeholders. The board is generally responsible for hiring the CEO and supervising his or her performance,

Figure 3.1 Bicameral Governance Model

Source: Author’s compilation.

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approving the organization’s strategic plan, approving operating and capital budgets, ensuring appropriate communication of financial and operating results, and overseeing the operation of the entity in accordance with its mission, vison, values, and strategy. These duties are grounded on a rich regulatory regime that includes applicable laws and regulations, by-laws, and board policies. Each board member must meet his or her fiduciary duty to act honestly, in good faith, and with the best interests of the organization in mind; each must also act in accordance with his or her duty of care, that is, with diligence and the skill that a reasonably prudent person would use in similar circumstances. These duties are the subject of much best practice discussion in the governance literature as well as in professional discussions (see, for example, Hansell 2003). Moreover, these duties are set out for the private sector in the Canada Business Corporations Act (1985, sec. 122) and for the not-for-profit sector in the Canada Notfor-profit Corporations Act (2009, sec. 148). The language stating the fiduciary duties is substantially the same in both Acts. What is important for our discussion of the HIAC is that the duty of loyalty requires that each director act in the best interest of the corporation. It is not their responsibility to act for, or in accordance with, the dictators of their nominating or sponsoring organization. As Hansell (2003, 111) notes: The courts have been very clear that the fact of a director having been nominated to the board by a particular person does not entitle that director to prefer the interests of that person to the interests of the corporation. A director must be first and foremost concerned with the interests of the corporation.

Herein lies the perennial problem of mixed private and public sector boards, which are often populated by government officials, bureaucrats, or appointed representatives. Usually, they are expected to promote the interests of their respective nominating governments, agencies, etc. This creates a conflict of interest between their perceived duty to their government nominators and to the organization to which they are legally obligated to serve. This makes the fiduciary duty of loyalty difficult, if not impossible, to achieve. To overcome this problem, the BGM entails the establishment of a board that can meet its fiduciary duties, not simply because of the personal eminence and competence of each director, but also by virtue of the separation of its operating processes and procedures from the nom-

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inee governments. The Operating Agreement creates this separation. Operating Agreement. The BGM is dependent upon an Operating Agreement that mediates between the authorities of the two main governance bodies, namely the Board and Policy Council. The latter will be outlined below. The Agreement is a master accord that can be composed of a collection of separate agreements. Its function is to contain substantially all of the high level policy mandates needed to guide the board. It would be subject to the legal regulatory framework mentioned above, and would include the statements of purpose of the organization, such as the charter or legal mandate; and it could include the bylaws specifically related to the appointment of directors, frequency of meetings, reporting requirements, and other fundamental operational directives. The Operating Agreement would be established by the Policy Council, so it would need to contain within its master structure the terms and conditions under which the partner governments would come together and exercise their own authorities. But, fundamentally, the Operating Agreement must function as a buffer between the Operating Board and the Policy Council.2 Policy Council. The composition of the Policy Council would be determined by the governments who partner with the Healthcare Innovation Agency of Canada. The members of the Policy Council could comprise elected officials, bureaucrats, or nominees. Their roles would be to establish cooperatively the Operating Agreement, and to ensure on a continuing basis that the Board of Directors is acting in accordance with the terms of the Agreement. They would not be permitted to reach over the Operating Agreement into the decision making of the Operating Board. The remedies for addressing disagreements among the Policy Council members, or disagreements between any member of the Policy Council and the Operating Board, would need to be addressed within the Operating Agreement. If the Operating Agreement is to function as an effective buffer, it must be designed to keep the Policy Council out of operating governance oversight. The Policy Council would have some influence on, though not control over, the Operating Board, insofar as it could either appoint, or rat2 The Canadian Blood Service has a governance structure that is similar to the BGM (Sher 2015), except that its two governance bodies are not on an equal footing with a comprehensive operating agreement to establish the relationship between them.

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ify the appointment of, each director of the inaugural Operating Board. Once appointed, however, the Operating Board members would act independently from their nominators. The appointment or reappointment of directors thereafter could be a task given to the Operating Board itself, which would act in accordance with a process outlined in the Operating Agreement. To maintain some Policy Council influence, the process could require the Policy Council to ratify the new appointments, not by choosing or denying the candidate, but rather by satisfying itself that the process of appointment as set out in the Operating Agreement had been followed. How then would the Policy Council deal with major disagreements that it might have with decisions made by the Operating Board? There would need to be a dispute resolution mechanism contained in the Operating Agreement that would make it difficult for the Policy Council to reach into the jurisdiction of the Operating Board. Ultimately, though, the Policy Council would not be able to meet its own accountability role if it had no means to intervene. To enable this, the dispute resolution mechanism should focus on removing directors (potentially the whole board if the issues are egregious enough) rather than altering decisions. To conclude, it is important to recognize that two different political and business theories and traditions are at work in the BGM. The Operating Board is a product of corporate governance: it is enshrined in law and decades of research and best practices. Its fiduciary duty of loyalty requires each director to be committed solely to the interests of the organization of which he or she is a director, not to another organization or person. By contrast, the Policy Council comes out of a political theory and tradition of representation: duty and commitment to others. Both governance traditions share a duty of care necessitating performing with diligence and skill, but they are fundamentally different in terms of loyalty. Because of this, it would be difficult to imagine that the governance of HIAC would function well if the two traditions were pressed together. The BGM incorporates both traditions. It is a key feature of this model that the Policy Council is not placed hierarchically above the Operating Board. The two governance bodies are on the same level, each with its own role. The Operating Agreement mediates their relationship to each other: it is both an enabler of each governance role and a buffer to prevent one from interfering with the other.

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Stakeholder Advisory Panel. The report discusses the importance of Stakeholder Advisory Panels as a way of encouraging collaboration with both the HIA and HIAC. The involvement of multiple stakeholders, including patients, professional associations, and business, is very important to these entities’ success. And there are many places within institutions in which there can be varying forms of participation, from consultation to decision making. However, in a governance framework, the appropriate role is an advisory one. Where stakeholders can be most effective is in providing advice at the operational level. This is compatible with what was envisioned by the report. Figure 3.2 shows where advisory panels could be positioned. Figure 3.2 Stakeholder Advisory Roles

Source: Author’s compilation.

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Much contemporary research supports the valuable knowledge inputs to decision making that can result from public engagement at different levels in the healthcare system. Where that input is best placed in the design of the new HIF and HIAC is not something that can be addressed here, other than to say that the principal driver should be effectiveness. Conclusion The report of the Advisory Panel on Healthcare Innovation is a valuable document because it introduces a fresh and new approach to re-engaging the federal government with Canadian healthcare through the creation of the Healthcare Innovation Fund and the Healthcare Innovation Agency of Canada. These new vehicles can be nation building without diminishing provincial/territorial authorities. Indeed, they would encourage and support innovation at all levels. The Fund and Agency could seek out ways of taking innovative ideas from wherever they germinate and boosting their scale and scope for the good of all Canadians. In this chapter, I have focused on the Naylor report’s proposals for a Healthcare Innovation Fund and a Healthcare Innovation Agency of Canada. I would recommend that the new HIF look carefully at including, among its funding opportunities, provision of support for those public private partnerships and strategic alliances that have strong potential for creating scalable healthcare products and services. And with respect to the Naylor Panel’s desire to establish a governance structure for the HIAC that is well qualified and independent, I have proposed a bicameral governance model, which I believe would best meet the Panel’s governance objectives. References Canada Business Corporations Act. R.S.C. 1985. c. C-44. Ottawa ON: Minister of Justice, Government of Canada. http://laws-lois.justice.gc. ca/PDF/C-44.pdf Canadian Institute for Health Information (CIHI). 2015. National Health Expenditure Trends 1975 to 2015. https://www.cihi.ca/sites/default/files/ document/nhex_trends_narrative_report_2015_en.pdf Canada Not-for-profit Corporations Act. S.C. 2009. c. 23. Ottawa ON: Minister of Justice, http://laws.justice.gc.ca/PDF/C-7.75.pdf Canadian Medical Association (CMA). 2013, December. Health and

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Health Care for an Aging Population. https://www.cma.ca/Assets/assets-li brary/document/en/advocacy/policy-research/CMA_Policy_Health_and_ Health_Care_for_an_Aging-Population_PD14-03-e.pdf Carson, A. Scott. 2015. “Why Canadians Need a System-Wide Healthcare Strategy.” In Toward a Healthcare Strategy for Canadians, edited by A. Scott Carson, Jeffrey Dixon, and Kim Richard Nossal, 11–37. Montréal and Kingston: McGill-Queen’s University Press. Carson, A. Scott. 2016a. “The Role of the Private Sector in Canadian Healthcare: Accountability, Strategic Alliances and Governance.” In Managing a Canadian Healthcare Strategy, edited by A. Scott Carson, Jeffrey Dixon, and Kim Richard Nossal, 155–81. Montréal and Kingston: McGill-Queen’s University Press. Carson, A. Scott. 2016b. “Public Private Partnerships.” In Encyclopedia of Business Ethics and Society, 2nd ed., edited by Robert. Kolb. Thousand Oaks CA: Sage Publications, forthcoming 2018. Davis, Karen, Kristof Stremikis, David Squires, and Cathy Schoen. 2014. Mirror Mirror on the Wall: How the Performance of the U.S. Health Care System Compares Internationally. Washington DC: The Commonwealth Fund. http://www.commonwealthfund.org/~/media/files/publica tions/fund-report/2014/jun/1755_davis_mirror_mirror_2014.pdf Doz, Yves. L., and Gary Hamel. 1998. Alliance Advantage: The Art of Creating Value Through Partnering. Boston MA: Harvard Business Press. Drummond, Don. 2015. “Health Policy Reform in Canada: Bridging Policy and Politics.” In Toward a Healthcare Strategy for Canadians, edited by A. Scott Carson, Jeffrey Dixon, and Kim Richard Nossal, 239–54. Montréal and Kingston: McGill-Queen’s University Press. GE Healthcare. 2011. “GE Healthcare and M+W Group Form Strategic Alliance in Vaccines, Insulin and Biopharmaceuticals.” 13 December. http://www3.gehealthcare.com/en/news_center/press_kits/ge_healthcare_ and_mw_group_strategic_alliance Hansell, Carol. 2003. What Directors Need to Know: Corporate Governance. Toronto, ON: Carswell. Kirby, Michael. 2002. The Health of Canadians—The Federal Role. Vol. 6, Recommendations for Reform. Final Report of the Standing Senate Committee on Social Affairs, Science and Technology. Ottawa: Government of Canada. http://www.parl.gc.ca/content/sen/committee/372/ soci/rep/repoct02vol6-e.htm Naylor, C. David., Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare

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Innovation. Ottawa: Health Canada. http://www.healthycanadians. gc.ca/publications/health-system-systeme-sante/report-healthcare-innova tion-rapport-soins/alt/report-healthcare-innovation-rapport-soins-eng.pdf Romanow, Roy. 2002. Building on Values: The Future of Health Care in Canada—Final Report. Commission on the Future of Health Care in Canada. Ottawa: Government of Canada. http://publications.gc.ca/col lections/Collection/CP32-85-2002E.pdf Sher, Graham. D. 2015. “Canadian Blood Services as an Example of a Canadian Healthcare Strategy”. In Toward a Healthcare Strategy for Canadians, edited by A. Scott Carson, Jeffrey Dixon, and Kim Richard Nossal, 39-62. Montréal and Kingston: McGill-Queen’s University Press.

Part 2

Innovation for Whom? Special Populations

4

Influencing Health Policy and Programming for Military and Veterans Alice B. Aiken, Stéphanie A. H. Bélanger, and Julie Burch

The report of the Advisory Panel on Healthcare Innovation barely mentions military or veteran health: “Regarding federal healthcare, we did not comment specifically on active military personnel and veterans” (Naylor et al. 2015, vii). This is a gap that needs to be filled with innovative approaches to the health of military veterans and their families (MVF), and federal policies in support. Until such time as the MVF population is included in a strategy for government action to reform healthcare in Canada, the Canadian Institute for Military and Veteran Health Research (CIMVHR) will continue to lobby for favourable conditions for reform, such that • the Tri-Council funding agencies recognizes military, veterans, and their families as a unique population; • Canadian military personnel, veterans, and their families are recognized within provincial and territorial healthcare systems as a unique population; • robust data-sharing infrastructure is developed to start tracking our veterans, and our military and veteran families more easily across time, locations, and sources; and • on-going funding is committed to this academic institute dedicated to the health needs of military personnel, veterans, and their families. A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

66 Alice B. Aiken, Stéphanie A. H. Bélanger, and Julie Burch

CIMVHR was established in late 2010 to fill a void. Canada stood alone among major military allies in not having an academic institute dedicated to the health needs of military personnel, veterans, and their families. Concerned Canadian stakeholders were determined to build a pan-Canadian research enterprise dedicated to understanding the significance and complexity of the unique physical, mental, and social contexts of military service that distinguish MVF from the general population. There is good reason for developing this research enterprise. Globally, military forces are considered a population with specific life experiences that impact military personnel, veterans, and their families’ health and well-being. The social determinants of the health of this population are influenced during service, including the unlimited liability they assume in defence of their country, participation in wars and critical missions, exposure to loss and death, work-family conflicts, and the lack of personal freedom. Life after service is also impacted, and challenges include the lasting mental and physical health effects of service, seeking new employment opportunities, and re-integrating into civilian society. Providing them with the specific healthcare they need—and deserve—requires a centralized focus. Because of this, it is important for Canada to establish a policy approach to addressing the issues faced by MVF. This must begin with recognition that they are a special population. While in service, Canada’s 60,000 regularly serving members, and 25,000 reservists on full time service,1 receive comprehensive, firstrate healthcare provided through the federal system for the Canadian Armed Forces (CAF). However, civilian healthcare is the responsibility of the provinces where the unique needs of veterans (approximately 710,000 Canadian Veterans and 185,000 Veterans of other countries’ people, of which only about 20 percent are Veterans Affairs clients), their families, and reservists are not well understood. Rather than enjoying continuity of care, members of military families find themselves on new wait lists with each move, with limited ability to engage in routine health maintenance with a regular health provider. 1 Reservists can be employed on one of three classes of service: Class “A”, Class “B” or Class “C” Reserve Service. Their entitlement to care (including mental health care) is based on their class of Reserve Service and whether their injury or illness is related to service.

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Many Canadian military families travel back to their physician from their previous posting because they have been unsuccessful in securing one in their current residence. If members of the family have special medical needs or disabilities, navigating new healthcare systems can be onerous and frustrating, with eligibility and reimbursement policies causing considerable stress. This can be complicated if civilian healthcare providers have “limited understanding of the particularities of military life, which can also impact care quality and continuity” (Cramm et al. 2016). CIMVHR’s mission is to optimize the health and well-being of Canadian military personnel, veterans, and their families by harnessing and mobilizing the national capacity for high-impact research, knowledge creation, and knowledge exchange. To fulfill this mission, we understood that a number of factors must be in place. First and foremost, we needed to have an active network established to ensure that stakeholders could contribute to the process. It also required a dedicated staff and a knowledge translation budget to ensure that the network is able to communicate, meet regularly, and synthesize the most current evidence with relevant and timely policies, practices, and programs. Finally, in order to stimulate the formation and maintenance of long-term collaborative MVF health research relationships (for meaningful and innovative collaborative research projects to be supported beyond the conception stage), robust funding mechanisms were required. The first steps in the process of creating a national institute for Military and Veteran Health Research were taken in November 2010. With support from Queen’s University and Royal Military College of Canada (RMCC), a delegation of 250 researchers, clinicians, and others interested in military and veteran health research, from across Canada and beyond, gathered in Kingston to share their research. At the close of this first forum, a select group of academic, military, and government advisers held the first official meeting of the Canadian Institute for Military and Veteran Health Research (CIMVHR). What followed this gathering was swift and impressive. Within a year, twenty-six universities had joined the CIMVHR network. Participation in the second forum swelled to 400. Fully $5 million in directed research requests was operationalized through Public Works and Government Services Canada (PWGSW) to serve the needs of the Canadian Forces Health Services Group, Veterans Affairs Canada (VAC), and Defence Research and Development Canada (DRDC).

68 Alice B. Aiken, Stéphanie A. H. Bélanger, and Julie Burch

Since 2010, the four-member CIMVHR Implementation Committee has evolved into a 10-member board of directors. Working at arm’s length from the government, CIMVHR is further supported by an Advisory Council that includes the grand president of the Royal Canadian Legion, the surgeon general, the assistant deputy minister of policy from Veterans Affairs, as well as a Technical Advisory Committee of eleven members from relevant government stakeholder groups. CIMVHR works with, but at arm’s length from, the government. Being multidisciplinary in nature, CIMVHR continues to broaden its expertise in health research with a college of reviewers composed of over fifty researchers representing our member universities and government affiliates. This allows the diffusion of high impact and high quality research that is second to none. In 2015, CIMVHR secured vital support from Health Canada to foster partnership and collaborations and to bolster knowledge translation activities. This was matched by research funds from the True Patriot Love Foundation that will have far-reaching impacts in MVF research in the years to come. CIMVHR has also received scholarship funds from the Royal Canadian Legion and Wounded Warriors Canada, and research project support from General Dynamics and Calian, and was granted renewed and expanded commitment from PWGSC on behalf of National Defence and VAC. CIMVHR has burgeoned into a virtual network of more than 1,000 researchers from forty-two universities across Canada. Memoranda of understanding (MOUs) with seven international universities have been signed; thirty-three research contracts at twenty-six institutions have been awarded; six highly successful annual research forums have been hosted, which have showcased over 795 research projects to 3,000 stakeholders dedicated to health research that will serve those who serve us. CIMVHR has garnered support for PhD and masters scholarships and has helped many CIMVHR researchers secure successful tri-council grants. Additionally, the institute has developed a pan-Canadian graduate webinar that focuses on the health related issues associated with active military personal, veterans, and their families. Effective knowledge translation is key to the success of CIMVHR, and our official journal, the Journal of Military, Veteran and Family Health (JMVFH), demonstrates this. We make every effort to ensure the supply of professional, concise, timely and relevant communications activities to engage and inform all stakeholders about the value and importance of MVF health research. The JMVFH offers the highest standards of

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rigor for researchers and clinicians who publish in it, and encourages cross-disciplinary themes and MVF research questions. It also allows for the sharing of preliminary results from new therapies, and helps to generate the next great breakthroughs. The interdisciplinary nature of the journal also supports a broad perspective of cutting-edge research to inform timely, relevant work. For policy makers, clinicians, researchers and program developers, the JMVFH ensures the most current evidence is brought to light to inform new policies, and enhance and encourage new treatments and programming for military personnel, veterans, and their families. In addition to the JMVFH and related publications, CIMVHR focuses on education opportunities, speaking engagements, and media coverage, with the intention to have real world impact by supporting knowledge exchange, spurring collaborative projects, and encouraging policy development. CIMVHR’s leadership actively engages with a wide variety of professional health associations and various government departments from VAC to provincial health ministries to consult and advise on the need to provide seamless and effective continuums of care for veterans when they transition from the federal to a provincial health system, and for military families as they transition between provincial health systems. At such meetings research highlights are shared; such as, for the first time ever, we are able to follow a cohort of veterans to understand their use of the provincial healthcare system, including mental health reasons, and we have models to predict their disease incidence and prevalence. In linking Ontario Ministry of Health and Long Term Care military identifiers to Institute for Clinical Evaluative Sciences (ICES) data, we created the first ever cohorts of Canadian veterans and military families using administrative healthcare data in Ontario. This valuable resource has been used to inform the development of relevant provincial public health policy and resource allocation for veterans. The use of routinely collected healthcare data in Ontario will augment our current understanding of veteran health in Canada (Aiken et al. 2016; Mahar et al. 2016). We are also investigating access to pediatric and mental healthcare for the children and spouses of military families. This resource is the first of its kind in the country to generate objectively measured, longitudinal evidence for veteran and military family health policy and programming. There has been significant interest from key provincial and federal players to use this information for its capacity to inform policy.

70 Alice B. Aiken, Stéphanie A. H. Bélanger, and Julie Burch

Military medical care has long been recognized as a platform for learning and for applying lessons learned in civilian medical systems. In an effort to grow the awareness of the various disciplines interested in, and involved with, military medicine, CIMVHR has fostered collaborations between various disciplines at our partner universities. For example, links between mental health researchers and clinicians, and philosophy and sociology researchers have been established in order to further elucidate the nature of moral injury in returning soldiers. This new way of looking at the effects of post-traumatic stress disorder (PTSD) has served to inform new treatment strategies. We are also able to support innovative government research and its broad dissemination to a wider audience. Zamorski’s work, Sitting on a Gold Mine: The 2013 Canadian Armed Forces Cross-sectional Mental Health Survey Dataset, was the first-ever public acknowledgement by National Defence about the state of mental illness in the CAF. Zamorski demonstrated that, similar to the general population, approximately 20 percent of regular force males experience mental illness. This is a crucial piece of information for moving health policy within the military forward, but also highlights the need for improved understanding once these people are released from service. Another study found that of the estimated 650,000 veterans of the Canadian military, veterans are disproportionately prevalent in sub-populations of males, persons with chronic physical conditions, chronic pain, mental health conditions, and those with disabling activity limitations. Veterans are a population of interest to Canadian researchers, but there is no publicly available comprehensive list of veterans in Canada. The study published by VanTil et al. (2016) concluded that Canada needs a standard set of screening questions, suitable for self-report surveys amongst veterans, to identify Canadian veterans. A review has been done on the effectiveness of psychiatric service dogs in the treatment of PTSD for veterans. Upon completion of the scoping review, Gillett and his team concluded that there is a great need for further research on the use of psychiatric service dogs in the management of PTSD among Canadian veterans (Gillett and Weldrick 2013). This has led to an on-going randomized control study about the use of psychiatric service dogs by veterans with mental illness. Results are expected shortly. While such research highlights the common applicability of MVF research results to multiple special populations such as First Responders, and that military healthcare advances made in extreme situations, such

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as Afghanistan, can be translated readily to benefit the wider Canadian population, it also reveals the gaps. The Naylor report could not reasonably address Canadian healthcare policy in every respect. Still, Canada has special populations such as military veterans, First Nations peoples, and others that must be included in a comprehensive and coherent pan-Canadian healthcare strategy. With respect to MVF, CIMVHR will continue to cultivate the pockets of expertise that are emerging on the Canadian research landscape and to ensure that the health and well-being of this unique population is maximized through world-class research resulting in evidence-informed policies, practices, and programs. References Aiken A. B., A. L. Mahar, P. Kurdyak, M. Whitehead, and P. A. Groome. 2016. “A Descriptive Analysis of Medical Health Services Utilization of Veterans Living in Ontario: A Retrospective Cohort Study Using Administrative Healthcare Data.” BMC Health Services Research 16: 351. http://www.biomedcentral.com/1472-6963/16/351 Cramm, H., D. Norris, L. Tam-Seto, M. Eichler, and K. Smith-Evans. 2016. “Making Military Families in Canada a Research Priority.” Journal of Military, Veteran and Family Health 2, no. 1 (April): 8–12. http:// jmvfh.utpjournals.press/doi/full/10.3138/jmvfh.3287 Gillett, J., and R. Weldrick. 2013. “Effectiveness of Psychiatric Service Dogs in the Treatment of Post-Traumatic Stress Disorder Among Veterans.” CIMVHR Report, http://www.cf4aass.org/up loads/1/8/3/2/18329873/psd_and_veterans_living_with_ptsd_gillett_ march_23_2014_2.pdf Mahar A. L., A. B. Aiken, M. Whitehead, P. Groome, and P. Kurdyak. 2016. “Description of a Longitudinal Cohort to Study the Health of Canadian Veterans living in Ontario.” Journal of Military, Veteran and Family Health 2, no. 1 (April): 33–42. Naylor, C. David, Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare Innovation. Ottawa: Health Canada. http://www.healthycanadians.gc.ca/publications/ health-system-systeme-sante/report-healthcare-innovation-rapport-soins/ alt/report-healthcare-innovation-rapport-soins-eng.pdf VanTil, L. D., J. M. Thompson, M. B. MacLean, and D. J. Pedlar. 2016. “Screening Questions to Identify Canadian Veterans.” Journal of Mil-

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itary, Veteran and Family Health 2, no. 1 (April): 28–32. http://jmvfh.utp journals.press/doi/abs/10.3138/jmvfh.3587 Zamorski, M. A. 2013. “Sitting on a Gold Mine: The 2013 Canadian Armed Forces Cross-sectional Mental Health Survey Dataset.” Presentation given at MVHR Forum 2013.

5

Frail Seniors: Reorganizing the Healthcare System to Address the Needs of Some of Its Most Vulnerable Clients John Muscedere

Aging Globally and in Canada According to the United Nations (2011), global population aging is without parallel in human history and will continue to accelerate in the twenty-first century. By 2050, it is estimated that the number of people over the age of sixty will increase by 350 percent from the present. Those at the extremes of aging are the fastest growing segments of the population and over the next thirty years, those over the age of sixty-five will almost double, those over the age eighty-five will quadruple and those over the age of one hundred will increase ten-fold. Canada is similarly affected by global aging demographic trends. In the 2016 census, for the first time in Canada’s history, the proportion of people over the age of sixty-five at 16.9 percent exceeded the proportion of people under the age of fifteen at 16.6 percent (Statistics Canada 2016). By 2031, the number of people over the age of sixty-five will increase to one in four. Aging populations in Canada and around the world will pose significant social and economic disruptions to societies and one of the biggest challenges will be in healthcare. The inexorable nature and magnitude of aging populations will A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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make it difficult for healthcare system planners to arrive at affordable and equitable solutions to the problems posed by demographic changes. Disruptions of health systems from aging demographics arise because older adults are the fastest growing segments of the population, of the increasing prevalence of chronic disease, of the adoption of new and expensive technological innovations, of the survival from diseases, often with residual chronic disease, which would have been fatal in the past and the challenge of caring for those in late life. Although Canadians are living longer in good health, the risk of developing a chronic medical condition increases as one ages. The most rapidly increasing segment of the population comprises those over the age of eighty, and up to 80 percent of those in that age bracket report at least one medical condition. However, as evidence of healthy longevity, up to 20 percent of those over the age of eighty do not self-report any chronic medical conditions (Canadian Institute for Health Information 2011). Through preventive interventions and better public health, we have been successful in shifting the aging curve where function is prolonged over longer periods of time into extremes of age. But the opposite is also true. Many individuals are surviving longer with functional loss, chronic debility, and poor quality of life and who require repeated use of the healthcare system. As a result healthcare costs are not uniform across all seniors: they rise with increasing age, with the highest costs being in those over the age of eighty and increase with the number of chronic conditions present. In 2015, healthcare costs in Canada were approximately $220 billion or 10.9 percent of the GDP. Although Canadians older than sixty-five account for approximately 17 percent of the Canadian population, they account for 45 percent of all healthcare costs; moreover, 20 percent of all healthcare costs occur in the last year of life (Fowler and Hammer 2013; Canadian Institute for Health Information 2007, 2015). Overall, the average yearly per capita healthcare cost in Canada is around $4,000; the average is $11,635 for those over sixty-five, rising to around $30,000 for those over the age of ninety (Canadian Institute for Health Information 2015). However, increasing costs with age are not equally distributed but are concentrated in some patients, with the most frequent clinical diagnoses being chronic diseases such as heart failure and chronic obstructive pulmonary disease, or acute events such as hip fracture and strokes. Hospitalization and continuing care accounted for the majority of costs (Wodchis, Austin, and Henry 2016). Many of the older patients accounting for increasing costs with age are frail.

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Seniors’ Strategies and Need for Risk Stratification With the recognition of the many challenges that aging demographics pose for healthcare systems, there have been an increasing number of calls for seniors’ strategies. The Canadian Medical Association (CMA) is advocating for a pan-Canadian seniors’ strategy and has articulated the principals which should underlie it (CMA 2015). These principles include the enhancement of the health care experience by incorporating person- and family-centred care, quality healthcare with its subdomains of timely access, appropriate care, optimal prescribing, continuous quality improvement and seamless transitions, promotion of health aging, equitable access, and value for resources consumed encompassing sustainability and accountability. However, in spite of the call for, and recognition of, the need for a national seniors’ strategy, one is not in place for the thirteen provincial and territorial health systems or the federally funded health systems such as those in the prison system or in the armed forces. Rather there is a patchwork of strategies across Canada with some more comprehensive than others, and many focusing on narrower populations that are composed of predominantly but not exclusively older individuals such as those in long-term care homes or requiring palliative care (CMA 2016). None of the strategies for seniors have been anchored on the proactive recognition of risk within this group. To maximize benefit in an era of limited healthcare resources there is increasing recognition that resources should be allocated on the basis of risk and this is particularly applicable to aging. The perception is that all aging is the same and that the risk of adverse health outcomes, mortality, and increased healthcare costs rises equally for individuals as they age. As an example, a fit octogenarian who is active with no chronic health conditions will have a very different risk profile and medical needs than a 65-year-old with multiple health problems and who is medically frail. This is the limitation that needs to be addressed in the number of increasing calls for federal healthcare funding to be allocated not just on a per capita basis, but based on age adjusted per capita formulae. Although age-adjusted per-capita funding sounds attractive and is to some extent intuitive, it is also inadequate since age alone does not correlate with medical risk and healthcare resource utilization. Although age and the number of chronic conditions may be used to quantify risk of adverse outcomes, they are also not optimal, since individual chronic conditions may have variable impact depending on

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severity, duration, and management. Overall, it is the impact of determinants of health including chronic conditions on the individual and their function not just their presence that determines risk and health resource utilization. Other risk stratification criteria such as the presence or degree of frailty, which measures overall function of the individual irrespective of age, may improve the matching of healthcare resource allocation to those in greatest need. In summary, there is a need to recognize that age and risk are not synonymous, and focusing on the most vulnerable of the elderly or those who are frail can catalyze the process of making the healthcare system more senior friendly and responsive to their needs. Frailty Frailty is one of the most pressing healthcare challenges facing the aging global population and, in particular, the Canadian healthcare system (Bergman, Beland, and Perrault 2002). Frailty is an underrecognized and underappreciated health condition defined as a state of increased vulnerability resulting from reduced physiological reserve and loss of function across multiple systems, resulting in reduced ability to cope with normal or minor stressors which can cause rapid and dramatic changes in health (Clegg and Young 2011; Walston et al. 2006; Xue 2011). Frailty is associated with worsened healthcare outcomes, including increased mortality, decreased quality of life and occurrence of adverse events. It is also associated with increased healthcare costs and healthcare utilization independent of age and the number of chronic conditions present (Agency for Healthcare Research and Quality 2006; Fried et al. 2001; Lee, Heckman, and Molnar 2015; Sirven and Rapp 2017). Although the incidence of frailty increases with age, they are not synonymous. It is estimated that 1.2 million Canadians are frail, which represents approximately 25 percent of those older than sixty-five and greater than half of those older than eighty-five (Hoover et al. 2013). Based on population growth, the human and economic costs of frailty will continue to increase since it is estimated that the number of frail individuals in Canada will surpass two million people in the next ten years (Statistics Canada 2010). From a societal perspective, frailty poses large burdens to families and/or the informal caregivers of those who are frail. In Canada, aging and frailty are the most common reason for caregiving and it was estimated that in 2012, 2.4 million Canadians were informal caregivers for

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their aged or frail parents, grandparents, in-laws, or friends (Turcotte 2013). It is estimated that the economic value of informal caregiving exceeds the amount spent on home and long-term care (Arno, Levine, and Memmott 1999). Having an informal or family caregiver is associated with decreased risk of institutionalization and reduced utilization of the formal healthcare system (Palmer et al. 2014). However, the stress and demands of being a caregiver can cause illness and has been associated with increased mortality in caregivers (Schulz and Beach 1999; Schulz and Sherwood 2008). The occurrence of health problems in caregivers is associated with increased risk of institutionalization for those in their care and interventions for frailty can reduce caregiver burden and improve their health (Aggar, Ronaldson, and Cameron 2012). Caregiving is associated with significant financial and familial costs along with productivity impacts. These are difficult to capture and for this reason, the actual impact of caring for the aged and those with frailty in Canada may never be known exactly. Since interventions that improve care for the frail elderly have the additional benefit of improving the lives of their informal caregivers, investments made in improving care for the elderly are effectively multiplied. Compounding the number of individuals who are frail and their impact on the healthcare system and caregivers is the lack of evidence to guide their care. The lack of evidence extends to all areas of care from medical therapies to models of care to organization of the healthcare system. In the absence of evidence, therapies shown to be effective in those without frailty are utilized for those who are frail, or continued in those who become frail. As a consequence, such therapies may not be effective and may waste healthcare resources, or potentially cause harm and increase healthcare resource utilization. The reason for the lack of evidence is that most healthcare studies are conducted on those who are not frail or elderly (Van Spall et al. 2007; Zulman et al. 2011). An example of this is the institution of dialysis, a very costly healthcare intervention that in frail elderly patients is associated with worsened quality of life without increases in the quantity of life (Kurella Tamura et al. 2009). Moreover, the opposite may also be true where interventions not shown to be of benefit in non-frail patients may actually be beneficial to those who are frail. An example is exercise/nutrition interventions that may be of minimal benefit to an older fit individual, but that may actually be effective in someone who is frail (Artaza-Artabe et al. 2016). Additionally, in the absence of evidence, medical care is often escalated

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at the end of life without benefit and at times against the expressed wishes of patients or their families (Fowler and Hammer 2013). Although additional evidence for the treatment of frailty is urgently required, there is evidence that the recognition of frailty and the implementation of targeted care plans leads to improved outcomes and reduced healthcare resource utilization on a system level. This has been demonstrated in local projects within Canada and internationally. In Scotland, the implementation of frailty screening in acute care environments led to a reduced number of falls, reduced length of stay, and reduced emergency visits (HealthCare Improvement Scotland 2015). In the emergency department of Mt. Sinai hospital in Toronto, the identification of vulnerable elderly led to reduced length of stay, reduced costs, and the ability to treat more patients (Sinha 2014). In Nova Scotia, the recognition of frailty and the re-evaluation of healthcare interventions has led to better integration of patients’ wishes within their care plans and improved patient satisfaction (Moorhouse and Mallery 2012). When considering the socio-economic benefits of improving care for frailty, we need to consider more than healthcare resource utilization. The prevention of negative outcomes and improvement of quality of life for the individual also implies the possibility of benefiting from a person’s independence for a longer time. In other words, cost-effectiveness analyses never include what a person will be able to do with the restored independence and/or improved quality of life for the society (e.g., less caregiver burden, more participation in society, etc.). This is difficult to qualitatively measure but is a worthwhile consideration that potentially transforms costs into investments. Overall, it is undeniable that frailty is vitally important for Canadian society and the healthcare system because of its adverse impact on healthcare outcomes, associated resource utilization, impact on informal caregivers, and because a large proportion of the rapidly aging population will face frailty as the end of life approaches. Although frailty is underappreciated in the healthcare system, there is an increasing awareness of frailty within the Canadian public as demonstrated by a recent Ipsos Reid poll: 94 percent of those surveyed recognized that some seniors are more vulnerable and in need of more support than other seniors; 90 percent said that the healthcare system needs to do a better job of identifying the needs of frail seniors and providing them with the additional care they require (Ipsos Reid HealthCareCan 2015).

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How Do We Address Frailty in the Canadian Healthcare System? The modern Canadian healthcare system came into being in the 1950s and ’60s where the average life expectancy was less than 70 years and was designed to deal mainly with acute illnesses as the prevalence of chronic illness and frailty was low. It is organized along single organ dysfunction and/or illnesses; for a fit person with an acute single disease, it functions extremely well and brings good outcomes. Moreover, healthcare advocacy and fundraising is also organized along single organ/diseases, such as through the Canadian Diabetes Association, Canadian Society of Nephrology, Heart and Stroke Foundation, etc., with the result being that there is little awareness of multi-system diseases such as frailty. Although the current healthcare system deals with acute illness relatively well, it has difficulties coping with individuals who have chronic multiple medical problems and who may also be nearing the end of life. There are many reasons for this. Care plans that are adequate for those who are fit may not only be inappropriate for those who are frail, but may even cause harm. The goals of care for such individuals may not align with that of the healthcare system, which may be focused on increasing the quantity of life rather than its quality. Individuals who have multiple illnesses such as those with frailty may depend on multiple specialists to address their healthcare needs; their care plans may thus occur in isolation and at times be at cross purposes to each other. There is inadequate support to aid in the long-term recovery or in the chronic maintenance of function of those who are frail as opposed to the short-term episodic care required by one with an acute illness. There have been other Canadian initiatives focused on the elderly and the management of chronic diseases including chronic pain, kidney disease, diabetes and inflammation but none have focused on the individual as a whole (Canadian Institutes of Health Research 2016). Similarly, for end of life care and advanced care planning, much of the available knowledge has been gained from studying rapidly progressing terminal diseases such as malignancies, but deaths from non-malignant diseases, chronic disease and frailty exceed those from cancer diagnoses (Statistics Canada 2017). Furthermore, most of the evidence for palliative care treatments comes from cancer diagnoses and little is known about how to address frailty which may be associated with many different life trajectories, including one of a prolonged slow decline occurring over many years (Huijberts, Buurman, and de Rooij

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2016). A particular challenge in this regard is integrated palliative care where symptom relief is incorporated with life-prolonging care (American Academy of Hospice et al. 2004; Dalkin et al. 2016; Hauptman and Havranek 2005). In those who are aged, frail, and likely to die from non-malignant disease, additional evidence is required on how to inform end-of-life care, advance care planning, and integrated palliative care. Finally, the fragmentation of care in the highly siloed Canadian healthcare system—between settings of care such as home care, longterm care, and acute care, and specialized institutions, care providers, and regional organizations—can lead to poor outcomes for those with complex chronic diseases. The impact of fragmentation is compounded by the lack of transportable health records between jurisdictions such as an electronic medical record. As a result, those with frailty who experience many transitions of care within the healthcare system are at risk of poorly coordinated care and adverse events. Transitions of care between settings are more risky for those who have chronic complex medical needs as compared to those with single acute diseases. To address frailty in the healthcare system, it needs to be better recognized and its impact better appreciated; new evidence for the care of those who are frail needs to be developed. Any new evidence needs to be integrated into holistic models of care that take into account the multi-faceted and multi-system care needs of those who are frail. Along with this, the system needs to be better integrated as a whole to reduce the impact of transitions of care. Moving Forward Policy changes are essential given the magnitude of challenges posed by frailty for the healthcare system as it is currently organized. In this regard, a major driver of policy change will be the recognition that a large and growing proportion of healthcare spending is on seniors, particularly those who are frail and nearing the end of life. Moreover, the baby boomers, one of the largest segments of our population, are now entering age brackets where frailty is increasingly prevalent and they may also be caring for frail parents or relatives; politically, they will advocate for changes in how healthcare manages our aging population. In addition, there is the perception that those who are frail receive inadequate and fragmented care. These factors will catalyze change in the healthcare system with the necessary policy changes.

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Aspects of frailty that will need to be addressed by health system policy changes (Muscedere et al. 2016) include: How do we increase the recognition of frailty in the healthcare system? How do we implement frailty screening? What funding models should be used for frailty and frailty screening? Who will evaluate whether screening is working or if it could work better? How can frail seniors, their families, and caregivers be included in decision making? How do we ensure that appropriate evidence-based care plans are implemented in response to the identification of frailty? How can public reporting of quality indicators for frailty be instituted? To inform the policy changes required, the following approach will be necessary. First, to the extent possible among researchers, clinicians, and decision makers, consensus will be required as to how to detect and measure frailty in the Canadian healthcare system. Although this has not been done in the past, given the increasing focus on seniors across Canada and efforts already underway in many jurisdictions, we are at the “tipping point” where change can occur. As a demonstration of this, two recent national fora, sponsored by the Canadian Frailty Network and specifically designed to advance the concept of the implementation of the detection of frailty in Canada, there was broad interest and the fora were attended by over 200 decision makers, clinicians, researchers, and citizens (Canadian Frailty Network 2017). This led to a discussion paper authored by leading Canadian experts articulating the specifics of how frailty screening can be applied to the Canadian healthcare system (Muscedere et al. 2016). The current health system is fragmented with different information, different assessment of tools, and variable reporting of the information where it is difficult or impossible to evaluate care, outcomes, and healthcare resource utilization since these depend on the underlying population, their needs, and levels of risk. Although frailty in the elderly is a more important determinant of risk than age, it is poorly documented, and undercoded in medical encounter data, hospital discharge summaries, and death certification. The implementation of standardized frailty determination will enable comparisons between jurisdictions allowing for the identification of variations in care, outcomes, and healthcare resource utilization. The identification of variations of care can help improve underuse and overuse of care for those who are frail thereby enhancing value for the healthcare resources spent. In addition, variations of care will help identify areas where existing knowledge has failed to be adopted that can be addressed by further Knowledge Trans-

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lation (KT) efforts. As an example, a recent study using standardized interRAI assessments found wide variations in the transfer of patients to hospital and mortality for similar levels of frailty in nursing homes across provinces (Hirdes and Hebert, forthcoming). Aiding these efforts is the fact that in some settings we will be able to leverage the work that has already been done. This includes the work done by the Canadian Institute of Health Information (CIHI) and interRAI for this purpose (Canadian Institute for Health Information 2017; interRAI 2017). CIHI collects data on the health system and one of their foci is seniors’ care. InterRAI is a network that aims to improve care for persons who are disabled or medically complex by the collection and interpretation of data and standard outcomes. Their work will provide crucial actionable data as the healthcare system pivots to focus on the most vulnerable. InterRAI is used in many provinces and in many settings, including long-term care and home care, and by others researching its use in acute care. There are also efforts being made to implement interRAI in provinces that have not previously used it. Frailty measures can be readily derived from interRAI measurements and this work will aid in the implementation of the systematic detection of frailty in the health system. To the extent possible, the goal will be for the transferability of frailty tools across settings of care. Frailty should not only inform clinical decision making at the bedside. Related evidence should also be systematically collected for administrative uses. Once these tools are implemented broadly, with the data obtained, we will be able to track the incidence, prevalence, and impact of frailty in the Canadian population on a real time basis, including the social and economic costs of frailty. In addition, if frailty tools are linked to quality indicators for those who are frail, such as the requirement for emergency visits, ability to age at home, evidence-based care practices, and appropriate medication utilization, the healthcare system will be able to determine the quality of care being received by the frail elderly across settings and regions of care. If these are implemented and publicly reported, the readily available data will allow for system learning and comparison that will drive future changes in policy. In parallel, new evidence will need to be generated to show how to prevent, slow the progression of, and alleviate the effects of frailty. Research funding agencies should mandate the measurement of frailty in any studies enrolling elderly patients. This should include registration studies for pharmaceuticals and medical devices, and this approach is

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being considered by the European Medicines Agency (2015). From current evidence and new evidence as it arises, practice guidelines and tools to inform care plans that address frailty and its prevention need to be developed and implemented. The evidence will inform public policy and drive changes in practice, to diminish the impact of the causes of frailty (primarily at the home and community care levels), reduce its progression (primarily in clinical practice) and promote optimal evidence-based practice. A major consideration is the multi-jurisdictional responsibility for healthcare in Canada, which is divided between the federal, provincial, and territorial governments. Efforts will be required in all of these. These efforts need to be facilitated by national organizations. Policy changes will need to occur through both a top down and bottom up approach. For the top down approach, policy makers at all levels of government, from federal to provincial to territorial, will need to be engaged. For the bottom up approach, the voices of clinicians and researchers will need to be considered. Ultimately, regional networks or constructs such as the Strategic Clinical Networks in Alberta, or the Local Health Integration Networks in Ontario, can be used as vehicles to drive change. To disseminate knowledge on frailty and the need for screening, a systematic approach will need to be taken to bridge the evidence-to-action gap and address barriers and enablers. Potential barriers include lack of knowledge on frailty and its impacts, lack of caregiver skills, ingrained social or professional roles and identities, existing beliefs about capabilities of, and consequences for, frail people and about healthcare providers, existing intentions or goals, environmental context and resources, social influences, and behavioural regulation. Potential enablers include the strong desire to change the status quo and the work that has been done up to the present in Canada, including the widespread implementation of the interRAI assessments in many provinces and healthcare settings. Understanding of barriers and enablers will allow for the addressing of barriers and the leveraging of enablers at the system level. It needs to be emphasized that improvements in the care of the frail elderly and realization of socio-economic benefits is not about reducing care. It is about tailoring care to individuals commensurate with their risk as a measurement of frailty and ensuring that any contemplated care has been shown to be effective in that population. In some circumstances, investments will need to be made to improve outcomes and

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health resource utilization in the long term (e.g., caregiver support). The identification of frailty may mean modifying care interventions to ensure that they are appropriate for a frail individual such as appropriate medication utilization, less invasive procedures, more intensive rehabilitation pre- and post-procedure, etc. Moreover, preliminary evidence has demonstrated that frailty and mobility disability can be reversed with cost effective interventions. In some cases it may mean substituting or adding care plans such as the provision of palliative care in those who are too frail to benefit from medical interventions. The Canadian healthcare system is at a point where system transformation is required and desired by citizens, clinicians and decision makers. Although this is a massive undertaking, starting with a large and vulnerable segment of the population—those who are frail—would be a good first step that would bring significant benefits to those affected, caregivers, and society in general. The following innovations that could be accomplished in a short time frame would be a good start to spur the required changes in the healthcare system. Targets for Innovation Involve Consumers in the Redesign of the Healthcare System Citizen engagement has become an increasingly important focus for healthcare systems, and Canadian and international organizations, such as Canadian Institutes for Health Research (CIHR) Strategy for Patient Oriented Research (SPOR), INVOLVE, and PCORI (Patient-Centered Outcomes Research Institute 2017; Canadian Institutes of Health Research 2017; National Institute for Health Research 2017). However, none of these initiatives have focused on the elderly or frail elderly who have specific needs and barriers to engagement, and it is important that their desires, wishes and voices are heard when setting research priorities or determining policy for the healthcare system. Further, there is a need to educate the public on frailty and late life. The engagement of the frail elderly will bring better alignment of the preferences of patients and their caregivers with research conducted, policies enacted and the delivery of healthcare. This will ultimately lead to improved satisfaction with the delivery of care including location, types, and intensity especially as the end of life approaches.

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Identification of Frailty in the Healthcare System The identification of frailty in the healthcare system can be done through mass screening (wholescale screening of large populations) to case finding or opportunistic screening (screening of populations that consult health services for another purpose; University of Ottawa, n.d.). Case finding can systematically or opportunistically identify individuals from a larger population for a specific purpose, such as comprehensive geriatric assessment (National Health Service England 2015). Case finding can be combined with risk stratification, which is the systematic process to identify individuals for additional clinical interventions such as alternative care pathways. Although mass screening has been advocated by some organizations, it remains controversial (Morley et al. 2013); other organizations such as the British Geriatrics Society advocate for case finding or opportunistic screening (Turner et al. 2014). Although both approaches have merit, the easiest approach would be that all older adults meeting pre-specified criteria coming into contact with the healthcare system should be assessed for frailty (i.e., case finding/opportunistic screening). Simple and effective tools to assess frailty are readily available and can be incorporated into routine practice (Clegg, Rogers, and Young 2015). Tools commonly used to measure frailty often lend themselves to identifying possible interventions (Marshall et al. 2015). For example, the identification of older adults at greater risk for negative outcomes will facilitate earlier intervention during periods of crisis and drive the implementation of better ways to care for them thereby potentially preventing, slowing, or significantly delaying negative outcomes (Tavassoli et al. 2014). This will lead to outcomes desired by older adults, most of whom express the desire to remain in their homes and communities and to be as functional as possible for as long as possible. In addition, the recognition of the impact of frailty on life span will assist in better integrating each person’s goals of care into potential treatment options (Koller and Rockwood 2013). Despite the large potential benefits of frailty screening, its implementation within the healthcare system should be accompanied by continual evaluation to ensure that its benefits are realized and that any potential harms, such as labelling or ageism, are recognized and mitigated. Increase the Availability and Interpretability of Frailty Evidence There is an urgent need to increase evidence for decision making for those who are frail and the only way to do this is through studies and

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interventional trials. However, to aid in study interpretation, the populations studied need to be easily identifiable and should reflect those in health systems. In addition, the outcomes reported must be relevant to patients, caregivers, decision makers, and any other relevant stakeholders. Unfortunately, many of the studies done thus far studying frail patients have used a variety of criteria for frailty, or have not explicitly defined frailty and used a variety of outcomes, many of which are not patient centred. As a result, the studies are difficult to interpret, including their generalizability. To make evidence more interpretable, allow for data integration, and make it more actionable, it is necessary to standardize the data elements used to identify patients included in studies and the outcomes studied. This has been done for other disease states (Tugwell et al. 2007) and is urgently needed for frailty studies. These criteria need to be enacted by study funders and decision makers and the research community needs to come together to develop the data elements and core outcomes. Implement Integrated Models of Care Although there are a variety of definitions for integrated models of care, all of them encompass the notion that it should integrate the needs of individuals, their families, and communities (World Health Organization 2016). Some of them also include the elements of connectivity, alignment, and collaboration between the acute and chronic care sectors. A recent systematic review of integrated care for people with chronic conditions or multimorbidity, found that integrated models of care resulted in a 19 percent reduction in hospital admissions and concluded that there was sufficient evidence for its implementation with the elements of patient education and empowerment, care coordination, multidisciplinary teams, and individual care plans being particularly important (Dorling et al. 2015). Community-based integrated models of care, focusing on the elderly or people with chronic diseases, have variably reduced rates of hospitalization and costs (Eklund and Wilhelmson 2009; Johri, Beland, and Bergman 2003). In Canada, an integrated care model called PRISMA found that integrated service delivery models resulted in reduced functional decline, reduced unmet needs, increased satisfaction and empowerment, and reduced health service utilization (Hebert et al. 2010). Although integrated models of care have been variably implemented in some provinces on a small scale, they have been successfully im-

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plemented in large systems such as Kaiser-Permanente in California which serves over nine million clients (Pines et al. 2015). Key to the implementation of this program is a comprehensive electronic medical record with each participant’s complete medical history, integration of acute care with community support services, and better transitions of care. Continuing efforts to develop electronic medical records, which encompass all the elements of patients care, need to be enhanced. In order to better serve the aging population and those who are frail, increasing adoption of integrated models of care will be required in the Canadian healthcare system. Increasing adoption should also be combined with health services research to determine which are, or are not, the most effective elements of these systems. Improved Support for Caregivers Support for caregivers of older adults has been shown to reduce institutionalization, hospitalization, and readmission but these have not been widely adopted in healthcare systems ( National Academies of Sciences, Engineering, and Medicine 2016). The most effective interventions assess the needs of caregivers, include education and skills training, respite, and self-care for the caregiver. With the rapid increase in frail populations it will be difficult for the formal healthcare system to meet their needs and innovative ways to support caregivers will be crucial. Although caregiver benefits are available in Canada, these are limited in scope and support, are focused on catastrophic illness, and need to be expanded greatly to ensure that they are applicable to everybody who is willing to provide the service (Government of Canada 2016). Innovative models includes the social long-term care insurance model in Germany, which can support both the elderly and their caregivers (Schulz 2010). In addition, there is a need to redevelop home care from reactive models of care where support is provided when changes in health status occur, to models where support is provided earlier in the patients’ journey to prevent changes in health status from occurring. This could be combined with the identification of early stages of frailty and support instituted before hospitalization or institutionalization is required. The current focus on increasing home care provision by the federal government would be an opportune time to redevelop the underlying models of home care.

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Conclusion Improving the care of the frail elderly will produce significant societal and economic benefits. The societal benefits will result from improved patient-centred outcomes and benefit patients, families, and caregivers. The frail elderly are high consumers of healthcare resources, but many of the therapies currently being delivered may be inappropriate or ineffective. Hence, improving care may uniquely also improve healthcare resource utilization. In addition, the improvement of care for those who are frail will also benefit their informal caregivers; this can include minimization of the health problems of elderly informal caregivers and an increase in the productivity of younger caregivers such as the children of those who are elderly. Finally, an additional benefit of better identifying and focusing on this underserved population would spur innovations in care or technologies that would enhance the function of the Canadian healthcare system but could also enhance Canadian competitiveness in the burgeoning worldwide market of aged and frail populations. Frailty is not only a Canadian problem and any solutions developed or tested in Canada including pharmaceuticals or technologies would have worldwide applicability. References Agency for Healthcare Research and Quality. 2006. “The High Concentration of U.S. Health Care Expenditures: Research in Action.” European Medicines Agency, Volume 19. Rockville, MD. Aggar, C., S. Ronaldson, and I. D. Cameron. 2012. “Reactions to Caregiving During an Intervention Targeting Frailty in Community Living Older People.” BMC Geriatrics 12: 66. American Academy of Hospice and Palliative Medicine, Center to Advance Palliative Care, Hospice and Palliative Nurses Association, Last Acts Partnership, National Hospice, and Palliative Care Organization. 2004. “National Consensus Project for Quality Palliative Care: Clinical Practice Guidelines for Quality Palliative Care, Executive Summary.” Journal of Palliative Medicine 7 (5): 611–27. Arno, P. S., C. Levine, and M. M. Memmott. 1999. “The Economic Value of Informal Caregiving.” Health Affairs (Millwood) 18 (2): 182–8. Artaza-Artabe, I., P. Saez-Lopez, N. Sanchez-Hernandez, N. Fernandez-Gutierrez, and V. Malafarina. 2016. “The Relationship Between Nutrition and Frailty: Effects of Protein Intake, Nutritional Supple-

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mentation, Vitamin D and Exercise on Muscle Metabolism in the Elderly. A Systematic Review.” Maturitas 93: 89–99. Bergman, H., F. Beland, and A. Perrault. 2002. “The Global Challenge of Understanding and Meeting the Needs of the Frail Older Population.” Aging Clinical and Experimental Research 14 (4): 223–5. Canadian Institute for Health Information. 2007. “Healthcare Use at the End of Life in Western Canada.” Author. ———. 2011. “Health Care in Canada, 2011: A Focus on Seniors and Aging.” ———. 2015. “National Health Expenditure Trends, 1975 to 2015.” ———. 2017. https://www.cihi.ca/en Canadian Institutes of Health Research. 2016. “SPOR Networks in Chronic Disease.” http://www.cihr-irsc.gc.ca/e/49719.html ———. 2017. “Strategy for Patient-Oriented Research.” http://www. cihr-irsc.gc.ca/e/41204.html Clegg, A., L. Rogers, and J. Young. 2015. “Diagnostic Test Accuracy of Simple Instruments for Identifying Frailty in Community-dwelling Older People: A Systematic Review.” Age Ageing 44, no. 1: 148–52. Clegg, A., and J. Young. 2011. “The Frailty Syndrome.” Clinical Medicine (London) 11 (1): 72–75. Canadian Frailty Network. 2017. “CFN National Forum.” http://www. cfn-nce.ca/news-and-events-overview/cfn-national-forum/ Canadian Medical Association (CMA). 2015. “A Policy Framework to Guide a National Seniors Strategy for Canada.” https://www.cma. ca/Assets/assets-library/document/en/about-us/gc2015/policyframework-to-guide-seniors_en.pdf ———. 2016. “The State of Seniors Health Care in Canada.” https:// www.cma.ca/En/Lists/Medias/the-state-of-seniors-health-care-incanada-september-2016.pdf Dalkin, S. M., M. Lhussier, P. Philipson, D. Jones, and W. Cunningham. 2016. “Reducing Inequalities in Care for Patients with Non-malignant Diseases: Insights from a Realist Evaluation of an Integrated Palliative Care Pathway.” Palliative Medicine 30, no. 7: 690–97. Dorling, G., T. Fountaine, S. McKenna, and B. Suresh. 2015. “The Evidence for Integrated Care.” Healthcare Practice (March): 1–24. Eklund, K., and K. Wilhelmson. 2009. “Outcomes of Coordinated and Integrated Interventions Targeting Frail Elderly People: A Systematic Review of Randomised Controlled Trials.” Health and Social Care in the Community 17, no. 5: 447–58. European Medicines Agency. 2015. “Points to Consider on Frailty:

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MedCaseStudyKaiser.pdf Schulz, E. 2010. “The Long-term Care System for the Elderly in Germany.” European Network of Economic Policy Research Institutes. http://www.ancien-longtermcare.eu/sites/default/files/ENE PRI%20_ANCIEN_%20RRNo78Germany.pdf Schulz, R., and S. R. Beach. 1999. “Caregiving as a Risk Factor for Mortality: The Caregiver Health Effects Study.” Journal of the American Medical Association 282, no. 23: 2215–59. Schulz, R., and P. R. Sherwood. 2008. “Physical and Mental Health Effects of Family Caregiving.” American Journal of Nursing 108 (9 Suppl): 23–27; quiz 27. Sinha, S. 2014. “An Overview of Mount Sinai Hospital’s Acute Care for Elders (ACE) Strategy.” The CommonWealth Fund. 2014 International Symposium on Health Care Policy. www.cfi-fcass.ca Sirven, N., and T. Rapp. 2017. “The Cost of Frailty in France.” European Journal of Health Economics 18, no. 2: 243–53. Statistics Canada. 2010. “Population Projections for Canada, Provinces and Territories 2009 to 2036.” http://www.statcan.gc.ca/pub/91520-x/91-520-x2010001-eng.pdf ———. 2016. http://www12.statcan.gc.ca/census-recensement/2016/ dp-pd/prof/details/page.cfm?Lang=E&Geo1=PR&Code1=01& Geo2=&Code2=&Data=Count&SearchText=Canada&Search Type=Begins&SearchPR=01&B1=All&TABID=1 ———. 2017. “Leading Causes of Death, Total Population, by Age Group and Sex, Canada.” http://www5.statcan.gc.ca/cansim/ a26?lang=eng&id=1020561 Tavassoli, N., S. Guyonnet, G. Abellan Van Kan, S. Sourdet, T. Krams, M. E. Soto, et al. 2014. “Description of 1,108 Older Patients Referred by Their Physician to the ‘Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability’ at the Gerontopole.” Journal of Nutrition, Health & Aging 18, no. 5: 457–64. Tugwell, P., M. Boers, P. Brooks, L. Simon et al. 2007. “OMERACT: An International Initiative to Improve Outcome Measurement in Rheumatology.” Trials 8: 38. Turcotte, M. 2013. “Family Caregivers: What Consequences? Insights on Canadian Society.” September Statistics Canada Catalogue no. 75006-X. Turner, G., A. Clegg, Society British Geriatrics, U. K. Age, and Practioners Royal College of General. 2014. “Best Practice Guidelines for the Management of Frailty: A British Geriatrics Society, Age UK and

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Innovation and Healthcare for Indigenous Peoples Michael E. Green

One of the greatest challenges facing the Canadian Healthcare System is the persistent disparity in health status and outcomes for Indigenous peoples (Adelson 2005). While healthcare systems can potentially mitigate some disparities, they can also contribute to widening the gap. Jacklin et al. (2017) describe the experiences of Canadian Indigenous people with the healthcare system. The importance and enduring impact of colonialism, the perpetuation of inequities in the present day, and structural barriers to care were key features that emerged, as was the potential positive and mitigating impact of access to experienced and caring health professionals who were culturally attuned to the needs and realities of their Indigenous patients (Jacklin et al. 2017). As the Truth and Reconciliation Commission (TRC) noted in its Calls to Action on health, these issues are deeply rooted in colonial history and policy: “the current state of Aboriginal Health in Canada is a direct result of previous Canadian government policies, including residential schools” (Truth and Reconciliation Commission of Canada 2015). This view is shared by, and recognized within, the health professions (King, Smith, and Gracey 2009; Greenwood et al. 2015; Leyland et al. 2016). The TRC’s Calls to Action recognize that no one sector alone can fully address these issues, but the Commission called upon the healthcare sector to contribute in a number of key areas, including A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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• recognition of Indigenous rights, improved measurement of outcomes, and establishment of clear targets to close identified gaps; • enhanced funding of integrated health and healing centres; • engagement and recognition of the importance of elders and traditional healing practices; • improved training for health professionals to prepare them to deliver culturally safe care and address racism; • resolution of jurisdictional disputes as they relate to the funding and delivery of healthcare for all Aboriginal peoples; and • increasing the participation of Aboriginal Canadians in the health workforce. (TRC 2015, Calls to Action, 18–24). Positive change to address these persistent inequities will require innovation in both policy and practice within the health and social care sectors that provide services to Indigenous people in Canada. While the members of the Advisory Panel on Healthcare Innovation (Naylor et al. 2015) did not address this in their 2015 report on healthcare innovation in Canada, it is important to ensure that this is not forgotten, and that innovation for improved Indigenous health outcomes is a part of this national discussion. The four cases presented below represent a sampling of the possible approaches to innovations in care delivery that demonstrate success in diverse contexts, and all address one or more of the TRC’s Calls to Action. The chapter will conclude with a reflection about what these cases can teach us about innovation in Indigenous health. Four Short Cases The First Nations Health Authority (FNHA) in British Columbia was created to address jurisdictional issues relating to funding and care delivery, and to bring First Nations control to an integrated Health Authority that relates to federal, provincial/territorial, and Aboriginal governments and communities. It is the result of a decades-long process of bringing key partners together to develop a governance structure that would “effectively separate business from politics, while respecting both” (Gallagher, Mendez, and Kehoe 2015). There were a number of key steps and agreements predating the launch of the FNHA that laid the foundations for this innovative agency to be created. The first was a coming together of First Nations leaders across the province through the First Nations Leadership Accord. This allowed for development of a clear and united First Nations–derived vision of improved

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health and quality of life for all First Nations people in the province that could be used to engage provincial, federal, and regional partners. This vision was then translated into a series of progressively broader agreements that culminated in the Framework Agreement on First Nations Health Governance and the transfer of Health Canada’s First Nations and Inuit Health Branch core functions to the FHNA in 2013. Under this agreement, the FNHA is one of four components of an integrated First Nations Health Governance system in the province. Its role is in the direct management, delivery, planning, and funding of services for First Nations communities. It does this in partnership with the communities and a range of other health system partners including the provincial Ministry of Health, regional health authorities, and Health Canada. The First Nations Health Council, by contrast, is responsible for governance, leadership, and oversight functions, especially for ensuring the implementation of health plans. The First Nations Health Directors Association comprises health directors and health services managers from communities; it provides important technical advice to both the FNHA and the FNHC as well as supporting educational and knowledge transfer initiatives. The fourth component is the Tripartite Committee on First Nations Health (TCFNH), which brings together the other three organizations with provincial, federal, and regional partners (FNHA 2017), and works with the other partners to establish seven directives that are shared by all parties and that support their shared vision of “Healthy, Self Determining and Vibrant BC First Nations Children, Families and Communities.” These in turn guide the FNHA in its work to ensure that First Nations people and communities in British Columbia receive high quality comprehensive health and wellness services. They have also worked to develop a model of First Nations wellness, and then have used this model and the seven directives to establish their own operating principles that are congruent with these. While the FNHA is still in its infancy, its early successes in partnership development, the establishment of a Joint Project Board with senior-level British Columbia Ministry of Health officials to address primary care and mental health needs, and the roll out of enhanced telehealth initiatives, are promising signs that it can make a difference in the longer term. The Tui’kn Partnership is a health partnership of all five First Nations located in Cape Breton, Nova Scotia. It was launched in 2004 as a two-year primary healthcare transition fund project focused on developing a holistic model of primary care delivery for these communities. Since then it has become a platform for collaboration on a range

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of health and wellness related issues and has not only endured, but grown, taking on over thirty joint projects that all support improved health status and/or service delivery for members of the participating First Nations (Tui’kn 2017). Leadership is provided by the health directors of the participating First Nations, and supported by a project manager and an administrative assistant. Their first success was in the development and implementation of a First Nations–led integrated primary care service, which has now been running for more than a decade. Subsequent projects have covered a broad range of service priorities including a series of projects on expanding access to telehealth services, improving chronic disease management, and system navigation supports, mental health and residential school survivor support, and improved maternal and child health. Crucial to the success of all of these initiatives have been effective partnerships with academic centres and researchers. Equally important has been a focus on improving access to health information that is locally relevant, supports improvements in health status or health service delivery, and provides appropriate local governance and leadership for the collection and use of this important information. Beginning with an initial project on health information and planning, the partnership then developed the “Telling our Stories” project and subsequent extension to the “Strength in Numbers” project. These projects included the creation of the Unama’ki Client Registry that allowed initial reports on maternal and child health, cancer, chronic disease prevalence, and health services utilization to be produced that could compare health status and utilization for members of the Tui’kn partner communities to that of other Cape Breton residents and all Nova Scotians. The success of this project as been leveraged to engage other Nova Scotia First Nations in the creation of the Nova Scotia First Nations Client Linkage Registry. Access to high-quality credible data has been key to the effectiveness of the partnership in its ability to effectively lobby for, and obtain the financial support required, to provide high quality comprehensive care to its members. The Cree Board of Health and Social Services of James Bay (CBHSSJB; 2017) in Quebec provides medical and social services to approximately 19,000 residents of the James Bay Lowlands of Northern Quebec (Eeyou Estchee). They operate Community Medical Centres in all nine communities in the region. The Centres deliver local medical, dental, home care, and social services similar to those offered by Centres Locals de Services Communitaires (CLSCs) in the rest of Quebec, as well as the regional hospital, three youth facilities, public health services, and cen-

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tral services that support administration, planning, and co-ordination of care outside the region (liaison services). The CBHSSJB was created as a result of the James Bay and Northern Quebec Agreement of 1975 related to the large-scale development of hydroelectric power. The ability to take control of service delivery and to use a focus on Cree values and traditions to improve health and wellness was central to those aspects of the agreement related to health and social services. The extensive and detailed report by Torrie et al. (2005) details the challenges the organization faced in launching a process that was the subject of significant controversy up until the early 1980s. Development in the early years was hindered by a number of missteps and disagreements about the appropriate role and composition of the board. A further challenge was the limited resources allocated to undertake what really was a very large task. A major outbreak of gastrointestinal disease was the catalyst for a reboot in 1980, and the subsequent development of new facilities and expanded services. There was another period of discontent and renegotiation, primarily related to the issue of funding in the 1990s that was resolved in 2002–03. The organization is now mature, and operating a functioning regional health system. Population health and the importance of health determinants, as well as treatment of illness, have been a focus of the organization since its inception. Major investments in a number of different areas have contributed to substantial improvements in heath status, including improved mortality, life expectancy and infant mortality. While gaps persist in comparison to the general Quebec population as a whole, there is no doubt that this has improved significantly over the years. The CBHSSJB has also been able to use data partnerships with major research centres and funders, including McGill University and the Institute Nationale de Sante Public de Quebec (INSPQ), to ensure that accurate data is available to help guide health services delivery and public health programming, and to provide access to key performance and outcomes data to track health status of the population. The comprehensive and detailed report by Torrie et al. (2005) includes decades of data on key markers such as mortality, infant mortality, and hospitalizations as well as on important determinants including diet, housing, and the environment. The improvement documented here support the conclusion that despite its rocky road, this integrated regional self-governance approach has made an important positive impact. The Southcentral Foundation in Alaska has won international acclaim for its work in transforming care delivery and outcomes through the

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development of a locally driven care model—the Nuka System of Care. Gottlieb (2013) provides an excellent summary of progress and historical overview of the organization. The Southcentral Foundation was established in 1982 by Cook Inlet Region Inc., one of the regional Alaska Native corporations created by the Alaska Native Claims Settlement Act. Its vision was to be “A Native Community that enjoys physical, mental, emotional and spiritual wellness.” The Foundation developed an approach to care focused on shared responsibility and a commitment to quality and family wellness. With this vision and focus, the Foundation began a process of assuming ownership and responsibility for the services delivered to their approximately 60,000 “customerowners.” They translated their broad vision into operational principles centred in respectful relationships and core concepts focused on wellness. In doing so, they grew from an organization with a $3 million annual budget with twenty-five employees to one that has a $210 million annual operating budget with 1,500 employees that also delivers, or contracts for, comprehensive health, dental, mental, and behavioural health services, including primary care and more advanced levels of hospital-based care. Research on the needs of their customer-owners led to a focus on high quality team-based primary care. They have invested heavily in this area, redirecting savings from reductions in hospital and emergency care to support expansion of primary care capacity and enhanced multidisciplinary teams. These teams have a commitment to rapid access and continuity of care, using tools such as advanced access scheduling, telephone and telemedicine visits, and email to allow customer-owners consistent access to the primary care team that knows them best. This process was not without its challenges, however. In the early years providers who had difficulty adapting to the new system and its expectations were unhappy, and many left the organization. The Foundation made a concerted effort in hiring and recruitment to find providers who were a good fit for their model of care and invested significant resources into orienting and “onboarding” new staff as well as actively recruiting and grooming local Alaskan Native candidates for roles at all levels of the organization. This approach has stabilized their workforce, reducing turnover, and has now reached the point where the majority of the workforce comprises Alaskan Natives. In addition to the importance of relationship and continuity of care, the Foundation has also had an unrelenting focus on quality improvement. Data and regular reporting on performance metrics, which are

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aligned with their vision, drive day-to-day operations and proposals for changes to service delivery. Processes of care, including access to same day appointments, attachment to a primary care provider, and disease-specific quality metrics for common chronic diseases including asthma and diabetes, have all shown significant improvements (Johnston et al. 2013; Smith et al. 2015). This has translated into reduced emergency department visit rates for all reasons, asthma, and unintentional injuries (Driscoll et al. 2013). It has also resulted in reduced hospital admissions, with monthly admission rates dropping from 9.1 per 1,000 in 1996 to 5.8 per 1,000 in 2009. A portion of the cost savings from these reductions has allowed major investments in the primary care sector to help sustain and improve these gains. They are now recognized as a world leader in the provision of high quality integrated care, being recognized as providing the highest level of service in the certification process for “Patient Centred Medical Homes” and receiving the highest honour in the United States for Quality Improvement in Healthcare, the Malcomb Baldrige National Quality Award. Concluding Comments What can we learn from these experiences? First, positive change is possible. Improving the health status or health services delivery for Indigenous peoples is often characterized as an impossible or Herculean feat that is too complex to take on. The major inequities in the social and economic determinants of health that are important drivers of health status for Indigenous peoples can sometimes be used as an excuse for healthcare professionals or organizations to simply carry on with the status quo. Health professionals often feel that they are not able to adequately address these issues, and are then discouraged from trying harder to maximize the impact that the healthcare sector can have in mitigating these impacts (Crowshoe et al. 2017). These case examples show us that change is possible, and that the results can be significant, even when many other important issues cannot be fully addressed. Second, these experiences also demonstrate the importance of persistence and allowing sufficient time to bring about real and lasting change. All of these initiatives required years of groundwork to get started, and then years or decades to reach maturity. The process of developing the FNHA took almost a decade (2005–2013) before it was able to assume responsibility for operations. A similar time frame was reported for the initial launch of the CBHSSJB followed by the need

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for a substantial renegotiation as the organization matured. The Tui’kn partnership started small and has used incremental change since 2004 to slowly grow in scope and impact over time, while the Southcentral Foundation continues to innovate thirty-five years after its inception. They all also required meaningful engagement between Indigenous leaders and communities, and various levels of government and health service delivery organizations. In the cases of the Foundation and the CBHSSJB, this engagement occurred and was supported as a part of broader claims agreements (The Alaska Native Claims Settlement Act and the James Bay Agreements respectively). For Tui’kn these partnerships were developed and supported through local and regional networks of people within local community governments, regional health service organizations, academic institutions, and the provincial and federal governments. In the case of the FNHA, the development of governance structures that brought the diverse First Nations communities in BC together to collaborate on this important work was a key supporting factor and provided a means for collective engagement with other levels of government and health services organizations. Third, in these partnerships, Indigenous leadership was essential. Other partners, who may traditionally have been charged with leading and managing health systems and programs, needed to be willing to give way to make room for Indigenous leaders. Innovation has often been stifled by outdated colonial and paternalistic policies and institutions that have hindered, rather than helped, champions move change forward. For example, communities that took on lower level transfer arrangements to administer federal programs locally were often prevented from adapting these to address local needs and priorities by clauses requiring them to adhere to federal policy. As a result, they were only able to carry on doing exactly what they were unsatisfied with before the transfer. This sort of experience causes disillusionment with change at the community level. The development of legal frameworks or new legislation to recognize and support Indigenous leadership and self-determination in health and to provide the flexibility to innovate to achieve desired outcomes was central to many of these efforts. Fourth, on the ground, these examples all required meaningful engagement also with the Indigenous people who they served. All of these case examples used frequent and regular communication, including many community-based events with opportunities for face-to-face discussion. Bidirectional dialogue that allowed for soliciting input and providing information on health status and outcomes, as well as pro-

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posed innovations or initiatives, was a shared feature of these events. Community feasts, information sessions, and formal advisory structures were strategies that were commonly used and proved successful in engaging both communities and individuals. In all cases this included the development of locally informed, culturally relevant frameworks of health and wellness, and the enunciation of how these could be moved forward into practice within their own contexts. They all also developed a sense of the importance of mutual responsibility for health, with communities and individuals being partners in health with the service delivery agencies. Finally, all have recognized the importance of accurate and timely data to support performance measurement, planning, and accountability in different forms. References Adelson, N. 2005. “The Embodiment of Inequity: Health Disparities in Aboriginal Canada.” Canadian Journal of Public Health, 96: S45–S61. Cree Board of Health and Social Services. 2017. “About Us.” http://www.

creehealth.org/about-us

Crowshoe, L., M. E. Green, K. Jacklin, L. Walker, R. Henderson, and B. Calam. 2017. “Exploring Canadian Physicians’ Experiences with Diabetes Care for Indigenous Patients.” Submitted to Canadian Journal of Diabetes, forthcoming. Driscoll, D. L., V. Y. Hiratsuka, J. M. Johnston, S. Normal, K. M. Reilly, J. Shaw, J. Smith, Q. N. Szafran, and D. Dillard. 2013. “Process and Outcomes of Patient-Centred Medical Care With Alaska Native People at Southcentral Foundation.” Annals of Family Medicine, 11: s41–s49. First Nations Health Authority. 2017. “First Nations Health Authority Governance Structure in British Columbia.” http://www.fnha.ca/Doc

uments/First-Nations-Health-Governance-Structure-in-British-Colum bia.pdf

Gallagher, J., J. K. Mendez., and T. Kehoe. 2015. “The First Nations Health Authority: A Transformation in Healthcare for BC First Nations.” Healthcare Management Forum, 28 (6): 255–61. Greenwood, M., S. de Leeuw, N. M. Lindsay, and C. Reading. 2015. Determinants of Indigenous Peoples’ Health in Canada: Beyond the Social. Toronto ON: Canadian Scholars’ Press. Gottlieb, K. 2013. “The Nuka System of Care: Improving Health Through Ownership and Relationships.” International Journal of Circumpolar Health, 72: article 21118.

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Jacklin, K., R. Henderson, M. E. Green, L. Walker, B. Calam, and L. Crowshoe. 2017. “Healthcare Experiences of Indigenous People Living with Type 2 Diabetes in Canada: Sequential Focus Group Findings from Diverse Indigenous Contexts.” Canadian Medical Association Journal, 189: E106–12. Johnston, J. M., J. J. Smith, V. Y. Hiratsuka, D. A. Dillard, Q. N. Szafran, and D. L. Driscoll. 2013. “Tribal Implementation of a Patient-centred Medical Home Model in Alaska Accompanied by Decreased Hospital Use.” International Journal of Circumpolar Health, 72: article 20960. King, M., A. Smith, and M. Gracey. 2009. “Indigenous Health Part 2: The Underlying Causes of the Health Gap.” Lancet 374: 76–85. Leyland, A., J. Smylie, M. Cole, D. Kitty, L. Crowshoe, V. McKinney, M. E. Green et al. 2016. “Health and Healthcare Implications of Systemic Racism on Indigenous Peoples in Canada.” College of Family Physicians of Canada Fact Sheet, February. Naylor, C. David, Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare Innovation. Ottawa: Health Canada., https://www.canada.ca/en/health-canada/ser vices/publications/health-system-services/report-advisory-panel-health care-innovation.html Smith, J. J., J. M. Johnston, V. Y. Hiratsuka, D. A. Dillard, S. Tierney, and D. L. Driscoll. 2015. “Medical Home Implementation and Trends in Diabetes Quality Measures for AN/AI Primary Care Patients.” Primary Care Diabetes Europe 9: 120–26. Torrie, Jill, Ellen Bobet, Natalie Kishchuk, and Andrew Webster. 2005. The Evolution of Health Status and Health Determinants in the Cree Region (Eeyou Istchee): Eastmain 1-A Powerhouse and Rupert Diversion Sectoral Report, vol. 2: Detailed Analysis. Cree Board of Health and Social Services of James Bay, Chisasibi, Quebec. http://www.gcc.ca/pdf/QUE000000012.pdf Truth and Reconciliation Commission of Canada (TRC). 2015. “Calls to Action.” Government of Canada, Ottawa. Tui’kn Partnership, 2017 “Tui’kn Partnership: Because health belongs to all of us.” http://www.tuikn.ca

Part 3

Creating Innovation

7

The Role of Performance Data and Information in Driving and Supporting Health System Innovation Sara Allin, Mélanie Josée Davidson, Keith Denny, and David O’Toole

Transforming healthcare through innovation cannot be accomplished without strong evaluation and procedures for spreading successes across health systems. When effective, these attributes provide health systems with the insights to drive, support, and scale performance improvement and innovation. Canada has a strong administrative information base for the hospital sector across the country, and a growing clinical-administrative information base for both long-term care and home care sectors. Yet there are still many sectors of care where high quality, comparable administrative, and clinical data are not routinely collected and available in formats that support quality improvement and health system management. Of note, primary healthcare services, which represent the majority of healthcare encounters in Canada, are largely absent from provincial and pan-Canadian reporting due to a lack of comparable data. Similarly, limited comparable data collection in community-based mental health and addictions settings or home care settings means that data cannot be aggregated and compared to inform policy, management, and research in these important and growing sectors. Moreover the emerging interest in health systems in CanaA Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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da in improving health equity and addressing the needs of vulnerable populations is not yet matched with a sound evidence base to make demonstrable progress (CIHI 2015). New initiatives under way to collect and/or link health and social data will inform performance improvement and outcomes for vulnerable populations (Anti-Racism Directorate—Ontario 2017; Nova Scotia Health and Wellness 2016). The rise of “big data” and the conversion of paper records into electronic medical records (EMRs), electronic health records (EHRs) and hospital information systems has raised expectations for increased availability of data and information, and their potentially transformative nature on health systems. Certainly, these technologies are creating opportunities for new and richer sources of information—both at the point of care and for management, planning, policy, and research. When well integrated into the clinical workflow, digital data collection can be easier and less expensive than more traditional administrative data collection methods. Meaningful use of digital data, however, requires more than capture in an electronic format. Without the ability to structure that data for analysis and without the ability to extract and share aggregate data, an electronic record adds little value over the traditional paper file. Thus, while the majority of primary care doctors now use an EMR, and development and implementation of EHRs have been progressing across the country, much progress remains to be made in order for these investments to be systematically and routinely extracted, aggregated, and analyzed to support innovation and performance improvement in health systems. The extent to which data and performance information drive innovation to support performance improvement in Canadian healthcare does not simply depend on the quantity, availability, and accuracy of data and information. How this information is put to use to advance the goals of performance improvement is equally, if not more, important. Information use in policy and decision making does not necessarily follow a straightforward logic whereby information coherently informs decision making in a linear way. Information use will always be a context-dependent process in which information producers and stakeholders construct knowledge through “feedback mechanisms, iterations and complex relationships” (Molas-Gallart and Tang 2011). Information is used insofar as it is perceived by “adopters” to be accessible, credible, relevant, and valuable (Nutley, Walter, and Davies 2003). In this chapter we want to bolster our claim that innovation requires high quality information and to explore some of the areas in which

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progress has been made. Despite the many success stories across the healthcare spectrum, we will narrow our focus to three areas: quality and safety, efficiency, and patient experience. These are consistent with the dimensions of performance included in the definition of innovation articulated in the 2015 report of the Advisory Panel on Healthcare Innovation (Naylor et al. 2015), and with frameworks of health system performance. Reoccurring themes in our our discussion will be the role health systems play in promoting health equity (CIHI 2013; Wyatt et al. 2016), and the importance of actual health outcomes. Given the authors’ affiliation with the Canadian Institute for Health Information (CIHI), we draw heavily on CIHI examples. This is especially appropriate because of the unique role that CIHI plays in the health information landscape in Canada. CIHI has the mandate to “deliver comparable and actionable information to accelerate improvements in health care, health system performance and population health across the continuum of care” (CIHI 2017a). In support of this, CIHI is the repository of provincial and territorial clinical-administrative databases, a leader in the development of data standards, and a source of publicly available comparable information on health system performance. So, the authors are well placed to reflect on the role this information plays in supporting the health systems’ capacity to learn, improve performance, and innovate. Quality and Safety Innovation and performance improvement in Canada’s healthcare systems are intimately intertwined. The capacity of a health system to learn and innovate is an important lever for improving health system performance (CIHI 2013; Commonwealth Fund 2006). Innovation can be understood as the adoption of new ideas or activities (e.g., devices, systems, policies, or programs) that help an organization achieve its goals and to adapt to changes in the environment (Damanpour and Evan 1984). Performance improvement is a dynamic process whereby objectives are set, progress is measured and monitored, information is generated on where improvements could be made and how, and then this information is used to guide change. This intimate connection between innovation and performance improvement is a critical ingredient in the pursuit of high quality and safe patient-centred services. Health care settings are complex and initiatives to improve the safety and quality of care may involve multifaceted strategies. Such strategies need to

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be supported in practice through the use of performance information to monitor progress and to enable continual calibration. Safety in healthcare is an integral component of its quality. Safety refers to the avoidance of injuries or harms to individuals from the care they receive (CIHI 2013, 2015). There have been recent developments to assess performance by developing comparable indicators related to safety, including potentially avoidable in-hospital deaths, in-hospital falls, pressure ulcers and hospital-acquired infections. Comparable information on the extent of safety problems in hospitals can be used to support the development and evaluation of quality improvement initiatives. One of the first publicly available hospital-level performance indicators of quality in relation to safety in Canada was the hospital standardized mortality ratio, or HSMR (CIHI 2007). The HSMR allows a hospital to compare the deaths that occurred to the number that would be expected in the average hospital, after adjusting for the differences in the patients a hospital sees, such as demographics, diagnoses, and severity of illness. When tracked over time, this measure can indicate whether hospitals have been successful in reducing patient deaths and improving care. As seen in other countries with public reporting of HSMR, such as the United Kingdom (where the indicator was first developed and publicly reported since 2000) and the United States, the past decade has seen an overall decline in hospital deaths in Canada. For instance, from 2006–07 to 2012–13 the decline in HSMR was 22 percent nationally (Fekri et al. 2015), with considerable variation across hospitals in the rate of decline. In part this trend is likely a reflection of improved quality of care; it also relates to other factors unrelated to care received in hospital such as the general decline in in-hospital deaths (with an increase in deaths in the community), as well as changes in coding practices (Fekri et al. 2015). In another example, a recent collaboration between CIHI and the Canadian Patient Safety Institute brought together the measurement of hospital harm (unintended harm resulting from health care) with a compilation of evidence-informed practices for improving patient safety to help drive the innovations to improve safety for hospital patients (CIHI and CPSI 2016). Monitoring the extent of hospital harm will be important for individual hospitals and regions going forward; over the past three years, the composite indicator of harm has remained relatively stable in Canada (at about one out of every eighteen acute care hospitalizations experiencing harm).

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Hospital harm may include a number of preventable events. One such event is the development of sepsis (a complication from infections). Sepsis is a leading cause of in-hospital mortality and can be an important draw on hospital resources by extending patients’ stay in intensive care units (Angus et al. 2001; CIHI 2009). Yet appropriate preventive and therapeutic measures during a hospital stay can reduce the rate of infections and/or progression of infection due to sepsis. Thus the sepsis indicator was developed by CIHI to allow hospitals to assess the extent to which they are effective in preventing the development of sepsis as an important component of safety. The growing availability of comparable performance information on hospital safety will help draw attention to the magnitude of the issue. However the extent to which this information can lead to performance improvement will depend in part on the context in which this information is recorded, including the presence of supportive environments to introduce and sustain interventions. Performance information on the quality and safety of care received in settings outside of hospitals, such as in primary care settings and community care is less well developed. Recently, however, comparable patient-level information gathered through standardized assessment tools (using interRAI1) has permitted the measurement of quality of care in long-term care and home care settings. As of June 2015, a set of quality indicators has been reported publicly for 1,200 long-term care homes across the country including restraint use, falls, and changes in pain and functioning. One of the indicators publicly reported at the facility level is the “potentially inappropriate use of antipsychotics in long-term care.” Antipsychotics are a class of medication typically used to manage psychosis. These drugs are sometimes used to manage challenging behaviours in residents who have dementia, despite evidence of limited positive effects on dementia symptoms (Ballard and Howard 2006; Banerjee 2009). Their use is associated with side effects such as sedation and movement disorders, which can lead to increase risk of falls, and even premature death (Jalbert et al. 2010; Schneider, Dagerman, and Insel 2005). Residents without a diagnosis of psychosis who have been prescribed this medication raises potential concerns about safety and quality of care. As with HSMR, this 1 interRAI (www.interrai.org) is an international research network that provides organizations with measures of quality across key domains, including physical and cognitive function, safety, and quality of life.

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indicator has revealed broad improvements over time: from 33 percent in 2011–12 to 24 percent in 2015–16 nationally. Specific examples of success stories include Winnipeg health region where antipsychotic medication use was reduced by 20 percent in just six months (CIHI 2012), and a Saskatchewan long-term care home which reduced the use of restraints by 40 percent (CIHI 2017b). In the case of Winnipeg, an interdisciplinary team from the region worked closely with the Canadian Foundation for Healthcare Improvement as part of its pan-Canadian collaborative aimed at reducing the inappropriate prescribing of antipsychotics in long-term care (Canadian Foundation for Healthcare Improvement 2014). Alberta Health Services also created the Appropriate Use of Antipsychotics toolkit in 2013–2014. Since its implementation in long-term care homes, a decrease from 25 percent to 18 percent of residents being prescribed an antipsychotic has occurred, giving Alberta the lowest rate in Canada—an average of 23 percent (Alberta Health Services, n.d.). The impact of local level information on performance in home care was evidenced in the Alberta First Nations Home Care Pilot Project that was initiated in 2008 in partnership with several organizations and providers (CIHI 2016a).2 The objectives of this project were to reduce wait times for assessment, and to increase access to, and provide seamless delivery of, healthcare services in First Nations communities. To do so there was ongoing engagement with the community, a move from paper-based to electronic needs assessments, training of staff on the use of new technology, and considerations of privacy, as well as ensuring adherence to OCAP principles throughout the project’s lifecycle. By 2012 interRAI assessments were adopted in six communities: Frog Lake First Nation, Blood Tribe, Loon River First Nation, Whitefish Lake First Nation, Woodland Cree First Nation, and Lubicon Lake. Moreover, the following outcomes were achieved: wait lists for assisted living and long-term care dropped significantly and reached the same level as the average for Alberta; wait times for long-term care placement decreased from six to eighteen months3 to several days/weeks; and communi2 Original partners included CIHI, Health Canada, CIHI, interRAI, First Nations (Alberta) Technical Services Advisory Group, Alberta Health Services, Alberta Health, and Momentum Healthware, Frog Lake First Nation, Blood Tribe, Loon River First Nation, Whitefish Lake First Nation, Woodland Cree First Nation, and Lubicon Lake. 3 In 2008 the average wait was 6–18 months for a provincial nurse to travel to their community to conduct an interRAI assessment required for receipt of home care (to confirm) and placement into long-term care.

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ty nurses have the tools and skills to assess the care need including for acute, palliative, rehab, long-term care, and supportive living. The successes of this pilot have led to the phased implementation among all forty-four First Nations communities in Alberta by 2018, the development of a national implementation strategy which is underway, and interest expressed among other First Nations communities outside Alberta in adopting the standard assessment tools. In home and community care, the adoption of standardized assessment tools (e.g., interRAI) and provision of local level performance information are two ways to drive change. Information on the quality and safety of care in primary care settings remains more challenging to gather. Although most Canadians (85 percent) have a regular doctor according to the Canadian Community Health Survey from 2014, and a study in Ontario estimated that 80 percent of the population had visited a family or general practitioner in a two year period (CIHI 2012), the information sources are still in their infancy given the relatively slow adoption of interoperable electronic medical records within and across jurisdictions. Performance information in primary care has thus relied in large part on survey data to yield important insights into patients’ and providers’ perceptions of the care they receive. These surveys thus allow for comparisons to be made over time and across jurisdictions, however we are generally limited in our ability to link these responses to administrative data which would allow us to follow the person throughout the care pathway or to associate their responses with their providers. To fill this information gap in primary and community care, there have been several projects to make use of electronic medical records, as well as reporting hospital-based indicators as proxy measures of primary care performance. One such hospital-based indicator captures hospitalizations for ambulatory care sensitive conditions—hospitalizations that may be potentially avoidable if timely and effective primary care is readily available (the types of conditions included in this indicator include diabetes, asthma, COPD). Another is an indicator of medication safety that counts the number of hospitalizations that are due to adverse events from medications (CIHI 2017c). The examples described here provide some insights into how data and information has been adopted in various settings in healthcare to drive innovation to achieve demonstrable quality improvement in healthcare. A common theme throughout these cases is the pairing of a strong health information infrastructure with a commitment to per-

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formance improvement, effective change management and a culture of learning and continuous improvement. While much progress has been made to enable the use of information to drive innovation, there are many challenges remaining to address information gaps in priority areas such as primary and community care, to ensure quality improvement initiatives are improving outcomes for all patients including those most vulnerable, and to shift culture to embrace change. Efficiency In particular, during times of economic recession, health systems tend to shift emphasis from quality improvement to cost containment. Thus a central objective of change and performance improvement in healthcare in recent years has focused on reducing inefficiency. An efficient health system is one that avoids waste of resources (financial, human, time), equipment, supplies, ideas, and energy. It results in the delivery of more or higher quality services and better outcomes, with the same or fewer resources. Efficiency can be estimated for the health system as a whole; such estimates can be analyzed to identify population and health system indicators that are correlated with inefficiency to improve performance improvement. For example, a study of variations in inefficiency across health regions in Canada found that among other things, a higher rate of smoking and hospital readmission in a region were associated with inefficiency (CIHI 2014). Comparable information on efficiency can also be derived from data on the use of services that are considered unnecessary or of little or no clinical value to patients. Recently CIHI partnered with Choosing Wisely Canada (CWC)—a national clinician-led campaign to identify these low value tests, treatments, and procedures—to report on the use of eight of these services across Canada. These include head scans in emergency departments for low-risk patients with minor head trauma, use of benzodiazepine to treat insomnia, agitation, or delirium, and use of low-dose quetiapine (likely used to treat insomnia) among children and youth. The wide variations among regions and facilities in the number of unnecessary tests and procedures performed indicates an opportunity to reduce inefficiency and improve outcomes for patients. The Organisation for Economic Co-operation and Development (OECD) has also worked closely with the Choosing Wisely campaign to develop internationally comparable indicators of inappropriate care. Moreover, its recent report reviewed effective strategies to reduce

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waste in the health system, including obtaining lower prices for medical goods and procedures to better target the use of expensive inputs (OECD 2017). There are a number of quality improvement efforts across the country that target unnecessary and low value care and demonstrate the impact of this type of information on efficiency. For example, North York General Hospital in Ontario updated common lab test order sets based on clinical evidence, and CWC campaign recommendations, which led to a 31 percent decline in the number of low value tests ordered in the emergency department (CIHI and Choosing Wisely Canada 2017). Alberta Health Services identified substantial regional variations in the use of potentially unnecessary tests—specifically statistical toxicology tests (STATs) for psychiatric patients—that were the result of the practice of automatic orders in the Calgary Zone. Implementing order set changes in 2013 to move away from automatic orders to include an additional approval led to a 96 percent reduction in the use of these STAT drug tests, bringing the level closer to Edmonton Zone which had virtually no orders. Similarly Alberta Health Services Laboratory Services was also able to reduce vitamin D testing by 92 percent in a nine-month period following changes to order forms and increased education (CIHI and Choosing Wisely Canada 2017). The take up of performance information to achieve efficiency gains is evident across the system, as evidenced by the shifting culture around identifying and reducing low value services, with the bulk of the activity focused at the clinical and organizational levels to date. There remains a challenge of connecting comparable performance information with ongoing system reforms in the pursuit of efficiency, such as the recent restructuring and centralization of governance structures in several provinces and territories. Because of gaps in health data and information for certain sectors of care, it is also difficult to demonstrate how innovation in one sector of care can lead to efficiencies in others. However, the availability of performance information on efficiency and value for money will expand as data on resource use and spending continue to grow, alongside measures of outcomes such as those reported by patients. The potential for data to drive the innovation in this area will also be strengthened as we move toward convergence of the system managers and public priorities around the need for, and benefits of, improved efficiency in healthcare.

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Patient Perspectives: Opportunities for the Improvement Agenda More patient-centred care is a goal of most health systems in Canada. Historically, performance improvement in health systems has been viewed from clinical and administrative perspectives. Increasingly, this view is expanding to incorporate the perspectives of the recipients of care. Measuring the opinions, experiences, and outcomes of care directly from patients is one of the ways that discussions on healthcare innovation can be expanded in practical terms. An international survey led by the Commonwealth Fund asks Canadians about their healthcare experiences and perceptions.4 The survey is undertaken every year but alternates its focus on a three-year cycle among adults, seniors, and primary care providers. The responses to the survey provides perspective on how well the needs and expectations of Canadian patients are met. Compared to their peers in ten other developed countries, in 2016 Canadians continued to report longer wait times (CIHI 2017c). For example, Canada had the lowest proportion of patients able to get a same- or next-day appointment the last time they needed medical care. Canadians reported less access to after-hours or weekend care (without going to the emergency room) and Canada had the highest proportion of patients waiting four or more hours for a visit to the emergency department. Fewer Canadians than the international average reported skipping a medical appointment, test, or treatment due to cost, demonstrating lower barriers to financial access. This was not the case for medical services not considered insured services under the Canada Health Act. In fact, a higher proportion of Canadians than their international peers said that they did not fill a prescription or skipped a dose due to cost, and more than a quarter (28 percent) reported skipping a dental visit due to cost (CIHI 2017c). Once care is received, however, most Canadians reported positive experiences. In fact, three quarters of Canadians rated the quality of care they receive from their regular doctor or place of care as very good or excellent. Canadians also reported better experiences than their peers when asked about their regular doctor knowing their medical history, being involved in medical decisions, and receiving clear and easy to understand explanations from their doctor. Similarly, Canadians discharged from a hospital reported good planning for follow-up care 4 http://www.commonwealthfund.org/topics/current-issues/international-surveys

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and received written instructions on what symptoms to watch for at home. In contrast, coordination of care between specialists and regular doctors, although in line with the international average, showed room for improvement—one in five Canadians reported their regular doctor was not up to date about the care they received from a specialist (CIHI 2017c). While positive about the care they receive on a one-on-one basis, more than half (55 percent) of Canadians believe the healthcare system overall requires fundamental changes (CIHI 2017c). Questions about the financial sustainability and need for reform are usually raised when Canadian spending on healthcare is compared to other OECD countries, as this shows that Canada is a top spender at $5,543 per capita in 2014 compared to the OECD average of $4,463 (CIHI 2016b). Of course, comparing spending rates does not allow for a comparison of the value received from money spent—which is multidimensional, difficult to define, and therefore very hard to measure. Nevertheless, steps can be taken to enable a better assessment of value for money. One of the steps that can be taken to determine value for money is to get better at measuring outcomes, and in particular, patient-reported outcomes. As noted above, millions of tests, procedures, and drugs used every year may be of limited value to the quality of life and care of patients (CIHI and Choosing Wisely Canada 2017). The Choosing Wisely Canada recommendations are based on clinicians’ experiences. Another way of identifying unnecessary care is by tracking patient-report outcome measures (PROMs). PROMs are tools used to solicit patients’ perspectives on their health status and overall quality of life. They focus on a range of domains such as the presence and absence of symptoms, a patient’s functionality (such as walking, seeing, and activities of daily living), pain and its management, mental health and affect. PROMs assessments can be used to evaluate the overall health of different populations or in different health sectors at specific points in time. They can also be designed to use with patients suffering from particular diseases or conditions. They are particularly powerful when used to measure change over time to track disease progression or the effects interventions (through pre-/ post-intervention measures). These types of PROMs enable an evaluation of the impacts of conditions and healthcare interventions on quality of life. Thus, they allow the effectiveness of services to be evaluated from the patients’ perspective. With more systematic use and over time PROMs programs could en-

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able a shift in health system resource management from an approach that is volume-based to one that is more value-based. This is particularly interesting in a context of fiscal restraint and with the rise of chronic conditions and multiple morbidities. Using PROMs to inform clinical decisions could help reduce low-value care, and focus on interventions with highest likelihood to improve a patient’s quality of life. From a systems perspective, PROMs could inform quality improvement initiatives by providing feedback to clinicians and, ideally, patients themselves by allowing comparative reporting and benchmarking at regional, national, and international levels. In addition, PROMs could be used to support health system performance—for example, by advocating for better access and appropriateness of care based on need (e.g., by monitoring pre-operative disease severity and progression) and by enabling cost-effectiveness assessment by comparing treatment options and care plans. Although still in its infancy as pan-Canadian measures, the United Kingdom (National Health Service 2017) and United States (Centres for Medicare and Medicaid Services 2016) both adopted PROMs programs. Currently, the publicly available My NHS Health System Performance tool reports PROMs for elective surgeries5 and allows comparisons of health improvements reported by patients by procedure and facility. Patient-reported data for hip replacements, for example, show that overall one in four patients (26 percent) undergoing their first surgery did not report reduced pain and discomfort after surgery, while nearly half of patients (47 percent) undergoing revisions did not report improvements in pain and discomfort. Slightly more than half of patients reported improved mobility (52 percent) and functioning (59 percent) after a primary hip replacement (again, gains were lower for hip replacement revision surgeries; National Health Service 2015a). By examining results such as these, patients and their caregivers are better equipped to discuss care options and manage expectations. The ability to benchmark and compare PROMs for local areas to others can also encourage more systematic changes. Using the local PROMs data for their Trust, the Northumbria NHS Healthcare Foundation Trust found they had lower than average health gains for hip and knee replacement surgeries. Using this information, they investigated their practices. In response, they tweaked the way 5 PROMs measure health gain in patients undergoing hip replacement, knee replacement, varicose vein, and groin hernia surgery in England.

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surgeons in the Trust operate for hips and knees, and changed the brand of implants they used for one found to provide better health gains according to patients. As a result, they now outperform most of their peers for health gains their patients make. Other local Trusts have incorporated their hip and knee PROMs data and subsequent investigations into practices to change the way they provide post-operative care, pain management, and rehabilitation following hip and knee replacements (National Health Service 2015b). Data collected directly from patients—whether through surveys or as part of the care process—are increasingly used to assess the performance of health systems and the relative value of different types of care. Patient voices can be important drivers for change and can create openings for innovation. In Canada, patient-reported outcome measures and patient-reported experience measures (PROMs and PREMs) are nascent but promising areas for new data and information on health systems. Conclusion This chapter considered how data and information are critical enablers of an innovation agenda for health systems in Canada. A strong information base is essential to spur innovation and action by • identifying opportunities for innovation by making comparisons and benchmarking possible; • finding initiatives that have been demonstrated to work so that they can be scaled or spread; and • highlighting where efforts are likely to yield the greatest impact by evaluating which interventions are most effective and cost-efficient. Canada has a strong, comparable, administrative information base for hospital services, and a growing base of clinical and administrative data for long-term care and home care. As described in this chapter, these have been used to improve the quality and safety of care in these sectors and to measure (in)efficiency in health systems. Increasingly, patient-reported data is being used to support more patient-centred care and to evaluate value for money. Despite advances in the digitization of medical records, gaps in standardized and comparable data from sectors such as primary healthcare and community mental health services, continue to inhibit learning and scaling of best practices in

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these sectors. Data and information gaps in these sectors also create difficulties for evaluating system performance and supporting innovation within the health system as a whole. Filling these gaps should be prioritized as part of Canada’s health systems innovation agenda. In addition, as we said at the outset of this chapter, more than data is needed for innovation to take root. Research by Moynihan and colleagues on the factors associated with performance information use in the public sector emphasizes the importance of what they call “transformational leadership” (Moynihan, Pandey, and Wright 2012). Transformational leaders set the tone of their organization’s orientation to performance management by shaping “key conditions (improved goal clarity and a more innovative culture) that in turn shape performance information use.” What is more, “purposeful performance information use” (rather than passive or political use) which uses information with the explicit goal of improving performance, “is a form of behavior that, in most public organizations, fosters collective … benefits” (Moynihan et al. 2012). In addition to transformational leadership, the successful and sustained adoption of evidence to improve quality and effectiveness of care also depends on effective and active change management (Damschroder et al. 2009). A recent review of the literature identifies the key success factors associated with the implementation of best practice into routine use within health organizations (Braithwaite, Marks, and Taylor 2014). These include preparing for change, training on how an intervention or action will be implemented, promoting a culture of safety and collaboration, providing time and resources, and harnessing opinion leaders or champions to support change (Braithwaite et al. 2014). Transformational leadership and change management can foster innovation and support the scale and spread of innovations across organizations and systems. However, to achieve this successfully, leadership also needs to create organizational environments that enable the purposeful use of performance information to be translated into innovation. This means shifting cultural norms that do not make room for error or are unable to tolerate certain kinds of failure. A caveat to our earlier comments on health system efficiency is that innovation in Canadian healthcare is burdened, as is the public sector more generally, by particular accountability constraints. A powerful tension exists between the twin imperatives for efficiency (stewardship of public dollars) and innovation (aimed at performance improvement). In practice, the efficiency imperative has tended to carry more weight than the in-

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novation imperative. The upshot is often that the pursuit of efficiency can crowd out the goal of innovation by insisting on the elimination of “good waste” (the costs of experimentation) as well as “bad waste”— the costs of inefficiency (Potts 2009). Healthcare innovation, whether local or large scale, requires a strong underlying health information infrastructure as well as a widespread culture of performance measurement, effective change management, continuous improvement, and a tolerance for “good” failure. Integral to the innovation agenda will be the continued effort to fill key information gaps in care received outside hospital, the quality of care and outcomes of vulnerable populations, and experiences and health gains reported by patients. References Alberta Health Services. n.d. Appropriate Use of Antipsychotic Medication in Dementia Summary. http://www.albertahealthservices. ca/assets/about/scn/ahs-scn-sb-seniors-aua.pdf Angus, D. C., W. T. Linde-Zwirble, J. Lidicker, G. Clermont, J. Carcillo, and M. R. Pinsky. 2001. “Epidemiology of Severe Sepsis in the United States: Analysis of Incidence, Outcome, and Associated Costs of Care.” Critical Care Medicine, 29 (7):1303–10. PMID: 11445675 Anti-Racism Directorate—Ontario. 2017. A Better Way Forward: Ontario’s 3-Year Anti-Racism Strategic Plan. https://files.ontario.ca/ar2001_ard_report_tagged_final-s.pdf Ballard, C., and R. Howard. 2006. “Neuroleptic Drugs in Dementia: Benefits and Harm.” Nature Reviews Neuroscience, 7(6):492–500. doi:10.1038/nrn1926 Banerjee, S. 2009. The Use of Antipsychotic Medication for People with Dementia: Time for Action. London: Department of Health. https://www. rcpsych.ac.uk/pdf/Antipsychotic%20Bannerjee%20Report.pdf Braithwaite, J., D. Marks, and N. Taylor. 2014. “Harnessing Implementation Science to Improve Care Quality and Patient Safety: A Systematic Review of Targeted Literature.” International Journal for Quality in Health Care. 26 (3):321-9. doi:10.1093/intqhc/mzu047 Canadian Foundation for Healthcare Improvement. 2014. Improving the Lives of Patients at Personal Care Homes in Winnipeg and Beyond: Innovative Approach Finds Major Savings. http://www.cfhi-fcass.ca Canadian Institute for Health Information (CIHI). 2007. HSMR: A New Approach for Measuring Hospital Mortality Trends in Cana-

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da. https://secure.cihi.ca/free_products/HSMR_hospital_mortali ty_trends_in_canada.pdf ———. 2009. In Focus: A National Look at Sepsis. https://secure.cihi.ca/ free_products/HSMR_Sepsis2009_e.pdf ———. 2012. From Clinician to Cabinet: The Use of Health Information Across the Continuum. https://www.cihi.ca/sites/default/files/doc ument/hsu_clinic_cab_pdf_en.pdf ———. 2013. A Performance Measurement Framework for the Canadian Health System. https://secure.cihi.ca/free_products/HSP_Frame work_Technical_Report_EN.pdf ———. 2014. Health System Efficiency in Canada: Why Does Efficiency Vary Among Regions? https://secure.cihi.ca/estore/productFamily. htm?locale=en&pf=PFC2561 ———. 2015. Trends in Income-Related Health Inequalities in Canada: Technical Report. https://www.cihi.ca/en/trends-in-income-relat ed-health-inequalities-in-canada ———. 2016a. “CIHI wins award at the ITAC 2016 Ingenious Award Gala.” https://www.cihi.ca/en/cihi-wins-award-at-the-itac-2016ingenious-award-gala ———. 2016b. National Health Expenditure Trends, 1975–2016. https://se cure.cihi.ca/free_products/NHEX-Trends-Narrative-Report_2016_ EN.pdf ———. 2017a. CIHI’s Strategic Plan 2016–2021. https://www.cihi.ca/ en/about-cihi/corporate-strategies/cihis-strategic-plan ———. 2017b. CIHI Data Helps Put Philosophy Into Practice. https:// www.cihi.ca/en/cihi-data-helps-put-philosophy-into-practice ———. 2017c. How Canada Compares: Results from the Commonwealth Fund’s 2016 International Health Policy Survey of Adults in 11 Countries. https://www.cihi.ca/en/commonwealth-fund-survey-2016 Centers for Medicare & Medicaid Services. 2016. CMS Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs). Baltimore, MD: Centers for Medicare & Medicaid Services. https://www. cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ Value-BasedPrograms/MACRA-MIPS-and-APMs/MACRA-MIPS-andAPMs.html CIHI, and Choosing Wisely Canada. 2017. Unnecessary Care in Canada. https://www.cihi.ca/en/unnecessary-care-in-canada CIHI, and Canadian Patient Safety Institute. 2016. Measuring Patient Harm in Canadian Hospitals. What Can Be Done to Improve Patient

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Safety? by B. Chan and D. Cochrane. https://www.cihi.ca/sites/de fault/files/document/cihi_cpsi_hospital_harm_en.pdf Commonwealth Fund, The. 2006. Framework for a High Performance Health System for the United States. New York: The Commonwealth Fund. Damanpour, F., and W. Evan. 1984. “Organizational Innovation and Performance: The Problem of ‘Organizational Lag.’” Administrative Science Quarterly, 29 (3): 392–409. doi:10.2307/2393031 Damschroder, L. J., D. C. Aron, R. E. Keith, S. R. Kirsh, J. A. Alexander, and J. C. Lowery. 2009. “Fostering Implementation of Health Services Research Findings into Practice: A Consolidated Framework for Advancing Implementation Science.” Implementation Science, 4: 50. https://doi.org/10.1186/1748-5908-4-50 Fekri, O, J. Amuah, V. Herasimovich, Z. Chaudhary, K. Leeb, and Y. Gurevich. 2015. “Palliative Care Coding Practices in Canada Since the Introduction of Guidelines and the HSMR Indicator.” BMJ Open, 5 (11): http://dx.doi.org/10.1136/bmjopen-2015-008753 Jalbert, J. J., C. B. Eaton, S. C. Miller, and K. L. Lapane. 2010. “Antipsychotic Use and the Risk of Hip Fracture Among Older Adults Afflicted with Dementia.” Journal of the American Medical Directors Association, 11 (2): 120–7. doi:10.1016/j.jamda.2009.10.001 Moynihan, D., S. K. Pandey, and B. E. Wright. 2012. “Setting the Table: How Transformational Leadership Fosters Performance Information Use. Journal of Public Administration Research and Theory, 22 (1): 143– 164. https://doi.org/10.1093/jopart/mur024 Molas-Gallart, J., and P. Tang. 2011. “Tracing ‘Productive Interactions’ to Identify Social Impacts: An Example from the Social Sciences.” Research Evaluation, 20 (3): 219–226. https://doi.org/10.3152/09582021 1X12941371876706 National Health Service. 2015a. Patient Reported Outcome Measures (PROMs) in England—2012–13, Special Topic, Quality of Life Dimensions. http://content.digital.nhs.uk/catalogue/PUB17479 National Health Service. 2015b. PROMs Clinical Case Study: Data Informs Clinical Practice. http://content.digital.nhs.uk/article/6542/ PROMs-clinical-case-study-data-informs-clinical-practice National Health Service. 2017. Patient Reported Outcome Measures (PROMs). http://content.digital.nhs.uk/proms Naylor, C. David, Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare Innovation.

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Ottawa: Health Canada. http://www.healthycanadians.gc.ca/publications/ health-system-systeme-sante/report-healthcare-innovation-rapport-soins/ alt/report-healthcare-innovation-rapport-soins-eng.pdf Nova Scotia Health and Wellness. 2016. Health Data Sharing Agreement Will Improve Health Care in First Nations Communities. NS News Release. https://novascotia.ca/news/release/?id=20160324006 Nutley, S. M., I. C. Walter, and H. T. O. Davies. 2003. “From Knowing to Doing: A Framework for Understanding the Evidence-into-Practice Agenda.” Evaluation, 9 (2): 125–148. https://doi. org/10.1177/1356389003009002002 Organisation for Economic Co-operation and Development (OECD). 2017. Tackling Wasteful Spending on Health. http://www.oecd.org/pub lications/releasing-health-care-system-resources-9789264266414-en. htm Potts, J. D. 2009. “The Innovation Deficit in Public Services: The Curious Problem of Too Much Efficiency and Not Enough Waste and Failure.” Innovation: Management, Policy & Practice, 11 (1): 34–43. https:// doi.org/10.5172/impp.453.11.1.34 Schneider, L. S., K. S. Dagerman, and P. Insel. 2005. “Risk of Death with Atypical Antipsychotic Drug Treatment for Dementia: Meta-analysis of Randomized Placebo-controlled Trials.” Journal of the America Medical Association, 294 (15): 1934–43. doi:10.1001/jama.294.15.1934 Wyatt, R., M. Laderman, L. Botwinick, K. Mate, and J. Whittington. 2016 Achieving Health Equity: A Guide for Health Care Organizations: IHI White Paper. Cambridge, MA: Institute for Healthcare Improvement. www.ihi.org

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The Management of Innovation: Strengthening Patient Safety and Creating Value through Supply Chain Transformation Anne Snowdon and Charles Alessi

Introduction While quality and safety have been the fundamental goals of all global healthcare systems, performance of North American healthcare systems remains far behind that of other OECD countries: Compared to the other eleven countries in the OECD group, Canada ranks tenth and the United States ranks last (Davis, Squires, and Schoen 2014). Despite many well-funded initiatives to strengthen quality and safety, healthcare systems worldwide have not been able to achieve significant improvement in these key dimensions of health system performance. One of the key drivers of quality and safety in health systems is healthcare delivery—something that is becoming more complicated as countries experience increasing demands for health services for their aging populations, and health products themselves—pharmaceuticals, medical devices, new technologies—become more complex and more expensive. While new and innovative technologies, devices, and drugs are being introduced in health systems with the promise of strengthening A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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quality of patient care, to date, there is no health system in the world that has been able to accurately assess the safety, quality, or value of products or technologies used in health services delivery at the system level. Specifically, health systems cannot document or evaluate product effectiveness, safety, or value because health systems cannot track or trace products, care procedures, or outcomes to an individual patient. This is a system infrastructure challenge in the health sector. Patient safety is a particular challenge, despite more than two decades of research and safety initiatives to define the problem at both a national and a global level. Medical error, a core element of patient safety, has now become the third leading cause of death in North America, behind heart disease and cancer. In the United States, approximately 440,000 patients die annually from medical error; in Canada, that figure is 23,000 (Makary and Daniel 2016; Baker and Black 2015; Statistics Canada 2017; Centers for Disease Control and Prevention 2017). In the United Kingdom, the rate of preventable deaths in English National Health Service acute hospitals has been estimated at 5.2 percent of deaths occurring in hospital, which extrapolates to 11,859 preventable deaths in hospitals in England (Hogan 2012). Although there is growing awareness of the challenge of patient safety, there has been little evidence of improvement in the increasing rates of deaths and serious injury related to error and adverse events. Safety outcomes are not well documented in community and long-term care settings. Not only are adverse events, particularly those that are preventable, devastating for patients and their families, they are very costly to the patient, to the organization, and to the healthcare system more broadly. The important question to consider is why quality and safety continue to be so resistant to improvement with the many initiatives and investments made to strengthen the safety of patient care in health systems. This chapter describes the features of healthcare systems and the infrastructure strategies that could support and accelerate progress towards a safe, high performing healthcare system. We propose a strategy to transform clinical environment infrastructure, which is currently very manual and paper-based, to create a high performing digital supply chain strategy for Canadian and global health systems. Transforming supply chain strategies in health systems holds the key to achieving substantial cost savings to contribute to system sustainability, while at the same time strengthening quality and safety, both within and across global health systems.

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Current Supply Chain Infrastructure in Health Systems In healthcare, “supply chain” refers to the information, supplies, and finances involved with the acquisition and movement of goods and services from the supplier to the end user in order to enhance clinical outcomes while controlling costs (Luke, Walston, and Plummer 2003). A robust supply chain system that is highly visible tracks every product, every patient, and every process in healthcare digitally and intuitively, requiring little effort on the part of clinicians. This makes the entire continuum of care transparent and visible for all stakeholders—most importantly, patients and provider teams. The majority of business sectors outside of healthcare employ advanced supply chain systems, with embedded tools and technology that enables full transparency of the movement of products and processes. Supply chain processes in sectors such as retail, grocery, and pharmaceuticals create visibility to support strategic value that enables sector leaders to measure the effectiveness, efficiency, performance, and value of every step of the business process. Examples of a well-developed supply chain can be seen in many industry sectors, which have been able to achieve tremendous impact in terms of safety, efficiency, and performance. The grocery industry, for example, tracks every food item from the farm to the end consumer to ensure that safety and traceability are highly visible. This allows consumers to be notified immediately in the event that food items are found to be contaminated or unsafe. In the event of food contamination or medication recall in the retail sector, consumers are identified in as little as 60 minutes, to mitigate the risk of products causing harm. Such automated supply chain infrastructure and use of tracking tools can transform healthcare environments to support clinicians to ensure every product and care process is delivered to patients safely and accurately. One of the most significant limitations of clinical environments in health systems today is the absence of tools and infrastructure that track and trace patients, products, and procedures to create system-wide visibility of care processes and product use (e.g., medications, devices, and implants) and the outcomes achieved for patients (Sedrakyan 2012; Rising, Reynolds, and Sedrakyan 2012). While retail groceries or pharmacies can recall a product within 60 minutes, there is no comparable capacity in health systems to identify what products patients are receiving. Thus, if a food product is recalled for possible E. coli contamination, Canadian hospitals simply do not know which of

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their patients may have received that product on a food tray. Similarly, there is currently no system-level infrastructure that can identify those patients who have received an implantable device or joint implant that is recalled so that patients can be notified for follow-up care. This is not just a Canadian failing, however: There is no health system in the world that has implemented this kind of system-wide infrastructure. In short, the current supply chain strategies in health systems have contributed to the following key challenges in health systems: • There is no system capacity globally to track and trace health products (including devices such as stents, pacemakers, joint implants, etc.) to link products and care procedures to either patient health outcomes, nor assess the strategic value of these products for patients or health systems (i.e., cost of the products versus the value the product achieves for patients and health system outcomes). • Health system supply chains are complex and challenging to navigate; moreover, they are unique in each country. Health products are manufactured and distributed globally, yet there is no collaboration or alignment of supply chain pathways, policy, or strategy across global borders, which is costly for manufacturers who must navigate multiple, complex pathways to get their products to market in each country and each jurisdiction (province or state) in each country. • Policy and regulatory frameworks vary widely across jurisdictions. The lack of clearly aligned regulatory requirements across global jurisdictions adds significant complexity and cost to manufacturing and product distribution for industry, which contributes to the cost of products and health systems globally. • Supply chain knowledge and leadership capacity in healthcare is lacking compared to other industry sectors. Supply chain practices and best evidence established in business schools have focused on traditional business sectors such as retail and manufacturing, with little or no attention to the complex and unique features of supply chain in the health sector. • Business models that support the transformation of a supply chain into a strategic asset are not well developed. There are few business models that inform health leaders of the return on investment and strategy required to transform the health supply chain to be a strategic asset to achieve safety, cost savings, and stream-

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lined inventory management of products in health systems. • The transportation of health products across borders is not linked to health system inventory, and mechanisms to identify counterfeit products, product tracking, and traceability, which are not well developed and often non-existent. Processes that link transportation of health products across global borders to health systems to enable traceability of products are needed to ensure authenticity, safety, availability, and access to life saving products in healthcare. • Supply chain measurement strategies to document outcomes and impact of supply chain efficiency are not well developed. Although health systems have well developed measures of health system cost, quality, safety, access, and performance, there are no such measures of supply chain impact such as inventory management, product recall, adverse event prevalence, out of stock or expired products. Strategic Supply Chain Infrastructure in Health Systems Supply chain transformation in health systems would enable tracking products from manufacturer to patient outcome, automating inventory processes to achieve transparency in product supply and demand to reduce product shortages, reduced inventory costs, and reduced risk of adverse events (e.g., wrong medication to wrong patient), which achieve safer and more cost-effective health services. Strategic supply chain processes create transparency and traceability that ensures only the inventory needed for patient care is purchased, and products used in procedures are linked to patient outcomes to understand value and outcomes for patients. Tracking products and processes to patient outcomes, not only informs opportunities for new product designs and innovation, but also identifies the value of care procedures relative to cost and patient outcomes. The economic imperative for health systems is compelling: The cost of supply chain inefficiency today is estimated to account for 25 percent of drug costs and 40 percent of the cost of medical devices (Ebel, Larsen, and Shah 2013). While some progress in supply chain innovation has begun to emerge across the United Kingdom and Australia, there is little collaboration across global health systems to accelerate the transformational change in health sector supply chains globally. A modern and integrated supply chain requires redesigning clinical

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infrastructure to include tools (i.e., barcode scanning to identify products, patients, and procedures linked to patient records) and processes in clinical environments to transform supply chain strategies to be as successful as other industry sectors. Ultimately, automated supply chain processes built into clinical environments achieve safe patient care, efficiency of service delivery, and cost savings related to inventory and reduction in adverse events. Traceability of people, products, and processes offer visibility in healthcare systems to support accountability to citizens for the value proposition that health systems deliver to populations—safe, accountable care that delivers value to all stakeholders, is cost effective and sustainable. Figure 8.1 illustrates the key features of a highly visible healthcare system, characterized by embedded tools that track and trace every process in the supply chain. The following are the key features of strategic supply chain capacity in health systems necessary to strengthen safety and performance of health systems. Adoption of GS1 Standards The most important step needed to transform supply chain in health systems is creating the policy framework requiring that the healthcare sector uses global GS1x standards that identify products, people, and processes used in care delivery and link them to patient outcomes. The standards essentially create a common language that enables every health system globally to track products, care processes, and patient outcomes, as well as to track quality and safety of healthcare services. GS1 standards offer an internationally accepted system to achieve the following: (a) to identify products and manage inventory, (b) to ensure that products are available when and where they are needed, and then (c) to track products used in care delivery to determine value and impact for patients. Many business sectors have adopted GS1 standards, including grocery and retail pharmacy, to enable fully automated systems for traceability of food and pharmaceutical products to individual consumers. Health systems in both the United Kingdom and the United States have adopted GS1 standards, and they both report this as the single most important catalyst to transform supply chain infrastructure in their health systems. Once policy makers establish this requirement, healthcare organizations can ensure only products with GS1 barcodes are used, thus leveraging the global language of GS1 to encode criti-

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Figure 8.1 Key Features of a Highly Visible Healthcare System

Source: Author’s compilation.

cal supply chain product and process information, that is standardized across health systems worldwide, to create the traceability needed in the health sector. Automated e-Commerce Processes Inventory management using standardized GS1 product identification enables healthcare systems to ensure that minimal product inventory is maintained and products are available when and where they are needed. Product inventory is more accurately managed based on evidence of demand and safety of products relative to patient outcomes. Currently, most clinical units use paper-based inventory management that is based on a “best guess” of product utilization needed in health services. This has a tendency to result in purchasing more products than are actually used. Thus, automated e-commerce reduces the high-

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ly prevalent waste of products that are purchased and then discarded when expiry dates are exceeded. When inventory is based on accurate product demand, expiry dates are monitored to ensure products are used within product expiry time frames, and product attributes are available to ensure the right product is used for the right patient. Automated e-commerce ensures that every time a product is removed from inventory and used for patient care, it is scanned and automatically replenished by generating a purchase order to maintain inventory and avoid shortages of products. Automated e-commerce tools in healthcare enable automated inventory management based on patient care volumes and product demand during care procedures. This reduces the risk of waste due to expired dates, it reduces the cost of carrying too much inventory, and it enables tracking of utilization with automated replenishment to minimize inventory costs while at the same time ensuring that a product is available when and where it is required (Snowdon et al. 2012). Automated Tracking, Traceability, and Reporting An important feature of strategic supply chain processes is the implementation of clinical safety tools to track the products and processes linked to each individual patient, which in turn is used to evaluate safety and effectiveness of care outcomes. Automated barcode scanning offers an alert system for provider teams that alerts the provider to potential error when the product barcode and the patient ID barcode are incompatible. Consider how these tools would work in an operating room where every surgical item (e.g., sponge, clamp, suture) is scanned and linked to the patient’s ID barcode to enable automated counts of products used in each individual surgical case. By way of comparison, consider a grocery store clerk who scans every food item: the item appears on the monitor for both the cashier and the customer to see. In a hospital operating room, so, too, would all surgical products be scanned and displayed on monitors for the clinical team to visualize and reconcile all products used at the end of the surgery. The visual representation of the scanned product list offers two opportunities: (a) the complete listing of items to account for, ensuring that no foreign body is left in the surgical cavity, and (b) an accounting of product use for each surgical patient to provide an accurate case costing for each patient that not only accurately identifies cost, but also links cost to quality of patient outcomes to assess the true value of the surgical care procedure.

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Traceability of Product Outcomes Product attributes, such as presence of latex or metal, linked to patient health records, enables notification of product contents to clinical teams to prevent adverse events (e.g., latex allergy, MRI causing harm to patients with metal implants). Traceability of products, care processes, and patients would automate product recall to quickly and effectively identify patients who have received the recalled product for follow-up care. In Canada, there are an estimated 3,500 recall notifications annually from Health Canada and product manufacturers reporting product failures or product warnings. In most health systems, recalls are not possible due to the requirement for reviewing patient care records by hand to identify patients who have received the product. For example, currently there are over 500,000 patients globally who received a hip implant device that has been recalled due to harm experienced by a number of these patients (Sedrakyan 2012). There is no capacity to identify these patients, given the lack of traceability of products across global health systems. An automated process of tracking and tracing such product notifications creates “extreme transparency” by enabling safety information to be reported and made available to patients and providers to inform care decisions. An automated recall and tracking system not only enables system-wide analysis of adverse events, it also provides automated feedback for clinical teams, to inform practice and streamline preventive measures that would reduce the risk of error that causes harm to patients. Traceability across health systems and global jurisdictions also provides visibility to industry, whereby patient outcomes and adverse event data specific to product batch and lot numbers can very quickly inform industry of patterns of adverse events to readily identify product failure and remove the product from the market before too many patients experience harm. A case currently in the court system projected 500,000 patients who had received a joint implant that is now causing harm (e.g., cardiac disease) for patients (Sedrakyan 2012). Traceability across health systems would have identified this trend in patient harm long before half a million patients had received the implant device, potentially saving millions of dollars for the company, which is now facing a very significant class action lawsuit. Measuring Impacts of Strategic Supply Chain Outcomes Unlike so many other business sectors, there are few, if any, global health systems that measure the impact and effectiveness of strate-

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gic supply chain processes relative to patient safety outcomes at the system level. There is currently no ability to identify outcomes across global or system-level jurisdictions. A robust measurement framework to track progress towards strategic supply chain management includes key metrics that track and monitor the prevalence and type of adverse events using automated reporting that is traceable across health organizations. Key metrics would also track inventory management outcomes such as frequency of product shortages, product safety outcomes linked to individual patients, inventory cost, accurate case costing, rate of shortages and stock-outs, the rate of adverse events that are proactively prevented, and the effectiveness of prevention strategies. Supply chain measures inform and support accountability, empowered by automated reporting to clinical teams and health system leaders, to understand root causes of adverse events that inform risk mitigation strategies. Measurement enables clinical teams to design and evaluate risk mitigation strategies to protect patients from harm, achieving optimal outcomes for individual citizens and populations. The Value Proposition of Strategic Supply Chain Innovation In order to implement and scale innovative supply chain infrastructure in health systems, the value proposition of supply chain outcomes for stakeholder groups must be considered—patients, clinicians and provider teams, health organizations, industry, and healthcare systems more broadly. While the word “value” has many definitions, we define the concept of value as a quality based on a person’s principles or standards, one’s judgment about what is valuable and important in life, and what a person deems important. Values are learned and are often influenced by parents, teachers, religion, social networks, and society more broadly. People’s values are often a function of how they were socialized, both formally in school and informally by family, friends, and communities. (Snowdon et al. 2012)

The value proposition for what a strategic supply chain solution offers each stakeholder group in health systems must be clearly delineated to support successful implementation. The unique value propositions are outlined as follows.

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Value Proposition for Patients and Families Patients and families value and expect safe, effective care that is accessible when and where it is needed, and that contributes to quality of life, health, and wellness (Snowdon et al. 2012). Strategic supply chain innovation in healthcare systems tracks and accounts for all transactions linked to individual patient records, which can in turn be made easily accessible to patients and their families. Specifically, the effectiveness of treatments, procedures, or medications is tracked and recorded so that every patient and family can understand what products or processes were used during care procedures, that can help inform patient decisions on care strategies to progress towards their health goals. This comprehensive record can be shared with clinicians across the continuum of care. Such comprehensive tracking and traceability enables patients to schedule and manage follow-up care. It can also be used to inform decision making to support self-management of health conditions, manage provider appointments, and navigate care pathways. For example, in a highly visible health systems, all medications are tracked and linked to patient records and pharmacy data files to ensure medications can be tracked, including alerts and recalls, to avert risk of medication interactions and allergic responses. Patients and their families are readily able to manage health information ensuring that the complex nature of care can be understood and tracked with priority information (e.g., medication profile, allergy status, diagnostic investigations completed) that is readily accessible. The ability of patients to know what care procedures were conducted, by whom, using what products (e.g., pacemaker, joint implant, stent) offers significant visibility to patients that can reduce the stress and uncertainty of healthcare processes. Patients are able to access their health information to inform their discussions and decisions with providers to more effectively support self-management of health conditions. For many sectors of the population who suffer multiple comorbidities, access to accurate health information can reduce the risk of adverse events and can empower patients to overcome the challenges related to multiple provider treatments and therapies. In addition, supply chain traceability strengthens public reporting of health system performance and outcomes across populations and jurisdictions, including the rate and type of adverse events, safety outcomes linked to products and care processes, and key outcomes of health services delivery such as quality of care, safety, and population level outcomes that are meaningful to consumers. When strategic supply chain

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innovation is scaled across health systems, all patients are able to track their progress towards personal goals, make informed healthcare decisions, oversee accuracy and effectiveness of care, which contributes to quality outcomes of health systems (Marshall et al. 2003). In fact, public reporting has been found to be a highly effective strategy for improving measures of healthcare performance, in addition to quality and safety (Totten et al. 2012). Value for Clinicians and Provider Teams Strategic supply chain processes enable and support provider teams in three ways: first, they provide access to detailed and accurate patient information across the care continuum; second, they reduce workload related to adverse event reporting and risk mitigation; finally, they provide an “early warning” system to proactively identify risk of adverse events that clinicians can use to proactively intervene to effectively prevent and protect patients from harm. While clinical teams and providers see patients every day in healthcare settings, they do so with little insight into the patient’s medical record across the continuum of care. Thus, every patient interaction with a provider must necessarily start from “ground zero,” requiring the provider to assess patients in detail, go over every event or care interaction they have experienced, and recount medications, treatments, or procedures they have received in their care journey. Providers must piece together the patient’s story in sufficient detail to inform care decisions, and they must rely on the accuracy of the patient’s account of their history when making these decisions. In a highly visible system, clinicians no longer “work in the dark.” Patient care processes, products used, and care procedures are tracked and shared with patients to support access to information—how many times a person has been to the emergency department, or what exacerbations or health challenges have been experienced in the last several days, weeks, months, or years. Patients and providers have access to outcomes of specialist care, wait times between these phases of care, and line of sight towards how the condition or health outcomes may have impacted patients or changed during waiting periods (Pedersen, Schneider, and Scheckelhoff 2015). Such access informs provider teams or clinicians of the professionals with whom they will need to engage or collaborate across the continuum of care, including clinical specialties and clinical units. One of the key issues related to current safety reporting systems is

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the workload they place on provider teams. In a highly visible system, the workload required to complete adverse event reports for clinicians and provider teams is automated to reduce time. Digital tools in clinical environments automatically generate reports to clinical leaders and decision makers, thus tracking all adverse events, the type and prevalence of events across systems. Alberta Health Services has implemented this type of tracking across the entire provincial health system. Adverse events are digitally reported and tracked, and a dashboard to measure impact and outcomes of adverse events is distributed to clinical teams, to support rapid intervention and ensure future risk of harm to patients is reduced. This system identifies root causes so that faulty equipment or failed products can be removed and clinical processes can be strengthened (where needed) to prevent recurrence of adverse events. This comprehensive reporting system enables system learning so that adverse events in one setting informs and enables prevention of those same events in other settings across the province. Such automated reporting not only informs organizations and provider teams of the patterns of potential or actual adverse events, they also inform strategies to mitigate future risk and inform accountability frameworks related to quality and safety initiatives. Objective data can be linked to stakeholders to create a system of learning and accountability. Provider workload is further reduced by automated recall management in the event of a failure in product performance. As a clinician is working with a patient, scanning a device or scanning a medication creates an early warning system by identifying a red light to signal potential error, such as wrong product, wrong patient, or wrong procedure. Clinicians have no such early warning system in today’s clinical settings. In the words of one general surgeon, “why don’t we have this system in our hospital? I have a patient with a stent and no one can tell me if it has metal in it so I can decide whether she can have an MRI” (general surgeon, personal communication, May 2016). Value for Healthcare Organizations Organizations strive to balance patient care demands and wait times within fiscal resources that support safe, high-quality care delivery. Healthcare organizations work within tight budgets and must use their limited resources wisely. Procurement of products and supplies accounts for significant costs for health systems. To be efficient and cost effective, procurement departments must have valid and reliable in-

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formation on product demand and quantities required for each unit. Yet purchases are often made without objective information on patient demand or need, or product performance and value for patients. As a result, procurement departments may purchase too much, too little, or the wrong type of product (using lowest cost as the deciding factor), equipment, service, or medications for a particular patient population. A strategic supply chain enables comprehensive tracking and tracing of goods, consumables, and medications within a healthcare organization to identify the products that offer the greatest value to patients. Information regarding product performance and outcomes add tremendous value to procurement teams, offering data to inform purchasing decisions and to determine the value and return on investment linked to product and patient outcomes. Strategic supply chain processes have the potential to achieve significant cost savings to healthcare organizations and the healthcare system as a whole. Inventory savings have been identified anecdotally in a number of reports (Ebel et al. 2013). In a current study (Snowdon, forthcoming) of system leaders in the UK, Australia, and Canada, respondents estimate an $8 million savings in inventory tracking and product procurement for every $1 million invested in infrastructure (such as standards adoption, barcode scanning, and data infrastructure). These figures do not include additional savings related to patient safety outcomes or reduced product shortages. Inventory management has been a significant focus in US health systems, and it is now emerging as a focus in Canadian healthcare systems. Supply chain transformation enables accurate, value-based procurement in health systems whereby products are procured based on the true value of a product or technology determined on the basis of patient outcomes, product performance, and the impact on workload and ease of use for clinicians. Traceability of products linked to patient outcomes makes it possible to accurately assess the cost and return on investment of products through such linkages. Strategic supply chain processes enable procurement teams to work closely with clinical teams to review product outcomes, tracking these to identify the real cost and value for patients and the workload impact for clinicians. There is a widespread view that physicians are a major barrier to supply chain transformation because many “prefer” a particular brand of product, particularly in cardiology, spinal medicine, and orthopaedics (Eckler and Schneller 2015). Yet, a key enabler of improved supply chain performance is leadership from physicians who can access objective data to understand the value proposition in improving the supply chain,

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that offers a rational basis for decision making in procurement and standardization of health products used in patient care. Cost savings potential is substantial given that products used in healthcare services account for the second largest health system cost after labour (Smith and Pohl 2011). Value for Industry The pharmaceutical and medical device industries rely on sales of products that enable healthcare systems to meet the needs and demands for care. In many cases, these are lifesaving treatments and interventions that greatly increase life expectancy and quality of life. Healthcare systems rely very heavily on cutting-edge technologies and innovative products that enable clinical teams to deliver high-quality, safe, effective care. The tracking and reporting of patient care, products, and outcomes enables systematic assessment and in vivo evidence to demonstrate product performance. Traceability also affords much greater objectivity and accuracy in assessing product performance to identify those products that are being used in particular clinical settings, the patients who are receiving them, and the frequency and purpose of product use. Such a system quickly and accurately identifies patient risk early, before thousands of patients receive products or care that place them at risk. Despite this, manufacturers have no access to objective health system data or evidence of outcomes to inform their innovative product design and development, or to work with health systems to either introduce products with demonstrated safety outcomes, or remove products demonstrating patterns of harm or failure. In the current system, industry representatives have very restricted access to clinicians or clinical teams, and there is no objective, data-driven evidence linking product use and patient outcomes to product design and performance. Objective evidence of product use and patient outcomes empowers industry to identify the needs of patients and clinical teams in healthcare systems based on objective evidence. Manufacturers are able to more accurately assess the value of their products, identify which products work best for which segment of patients, and determine how the next generation of products can be improved. Transparency also offers manufacturers insights into whether products are being used as they were intended, and can offer accurate data to identify when and where error in the use of a product needs to be addressed. This evidence becomes

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critical for industry to build market growth in global health systems. Industry has very well developed supply chain processes that track every product, raw material, and manufacturing process. Yet, this same high performing supply chain system has not been adopted by healthcare systems using global (GS1) standards. The Canadian Pharmaceutical Barcoding Project (Institute for Safe Medication Practices Canada 2013) has made headway in attempting to establish tracking and identification of pharmaceuticals to reduce preventable medication errors in Canadian health systems. While this project detects and attempts to address preventable medication errors caused by human error, the tracing of pharmaceutical use in aggregate to show adverse events and reactions of drugs has not yet been demonstrated. The value proposition of strategic supply chain processes for industry are significant. The movement of products into health systems using automated generation of purchase orders to replenish stock, inventory tracking to avoid stock-outs (i.e., out of stock or expired products), or urgent requests for product, are cost effective and reduce the burden on industry to manually process orders and urgently supply products when stockouts have occurred. The access to objective data on product use, also informs industry on the opportunity for designing and developing the next generation of products and technologies for global health systems. Value for Healthcare System Leaders and Policy Makers Value for healthcare systems is defined by the quality outcomes achieved across a defined population served by the health system and the cost of providing that care (Porter 2010). Yet value is not well measured for the majority of healthcare systems (Porter 2010). Visibility in healthcare systems—relative to accurate measurement of cost and quality outcomes at the product and patient levels—holds the potential to accurately measure value (Smith 2016). Porter (2010) underscores the importance of value, making clear that what is most centrally important in healthcare is what matters to patients, and that value for patients must therefore be central for all stakeholders in the system. The value proposition for policy makers of a highly visible system is linked to the legislated mandates of publicly funded healthcare systems such as those in Canada, the United Kingdom, Australia, and the Medicare/ Medicaid/Veterans Affairs healthcare systems in the United States, among many others. The objective and comprehensive data that comes from strategic supply chain innovation can be used to guide and inform

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cogent policy and legislation strengthened by objective evidence that is fully visible across entire health systems. For example, the Canada Health Act—the federal legislation that guides all provincial healthcare systems—protects and upholds the expectation of the Canadian public, through the legislative requirement for all healthcare systems to be publicly administered. Ministries of health in every province and territory must uphold the key legislated requirements of the Act, including public administration, portability, accessibility, universality, and comprehensiveness. All healthcare systems are accountable for meeting these legislated conditions in order to secure federal transfer payments to support health system care delivery. However, with limited visibility of how the system achieves and delivers on these principles (e.g., access, comprehensiveness), it is challenging to meet the public accountability mandate if the public cannot fully “see” and understand the degree to which healthcare systems are achieving value for the populations they serve. It is also challenging for health system stakeholders to make visible the degree to which healthcare systems are achieving their mandated outcomes, or how system processes can be strengthened to more effectively and safely deliver quality care to populations served by the system. Despite legislation to support public administration and accountability, there is very limited objective evidence of outcomes for consumers to fully understand the value that healthcare systems are delivering in terms of safe health. As Porter (2010) notes: Achieving high value for patients must become the overarching goal of healthcare delivery, with value defined as the health outcomes achieved per dollar spent. This goal is what matters for patients and unites the interests of all actors in the system. If value improves, patients, payers, providers, and suppliers can all benefit while the economic sustainability of the healthcare system increases. Value—neither an abstract ideal nor a code word for cost reduction—should define the framework for performance improvement in healthcare. Rigorous, disciplined measurement and improvement of value is the best way to drive system progress. Yet value in healthcare remains largely unmeasured and misunderstood.

Policy makers and health system leaders are being held to account for value delivered by healthcare systems, particularly in publicly funded healthcare systems such as Canada. Supply chain transformation offers all stakeholders in health systems, particularly consumers, the trans-

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parency and visibility of healthcare services, the use of products during care procedures, and the outcomes achieved for citizens, a strategy for objective and comprehensive measurement of value delivered by healthcare systems to global populations. Conclusion Implementing supply chain processes in healthcare systems can achieve two fundamentally important outcomes at the health system level: quality outcomes and cost savings. Both are centrally important to the sustainability of healthcare systems. Quality outcomes include patient safety outcomes, which carry substantial cost implications. Cost savings, primarily from labour and inventory cost reduction, as well as case costing transparency, are readily achieved when supply chain tracking and tracing are implemented. The visibility and transparency offered by supply chain transformation in healthcare systems creates value for the multiple, but different, perspectives of each stakeholder group; patients, clinicians and provider teams, health organizations, industry, and healthcare systems more broadly. The technologies to support tracking and traceability in health settings are commercially available, yet are currently integrated in very few healthcare systems we could identify in Canada. Requiring, enabling, and scaling supply chain traceability based on GS1 global standards achieves better value and builds confidence in the healthcare system. The most substantial challenge of transforming supply chain processes across Canadian health systems is not the design of new technologies, but rather creating the policy frameworks to hold health systems accountable for a strategic supply chain system that enables and accelerates health systems to achieve value for patients, providers, industry, and health systems globally through supply chain transformation. References Baker, G. R., and G. Black. 2015. Beyond the Quick Fix: Strategies for Improving Patient Safety. Toronto: 64 Institute of Health Policy, Management and Evaluation, University of Toronto. http://ihpme.uto ronto.ca/wp-content/uploads/2015/11/Beyond-the-Quick-FixBaker-2015.pdf Centers for Disease Control and Prevention. 2017. Leading Causes of Death. http://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm

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Davis, K. K. Stremikis, D. Squires, and C. Schoen. 2014. Mirror, Mirror on the Wall, 2014 Update: How the U.S. Health Care System Compares Internationally. New York, NY: The Commonwealth Fund. Ebel, T., E. Larsen, and K. Shah. 2013. “Strengthening Health Care’s Supply Chain: A Five-Step Plan.” Our Insights. Toronto: McKinsey & Company. http://www.mckinsey.com/industries/healthcare-systems-and services/our-insights/strengthening-health-cares-supply-chain-a-five-stepplan Eckler, J., and E. S. Schneller. 2015. “Physician Leaders’ Roles in Supply Chain Management.” Physician Leadership Journal 2 (6): 22–25. Hogan, H., F. Healey, G. Neale, R. Thomson, C. Vincent, and N. Black. 2012. “Preventable Deaths Due to Problems in Care in English Acute Hospitals: A Retrospective Case Record Review Study.” BMJ Quality & Safety 21: 737–745. doi:10.1136/bmjqs-2012-001159 Institute for Safe Medication Practices Canada. 2013. Canadian Pharmaceutical Bar Coding Project: Medication Bar Code System Implementation Planning, a Resource Guide. https://www.ismpcanada.org/barcoding/down load/ResourceGuide/BarCodingResourceGuideFINAL.pdf Luke, R. D., S. L. Walston, and P. M. Plummer. 2003. Healthcare Strategy: In Pursuit of Competitive Advantage. Chicago, IL: Health Administration Press. Makary, M. A., and M. Daniel. 2016. “Medical Error—The Third Leading Cause of Death in the US.” BMJ 353: i2139. Marshall, M. N., P. B. Shekelle, H. T. O. Davies, and P. C. Smith. 2003. “Public Reporting on Quality in the United States and the United Kingdom.” Health Affairs 22 (3): 134–148. Pedersen, C. A., P. J. Schneider, and D. J. Scheckelhoff. 2015. “ASHP National Survey of Pharmacy Practice in Hospital Settings: Dispensing and Administration—2014.” American Journal of Health System Pharmacy 72 (13): 1119–1137. doi:10.2146/ajhp150032 Porter, M. E. 2010. “What Is Value in Health Care?” New England Journal of Medicine 363 (26): 2477–2481. doi:10.1056/NEJMp1011024 Rising, J. P., I. S. Reynolds, and A. Sedrakyan. 2012. “Delays and Difficulties in Assessing Metal-on-metal Hip 61 Implants.” New England Journal of Medicine 367 (1): e1. doi:10.1056/NEJMp1206794 Sedrakyan, A. 2012. “Metal-on-Metal Failures—In Science, Regulation, and Policy.” Lancet. 2012;379 (9822): 1174–1176. doi:10.1016/S01406736(12)60372-9 Smith P. 2016. The NHS GS1 Programme—The Inside Story from Owen Inglis Humphrey. http://spendmatters.com/uk/nhs-gs1-programme-inside-

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story-owen-inglis-humphrey/ Smith, B. H. Nachtmann, and E. Pohl. 2011. “An Investigation of the Healthcare Supply Chain: Literature Review.” In Proceedings of the 2011 Industrial Engineering Research Conference. Snowdon, A. Forthcoming. Building Capacity for Supply Chain Innovation in Health Systems. Snowdon, A., K. Schnarr, A. Hussein, and C. Alessi. 2012. Measuring What Matters: The Cost vs. Values of Health Care. London, ON: International Centre for Health Innovation, Western University. http://sites. ivey.ca/healthinnovation/files/2012/11/White-Paper-Measuring-What-Mat ters.pdf Statistics Canada. 2017. Leading Causes of Death, by Sex (both sexes).” http://www.statcan.gc.ca/tables-tableaux/sumsom/l01/cst01/hlth36a-eng. htm Totten, A. M., J. Wagner, A. Tiwari, C. O’Haire, J. Griffin, and M. Walker. 2012. “Closing the Quality Gap: Revisiting the State of the Science.” Evidence Report/Technology Assessment (Full Report) July 208 (5): 1–645.

9

Health Profession Regulation: Improving the Prospects for Innovation Jennifer Medves

Introduction Globalization has created challenges for the migration of healthcare professionals between countries because most countries have their own particular regulations. The European Union has managed to overcome this challenge because there are virtually no restrictions on the mobility of many healthcare professionals if they meet the commonly accepted minimum standards across Europe. In other countries, by contrast, strict adherence to “in-country-only” standards have precluded immigrant healthcare providers from practicing without undergoing extensive and often expensive evaluations of their education and previous practice. Barriers in some places have been so great that immigrants often restart their education programs from the beginning—or go into a different occupation entirely. Rigid regulation impedes the ability of healthcare professionals to enact innovative healthcare programs, place of care, and composition of interprofessional practice. And regulation tends to reinforce traditional models of health professional education and healthcare. Regulation has been used in the past to protect the scope of practice to ensure that it gives an exclusive right to provide certain types of care. Until recently only physicians were able to prescribe the vast majority A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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of medications. Over time the exclusive nature of prescribing has been opened up to those healthcare professionals who have the competency to diagnose and prescribe medications, including most recently controlled substances. Innovation in healthcare requires those with the appropriate competencies to be able to work together to provide care for Canadians. The “right-touch” model takes a competency-based approach. It reflects a redirection of emphasis from models that focus on protecting patients from those who potentially could harm them. Switching health regulation and exclusionary practices to “right-touch” regulation would promote the triple aim of better health, better care, better value (IHI 2018). The proposed changes will not be easy to make in Canada because its federal system has the complication of assigning shared responsibility over healthcare between both the federal and provincial/territorial levels of government. In this system, health professional regulation is a provincial responsibility enshrined in the Constitution Act, 1867 in sections 92(7), 92(13), 92(16), Canada v. PHS Community Services 2011 and section 4 of the British North America Act, 1871 for the territories. Even in a system in which provinces and territories have responsibility for health professional regulation, they are not the same. It is unusual that, within a country in one province or territory, a healthcare profession is regulated while in another province or territory the same profession is not regulated, given that the primary mandate of regulation is patient protection (Conference Board of Canada 2007). As Steven Lewis (2013) notes, we have duplication and inefficiency in healthcare professional regulation. And it is not easy to deploy health human resources when entry to practice competencies differ across provinces and territories. He goes on to point out that healthcare professionals are constantly seeking an increase in education standards that makes the problems more pronounced. Regulation of Healthcare Professionals Healthcare professionals are regulated to protect the public, protect the discipline, and control the number of practitioners. Regulators approve programs to educate healthcare professionals, determine entry to practice competencies, and monitor continued competency for practice. In Canada, regulation is conducted by provincial regulatory colleges, some of which are also the professional associations (although that is rapidly changing). Consequently, the model is self-regulation. In this

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model, peers are responsible for approving pre-licensure education programs, determining competency to practice, and investigating disputes. As most regulatory organizations investigate complaints against their members, they have been accused of protecting their members in the past from poor performance charges. In other parts of the world there has been a shift away from self-regulation to more government control where self-regulation has not been perceived to protect the public. Notably this has occurred in the UK following damning reports of inappropriate oversight of healthcare professionals including the Bristol Royal Infirmary inquiry (Kennedy 2001) into the high mortality rate following cardiac surgery. Although there are still people charged with practicing a profession for which they are not registered or licenced to perform, in western countries this is not as significant a problem as it was in the nineteenth century when dentists were accused of being charlatans and quacks (Thorogood 2002) and midwives as meddlesome and unscientific (Mason 1987, quoted in Kaufman 1998). Self-regulation also has the built-in restriction on the people who can practice controlling scopes of practice in exclusionary ways. The first medical society to organize in North America was in 1766 in New Jersey. Its founding mandate was to determine educational standards for apprentices, regulate practice, and deal with all issues of concern to the profession, and it produced a code of ethics. In Canada there were several efforts to regulate medical professionals and with this came much debate over whether a medical degree from a university constituted the right to practice medicine. Despite numerous efforts, including an abortive effort in 1839 in Toronto to enact legislation, it was not until 1869 that the Ontario Medical Act incorporated a new College of Physicians and Surgeons of Ontario with the power to examine graduates of education programs and others who wished to practice medicine (Roland 2006). It should be noted that the Canadian Institute for Health Information (CIHI) reports the first year of regulation in Ontario as 1795. Health professional regulation accelerated during the twentieth century. Nurses and midwives were regulated in the early 1900s in most countries; pharmacists in Ontario were incorporated in 1871; the Massage Therapist Association of Alberta was established in 1953. Massage therapy is regulated in British Columbia, Newfoundland and Labrador, Ontario, and New Brunswick. In other provinces there are associations that are open to massage therapists who have completed a recognized

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education program and uphold standards, but they are not regulated by the government. However, Albertan massage therapists have been petitioning the government to create the regulation necessary so they can ensure an “absolute agency of public accountability” (Massage Therapist Association of Alberta 2016). Midwifery regulation has had a varied history in Canada. While legislation was implemented in 1902 in England and Wales, in 1916 in Scotland, in 1918 in Northern Ireland, and in the United States in 1925, it was not until 1994 that Ontario and Alberta moved to regulate midwifery. Early models in the UK and US were nurse-midwifery models. Support for midwifery to be recognized as an autonomous profession was not generally recognized until the World Health Organization did so in 1976. In Ontario, the regulatory and legislative processes are complex and interconnecting. Midwives in Ontario are regulated by the following legislation: Regulated Health Professions Act, 1991; Midwifery Act, 1991, S.O. 1991, c. 31; General, O. Reg. 240/94; Registration, O. Reg. 168/11; Designated Drugs, O. Reg. 884/93; and Professional Misconduct, O. Reg. 388/09. In addition midwives, except Indigenous midwives, had to register with the College of Midwives of Ontario in order to be able to legally practice in the province (Mah 2013). There has been a major shift in health professional regulation in the early twenty-first century across the western world. While some changes occurred because older models were not working to protect the public, a number of new healthcare groups have sought regulation as a way to demonstrate their own unique profession within healthcare. Allsop and Saks (2002) is a classic resource, and has generated numerous reports including the Conference Board of Canada’s examination of collaborative care (2007), and the HPRAC report on Interprofessional Regulatory Collaboration (2008). There are few regulations that prohibit or enable collaboration. Yet, without interprofessional collaboration innovation in healthcare is made more difficult. In the last decade, there have been significant changes to align regulation in the provinces by using so-called umbrella regulation. Types of Regulation In his work on nursing regulation around the world, Benton (2013) used three conceptual perspectives on regulation: public interest theory, capture theory, and public economy theory. The Conference Board of Canada (2007) describes two models of self-regulation in Canada:

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modes of regulation are the how—that is, through controlled Acts and licensure, and orders of regulation are three types—self-regulation, self-administration, and direct government regulation. The National Consumer Council (1999) determined that self-regulation was further divided into statutory self-regulation, voluntary regulation, and employer regulation. Recently there has been an interest in the UK’s “right-touch” regulatory model mentioned above. It embraces the following concepts: proportionate, consistent, targeted, transparent, accountable, and agile. With respect to agile, “regulation must look forward and be able to adapt to anticipate change” (Professionals Standards Authority 2015, 4). The authors of the document further delineate eight elements, which if applied appropriately, would mean there may be less regulation or more regulation but it would ensure better regulation. The elements are described as: identify the problem before the solution, quantify and qualify the risks, get as close to the problem as possible, focus on the outcome, use regulation only when necessary, keep it simple, check for unintended consequences, and review and respond to change. (See Figure 9.1, next page.) In their next document the authors further identified three principles to test for any changes to regulation: proportionate to the harm it seeks to prevent, simple to understand and operate, and efficient and cost-effective (Professionals Standards Authority 2016, 3). Differences Across the Country In Canada, there are fundamental differences in the numbers of regulatory colleges and the scopes of practice. Pharmacists in some provinces can change medications, while in others it is not in the scope of practice; this makes no sense. If it is safe in one jurisdiction, it is safe in another (Canadian Pharmacists Association 2016). Pharmacists who can make a therapeutic substitution to another drug in the same therapeutic class are allowed to do so in all provinces except Manitoba, Ontario, and Quebec. If this is a patient safety issue, then if it is safe for those patients who reside in New Brunswick surely it is safe in Quebec as well. In Ontario, pharmacy technicians are now regulated through changes made to the Colleges Registration Regulation (O. Reg 451/94) in December 2010. In order to achieve these changes Bill 171 was introduced in 2007 to amend the Regulated Health Professionals Act, the Pharmacy Act and the Drug and Pharmacy Regulation

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Figure 9.1 Right Touch Regulation

Source: Professionals Standards Authority (2015).

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Act (Ontario College of Pharmacists 2017). The number of amendments required to different Acts in each province makes regulation of new occupations a lengthy process. In some provinces registered nurses are in a different college than licensed practical nurses, although there is ongoing consultation, and in British Columbia three nursing colleges are merging. In the United Kingdom there is one regulation body for nurses and midwives. In Canada, there are twenty-three regulatory colleges for nurses, and eight for midwives. Recommendations There are a number of ideas posed as recommendations that could assist in creating the right conditions that would increase the likelihood of better integration of the healthcare workforce that would make innovation more robust and transferable across the system. The recommendations are based on best available information at this time, while understanding that there are changes occurring across the country already. However, the process is piecemeal and appears uncoordinated, using a lot of resources that could be tailored and channelled to transforming the healthcare system through innovation. Remove “complaints” from the regulatory college framework and appoint a different body to conduct investigations and make recommendations back to the regulatory colleges about the outcome and suggested remediation or removal from the register The burden of investigating individuals who are reported to the regulator can be overwhelming. In addition, healthcare providers may not seek appropriate advice from the regulator, even in a self-regulating model, which may help to promote more collaboration and alert the regulator to changes in practice. If a regulator is also the investigator and enforcer there is also a potential conflict of interest which makes investigating and making changes to protect the public in a just culture more difficult. Other countries have adopted this model including New Zealand. The Health Practitioners Disciplinary Tribunal conduct investigations for twenty-three healthcare professions including medical practitioners, midwives, nurses, occupational therapists, and physiotherapists. In 2016, sixty-two charges were received, thirty-nine practitioners were charged, and twenty-four were found guilty of professional miscon-

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duct, six were convicted, and twenty-eight charges have not yet been completed. (New Zealand Health Practitioners Disciplinary Tribunal, n.d.). One argument for having a single organization that investigates complaints is that it makes it easier for the public to know where to send their complaints. Also, if more than one profession is involved, then individual members of the public do not have to put in multiple complaints (Professional Standards Authority 2016). One organization could then assess complaints from a healthcare team approach and be able to provide advice on how teams can mitigate hazardous and high risk situations. Encourage “right-touch” regulation for all healthcare professionals This will involve a massive paradigm shift, but it is essential if we are to support innovation in healthcare. There is discussion in the Ontario government about what right-touch regulation means. This is certainly important to address given that there are twenty-six regulatory colleges for twenty-eight healthcare professions. In British Columbia, there are twenty-six professions in twenty-two regulatory colleges, thirteen regulatory colleges in Yukon, thirty-one regulatory colleges in Alberta, including the Alberta College of Social Workers, and twenty-seven in Saskatchewan. See tables 9.1, 9.2, 9.3, and 9.4 for further information. It is very hard for healthcare providers across the country to even contemplate moving to another province or territory given the risk of changes to their professional status with respect to scope of practice and job title protection. An aspect of right-touch regulation that is not addressed is understanding that while we regulate individuals, these individuals very rarely work alone and that a simplified system needs to recognize team regulation. There is no way to regulate healthcare teams because healthcare teams change constantly. However, if we get right-touch to work, it will help teams to work together. As current legislation and regulation does not prohibit collaboration and collaborative practice we need to find ways to embed standards that actively encourage and support working together across professions and occupations (Conference Board of Canada 2007).

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Table 9.1 Canadian Network of Agencies for Regulation Alberta College of Paramedics Alliance of Canadian Dietetic Regulatory Bodies Alliance of Medical Radiation Technologists of Canada Association of Canadian Occupational Therapy Regulatory Organizations Association of Translators and Interpreters of Ontario Canadian Alliance of Audiology and Speech-Language Pathology Regulators Canadian Alliance of Physiotherapy Regulators Canadian Council of Human Resources Associations Canadian Council for Practical Nurse Regulators Canadian Council of Social Work Regulators Canadian Federation of Chiropractic Regulatory and Educational Accrediting Boards Canadian Nurses Association Canadian Organization of Paramedic Regulators Canadian Society for Medical Laboratory Science Canadian Veterinary Medical Association Certifies General Accountants Association of Canada College of Kinesiologists of Ontario Engineers Canada Federation of Canada’s Professional Chemists Federation of Law Societies of Canada Federation of Medical Regulatory Authorities of Canada Geoscientists Canada Immigration Consultants of Canada Regulatory Council National Alliance of Respiratory Therapy Regulatory Bodies National Association of Pharmacy Regulatory Authorities National Dental Examining Board of Canada Ontario College of Teachers Registered Psychiatric Nurse Regulators of Canada Source: www.cnar-rcor.ca

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Table 9.2 Alberta Federation of Regulated Health Professions College and Association of Acupuncturists of Alberta Alberta College and Association of Chiropractors College of Alberta Dental Assistants Alberta Dental Association and College College of Registered Dental Hygienists of Alberta College of Dental Technologists of Alberta College of Alberta Denturists College of Dietitians of Alberta College of Hearing Aid Practitioners of Alberta Alberta College of Combined Laboratory and X-Ray Technologists Alberta College of Medical Diagnostic and Therapeutic Technologists College of Medical Laboratory Technologists of Alberta The College of Midwives of Alberta College of Naturopathic Doctors of Alberta College of Podiatric Physicians of Alberta College of Licensed Practical Nurses of Alberta College of Registered Psychiatric Nurses of Alberta College and Association of Registered Nurses of Alberta College and Association of Respiratory Therapists of Alberta Alberta College of Occupational Therapists Alberta College and Association of Opticians Alberta College and Association of Optometrists Alberta College of Paramedics Alberta College of Pharmacists Physiotherapy Alberta College and Association College of Physicians and Surgeons of Alberta College of Alberta Psychologists Alberta College of Social Workers Alberta College of Speech-Language Pathologists and Audiologists Source: www.afrhp.org

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Table 9.3 Alberta Federation of Regulated Health Professions College and Association of Acupuncturists of Alberta Alberta College and Association of Chiropractors College of Alberta Dental Assistants Alberta Dental Association and College College of Registered Dental Hygienists of Alberta College of Dental Technologists of Alberta College of Alberta Denturists College of Dietitians of Alberta College of Hearing Aid Practitioners of Alberta Alberta College of Combined Laboratory and X-Ray Technologists Alberta College of Medical Diagnostic and Therapeutic Technologists College of Medical Laboratory Technologists of Alberta The College of Midwives of Alberta College of Naturopathic Doctors of Alberta College of Podiatric Physicians of Alberta College of Licensed Practical Nurses of Alberta College of Registered Psychiatric Nurses of Alberta College and Association of Registered Nurses of Alberta College and Association of Respiratory Therapists of Alberta Alberta College of Occupational Therapists Alberta College and Association of Opticians Alberta College and Association of Optometrists Alberta College of Paramedics Alberta College of Pharmacists Phusiotherapy Alberta College and Association College of Physicians and Surgeons of Alberta College of Alberta Psychologists Alberta College of Social Workers Alberta College of Speech-Language Pathologists and Audiologists Source: www.afrhp.org

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Table 9.4 Manitoba Alliance of Health Regulatory Colleges Audiologists and Speech Language Pathologists Chiropractors Dental Hygienists Dental (Dental Assistants) Denturists Licensed Practical Nurses Medical Laboratory Technologists Midwives Naturopathic Doctors Occupational Therapists Opticians Optometrists Pharmacists Physicians and Surgeons (Clinical Assistants and Physician Assistants Physiotherapists Podiatrists Psychologists Registered Dietitians Registered Nurses (Nurse Practitioners) Registered Psychiatric Nurses Registered Respiratory Nurses Source: Manitoba Alliance of Health Regulatory Colleges (n.d.).

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Examine all regulatory colleges and distinguish between those who should be “registered” rather than “regulated” In healthcare systems there is no uniform patient protection mandate: some areas of healthcare are very safe while others are not safe at all. Healthcare providers whose care poses high risk to patients should be regulated. However, those whose care has a low risk of harm need only be registered, i.e., not subject to restrictive practices. Vincent and Amalberti (2017) outlined three models of safety that govern healthcare today: those that are ultra-adaptive where there is an embracing of risk; high reliable where risk is managed; and ultra-safe, where risk is avoided. Examples of ultra-safe are radiotherapy and blood transfusion, high reliability processes entail scheduled surgery and chronic care, and ultra-adaptive models include innovative medicine and care provided in trauma centres. As Slawomirski, Auraaen, and Klazinger (2017) show, the cost of mistakes in healthcare is alarming. If the money saved could be put into developing innovation in healthcare, then the total costs of healthcare could be driven down. So, there should be an immediate moratorium on creating new regulated healthcare professionals in any province until there is a federally agreed list of who needs to be registered and who needs to be regulated. Create national regulatory frameworks that harmonize scopes of practice into standards of practice so there are minimal differences between provinces and territories Patient engagement is now recognized as absolutely key to ensuring care is appropriate to individuals, families, and communities. As part of patient engagement, the public needs to be aware of who has the legislative authority to perform a skill or procedure. While Canadians usually understand physician and dental practice, other healthcare professions’ scope of practice is often not fully understood. It is not understood by the public, and in some cases, not even by other healthcare professionals. Canadians simply want care by individuals who are competent and safe, and who are accountable for their actions. The excellent report by Nelson and colleagues (2014) on optimizing scopes of practice outlines clearly the work that needs to be completed in order to “have scopes of practice that will be most effective to support innovative models of care for a transformed healthcare system to serve all Canadians” (Nelson et al. 2014, 5). Umbrella legislation provides

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non-exclusive descriptions of activities and has a small number of controlled or restricted activities. One of the key informants said, “what those regulations essentially do…[are] ...basically freeze in place what we have today because it doesn’t allow for innovation, creativity, redefining roles, re-creating ways people related to each other for systems of care over time” (p. 56). Encourage one registration college for each profession at the federal level, with provincial colleges regulating those in practice in the province/territory on a regular basis to ensure they have province-relevant qualifications and complete quality assurance processes. Other countries around the world have one regulator for several professions, or at least one regulator for the whole country (both unitary systems like the United Kingdom and New Zealand, and federations like Australia). In Canada, where federal and provincial/territorial governments share healthcare responsibilities, this is more difficult to achieve. However, there are ways not only to assist in mobility of healthcare professionals across the country, but also to record the number of healthcare providers in the country. The Federation of Medical Regulatory Authorities of Canada was established in 1968 and has already achieved more regulatory harmony than other healthcare professionals. Its mandate is “Advancing medical regulation on behalf of the public through collaboration, common standards and best practices” (Federation of Medical Regulatory Authories of Canada, n.d.) Could its mandate be expanded to maintain a register of all physicians in Canada? There are examples of regulatory colleges working collaboratively with the formation of organizations of province wide regulatory bodies including the Alberta Federation of Regulated Health Professions whose mandate is “to help ensure that Alberta’s regulated health professionals practice and conduct themselves according to defined standards of practice and professional conduct. We strive for and promote excellence within our respective professions”(Aberta Federation of Regulated Health Professions, n.d.). There are other examples of national collaboration including the Canadian Network of Agencies for Regulation that have already collaborated on regulatory issues including Canadian Nurses Association and fifteen other health regulatory organizations. The core contribution of the Canadian Alliance of Physiotherapy Regulators (CAPR) is to con-

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duct evaluation services of all internationally educated physiotherapists. As CAPR already has data on all internationally educated physiotherapists, it seems logical that the agency could both be the repository for physiotherapists who are regulated in Canada and provide data to a new organization. The new organization would be encouraged to collaborate with the proposed agency, Healthcare Innovation Agency of Canada (Naylor et al. 2015). In 2017, the Canadian Institute of Health Information (CIHI) produces the only reports of the total number of regulated or registered healthcare providers. There are twenty-nine listed on the website. These reports are valuable because they aggregate data that would otherwise only be available provincially, hence of minimal use. If each healthcare provider were registered with a pan-Canadian organization, data would be more uniform and up to date. CIHI produced a table in January 2017 showing that there has been an increase in the number of medical radiation technologists from 16,464 in 2006 to 19,390 in 2015. The data is publicly available and is easy to access. The national register of each profession would also be the first organization that immigrants and newly qualified health providers would contact. As CIHI already receives data from all the provinces and territories, it would make sense that the national register would be hosted by CIHI, or at least by an organization that can seamlessly transfer data to CIHI. In addition to a national register, each healthcare professional could have a unique identifier that would make identification and tracking migration far easier. Develop a competency-based framework rather than a scope of practice framework to ensure the best care is given by those who are competent to provide the care. Competency, rather than scope of practice, is the language of healthcare providers. Healthcare providers share many competencies and by understanding other professionals’ competencies, teams can work more closely together. By recognizing core competencies it allows team members to develop a more collaborative approach to patient care based on recognition of others’ skills and respect for the unique contributions of individual team members. Earlier work clearly demonstrated the core competencies shared by medicine, nursing, occupational therapy, and physical therapy (Verma, Paterson, and Medves 2006) and medical radiation technology, social work, psychology, and pharmacy (Verma et

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al. 2009). Nelson et al. (2014) produced a scope of practice model supporting innovative models of care. The concepts included transferring individual regulation to combined/team accreditation and to a model of team-defined tasks to meet population needs (Nelson et al. 2014, p. 63, figure 6.2). Recommendation A6 advocates for supporting the development and ongoing implementation of umbrella health professional regulatory legislation across provinces and territories, and “take the lead to align regulations in order to enable respective professionals to better meet population health needs within collaborative care models, particularly in cases of overlapping and expanded scopes of practice.” The priority action was to create frameworks that recognize education and continuing professional development, especially in those areas of overlapping and changing scopes of practice. Innovation in Healthcare in Canada As a step towards creating the environment in which innovation can transform healthcare in Canada, we were reminded of the importance of using data not simply to create more regulations and bureaucracy but to identify where we can create opportunities. Statistics come out that show all the ways in which we do lots of harm and how healthcare systems really can be dangerous places, and the mistakes that are made. And so in reaction, political folks and regulatory folks want to do things to try to make things safer. And so they restrict. You know, this category of people can do this, they cannot do this, they cannot do this, they cannot do this. And we find it to be most terribly negative in that you have regulations starting to determine what your care team looks like rather than skills, abilities, and functions driving what your care team should look like and do. (Nelson et al. 2014, 57)

Innovation in healthcare is often listed as the degree to which information technology is integrated into systems, technology in general including robotic devices, use of databases to implement quality improvements, and outcome-based management (Thakur et al. 2012). Innovation in healthcare also requires a nimble, adaptable workforce that can take advantage of changes and expectations of patients. Innovation should also be striving to minimize the variation and therefore the quality of the outcomes from the innovation. Models of healthcare delivery are often quite revolutionary when proposed, but the roll out of a new

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model of care can diminish the model to become an old model with a new name. New Brunswick has long advocated for the extramural program (EMP) whose mission is to “provide a comprehensive range of coordinated health-care services to individuals of all ages for the purposes of promoting, maintaining, and restoring their health within the context of their daily lives and of providing palliative care services for terminally-ill individuals to improve their quality of life” (Horizon Health Network, n.d.). The EMP program has adapted over time and is well established in New Brunswick and the government has constantly tried to keep the costs manageable. Several models have been trialed including home pharmacy assessment (Doucette, Morrissey, and Nickerson 2015) and a quick response home care program (NBNU 2016) that did not bring either clinical or financial savings and were subsequently abandoned. These models would not be possible without adaptability and flexibility and perhaps would have been successful if different health professionals had been part of the teams. The changes required in the way healthcare professionals are regulated are revolutionary and disruptive, and they represent a long-term solution to simpler regulation. If regulation is a barrier to innovation and adaptation, then how will these changes assist in embracing innovation in healthcare? The speed with which innovation is now being embraced far exceeds the ability of healthcare to adapt. While there is plenty of evidence that communication would be enhanced with electronic health records that can be accessed by healthcare providers in multiple settings, the reality is one of chaos. In some areas in Canada all records are accessible (e.g., Canadian Forces healthcare) while in others there are multiple electronic health record databases that cannot be connected to each other. Primary care practitioners can’t access records of patients who have been admitted to acute care hospitals. These are not barriers of health professional regulation, but rather the barriers that impede innovation. Innovation in healthcare in Canada needs flexible systems that are still safe. It would be inadvisable for anyone other than a medical physicist to be responsible for planning the treatment for medical radiation with anyone other than a medical radiation oncologist—this is not the work of a registered nurse who works in radiation oncology. Medical physics is not a regulated health profession anywhere in Canada (Canadian College of Physicists in Medicine, n.d.), which is surprising given the nature of their work. A registered nurse does not have the skills and abilities to perform this work. However, there are potential opportuni-

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ties involving innovative techniques for those with skills and abilities, but regulations prevent people from trying. In emergency situations it is all hands on deck. There are times when different professionals perform different duties than they are normally “allowed” to do. Many different professionals have held surgical retractors and have performed admirably with appropriate guidance, some have even sutured—and yet in normal circumstances it is considered outside the scope of practice. Registered nurses constantly complain that the tasks and skills they are able to do between 1700 hours on Friday evening to 0700 hours on a Monday morning are far greater than during the normal work week. A lighter touch on health professional regulation that is streamlined and registered at the federal level would allow new healthcare disciplines to take on roles that do not pose high risk to people and allow those professions to adapt to changes in healthcare much more rapidly. Over time once risky procedures, including some surgical procedures, endoscopy, and prescribing medications, have been deemed far less risky and are not now the exclusive task of physicians. We do not know what healthcare innovations will be coming in the future, but we do know that complex regulation will make integration of innovation much slower to achieve without a more flexible system. Healthcare professional regulation changes will be disruptive and will require maximum flexibility and cooperation across the country. What is needed is a federal registration system. As well, there needs to be a system for investigating complaints. Further, the regulatory system must advocate for a nimble healthcare workforce that is safe, efficient, and able to respond to the revolution in healthcare innovation. Finally, and importantly, Canada needs a regulatory system that is patient-focused and affordable. References Alberta Federation of Regulated Health Professions. n.d. “Our Members.” http://www.afrhp.org/about-us/our-members Allsop, J., and M. Saks, eds. 2002. Regulating the Health Professions. London: Sage. Benton, David. C., M. A. González-Jurado, and J. V. Beneit-Montesinos. 2013. “A Typology of Professional Nurse Regulatory Models and their Administration.” Journal of Nursing Regulation 4 (2): 1–8. Canadian College of Physicists in Medicine. n.d. “Training Program

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FAQ.” http://www.ccpm.ca/ccpm-english/main/certification/faq-links/ training-program-faqs.html Canadian Pharmacists Association. 2016. A Review of Pharmacy Services in Canada and the Health and Economic Evidence. https://www.pharma cists.ca/cpha-ca/assets/File/cpha-on-the-issues/Pharmacy%20Services%20 Report%201.pdf Conference Board of Canada. 2007. Achieving Public Protection Through Collaborative Self-regulation. ReflectionsFor a New Paradigm. http://www. conferenceboard.ca/e-library/abstract.aspx?did=1960 Doucette, D., T. Morrissey, and A. Nickerson. 2015. “Home Care Pharmacy Services: A Demonstration Project” poster presentation at CSHP 2015. Accessed restricted to members of CSHP. http://www.cshp. ca/programs/cshp2015/ Federation of Medical Regulatory Authorities of Canada. n.d. “About Us.” http://fmrac.ca/about-us Horizon Health Network. n.d. “Extra Mural Programs.” http://en.hori zonnb.ca/facilities-and-services/services/extra-mural-programs.aspx HPRAC. 2008. Interprofessional Collaboration. A Summary of Interprofessional Regulatory Collaboration in Other Jurisdictions. http://www. hprac.org/en/projects/resources/hprac-collaboration.JurisdictionReviewEN FINAL.feb1208.pdf Institute for Healthcare Improvement (IHI). 2018. “IHI Triple Aim Initiative.” http://www.ihi.org/Engage/Initiatives/TripleAim/Pages/ default.aspx Kaufman, Karyn. 1998. “A History of Ontario Midwifery.” Journal of Obstetrics and Gynaecology of Canada, 20 (10): 976–81. Kennedy, Ian. 2001. Learning from Bristol: The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984–1995. http://webarchive.nationalarchives.gov.uk/20090811143745/http:/www. bristol-inquiry.org.uk/final_report/the_report.pdf Lewis, S. 2013. “Discussion Paper: Canadian Health Policy Since Romanow: Easy to Call for Change, Hard to Do.” Toronto: Queen’s Health Policy Change Conference Series. http://www.moniesonhealth. com/resources/Discussion_Paper-Canadian_Health_Policy_Since_Roma now_Easy_to_Call_for_Change_Hard_to_Do-Steven_Lewis.pdf Mah, Connie L. 2013. “Midwifery in Canada.” LawNow. November. http://www.lawnow.org/midwifery-canada Manitoba Alliance of Heath Regulatory Colleges. n.d. http://www. mahrc.net/#regulations Mason, J. 1987. “A History of Midwifery in Canada”. In Report of the

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Task Force on the Implementation of Midwifery in Ontario (Appendix 1). Toronto: Ministry of Health, Government of Ontario. Massage Therapists Association of Alberta. 2016. “Regulation of Massage Therapy Alberta.” https://www.mtaalberta.com/?page=174 National Consumer Council. 1999. Self-regulation of Professionals in Healthcare. Consumer issues. London: Author. NBNU. 2016. “Nurses Union Worried about Medavie EMS Taking over Extra-Mural Program,” https://www.nbnu.ca/blog/nurses-union-worriedabout-medavie-ems-taking-over-extra-mural-program/ Nelson, S., J. Turnbull, L. Bainbridge, T. Caulfield, G. Hudon, D. Kendel, D. Mowat, L. et al. 2014. Optimizing Scopes of Practice: New Models for a New Healthcare System. Ottawa, Canada: Canadian Academy of Health Sciences. Naylor, C. David, Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare Innovation. Ottawa: Health Canada. http://www.healthycanadians.gc.ca/publications/ health-system-systeme-sante/report-healthcare-innovation-rapport-soins/ alt/report-healthcare-innovation-rapport-soins-eng.pdf New Zealand Health Practitioners Disciplinary Tribunal. n.d. http:// www.hpdt.org.nz/Default.aspx?tabid=27 Ontario College of Pharmacists. 2017. “History and Overview of the Regulation of Pharmacy Technicians.” http://www.ocpinfo.com/prac tice-education/practice-tools/support-materials/technician-overview/. Professional Standards Authority. 2015. Right-touch Regulation. Revised. http://www.professionalstandards.org.uk/docs/default-source/publications/ thought-paper/right-touch-regulation-2015.pdf Professional Standards Authority. 2016. Regulation Rethought. Proposals for Reform. http://www.professionalstandards.org.uk/docs/default-source/ publications/regulation-rethought.pdf Roland, Charles. 2006. “History of Medicine to 1950.” Canadian Encyclopaedia. http://www.thecanadianencyclopedia.ca/en/article/history-of-medi cine/ Slawomirski, L., A. Auraaen, and N. Klazinga. 2017. The Economics of Patient Safety. Strengthening a Value-based Approach to Reducing Patient Harm at National Level. OECD. http://www.oecd.org/els/health-systems/ hcqi-patient-safety.htm Thakur, R., S. H. Y. Hsu, and G. Fontenot. 2012. “Innovation in Healthcare: Issues and Future Trends”. Journal of Business Research, 65, 562– 569.

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Thorogood, N. 2002. “Regulating Dentistry.” In Regulating the Health Professions, (Chapter 7), edited by J. Allsop and M. Saks. Sage: London, UK. http://www.cno.org/globalassets/1-whatiscno/council/observ er-package-for-web.pdf Verma, Sarita, Margo Paterson, and Jennifer Medves. 2006. “Core Competencies for Health Care Professionals: What Medicine, Nursing, Occupational Therapy, and Physiotherapy Share.” Journal of Allied Health, 35 (2): 109–115. Verma, Sarita, Teresa Broers, Margo Paterson, Cori Schroder, Jennifer M. Medves, and Carol Morrison. 2009. “Core Competencies: The Next Generation. Comparison of a Common Framework for Multiple Professsions.” Journal of Allied Health, 38 (1): 47–53. Vincent, Charles, and Rene Amalberti. 2017. Safer Healthcare. Strategies for the Real World. http://www.cpmb.ca/http://manitobadietitians.ca/ home.aspxhttp://www.crnm.mb.ca/ and http://www.crpnm.mb.ca/

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Improving Healthcare Value by Unlocking Innovation: An Industry Perspective Neil Fraser

The introduction of medicare in Canada in the 1960s stands as a shining example of successful disruptive innovation. It is a uniquely Canadian irony that in the half-century since then, our healthcare systems have been allowed to congeal and harden to the point that further disruptive innovation now seems almost impossible. Harvey Lazar and his colleagues at Queen’s University have called this phenomenon “paradigm freeze” (2013). Meanwhile, Canada’s healthcare performance, which once led the world, has declined relative to comparable countries and currently sits near the bottom of international rankings such as those published by The Commonwealth Fund (2017). What if we could defy the conventional wisdom and reverse that decline? What if we could improve the delivery of care and the outcomes of patients while reducing overall costs? What if we could not merely sustain healthcare but turn it into a driver of economic growth and job creation? And what if we could do all that without sacrificing our cherished universal access to care? That may sound like a pipe dream, but I believe it can be done, and within one decade. We have the financial, organizational, and human resources needed to achieve those goals, but several deeply entrenched A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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barriers prevent us from using our assets effectively. Canadian healthcare could lead the world again—provided we create new agility to change the way we do things by shaking free of the constraints on innovation that have evolved over the years. This view is based on a range of different experiences: working for a multinational medical technology company that operates in many countries; serving as a member of the federal government’s Health and Biosciences Economic Strategy Table (2018) and its Advisory Panel on Healthcare Innovation (APHI 2015); serving as a member of the Ontario Health Innovation Council (OHIC 2014); and acting as an adviser to various other provincial governments. It is important to understand what innovation means. Innovation is not invention, as Roger Martin at the Rotman School of Management has pointed out (Martin et al. 2011), and health research is not the same as health innovation. Research creates new knowledge; innovation uses existing knowledge to deliver results, to have an impact on things that matter. This is a big problem in Canadian healthcare: available knowledge that could improve patient outcomes or reduce costs is often not put into practice. For example, the APHI report, Unleashing Innovation: Excellent Healthcare for Canada, refers to a study done at McMaster University in the early 1970s. Published in the New England Journal of Medicine, that study showed that nurse practitioners working with family physicians could do much of the doctors’ work with no difference in patient outcomes or satisfaction (Spitzer et al. 1974). Healthcare organizations in the United States and Europe, recognizing the cost savings that could be achieved with this knowledge, hired more nurse practitioners and physician assistants as a direct result of the study. However, that did not happen in Canada, because the existing reimbursement model for physicians prevented it. Even today, nurse practitioners remain severely underutilized in Canada (Picard 2012). Our fee-for-service payment method was not intended to hinder innovation, but it had that consequence back then—and it still does today. Rethinking Patient Care Pathways Fee-for-service payments are one aspect of a longstanding approach to healthcare delivery that is structured around the volume of services provided. As growing economic and demographic pressures force countries around the world to reconsider how to improve healthcare

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performance, many leaders, e.g., the Netherlands, are moving away from the traditional focus on volume and turning instead to a more integrated, patient-centred approach known as value-based healthcare, whose overriding purpose is to deliver superior patient outcomes at a lower cost. Value-based healthcare provides a theoretical framework for improving performance across an entire health system. It began to draw widespread attention after the publication of the 2006 book, Redefining Health Care, by Michael Porter and Elizabeth Teisberg at Harvard University, who explained the concept of linking patient outcomes to the costs of care. They presented a way to increase quality and efficiency in the competitive healthcare system in the United States, but the basic ideas about value are now being applied in publicly funded health systems as well. In 2016, the United Kingdom–based Economist Intelligence Unit (EIU 2016) compared the progress of twenty-five countries with a variety of health systems in implementing value-based healthcare. Canada’s overall alignment with value-based principles was found to be moderate, along with nine other countries, including Australia, Germany, Japan, and the United States. Only Sweden and the United Kingdom were ranked higher. The EIU study (which was commissioned by Medtronic) identified Canada’s universal coverage of medical and hospital care as a core asset, but it suggested that improvements are needed in several areas, including motivating health professionals to embrace value-based care, moving towards value-based payment models, and integrating patient-reported outcome measures with existing government datasets. Value-based healthcare was defined by the EIU for the purposes of its study as “the creation and operation of a health system that explicitly prioritizes health outcomes that matter to patients relative to the cost of achieving those outcomes.” The phrase “that matter to patients” captures the essence of value-based care. Consider two men diagnosed with prostate cancer. Each undergoes a successful radical prostatectomy at the same cost to the system and the cancer does not recur, but one of the patients experiences long-term incontinence and erectile dysfunction while the other has no lingering after-effects from his treatment. Standard methods of measuring health system performance, which do not include patient reporting, would report these two outcomes as identical. To the patients themselves, however, their outcomes seem very different, and a truly patient-centred

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health system must take that difference into account. The central idea of value-based healthcare can be expressed as an equation: value equals outcomes divided by costs. Paradoxically, however, while the equation is simple, measuring outcomes and costs requires a highly complex analysis of care delivery at a very specific, granular level. To put the value-based theory into practice, every care pathway needs to be redesigned from scratch, understanding not just how to provide the care logistically but how to do it most efficiently and cost-effectively. Essentially, healthcare has to be reinvented one patient cohort at a time. Michael Porter and Robert Kaplan of Harvard Business School have developed a methodology to do this through their approach to value-based healthcare (Kaplan and Porter 2011). Four main types of outcomes can be measured: clinical outcomes (e.g., in the case of heart failure, the ejection fraction), functional outcomes (e.g., the patient’s exercise tolerance), surrogate outcomes (e.g., the number of readmissions to the emergency room or length of stay per incident), and patient-reported outcomes (e.g., “I feel terrible” or “I am ready to go back to work”). Probably the most important and valid of these outcomes is what the patient thinks, but doctors tend to concentrate on the clinical and perhaps functional outcomes, while administrators are interested in the surrogate outcomes. They all have different scorecards. To create real value, everyone needs to get on the same page and say, “With this group of patients, we’re going to measure this set of factors to determine the outcome.” Another question to be answered is when the outcome is to be measured. To continue the example of a patient with heart failure, if the company I work for delivers a pacemaker, it expects to be paid for it right away. At least, that is how things are done now. But a pacemaker is not an outcome. It might not work for this patient, so perhaps we should not get paid until, say, the patient has been stable for a year with no complications. Paying us for that outcome instead of only the device would help create change agility in the system. Obviously, this would be a major cultural change and not simple to implement, but it has the potential to get us to a much better place. Then there is the matter of measuring the total cost of delivering an outcome. In our example, it would include the cost of the pacemaker, the doctor’s time—Kaplan and Porter (2011) would insist on taking the total doctor costs allocated over time—and the cost of using the facility where the procedure was performed, including any readmissions or

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follow-up treatment. The patient would bear certain costs as well, such as loss of work and travelling to the hospital (not to mention parking), and there might also be societal costs, such as lost tax revenue if the patient had to stop working. This is a whole new way of framing and solving the problem of healthcare performance. It involves a great deal of work, but the results are worth the effort. A practical approach would be to begin with the health conditions that represent the greatest volumes and worst points of pain, and then, after those have been completed successfully, move into other areas. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) is working on this and has already developed about 135 care pathways and associated guidelines (2017). They still have a long way to go. The Boston-based International Consortium for Health Outcomes Measurement (ICHOM 2017) is developing similar sets. We need to get started on this kind of measurement in Canada as well in order to improve the value of our healthcare. To show how the process of analyzing and rethinking care pathways can create change agility within the system, take the example of a product Medtronic (the company I work for) invented some time ago: a pacemaker for pain. Even though it is extremely effective and has been adopted in Europe and the United States, it never found its way into mainstream Canadian healthcare because there was no place for it in the existing care pathway for pain. Although medical technology accounts for a far smaller proportion of healthcare spending than pharmaceuticals—about 3 percent for devices compared to 16 percent for drugs (CHPI 2016; CIHI 2016)—there are more opportunities to improve the structure of healthcare delivery with technology than with pharmaceuticals, due to the nature of the products. Swallowing a pill does not affect the care pathway, but a medical device can change the setting of care, the provider of care, or the whole model of care. That is where the barriers are, and why medical technology innovation is so hard to implement in Canada: because we constantly run up against barriers. Canada’s Healthcare Assets Before we discuss the barriers to innovation, we should recognize the significant underlying strengths that exist in Canadian healthcare. Taken in combination, they provide a strategic opportunity for achieving major improvements to system performance through the implementa-

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tion of value-based care, if the barriers can be overcome. One of Canada’s key advantages, as the EIU notes in its report on value-based healthcare, is the existence of a well-established single-payer system. This model is intrinsically efficient in many respects, with well-contained catchment areas, so we would be able to capture very high-quality datasets on the patient care pathways that we need to redesign. Another positive element is the concentration of medical volumes. Canada’s tertiary medical system is one of the most concentrated in the world. Medtronic sees this because we tend to work on the specialty side. In the United States, 5 percent of our business is done in tertiary academic teaching institutions, while in Canada the proportion is 80 percent. That is a very large difference and it is significant because concentrated volumes are associated with greater expertise, better outcomes, and sub-specialization. A third asset is the recent explosion of epidemiology and health economics in Canada. We have world-leading centres of excellence in evidence-based population health, for a variety of reasons, including our experience with SARS, the creation of the Public Health Agency of Canada, and the development of institutions like the Toronto Health Economics and Technology Assessment Collaborative, the Centre for Health Economics and Policy Analysis (McMaster University) and the Li Ka Shing Knowledge Institute (St. Michael’s Hospital, Toronto). At least as important as those strengths is the new political recognition, both federally and provincially, of the urgent need for health innovation. The more activist approach of Health Canada under the leadership of the former minister of health, Jane Philpott, who has identified innovation as one of her four priorities, is a welcome development. At the provincial level, intense financial pressures are driving change. For all these reasons, the environment of Canada today is highly conducive to creating the necessary agility to redefine the way healthcare is delivered in a very positive manner. How Barriers Inhibit Innovation The current lack of agility in Canadian healthcare can be traced back to several structural barriers that are more intransigent in this country than elsewhere, for various historical and political reasons. These barriers are well explained in the APHI report; I will outline them here simply as a preamble to some suggested solutions.

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Misplaced Incentives In general, doctors in Canada are compensated for their work on a feefor-service basis, while hospitals, with some exceptions, are funded through global budgets. By rewarding volume rather than value, these payment models discourage innovation and the greater integration of healthcare services. For value-based healthcare to work, the right incentives must be in place for care providers, both individual and institutional. There is no question that doctors should be well remunerated for what they do, so this is not about how much they are paid, but about what they are paid for, and how they are paid. There has been a migration away from the fee-for-service approach in countries such as the United Kingdom, which has a salary system for family physicians (ITUP 2008). Not coincidentally, one of the reasons the United Kingdom was ranked number one in the 2017 Commonwealth Fund survey was the strength of its primary care system. In the same survey, Canada came dead last—eleventh out of eleven countries—in timeliness of access to care. It is also worth noting that in the United Kingdom there is a greater recognition of the key role family doctors play as gatekeepers to the health system. In North America, specialists are typically afforded more respect than family physicians and tend to earn considerably more as well. In the United Kingdom, the disparity in income between the two groups is much lower (Hope 2012; Petch et al. 2012). Healthcare in the United States is highly variable, but the stars of the system, such as Kaiser Permanente and Intermountain Healthcare, employ physicians on a salary basis (Abelson 2013; James and Savitz 2011). The McMaster study of nurse practitioners is just one example of the unintended consequences of fee-for-service. Numerous innovative health technologies have not been adopted in Canada because of the way doctors are paid. The experience of two Canadian companies illustrates this point. In Ontario, BresoTec has invented a sleep apnea device for patients to use at home as a convenient alternative to spending the night at a sleep lab. But the sleep labs are owned by doctors and they have no incentive to use the home devices, which are not recognized on provincial fee schedules. The result is that BresoTec has difficulty selling in the Canadian market. A similar set of obstacles has been encountered by Calgary Scientific in Alberta. This company has developed a remote radiology service that allows medical images to be shared over the cloud with a radiologist who provides a diagnosis. Once again,

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however, this is not on provincial fee schedules, so the service is not used in Canada. Both of these companies have done well exporting to other countries, but the fee-for-service model makes it challenging for them to sell their products at home. It is a further Canadian irony that the two companies received financial support from their provincial governments to help them get started, but their healthcare systems were challenged to buy their products once they were commercially available. The global budgets through which most Canadian hospitals are funded are usually fully accounted for by the time they are approved each year, providing little or no ability to invest in new products or processes that would improve outcomes or save money over the longer term. Some progress is being made in provinces such as Ontario, Alberta, and British Columbia to replace global funding with bundled payment systems that reward quality. This is a step in the right direction and is why APHI recommended an innovation fund. Lack of Trust Disruptive change is inevitably confusing and controversial, and seeing it through successfully requires as much commitment and collaboration as possible among everyone involved. Unfortunately, any shift towards a more value-based system will be complicated by the lack of trust that currently exists throughout Canadian healthcare. Fee negotiations between medical associations and provincial health ministries are often conducted in an atmosphere of open hostility. The provinces complain bitterly about unilateral actions and funding cutbacks by the federal government. Many healthcare providers, unions, and members of the public mistrust the motives of industry. This suspicion of the private sector is a peculiarity of Canadian healthcare. It is not as prevalent in the health systems of other countries or in other parts of the economy in Canada. When we think of industries like car manufacturing, construction, or computer services, we think of jobs. Those companies are recognized for contributing to the economy, not criticized for making profits. Yet a kind of folklore exists that profit has no place in healthcare. It should not, but it does need to be said that earning a profit is how companies attract investment, sustain their operations, and employ people. If working more closely with industry can help the healthcare system improve patient outcomes at a lower cost, what could possibly be wrong with that?

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Another manifestation of mistrust is the excessive restriction on the use of patient data because of privacy concerns. We have extensive public repositories of real-world data in Canada, such as Alberta’s APPROACH cardiac registry and the surveys and databases of the Institute for Clinical Evaluative Sciences (ICES) in Ontario, which could be put to good use in developing innovative products and services. Regrettably, these agencies have been unable to decide how to allow industry to have access to their data, even though the kinds of questions that companies would ask—“If we had a product that did this, how many patients could it help?” for example—would not affect individual patients or jeopardize their private information. De-identifying the data would protect individual privacy. Such overprotectiveness of patient data is exacerbated by the fact that every province has its own privacy code. The codes are all different and not even harmonized, so a company with a new health IT solution, for instance, needs to obtain a privacy impact assessment in each province where it wants to do business, which can be prohibitively expensive. Given these challenges, the APHI recommended that the federal Privacy Commissioner work with his/her provincial counterparts to protect privacy across Canada while enabling innovation. Healthcare Procurement Hospital procurement presents a problem that has been recognized for some time; more recently it has become clear that the entire public sector is having trouble with procurement. Rigorous procurement practices were introduced for a very good reason—to achieve standardization and disciplined cost management—and they have succeeded in providing those benefits. But over time the focus on cost reduction has been taken to such an extreme that long-term value is often ignored for the sake of short-term savings. Healthcare procurement today is an expression of what economists call a monopsony. In a monopoly, one supplier controls the market and, as a result, can push prices higher. In a monopsony, by contrast, one customer controls the market and can push prices lower. As prices fall, the number of suppliers dwindles as companies that cannot afford to sell at those prices leave the market or go out of business. Smaller companies with limited resources are usually the first ones to go, so the end result tends to be a few large suppliers that are well-financed and can deliver the lowest cost. But even those big companies soon find that

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they can no longer afford to work with the customer to help solve problems or provide a better product or service. So they sell the customer exactly what was asked for, with little new investment. In industry, like healthcare, we have suppliers and cost targets, but we do not always go to the lowest-price suppliers. We look for value and we expect our suppliers to work with us as we improve things, maybe by finding new materials or new processes that will help us improve. We want reliable partners who will be around for the long term. In healthcare, however, those responsible for procurement have been trained to focus exclusively on the lowest price. Where, I often ask as a joke, do you usually find the hospital procurement office? The answer: Either in the basement, right next to the morgue, or in some offsite strip mall, far from the hospital. The point is that healthcare procurement people tend to work in isolation from the clinical environment, physically removed from what the hospital is actually doing. Since they are not aware of the real problems and needs of the clinicians, they look at their spreadsheets and pick the cheapest products they can find. A higher-priced product might result in a shorter length of stay or fewer readmissions for the patient, which would end up saving the system far more money than the additional upfront cost of the product, but that more expensive product is never considered because of its price. The economies achieved through traditional procurement methods are often false economies. We can see the possibilities by looking specifically at health technology. If a dedicated effort to get the lowest price resulted in squeezing the total cost of medical devices down from 3 percent of healthcare costs to 2.5 percent, that would still not address the remaining 97 percent. However, closer collaboration with industry could attack the bigger costs in the care pathway, through value-based healthcare, for example. There are different ways of doing procurement that could help deliver better outcomes while meeting the need for fairness and transparency that the system demands. Some re-education is going on now through the ideas of strategic procurement, and in Europe a different approach called a competitive dialogue has been developed for procurements that are particularly important and strategic. This allows different proponents to propose a solution, rather than a product and a price, so whole-system costs and the outcomes of patients can be addressed. Under current procurement practices, the tendering process is also a drawback because it puts smaller suppliers at a disadvantage. It is very

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complex and challenging to do a request for proposal (RFP) so small companies find it difficult even to get recognized. And a company in startup mode simply cannot compete for the lowest cost, especially when only price is considered, not value. It must be said that progress is being made in this area, especially in Ontario, where the Ministry of Government and Consumer Services has invested in re-education and research and developing new kinds of RFPs—still in the pilot phase—but there is still room for improvement and the focus needs to shift to scale and spread of innovative procurement models. Health Technology Assessment When a company comes out with a new product, Health Canada confirms that it is safe and does what it claims to do, but does not comment on whether it delivers outcomes or is cost-effective compared to the alternative, which might be a product currently in use or something else entirely. To deal with this, the provinces and the federal government now perform health economic assessments or health technology assessments (HTAs) to evaluate the performance and cost-effectiveness of new medical devices. This is a good idea in principle, but unfortunately the process is extremely demanding, and once it has been completed, the barriers to adoption remain in place. Scale and Spread In Canada, we do not have a healthcare system—we have ten provincial systems and three territorial systems plus the various federal systems that handle Indigenous, military, and inmate health. Each of these systems aims to provide a full range of healthcare services, but the smaller jurisdictions lack the scale and greater concentrations of the larger provinces, making it more challenging to deliver care at the same levels of quality and efficiency. We need to work across these geographic boundaries and see where the best care can be delivered to the patient at the lowest cost. Flying a patient to a larger centre for specialized surgery might well be less expensive to the home province than the cost of extended follow-up care and readmissions resulting from having the procedure done in a hospital with less expertise. On the other hand, being away from home has consequences for patients as well, especially if they are in hospital

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for a long time, so there are trade-offs to be considered and no quick solutions. Indeed, APHI found that some provinces—New Brunswick was a notable example—are in such severe financial straits that it is particularly challenging for them to invest in innovations that would reduce costs in the future. Most change involves costs, and if you literally cannot afford to make changes, you are stuck. That is one reason the APHI report recommends a federal change and innovation fund, an idea that has been greeted enthusiastically by the smaller provinces. Issues of scale and spread also arise when introducing innovative products or processes, to make sure they are adopted wherever they are needed and can do the most good. Ontario is developing its academic health centres to be a channel for scale and spread, while nationally, the Canadian Foundation for Health Improvement has a successful spread model that enables people with common problems to connect even if they are located at opposite ends of the country. Recommendations for Positive Change The barriers to health innovation in Canada are daunting but not insurmountable. Overcoming them will require fresh thinking and collaboration among all the major players in healthcare, including governments, health professionals, healthcare institutions, and industry. For that reason, perhaps the most formidable of all the barriers is the current lack of trust among these groups. But if we can begin by accepting that everyone shares the same fundamental objective of value-based healthcare—to improve patient outcomes and costs—and make a start at dismantling the structural barriers, perhaps we can chip away at that final, human barrier as well. Here, then, are my recommendations for constructive change that will improve the performance of Canadian healthcare. What Governments Can Do First, while everyone in the system can play a part in the move towards value-based healthcare, the overall effort must be enabled by governments, because only governments can make the architectural changes that are required to remove the structural barriers. As recommended in the APHI report, the federal government should create a new fund and a new agency to act as a catalyst for innovation throughout Canadian healthcare. With input from major stakeholders,

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including the provincial and territorial governments, the new agency would invest, critically and non-formulaically, in supporting high-impact initiatives, breaking down barriers, and accelerating the scale and spread of meaningful change, particularly for the smaller provinces and territories that struggle to do it themselves. APHI suggests that the new organization combine the mandates of three existing federal agencies—the Canadian Foundation for Healthcare Improvement, the Canadian Patient Safety Institute and, eventually, Canada Health Infoway—and recommends an eventual funding target of approximately $1 billion annually for the new health innovation fund. It is a common claim that every provincial or territorial health system is different from all the others, but when we were travelling the country for APHI, it became clear that while there are some subtle differences, all the provinces and territories face essentially the same set of problems. Innovations that work in one jurisdiction can be applied to others. While APHI took an ambitious, strategic look at the challenges facing healthcare nationally, the innovation group in Ontario, OHIC (2014), had a more pragmatic mandate and produced a highly relevant set of specific recommendations, which are complex but relatively easy to implement. The Ontario government has adopted all of the OHIC recommendations and is currently putting them into practice. This is a province that has previously lagged other jurisdictions in adopting new approaches in healthcare, but the financial crisis has heightened the focus on the need to do things differently and, on many fronts, Ontario is now leading the way. Several core recommendations from the Ontario report, The Catalyst: Towards an Ontario Health Innovation Strategy, should be addressed by every province and territory, and eventually harmonized among them as well. The first is to establish a central body or clearinghouse for innovative ideas. If an innovation offers a real opportunity to improve patient outcomes or reduce health system costs, it should be considered, whether it comes from a multinational or a startup. The principle is that incremental efforts within the system are not sufficient to drive meaningful change. There needs to be a champion, someone who is accountable for making change happen. As a result of the OHIC report, Ontario has set up an Office of the Chief Health Innovation Strategist (OCHIS), charged with ensuring that innovative ideas—projects, processes, or products that address priority problems—are brought to the attention of the right people in the

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healthcare system. For this kind of clearinghouse to work, as it is doing in Ontario, it needs to involve not only the health ministry, but also the ministries responsible for economic development and possibly finance, to address the innovation adoption barriers and challenge the health ministry to think more broadly about economics. Some of the other provinces, including Quebec, Nova Scotia, British Columbia, and Alberta, are engaged in similar processes, but every province and territory should aim to have such a group. The federal body proposed by APHI could also distribute itself in some way, with the cooperation of the provinces and territories. Whatever the structure, the important thing is to encourage access to innovation and a commitment to see things through. My second recommendation, borrowed from OHIC, is to accelerate the shift to strategic, value-based procurement by hospitals and other healthcare organizations. The process needs to change, and the people need to be re-educated with a new skill set on how to do procurement for value rather than for price, in a way that is more attuned to clinical processes. To be really effective, people involved in procurement should be expected to improve the cost of the whole program and bring in their suppliers to help with that. It is encouraging to see that Ontario has started pilots of innovation procurement and has created an expert panel on healthcare procurement. The other provinces and territories should do the same, or at least apply what is learned. My third recommendation is that adoption should be facilitated with evidence. The current system of health technology assessment needs to go further. A recommendation to use a new product is not enough. If a product is determined to be cost-effective and clinically better than the alternatives, it should be adopted, not as a recommendation, but as a requirement. This is the process used in the United Kingdom through NICE, and, again, Ontario is leading the way in Canada, with the deputy minister of health assuring MaRS EXCITE (n.d.) that the ministry will do its best to implement HTA recommendations over a three-year period, and will also enable entrepreneurs to recoup the cost of the HTA over three years. That is an incentive for entrepreneurs to do the assessments, and a huge step forward. Finally, there needs to be a concerted effort by the provinces and territories to reform health system funding, both for institutions such as hospitals and for clinicians. Several provinces are already working on activity-based funding models for hospitals. These efforts should be accompanied by a transition away from fee-for-service to bundled pay-

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ments for physicians. The federal government could play a role here by providing catalyzing or matching funding to the provinces that need it to demonstrate the value of these new funding models. Such transitional funding could alleviate the costs of change and help address conflict with medical associations and other groups that may want to continue to advance the status quo. What Industry Can Do Having just told governments what they should do, it is only fair that I offer similar suggestions for those of us who work for companies that supply healthcare organizations. First, industry should engage more creatively with healthcare, through OCHIS and its equivalents, and with the individual hospitals and health organizations we deal with, to help find solutions to the biggest problems. Second, suppliers should work with those who work in healthcare procurement to help solve their organizations’ problems. I have been very critical of the healthcare procurement process, but industry also has to present the right package. Instead of saying, “Here’s my widget and it costs this much and, by the way, I’ll sell it to you for that much,” we need to come forward and say, “Let’s work together to scope out the whole problem and solve it.” Industry should also make a point of developing a skill set that matches the new skill set on the procurement side. If we expect procurement to look at the total system cost, then we in industry must have a point of view and an ability to address the total system cost as well. Not only should we be able to submit a more comprehensive proposal that addresses all the issues, we also need to have teams of people who can come in and do it, with expertise in core pathway design, systems engineering, Lean Sigma, or remote management, for example. The relationship should not be about us selling you a bottle of water because you asked for one, but about both sides understanding why you are thirsty and figuring out what to do about it. We should not just offer you a device—we should work with you to come up with a smart device that can capture and annotate complex data and advise doctors and patients what to do with the data. Third, industry should invest in technology assessment. We need to put our money where our mouth is by investing in HTA and making it happen.

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Industry’s Changing Role in Healthcare We in the medical technology industry are rethinking how we see ourselves and the nature of our businesses. We are finding that simply delivering an innovative product to the hospital is not enough. If the care pathway design has to change, we need to get more deeply involved in the process of delivering a successful patient outcome. We still intend to provide high-quality, innovative products, but we also want to take accountability for the performance of those products through the health system to the patient’s outcome. That is leading us into all kinds of areas, such as improving the productivity of the programs that our products are used in, and helping get patients out of the hospital and back home by providing technology that can follow patients in their homes remotely. Another issue is the cost of managing a population of patients with chronic disease. Increasingly we are taking on the role of helping the payer, which in Canada is the government, to manage the patient population—not the clinical care, because that is still provided by doctors, but everything else. And to do that, we are providing more systems engineering and analytics to help improve productivity in delivering the outcome. If industry could sell outcomes rather than products, we would be able to apply all the qualities of what we do, in terms of service, engineering, and knowledge of clinical cohorts, to the process as well as to the product, and deliver it at a lower overall cost and with at least an equivalent outcome. That may seem like a strange idea, but it can be illustrated with an example. When a patient has a hip or knee replacement, the company supplying the artificial joint might propose to manage the patient’s post-operative care using remote technologies. We know that 40 percent of the cost of the whole episode is in the post-operative care, so by managing it more closely, looking for infections, attending to pain and getting the patient mobilized in an aggressive way, we could reduce the length of stay, the medication usage, and the cost to the healthcare system. In the United States at least, there is a payment model for that kind of process. Essentially, it consists of an envelope that pays for everything: the doctor, the product, the rehab and the cost of any complications. What we would propose to do, as a supplier, is reduce the cost of the whole envelope.

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Finally, while Canadians tend to think of healthcare as an essential but hugely expensive social service, countries such as Denmark and Israel have shown it can also be an engine of economic development. As a matter of policy, they promote the use of local products through procurement, and help local companies with prototyping and early clinical data. Healthcare and industry work closely together to provide economic benefits as well as better care. One of Denmark’s most successful companies is Novo Nordisk, a world leader in the diabetes field. Other Danish standouts include Coloplast and Leo Pharma. With more than six times Denmark’s population, Canada has few, if any, global healthcare stars, even though there have been, and continue to be, plenty of promising startups. By redesigning care pathways to enable the adoption of innovative technologies and by improving procurement and HTA processes, we would encourage companies like BresoTec and Calgary Scientific, and new ventures that have yet to get off the ground, to succeed both at home and abroad. If we start now to shift the focus of Canada’s healthcare systems towards a more value-based approach to care delivery, if we begin breaking down the barriers to innovation, and if we create more trusting and collaborative partnerships among governments, healthcare providers and industry—those are big ifs, but if we can do all that—then I predict that ten years from now we will look at the latest Commonwealth Fund survey and find Canada right at the top of the list. References Abelson, R. 2013. “The Face of Future Health Care.” The New York Times, 20 March. http://www.nytimes.com/2013/03/21/business/kaiserpermanente-is-seen-as-face-of-future-health-care.html Advisory Panel on Healthcare Innovation (APHI). 2015. Unleashing Innovation: Excellent Healthcare for Canada. http://www.hc-sc.gc.ca/ hcs-sss/innovation/index-eng.php Canadian Health Policy Institute (CHPI). 2016. “Medical Devices and Health Care Costs in Canada and 74 Other Countries, 2010 to 2015.” Canadian Health Policy. http://www.canadianhealthpolicy.com/ products/medical-devices-and-health-care-costs-in-canada-and-74other-countries--2010-to-2015.html Canadian Institute for Health Information (CIHI). 2016. National Health Expenditure Trends, 1975 to 2016. https://www.cihi.ca/sites/default/

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files/document/nhex-trends-narrative-report_2016_en.pdf Commonwealth Fund, The. 2017. Mirror, Mirror 2017: International Comparison Reflects Flaws and Opportunities for Better U.S. Health Care. http://www.commonwealthfund.org/Publications/Fund-Re ports/2017/Jul/Mirror-Mirror-International-Comparisons-2017 Economist Intelligence Unit (EIU). 2016. Value-based Healthcare: A Global Assessment. http://vbhcglobalassessment.eiu.com Hope, C. 2012. “Most Doctors Are Not Paid Six Figure Sums, Figures Show.” The Telegraph, 30 May. http://www.telegraph.co.uk/news/ health/9300823/Most-doctors-are-not-paid-six-figure-sums-figuresshow.html International Consortium for Health Outcomes Measurement (ICHOM). 2017. Our Standard Sets. http://www.ichom.org/medi cal-conditions/ Insure the Uninsured Project (ITUP). 2008. The UK: The Health Care System. http://itup.org/Reports/Fresh%20Thinking/UK.pdf James, B. C., and L. A. Savitz. 2011. “How Intermountain Trimmed Health Care Costs Through Robust Quality Improvement Efforts,” Health Affairs (May). http://content.healthaffairs.org/content/ear ly/2011/05/17/hlthaff.2011.0358.full Kaplan, R. S., and M. E. Porter. 2011. “The Big Idea: How to Solve the Cost Crisis in Health Care.” Harvard Business Review, September. Lazar, H., J. N. Lavis, P.-G., Forest, and J. Church, eds. 2013. Paradigm Freeze: Why It Is So Hard to Reform Health-Care Policy in Canada. Montréal and Kingston: McGill-Queen’s University Press. MaRS EXCITE. n.d. “What is MaRS EXCITE?” https://www.marsdd. com/systems-change/mars-excite/mars-excite/ Martin, R. et al. 2011. Canada’s Innovation Imperative. https://www.com peteprosper.ca/uploads/Report_on_Canada_2011_FINAL.pdf National Institute for Health and Care Excellence (NICE). 2017. NICE Pathways—Mapping Our Guidance. https://pathways.nice.org.uk Ontario Health Innovation Council (OHIC). 2014. The Catalyst: Towards an Ontario Health Innovation Strategy. http://health.gov.on.ca/en/ pro/programs/ochis/docs/OCHIS_strategy_report.pdf Petch, J., I. A. Dhalla, D. A. Henry, S. E. Schultz, R. H. Glazier, S. Bhatia, and A. Laupacis. 2012. “Public Payments to Physicians in Ontario Adjusted for Overhead Costs.” Health Policy 8 (2). http://www.long woods.com/content/23135 Picard, A. 2012. “Nurse Practitioners in Canada More Than Double in Five Years.” Globe and Mail, 26 January, updated 6 September. http://

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www.theglobeandmail.com/life/health-and-fitness/nurse-practi tioners-in-canada-more-than-double-in-five-years/article1359892/ Porter, M. E., and E. O. Teisberg. 2006. Redefining Health Care: Creating Value-based Competition on Results, Boston, MA: Harvard Business Review Press. Spitzer, W., D. L. Sackett, J. C. Sibley, R. S. Roberts, M. Gent, D. J. Kergin, B. C. Hackett, and A. Olynich. 1974. “The Burlington Randomized Trial of the Nurse Practitioner.” New England Journal of Medicine, 31 January.

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The Politics of Change: The Role of Medical Associations in Innovation for Quality Care Christopher Simpson and Owen Adams

How have medical associations in Canada tried to promote innovation that enhances the quality of patient care? To answer this question we first need to define key terms. Canadian experience has shown that innovation must be more than merely developing and testing new ways of doing things, and getting beyond former federal Health Minister Monique Bégin’s description of Canada as a “country of perpetual pilot projects” (Bégin, Eggertson, and Macdonald 2009). The Advisory Panel on Healthcare Innovation (the Naylor Panel) defined “innovation” as activities that “generate value in terms of quality and safety of care, administrative efficiency, the patient experience, and patient outcomes.” (Naylor et al. 2015). However, the Naylor Panel also argued that it was essential to consider the associated concepts of “spread” and “scaling up.” It defined the spread of innovation as “primarily a diffusion exercise, involving sharing and learning among relatively homogenous groups of practitioners or settings.” Scaling up was defined as “expanding, adapting and sustaining successful policies, programs or projects in different places and over time to reach a greater number of people” (Naylor et al. 2015, 19). In other words spread and scaling up refer to the process of moving innovations in the delivery of care from pilot projects to the mainstream. A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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All of the activities included by the Panel in its definition of innovation are elements of the quality of care. Similarly, in his foundational 1966 paper, Donabedian identified three dimensions of quality: structure, process, and outcome. Structure refers to the settings, conditions, and circumstances in which care is delivered. He cited examples such as the qualifications of the medical staff and their organization, administrative structure and operations of institutions providing care, and fiscal organization (Donabedian 1966). The process of care refers to aspects of the provision of care along the continuum, encompassing history-taking, physician examination and diagnosis, competence in the performance of diagnostic and treatment procedures, prevention activities, continuity of care, and acceptability to the patient. The outcome of medical care was defined “in terms of recovery, restoration of function and of survival.” In a subsequent paper more than two decades later, Donabedian set out what he called the “seven pillars of quality.” These were efficacy, effectiveness, efficiency, acceptability, the patient-practitioner relationship, legitimacy, and equity (Donabedian 1990). Ayanian and Markel (2016) have claimed that these pillars led to the six dimensions of quality improvement that were included in the United States’ Institute of Medicine’s (IOM) landmark 2001 report, Crossing the Quality Chasm. The six dimensions are • safe: avoiding injuries to patients; • effective: providing evidence-informed care to those who will benefit, and refraining from providing it to those who will not; • patient-centred: care that is respectful of, and responsive to, patient preferences, needs, and values; • timely: reducing waits and sometimes harmful delays; • efficient: avoiding waste; and • equitable: providing care that does not vary in quality on account of personal factors such as gender, ethnicity, geographic location, and socioeconomic status. These six dimensions have been widely adopted as the basis for quality improvement strategies although there is some local variation. The six IOM dimensions largely reflect the process dimension of Donabedian’s original framework, and this is where most of the focus has been in the years since his original paper. More recently however, attention is turning to structure (such as new payment models) and outcomes (such as patient-reported outcome measures, or PROMs).

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The incorporation of Donabedian’s framework in the delivery of healthcare in Canada has been a long journey, and a more or less sequential process over the past three decades. The remainder of this chapter will review the innovative initiatives that medical associations have undertaken to address them, with a focus on the Canadian Medical Association (CMA). The review will begin with the six IOM dimensions of process and will return to structure and outcomes later. Effective Care Clinical Practice Guidelines Beginning in the early 1990s medical associations began to promote “evidence-based medicine,” and in recent years they have built on this foundation by addressing appropriateness of care. This began with the emergence of clinical practice guidelines (CPGs), which made their first appearance in the literature in 1990 (Gottlieb, Margolis, and Schoenbaum 1990). CPGs are defined as “systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances” (Field and Lohr 1990). In the fall of 1990, the CMA struck a Quality Committee, chaired by Adam Linton. Linton and David Peachey had authored a two-part article on CPGs earlier that year; the first part set out a rationale explaining why they were needed, and the second part outlined a strategy for developing them (Linton and Peachey 1990; Peachey and Linton 1990). In the first paper they cautioned about the tendency to label guidelines as “cookbook medicine,” and suggested that they needed to be guidelines that would permit some flexibility rather than firm rules. CPGs became a major thrust of the CMA Quality Committee. In 1991 the CMA established the National Partnership for Quality in Health (NAPAQH) with five other medical associations and in 1992 NAPAQH convened a workshop on CPGs that brought together more than forty health organizations. The workshop resulted in a consensus document, Guidelines for Canadian Clinical Practice Guidelines (Canadian Medical Association 1994). This document set out fourteen guidelines under the topics of philosophy and ethics, methods and implementation and evaluation, as well as a proposed format for structured abstracts for CPGs. In 1996 the CMA launched the CPG Infobase, a searchable database that presently contains some 1,200 CPGs that are either developed or endorsed by Canadian medical and health organizations. The CMA subsidiary, Joule, also makes additional tools available to the membership,

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including Dynamed Plus®, a point-of-care reference tool that answers clinical questions and Patient-Oriented Evidence that Matters (POEMS) which provides summaries of newly published research. At the provincial level, the Alberta Medical Association and Alberta Health fund the Toward Optimized Practice initiative that develops CPGs to address practice gaps in Alberta (Toward Optimized Practice 2017). The premiers of the provinces and territories have increasingly taken a greater interest in health issues. At their summer 2010 meeting, they directed their health ministers to work with experts on CPGs; by 2011 the ministers had agreed to collaborate by focusing on three to five specific CPGs with a potential for better care and cost savings (Council of the Federation 2011). A summit meeting in November 2011 produced five key recommendations ranging from topic selection through to process and outcome evaluation (Canadian Medical Association 2011). In January, 2012 the premiers announced the formation of the Health Care Innovation Working Group (HCIWG), to be co-led by Brad Wall, premier of Saskatchewan and Robert Ghiz, premier of Prince Edward Island. The working group was charged with examining scope of practice (team-based models of care), human resources management and CPGs, in consultation with healthcare providers. Staff from the CMA, the Canadian Nurses Association, and the Health Action Lobby were invited to participate on the team-based models and CPG theme groups of activity. The CPG theme group assessed candidate CPGs on the basis of incidence and prevalence of disease, impact of the guidelines on patients, disease burden to the system, and availability of high quality CPGs. The HCIWG presented its first report to the premiers in July 2012. In the area of CPGs it recommended the adoption of the Canadian Cardiovascular Harmonized Guidelines Endeavour (or C-Change) guidelines for cardiovascular disease and the Registered Nurses’ Association of Ontario guidelines for the assessment and management of foot ulcers for people with diabetes. The premiers also agreed to expand the work on CPGs, with the next phase to include reviewing the appropriateness of certain tests and procedures (Council of the Federation 2012a; Council of the Federation 2012b). In the years since 2012, the premiers’ focus has shifted from CPGs to appropriateness. In their 2013 communiqué they cited estimates of the Canadian Association of Radiologists suggesting that 10 to 20 percent of imaging tests might be unnecessary and they agreed to adopt guidelines for the use of diagnostic imaging tests for minor head injuries, lower back pain, and headaches (Council of the Federation 2013).

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Following two further years of work, the HCIWG presented a report to the premiers at their 2016 meeting indicating that it was working on metrics to evaluate appropriateness initiatives (Council of the Federation 2016). Appropriateness Since 2012 there has been concerted attention by the CMA and other medical associations on promoting appropriate care. The CMA has defined appropriateness as “the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care” (Canadian Medical Association 2015a). A major impetus to the Canadian work on appropriateness has been the Choosing Wisely initiative of the ABIM Foundation in the United States. The origin of this initiative was a challenge issued by physician and bioethicist Howard Brody to medical specialty societies to develop a “Top Five” list. This list would comprise five diagnostic tests or treatments that were commonly ordered, expensive, and shown by evidence to provide no meaningful benefit to at least some groups of patients for whom they are commonly ordered (Brody 2010). In April, 2012 the ABIM Foundation, in partnership with Consumer Reports, launched Choosing Wisely with Top Five lists from nine specialty societies. Seventeen more societies joined in 2013 and today there are more than seventy (Choosing Wisely 2017). Wendy Levinson, the chair of medicine at the University of Toronto and former ABIM board member and chair, brought Choosing Wisely to Canada, launching it in 2014 in partnership with the CMA. Nine medical associations released a Top Five list in the initial launch. As in the United States, Choosing Wisely Canada (CWC) has grown almost exponentially since 2014. There are now more than 250 recommendations from more than forty different specialty areas (Choosing Wisely Canada 2017a). The CWC campaign partners include more than 100 professional societies, provincial-territorial medical associations, health system organizations and patient organizations. As in the United States, CWC extends beyond medicine. The Canadian Nurses Association has published a list of nine things that nurses and patients should question and is working with nursing specialty groups to develop nursing lists that are specialty-specific (Choosing Wisely Canada/Canadian Nurses Association 2017; Canadian Nurses Association 2017). In 2015 CWC introduced the Students and Trainees Advocating for Resource Stewardship (STARS)

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program, through which students from each of Canada’s seventeen medical schools are nominated to participate in CWC’s leadership training program, that has resulted in local campaigns in the medical schools (Choosing Wisely Canada 2017b). Notwithstanding the rapid uptake of CWC, a recent report co-authored with the Canadian Institute for Health Information has shown that there is room for improvement. It found that up to 30 percent of tests, treatments, and procedures associated with eight selected CWC recommendations were potentially unnecessary and that there is substantial variation in the numbers of unnecessary tests and procedures across facilities and regions (Choosing Wisely Canada/Canadian Institute for Health Information 2017). In addition to its participation in CWC, the Québec Medical Association (QMA) convened a Symposium on Overdiagnosis in 2014. Consensus was reached on the following definition: “overdiagnosis occurs when people are diagnosed with a disease that ultimately will not cause them to experience symptoms or early death, or a procedure is done that does not add value to a treatment.” The Symposium resulted in a seven-point action plan with recommendations in areas such as awareness and dissemination, teaching and professional development, and defensive medicine and compensation methods (Québec Medical Association. 2014). The QMA hosted the fifth international Preventing Overdiagnosis conference in August 2017. In summary, the CMA and other medical associations in Canada and internationally have shown considerable leadership in developing tools such as CPGs and Top Five lists. While more than twenty countries are now participating in the Choosing Wisely movement, much more needs to be done on uptake and evaluation at the grassroots clinician level. The integration of Top Five lists as decision support tools in electronic medical records would likely be a useful extension. Acclaimed Intermountain Healthcare, based in Utah, has been building alerts based on Choosing Wisely recommendations in its electronic medical records (EMRs; Choosing Wisely 2017). In Canada, one challenge to achieving this is the number of EMR software vendors. It is noteworthy that physician organizations in both the US and Canada have embraced Choosing Wisely very swiftly, seemingly with much greater buy-in than the early “watchful waiting” efforts to address surgical rate variation (Kasper, Mulley, and Wennberg 1992), suggesting that solid physician engagement can be a great accelerator for system reform.

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Timeliness of Care The timely access dimension has essentially dominated the quality agenda in Canada since the mid-1990s. Following an economic recession in the early 1990s, real per capita health spending declined in each of five years beginning in 1992. This was compounded by the decision of the federal government to reduce the cash health transfers to the provinces by $6 billion over two years beginning in April, 1996. Healthcare quickly rose to the top of the public’s concerns. Ipsos has regularly asked the Canadian public about their top issues for leaders to address since the early 1990s. Prior to 1996 healthcare was rated as the top issue by less than 10 percent of respondents. That began to change in 1996, and by the end of 1998 healthcare had become the top-ranked issue (Vail 2001). Since that time healthcare and unemployment/jobs have occupied the two top issue positions. On thirty-five surveys conducted by Ipsos between March 2010 and July 2017, healthcare has averaged 41 percent as a leading issue compared to 37 percent for unemployment/jobs (Ipsos Public Affairs 2017). At its 1996 annual General Council meeting the CMA adopted a resolution to advise the federal, provincial, and territorial governments and the Canadian public of the unacceptable waiting lists impeding access to healthcare. The following year delegates raised this issue directly with the federal health minister, Allan Rock, following his address to General Council. His response to the contention that healthcare funding was insufficient was a challenge to show him where the shortfalls were and then the government could address them either through re-allocation or other means. The CMA then compiled several binders of anecdotal waiting list stories from news media that CMA President Victor Dirnfeld presented to Rock in October 1997. Shortly after the annual meeting Health Canada issued a Request for Proposal for literature reviews on waiting lists. In January 1998, the CMA developed a proposal—Access to Quality Health Care—that set out a three-part proposal including frameworks for quality outcomes across the continuum of care, measurement of waiting times, and levels of evidence (Canadian Medical Association 1998a). This was put forward to the Conference of Deputy Ministers of Health prior to their January 1998 meeting. The result of this effort was Rock’s announcement at the CMA’s 1998 meeting of the $2 million Western Canada Waiting List (WCWL) project. WCWL was a consortium of nineteen organizations from the four Western provinces that included universities, governments, regional health authorities, and medical associations, plus the CMA. In its first phase of work, the WCWL developed

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and tested priority scoring tools for cataract surgery, general surgery, hip and knee replacement, MRI scanning, and children’s mental health. In a second phase that concluded in 2005, WCWL focused on implementation and evaluation of the tools, formulation of benchmark waiting times, and adaptation of tools for primary care (Western Canada Waiting List Project 2005). Beginning in 2004 there was an intense two-year period of activity to move wait times from research to the public policy agenda. In late 2003, the CMA commissioned Ipsos to lead a key informant study in Australia, New Zealand, England, and Sweden on experiences in managing wait times in those countries. The results formed the basis of a roundtable sponsored by the CMA and other organizations in March 2004. The roundtable resulted in the first of the Taming of the Queue conferences that ran annually from 2005 to 2015, and which brought together more than 150 participants each year to examine wait-time issues across the healthcare system (Canadian Foundation for Healthcare Improvement 2015). This activity was mirrored at the political level: the Liberal election platform for the June 2004 federal election promised a “fix for a generation” in healthcare. This included a “Five in Five” plan that would be a drive to achieve waiting times for five key areas by 2009, including cancer, heart, diagnostic imaging, joint replacement, and sight restoration (Liberal Party of Canada 2004). Following the election, Paul Martin, the prime minister, convened a four-day first ministers meeting that began on 13 September 2004. The result was a ten-year accord that included a $5.5 billion Wait Times Reduction Fund. The accord called for four commitments in the area of waiting times, the key one being the establishment of evidence-based benchmarks for medically acceptable wait times for the five conditions in the election platform by 31 December 2005 (Canadian Intergovernmental Conference Secretariat, n.d.). Almost immediately thereafter the CMA came together with six national specialty societies representing the five procedural areas to explore the development of benchmarks. Calling itself the Wait Time Alliance (WTA) the group began by setting out five guiding principles for wait-time benchmarks: • • • • •

They should be pan-Canadian. They must be clinically indicated and derived. Meaningful input of the practicing community is essential. Public accountability and transparency are important. Wait-time benchmarks and targets must be sustainable.

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The WTA released provisional benchmarks in March 2005 in the categories of emergency, urgent/semi-urgent, and routine cases for consultation purposes. With some refinement the final benchmarks were released in August 2005 with recommendations for their implementation (Wait Time Alliance 2005). The provincial-territorial health ministers requested assistance from the Canadian Institutes for Health Research, and following a request for application process, eight research teams, including WCWL, were selected to develop a synthesis on sight restoration, joint replacement, and cancer; the reports were released in November 2005 (Health Council of Canada 2012). Remarkably, on 12 December 2005, the provincial and territorial health ministers announced that they had agreed on common benchmarks for radiation therapy, hip and knee replacements, cataract surgery, and breast and cervical cancer screening, with a promise of more benchmarks to come (Ontario Ministry of Health 2005). While Watson and her colleagues (2007) have claimed that CIHR was responsible for this achievement, it seems highly likely that the publicity that the WTA had achieved contributed significantly. In July 2005, Dr. Brian Postl was appointed federal advisor on wait times. He consulted extensively across Canada, and his report was quietly released by the government in 2006, containing twenty recommendations that addressed wait-list measurement and management issues (Postl 2006). Wait times featured in the party platforms of both the Liberal and Conservative parties in the January 2006 federal election. Inspired by the 2005 Supreme Court of Canada decision in favour of Zeliotis/ Chaoulli, both parties pledged to introduce a patient wait-times guarantee. In the April 2006 Speech from the Throne, the new Conservative government of Stephen Harper committed to “engage the provinces and territories on a patient wait times guarantee for medically necessary services,” and it followed through in the 2007 budget, which included a $612 million “Patient Wait Time Guarantee Trust,” with $500 million to be allocated on a per-capita basis to those provinces and territories that had outlined plans to implement a wait-times guarantee in one of the priority areas in the 2004 Accord (Finance Canada 2007). Harper came to the 4 May 2007 Taming of the Queue conference to announce that all ten provinces and three territories had signed on. The WTA issued its first report card in November 2006: the ten provinces were rated on each of the five priority areas (Wait Time Alliance 2006). In the first report card there were a number of entries marked as “data incomplete,” but over time government website reporting

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improved, likely due at least in part to WTA evaluations and ranking of the government wait time websites themselves. Governments never did develop pan-Canadian benchmarks for diagnostic imaging, or for any additional procedural areas, but the WTA continued to expand with additional specialty societies and benchmark areas. By 2015, its final report included eighteen medical partners and members and a patient advisor, and had developed benchmarks for over 1,000 consultations, tests, and procedures in sixteen specialty areas (Wait Time Alliance 2015). CIHI released its first wait times report in 2007 and it continues to report annually on the areas where governments had set benchmarks; it also reports on diagnostic imaging wait times (Canadian Institute for Health Information 2017). Most of the focus of the wait time effort has been on the time between the decision to treat and when the procedure is carried out, or “Wait Two.” In 2007 the CMA and the College of Family Physicians of Canada struck a Primary Care Wait Time Partnership. It set out six recommendations in its 2009 report that address waiting time issues between referral from the family physician to specialist consultation, or “Wait One” (College of Family Physicians of Canada/Canadian Medical Association 2009). In 2011 and 2012 the CMA carried out a large project on referral and consultation, and a Referral and Consultation Toolbox was completed in 2012 that addressed issues such as central intake, physician directories, and the measurement of Wait One (Canadian Medical Association 2017a). In summary, the work to reduce wait times is far from over, but efforts continue to improve the situation. Provinces continue to expand the capabilities of their waiting list websites, and jurisdictions, including Alberta and Ontario, are introducing e-referral systems to address Wait One. Medical associations and governments are also developing remuneration programs to support electronic communication between physicians and between physicians and patients. One of the key lessons is that it took a long time to raise timely access to the point where it was acknowledged by governments as a serious issue: there was a lapse of seven years from Rock’s challenge to the CMA in 1997 to the 2004 Wait Time Reduction Fund. Key success factors included the efforts to gather credible evidence and the collaboration among the medical specialty societies. Unfortunately the concept of a wait-time guarantee has stalled.

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Safe Care In 1997 the CMA General Council adopted a resolution to “establish a medical risk management forum to attempt to achieve a consensus on methods of clinical risk reduction and their funding.” Subsequently the CMA convened an Invitational Forum on Risk Management in May 1998. The Forum agreed on a definition that risk management is “a process whereby risk factors are identified, analyzed, and then either minimized or eradicated” (Canadian Medical Association 1998b). It focused on the distinction between clinical risk and legal risk, and identified several action items including the need for a Canadian Risk Management Institute that would be an independent body with broad stakeholder representation. In 2000 the CMA struck an advisory group on risk management that developed a Patient Safety Policy Framework based on fourteen principles and a resource guide of safe medication practices (Canadian Medical Association 2001, 2002a). In May, 2001 the Board agreed to explore the formation of a risk management network, but it was decided to support the leadership of the Royal College of Physicians and Surgeons of Canada in convening a forum on patient safety in September 2001. This forum resulted in the National Steering Committee on Patient Safety that came forward a year later with nineteen recommendations, the main one being a call for the establishment of a Canadian Patient Safety Institute (National Steering Committee on Patient Safety 2002). The CPSI was established in 2003 and it continues its efforts to develop a national integrated patient safety strategy (Canadian Patient Safety Institute 2017). The CMA participated on the working group that developed the CPSI Canadian Disclosure Guidelines and endorsed them upon their completion (Canadian Patient Safety Institute 2011). In 2010 the CMA collaborated with the Royal College, College of Family Physicians of Canada, and the Canadian Medical Protective Association to convene a forum on improving patient safety through disclosure and quality improvement reviews. In summary, while the CMA was an early leader in recognizing the growing problem of patient safety it chose early on to play a mainly supportive role to the efforts of the Royal College. Although the decision-making process is not documented, as the preceding section has shown, the CMA made a major investment in the access and wait times agenda. This was also at a time when the Romanow Commission on the Future of Health Care had been struck, and the CMA undertook a massive consultation and policy development exercise in partnership with

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the provincial-territorial medical associations to make representation to it. The CMPA has taken on a much more prominent role on patient safety, and contributing to safe medical care is set out as the second of three strategic outcomes in its 2015–2019 strategic plan (Canadian Medical Protective Association 2015). Patient-Centred The Naylor Panel issued a strong call for patient-centred care in its report, and recommended that the federal government develop a strategy to promote patient and family-centred care that would include information tools, incentives for greater patient engagement at the organization and system levels, and best practices for patient portals (Naylor et al. 2015). There has been a burgeoning literature that addresses aspects of “patient-centred” care since the early 1990s. Early papers examined issues such as patient involvement in clinical decisions such as “watchful waiting” (since renamed “active surveillance”) for conditions such as benign prostatic hypertrophy (Barry, Mulley Jr., and Fowler 1988) and evolved to patient decision aids covering a broad array of conditions and decisions (Ottawa Hospital Research Institute 2017). More recently the terms “patient engagement” and “patient empowerment” have come into use to reflect a much stronger role for patients in directing all matters related to their health and healthcare. This shift is reflected on the evolution of the CMA’s mission statement over the past few decades. The mission, adopted in 1989, was “to provide leadership for physicians and to promote the highest standard of health and healthcare for Canadians” and a key objective of the health advocacy role was to “facilitate the role of the physician as advocate for the patient in the health care system” (Canadian Medical Association 1991). The mission adopted in 2017 was “empowering and caring for patients,” and the first of three strategic objectives is “consistently bring a patient-centred perspective to the work of the CMA” (Canadian Medical Association 2017b). For most of the past two decades the CMA’s advocacy focused on promoting the rights of patients to timely access to care. As is well known, the Canada Health Act (CHA) that defines medicare is silent on the issue of quality of care beyond equitable access without financial barriers. A proposal for a Health Charter for Canadians was first introduced in the 1964 Hall Commission report but was not acted on. A Canadian Health Charter was the centrepiece recommendation in the CMA’s 2002

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submission to Roy Romanow’s Commission on the Future of Health Care in Canada. Developed through a series of public focus groups conducted across Canada, the CMA’s proposal included rights and responsibilities for patients/citizens, providers, and governments. The rights specified for patients/citizens included access to timely, quality care; recourse should the public system fail to deliver timely access; choice of provider; and security and confidentiality of personal health information (Canadian Medical Association 2002b). Romanow’s first recommendation called for the establishment of a Canadian Health Covenant that set out responsibilities and entitlements for individual Canadians, health care providers, and governments (Romanow 2002). Romanow also recommended modernizing the CHA’s existing principles and adding a sixth principle of accountability. Neither recommendation was adopted. Undaunted, the CMA put forward a proposal, Building a Culture of Patient-centred Care, in 2010 as one of five pillars of its healthcare transformation framework. It proposed that patient-centred and sustainability be added as new principles to the CHA and defined patient-centred care as “seamless access to the continuum of care in a timely manner, based on need and not the ability to pay, that takes into consideration the individual needs and preferences of the patient and his/her family, and treats the patient with respect and dignity” (Canadian Medical Association, n.d.). Based on a second series of cross-country focus groups conducted with the public and physicians, the CMA put forward a proposed Charter for Patient-Centred Care that it described as a mutually reciprocal covenant among patients, providers, funders, and organizers of care. In 2011 the CMA and the Canadian Nurses Association put forward guiding principles for healthcare transformation, and patient-centred care was the first (Canadian Medical Association/ Canadian Nurses Association 2011). While there has been no action on a patient charter at the national level, the 2010 Alberta Health Act, which came into force in January 2014, provided for a health charter and a health advocate. The charter was issued in March 2014, and includes eleven items that patients can expect when they interact with the health system, such as “timely and reasonable access to safe, high quality service and care” and six items that will be expected of them, such as “ask questions and work with providers to understand the information I am being provided” (Alberta Health Advocates 2014). The CMA recognizes that there is much more to patient-centred care than timely access especially with the rapid advances in information technology. In 2005 the CMA adopted physician guidelines for online

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communication with patients and in 2015 adopted guiding principles for physicians recommending mobile health applications to patients (Canadian Medical Association 2005, 2015b). The College of Family Physicians of Canada (CFPC) has also been advocating for patient-centred care. Its 2011 vision document for the patient’s medical home includes patient-centred as the first of ten pillars. The document includes six recommendations under this pillar, the first of which is “care and caregivers in a Patient’s Medical Home must be person-focused and provide services that are responsive to patients’ feelings, preferences and expectations” (College of Family Physicians of Canada 2011). Looking ahead, Accreditation Canada and its affiliate Health Standards Organization have introduced changes that will likely have a significant effect in strengthening the role of the patient in the healthcare system. Changes in the accreditation standards were introduced in 2016 that ask client organizations to specifically include patient and family representatives on advisory and planning groups, and to include patient and family input in the monitoring and evaluation of service quality. They are going further to “walk the talk” by recruiting and including patient representatives on all technical committees that develop new accreditation standards, and they are starting to include patient representatives on accreditation survey teams, with a goal of including them on all survey teams in the future (Accreditation Canada 2017). With its new mission of “empowering and caring for patients” and the objective of bringing a patient-centred perspective to its projects, it is almost certain that patient advocacy groups will be watching closely to see how the CMA delivers! Equitable The issue of equity in healthcare has taken on a broader definition than what was set out by the IOM. While the IOM defined equitable as care of the same quality across a range of personal characteristics such as socio-economic status, there is now a much greater emphasis on how health professionals and the healthcare system can engage on the social determinants of health (SDoH) to mitigate their effects on vulnerable patients. The concept of SDoH was recognized in Canada during the Great Depression. Leonard Marsh and his colleagues conducted research among unemployed men in the 1930s and documented the health effects of poor nutrition and living conditions, asking in their conclusion how medical care could be provided more equitably

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(Marsh, Fleming, and Blackler 1938). In his wartime Report on Social Security for Canada, prepared for the federal Advisory Committee on Reconstruction, Marsh made a strong case for universal coverage for medical care (Marsh 1943). As Canada and other countries adopted universal coverage during the post–World War II period, it may have been implicitly assumed that universal access to medical and hospital services would mitigate the effects of health inequalities. The 1980 report by Sir Douglas Black in the UK came as a shock internationally. Black found that despite the introduction of the National Health Service in 1948, health inequalities across social class levels had not diminished; indeed, if anything, they might be widening (Townsend and Davidson 1982). In 1990 Robert G. Evans and Greg L. Stoddart published their paper “Producing Health, Consuming Health Care,” which ushered in the population health movement and an emphasis on multiple determinants of health and SDoH (Evans and Stoddart 1990). A 2009 Senate report on population health estimated that the healthcare system ac-

Figure 11.1 What Makes Canada Sick?

Source : Adapted from Chart 1 in Standing Senate Committee on Social Affairs, Science and Technology (2009).

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counts for 25 percent of health status, one-half the size of the contribution of socio-economic status, as shown in Figure 11.1 (Standing Senate Committee on Social Affairs, Science and Technology 2009). Since that time the CMA has undertaken several activities to raise awareness about the importance of SDoH and to identify opportunities for physicians to assist their patients to address them. Several resolutions on SDoH were adopted at the CMA’s General Council in 2011, one of which called for the preparation of a discussion paper on the role of physicians and the healthcare system in addressing the SDoH. As part of the development of the discussion paper key informant interviews were carried out with thirty-two physicians from across Canada. They were asked to identify areas of intervention, barriers, and potential actions. The physicians identified seven types of intervention such as linking patients with supportive community programs and services, and asking patients about their social and economic circumstances (Canadian Medical Association 2012). A strategic session on SDoH was held at General Council in 2012, which featured a plenary address by Sir Michael Marmot, the recognized world leader on SDoH. The discussion paper led to the adoption of two CMA policies in 2013; one on the role of the medical profession in addressing health equity and the SDoH and the second on strategies for government, planners, and the medical profession to ensure equitable access to care (Canadian Medical Association 2013a, 2014). In 2013 the CMA conducted a series of public town hall meetings in six cities across Canada on SDoH, plus an online consultation. The four main SDoH that were consistently identified were income, housing, nutrition and food security, and early childhood development. The report contained eleven recommendations addressing these determinants, and other areas including the health of indigenous peoples (Canadian Medical Association 2013b). In 2015 the CMA collaborated with the British Medical Association, World Medical Association and the University College London Institute of Health Equity to convene a global symposium on the role of physicians and national medical associations in addressing the SDoH. This was attended by some 140 delegates and speakers from over twenty countries. The symposium identified key actions for healthcare providers to take to address the SDoH both in their capacities as employers and managers and at the clinical front-line level in caring for patients, as well as actions that medical organizations can take to support them (Buckley 2015). The CMA also sponsored the development of an online module on SDoH by a consortium led by the Office of Professional

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Development at Memorial University but it is outdated and has been withdrawn. However in 2015 the CFPC issued a best advice guide on SDoH (College of Family Physicians of Canada 2015) that includes links to other resources such as the Poverty Intervention Tool developed by its Ontario Chapter and the Centre for Effective Practice (Centre for Effective Practice 2016). In summary, the CMA has made considerable efforts in promoting awareness about the health impacts of the SDoH among the physician community and the Canadian public. One area where further action might be anticipated is in the capture of SDoH indicators in electronic medical/health records (EMRs/EHRs), especially with the majority of Canadian physicians now using them at least partially to capture patient information. In 2014 the US Institute of Medicine recommended twelve core social and behavioural indicators for EHRs, including income and education (Institute of Medicine 2014). Aside from including such indicators as screening tools to assist patients to secure resources such as social welfare benefits, such data could provide valuable insight on equitable access and utilization of care. It must be emphasized, however, that these are “downstream” interventions, and do not address the structural factors that create socio-economic inequalities. In the last few years Canadian physicians including Drs. Ryan Meili and Monika Dutt have played a leadership role in launching Upstream, a non-partisan organization whose name describes their approach to social determinants of health (Upstream 2017). Efficient The IOM definition of efficiency focuses on waste. Following a strategic session at General Council in 2012, the CMA developed a policy statement on efficiency that is organized on an adaptation of a conceptual framework for waste in the US healthcare system (Canadian Medical Association 2015c; Bentley et al. 2008). This is depicted in Figure 11.2. In terms of the CMA’s activities related to this framework, there is a large overlap with the effective dimension of quality in the area of clinical waste. CMA’s activities on operational waste overlap with the activities on the timely dimension, in particular the activities with the WTA. In 2007 the CMA commissioned a study on the cost of waiting for the four priority areas of joint replacement surgery, cataract surgery, coronary artery bypass surgery, and MRI exams. The cumulative economic cost of waiting for treatment in 2007 was estimated at $14.8

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Figure 11.2

Waste in the Healthcare System

Source: Adapted from Bentley et al. 2008

billion (Centre for Spatial Economics 2008). In the area of administrative waste, the CMA has been concerned about the number of forms that physicians are required to complete by third parties in order for their patients to receive benefits. Sick notes requested by employers for short-term absences are a case in point. CMA’s 2017 policy statement on third party forms states that “such an absence does not require physician confirmation of illness and represents an inefficient use of scarce health care resources” (Canadian Medical Association 2017c). Most recently the Ontario government has proposed changes to employment and labour laws that would prohibit employers from requesting a sick note from an employee taking personal emergency leave of up to ten days per year (Ontario Ministry of Labour 2017). Looking ahead, as the body of research and recommendations on appropriateness, such as Choosing Wisely Canada continues to grow, medical associations will be challenged to act to reduce inappropriate care through what is being variously termed disinvestment, reducing low-value care, and de-adoption. Elshaug et al. (2007) have defined disinvestment as the “process of (partially or completely) withdrawing health resources from any existing health care practices, procedures,

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technologies or pharmaceuticals that are deemed to deliver little or no health gain for their cost.” Scott and Duckett have defined low-value care as the “use of an intervention where evidence suggests it confers no or very little benefit on patients, or risk of harm likely exceeds benefit” (Scott and Duckett 2015). Niven et al. (2015) define de-adoption as the discontinuation of a clinical practice after it was previously adopted. One of the key challenges to disinvestment identified by Scott and Duckett is that “very few clinical interventions are of no value in every clinical circumstance” (Scott and Duckett 2015). This was illustrated by the immediate reaction to a paper by Elshaug et al. that proposed a list of 150 items from the Australian Medicare Benefits Schedule that they identified as low-value (Elshaug et al. 2012). This quickly resulted in a spate of commentaries from several specialties criticizing the inclusion of procedures such as surgery for obstructive sleep apnoea and prophylactic use of implantable cardioverter defibrillators. Nonetheless the enthusiastic uptake of Choosing Wisely by specialty societies is encouraging. Bhatia et al. have proposed a comprehensive measurement framework to assess its impact on physician attitudes and behaviours and patient engagement and acceptance (Bhatia et al. 2015). Structure and Outcomes To date, most of the focus on quality has been on the process dimension of Donabedian’s framework. There has been some recent attention to structure and outcomes, although this has not been addressed in an integrated quality framework. Structure In a 1988 paper on measuring and assessing quality of care Donabedian categorized human resources under the structural dimension, including variables such as medical staff organization and methods of peer review and reimbursement (Donabedian 1988). The Naylor Panel called for a realignment of incentives and physician payment methods, and in particular recommended acceleration of what it referred to as “the long goodbye” to fee-for-service (FFS). Provider remuneration in Canada is a matter of provincial jurisdiction, and in the case of physicians is under the purview of the provincial-territorial medical associations (PTMAs) and the general practitioner and specialist federations in Quebec. The CMA does track physician remuneration through periodic surveys; the key tracking indicator is the proportion of physicians receiving 90

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percent or greater of their professional income from various methods. Since 1990 the proportion of physicians receiving 90 percent or more of their income from FFS has dropped from 68 percent to 37 percent in 2013, a drop by almost one-half (College of Family Physicians of Canada/Canadian Medical Association/Royal College of Physicians and Surgeons of Canada 2013). Over the past two decades provinces have introduced new funding models in primary care such as blended capitation for physicians (Ontario) and capitated funding for primary care services from providers other than physicians (Alberta). There has also been some introduction of pay-for-performance. Looking ahead, technology, and information technology in particular, will play a greater role in the structure of care. This did not receive significant attention in Donabedian’s work. Indeed the Canadian Agency for Drugs and Technologies in Health is less than thirty years old. In 2016 the CMA launched a new subsidiary, Joule, which has as one of its objectives to promote physician-led innovation (Canadian Medical Association 2016a). Joule has struck the Joule Innovation Council that comprises physician innovators and business leaders. In 2016 Joule launched an innovation grant program through which CMA members can compete for six grants in the categories of later-stage, early-stage, and social innovations. The first call resulted in 126 submissions that were evaluated by the Innovation Council on the criteria of degree of disruption, healthcare benefits, relevance, and scalability (Canadian Medical Association 2016b). A second call closed in May 2017. In February 2017 the Senate Standing Committee on Social Affairs, Science and Technology initiated a study on the role of automation in the healthcare system with a focus on robotics, 3D printing, and artificial intelligence. The study will examine the impacts on direct and indirect healthcare and home care (Standing Senate Committee on Social Affairs, Science and Technology 2017). Outcomes In 1989 Donabedian traced the career of US surgeon Ernest Amory Codman. In the early 1900s Codman had proposed an “end result system.” He proposed that each patient would have an “end result card” that would record symptoms, diagnosis, treatment plan, complications, diagnosis at discharge, and “the result each year afterward” until the definitive outcome could be determined (Donabedian 1989). Codman’s peers did not appreciate his proposals. Interestingly, Donabedian did

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not discuss Codman’s work in the modern context, but it is probably fair to say that most of the focus on outcomes in North America to date has been on intermediate outcomes of the processes of care, such as infection rates and readmissions. Internationally England has been a pioneer in the use of patient-reported outcome measures. Since 2009 the National Health Service has mandated the use of before-and-after patient surveys for four surgical procedures including groin hernia, hip and knee replacement, and varicose vein surgery. The surveys for each procedure include the Euroqol-5D index (EQ-5D), and the Euroqol Visual Analogue Scale (EQ-VAS). EQ-5D is a standardized instrument that measures health-related quality of life on the five dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Euroqol 2017). EQ-VAS records self-rated health on a visual analogue scale that asks the patient to rate their health on a scale of worst imaginable health state to best imaginable health state. By Canadian standards the results are reported in an extremely timely fashion. PROM results for April–December, 2016 were published in May 2017. For example, 51 percent of groin hernia patients during that period showed improvement on EQ-5D and 39 percent showed improvement on EQ-VAS, compared to 89 percent and 67 percent respectively for hip replacement patients (NHS Digital 2017). Kyte et al. have enumerated a number of challenges that must be addressed for PROM data to be used more effectively in improving patient care and outcomes, including improved efficiency of data collection and giving providers guidance on how to interpret and use the data (Kyte et al. 2016). In 2013 Alberta Health published a health system outcomes and measurement framework that identifies a number of outcome indicators, but does not go as far as PROMs (Alberta Health 2014). During the past several years there has been growing interest in the concept of “social impact bonds” whereby payment for a program is only made if an outcome target is achieved. Wise has recently proposed the establishment of a provincial or federal outcomes fund that would address the needs of a particular segment of the population that might be served through community interventions (Wise 2017). There seems little doubt that eventually the healthcare system will engage on patient outcomes but it seems unlikely to happen anytime soon.

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Conclusion The CMA and other medical associations have been promoting innovation in the quality of care for almost three decades. However, the six dimensions of safe, effective, patient-centred, timely, efficient, and equitable appear to have been pursued with varying intensity and largely in isolation of each other. One area where the medical community could likely make a significant contribution would be to advocate for a patient and population outcomes agenda. CIHI has been doing exploratory work on PROMs (Canadian Institute for Health Information 2015), and there are international organizations such as the Picker Institute and the International Consortium for Health Outcomes Measurement that are doing relevant work that could no doubt be applied in Canada. The urgency and importance of adopting a comprehensive approach to quality is underscored by the July 2017 release of the the Commonwealth Fund’s study that ranks eleven countries on six dimensions of care, including care process, access, administrative efficiency, equity, and health care outcomes (Commonwealth Fund 2017). On its first 2014 eleven-country survey Canada ranked tenth out of eleven, ahead of only the United States, and there was speculation that the US might overtake Canada on the next iteration. However France has now switched places with Canada for tenth in the 2017 version. This is not a cause for celebration. Indeed, among the five dimensions, Canada ranks no higher than sixth place (care process and administrative efficiency) and ranks ninth or tenth on the others. While more than one-half of the provinces have some form of health quality council, a greater national focus would be desirable. In conclusion, we are left with several questions for further research: • How is the pursuit of a comprehensive quality agenda being held back by the continued dominance of timely access to care in Canada? • The development of a quality agenda outlined above has taken place over almost three decades—is this slow place sustainable? • What lessons can be drawn from the rapid uptake of Choosing Wisely Canada, and will its momentum be sustained through to measurable outcomes? • Most of the quality focus has been on the processes of care—how can an integrated structure-process-outcome framework be fostered? • Individual patients and their clinicians care a great deal about the

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outcomes of care—how can interest in health outcomes be raised to a system level? References Accreditation Canada. 2017. Patient Partner Adds Real Value to Survey Team: Senior Quality Advisor. https://accreditation.ca/patientpartner-adds-real-value-survey-team-senior-quality-advisor/ Alberta Health. 2014. Health System Outcomes and Measurement Framework. https://open.alberta.ca/dataset/da2ccb08-3d8d-4b4f-8b66293fb55338d7/resource/806cb451-6a89-4bec-976a-86cb7ba5eef5/ download/PMIS-Outcomes-Measurement-Framework-2014.pdf Alberta Health Advocates. 2014. Alberta’s Health Charter. https://www. albertahealthadvocates.ca/education/Pages/Health-Charter.aspx Ayanian, J., and H. Markel. 2016. “Donabedian’s Lasting Framework for Health Care Quality.” New England Journal of Medicine 375 (3): 205–207. Barry, Michael J., Albert G. Mulley Jr., and Floyd J. Fowler. 1988. “Watchful Waiting vs Immediate Transurethral Resection for Symptomatic Prostatism: The Importance of Patients’ Preferences.” Journal of the American Medical Association 259 (20): 3010–17. Bégin M., L. Eggertson, and N. Macdonald. 2009. “A Country of Perpetual Pilot Projects.” Canadian Medical Association Journal 180 (2): 1185. Bentley, Tanya G. K., Rachel Ballard-Barbash, Kartika Palar, and Emmett B. Keeler. 2008. “Waste in the U.S. Health Care System: A Conceptual Framework.” Milbank Quarterly 86 (4): 629–59. Bhatia, R. S., W. Levinson, S. Shortt, C. Pendrith, E. Fric-Shamji, M. Kallewaard, et al. 2015. “Measuring the Effect of Choosing Wisely: An Integrated Framework to Assess Campaign Impact on Low-value Care.” BMJ Quality & Safety 24 (8): 523–31. Brody, H. 2010. “Medicine’s Ethical Responsibility for Health Care Reform—The Top Five List.” New England Journal of Medicine 362 (4): 283–85. Buckley, Jenny. 2015. Report of the Global Symposium: The Role of Physicians and National Medical Associations in Addressing the Social Determinants of Health and Health Equity. http://www.instituteofhealthequi ty.org/file-manager/PDFs/symposium-meeting-report-final.pdf Canadian Foundation for Healthcare Improvement. 2015. “Taming of the Queue 2015.” http://www.cfhi-fcass.ca/NewsAndEvents/Events/Tam ing_of_the_Queue.aspx

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Canadian Institute for Health Information. 2015. PROMs Background Document. https://www.cihi.ca/sites/default/files/document/proms_back ground_may21_en-web.pdf ———. 2017. “Wait Times for Priority Procedures in Canada, 2017.” https://www.cihi.ca/sites/default/files/document/wait-times-re port-2017_en.pdf Canadian Intergovernmental Conference Secretariat. n.d. [2004]. “A 10year Plan to Strengthen Health Care. http://www.scics.gc.ca/CM Files/800042005_e1JXB-342011-6611.pdf Canadian Medical Association. n.d. [2010]. Health Care Transformation in Canada: Change That Works. Care That Lasts. http://policybase.cma. ca/dbtw-wpd/PolicyPDF/PD10-05.PDF ———. 1991. Strategic Plan: The Mission, Roles, Goals and Objectives of the Canadian Medical Association. Ottawa. ———. 1994. Quality of Care Program. Guidelines for Canadian Clinical Practice Guidelines. Ottawa. ———. 1998a. Access to Quality Health Care. Ottawa. ———. 1998b. Report on the Forum on Risk Management. Ottawa. ———. 2001. CMA Patient Safety Policy Framework 2001. Ottawa. ———. 2002a. Safe Medication Practices: A Resource for Physicians. Ottawa. ———. 2002b. A Prescription for Sustainability. http://policybase.cma. ca/dbtw-wpd/BriefPDF/BR2002-12.pdf ———. 2005. Physician Guidelines for Online Communication with Patients. http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD05-03.pdf ———. 2011. “Canadian Clinical Practice Guidelines Summit: Toward a National Strategy.” Proceedings. Ottawa. ———. 2012. Reports to General Council 2012. Appendix 2—CMA and Canada’s doctors—health equity and the Canadian health care system. https://www.cma.ca/Assets/assets-library/document/en/ advocacy/2012-App2_SS1_HealthEquity-e.pdf ———. 2013a. Health Equity and the Social Determinants of Health: A Role for the Medical Profession. http://policybase.cma.ca/dbtw-wpd/Pol icypdf/PD13-03.pdf ———. 2013b. Health Care in Canada: What Makes Us Sick? https:// www.cma.ca/Assets/assets-library/document/fr/advocacy/Whatmakes-us-sick_en.pdf ———. 2014. CMA Position Statement: Ensuring Equitable Access to Care: Strategies for Governments, Health System Planners, and the Medical Profession. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD14-04.

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pdf ———. 2015a. Appropriateness in Health Care. http://policybase.cma. ca/dbtw-wpd/Policypdf/PD15-05.pdf ———. 2015b. Guiding Principles for Physicians Recommending Mobile Health Applications to Patients. http://policybase.cma.ca/dbtw-wpd/ Policypdf/PD15-13.pdf ———. 2015c. Improving Efficiency in the Canadian Health Care System. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-11.pdf ———. 2016a. Canadian Medical Association Launches Startup to Drive Physician-led Innovation. https://www.cma.ca/En/Pages/cma-launch es-startup-to-drive-physician-led-innovation.aspx ———. 2016b. 2016 Joule Innovation Grant Recipients. https://www. cma.ca/En/Pages/joule-innovation-grant.aspx ———. 2017a. “Referrals and Consultation.” https://www.cma.ca/ En/Pages/referrals-consultation.aspx ———. 2017b. CMA 2020 Strategic Plan. https://www.cma.ca/En/pages /cma-2020-aiming-for-new-heights.aspx ———. 2017c. Third-party Forms. http://policybase.cma.ca/dbtwwpd/Policypdf/PD17-02.pdf Canadian Medical Association/Canadian Nurses Association. 2011. Principles to Guide Health Care Transformation in Canada. https://www. cna-aiic.ca/~/media/cna/files/en/guiding_principles_hc_e.pdf Canadian Medical Protective Association. 2015. 2015-2019 Strategic Plan. https://www.cmpa-acpm.ca/static-assets/pdf/about/2015-2019_ CMPA_Strategic_Plan-e.pdf Canadian Nurses Association. 2017. “Choosing Wisely Canada Nursing List.” https://www.cna-aiic.ca/en/on-the-issues/better-care/ patient-safety/choosing-wisely-canada-nursing-list Canadian Patient Safety Institute. 2011. “Canadian Disclosure Guidelines: Being Open with Patients and Families.” http://www.pa tientsafetyinstitute.ca/en/toolsResources/disclosure/Documents/ CPSI%20Canadian%20Disclosure%20Guidelines.pdf ———. 2017. “About CPSI.” http://www.patientsafetyinstitute.ca/ en/about/Pages/default.aspx Centre for Effective Practice. 2016. Poverty: A Clinical Tool for Primary Care Providers. https://thewellhealth.ca/wp-content/uploads/2016/12/ Poverty_flow-Tool-Final-2016v4.pdf Centre for Spatial Economics. 2008. The Economic Cost of Wait Times in Canada. https://www.cma.ca/Assets/assets-library/document/ en/advocacy/EconomicReport-e.pdf

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Choosing Wisely. 2017. “Searching for that EMR Sweet Spot.” http:// www.choosingwisely.org/resources/updates-from-the-field/ searching-for-that-emr-sweet-spot/ Choosing Wisely Canada. 2017a. http://choosingwiselycanada.org ———. 2017b. “Students and Trainees Advocating for Resource Stew ardship (STARS).” https://choosingwiselycanada.org/campaign/ stars/ Choosing Wisely Canada/Canadian Nurses Association. 2017. “Nine Things Nurses and Patients Should Question.” https://choosing wiselycanada.org/wp-content/uploads/2017/05/Nursing.pdf Choosing Wisely Canada/Canadian Institute for Health Information. 2017. “Unnecessary Care in Canada.” https://www.cihi.ca/sites/ default/files/document/choosing-wisely-baseline-report-en-web. pdf College of Family Physicians of Canada. 2011. A Vision for Canada— Family Practice: The Patient’s Medical Home. http://www.cfpc.ca/up loadedFiles/Resources/Resource_Items/PMH_A_Vision_for_Cana da.pdf ———. 2015. Best Advice: Social Determinants of Health. http://patients medicalhome.ca/files/uploads/BA_SocialD_ENG_WEB.pdf College of Family Physicians of Canada/Canadian Medical Association. 2009. “The Wait Starts Here: The Primary Care Wait Time Partnership—Final Report.” College of Family Physicians of Canada/Canadian Medical Association/ Royal College of Physicians and Surgeons of Canada. 2013. National Physician Survey 2013. Q6a Remuneration method. http://national physiciansurvey.ca/wp-content/uploads/2013/08/2013-Nation al-EN-Q6a.pdf Commonwealth Fund, The. 2017. Mirror, Mirror 2017: International Comparison Reflects Flaws and Opportunities for Better U.S. Health Care. http://www.commonwealthfund.org/~/media/files/publica tions/fund-report/2017/jul/schneider_mirror_mirror_2017.pdf Council of the Federation. 2011. “Council of the Federation Tackles Health Sustainability in Preparation for Discussions with the Federal Government.” http://canadaspremiers.ca/wp-content/uploads/ 2017/09/communique_health_care_july22.pdf ———. 2012a. “From Innovation to Action: The First Report of the Health Care Innovation Working Group.” http://www.canadaspremiers. ca/wp-content/uploads/2017/09/health_innovation_report-e-web. pdf

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———. 2012b. “Premiers Drive Innovation.” http://canadaspremiers. ca/wp-content/uploads/2017/09/jul26_health_communique-final. pdf ———. 2013. “Canada’s Provinces and Territories Realize Real Savings in Healthcare through Collaboration.” http://canadaspremiers.ca/ wp-content/uploads/2013/04/health_care_july26-final.pdf ———. 2016. “Leadership in Health Care: Report to Canada’s Premiers on the Achievements of the Health Care Innovation Working Group.” http://canadaspremiers.ca/wp-content/uploads/2013/04/ july_2016_hciwg_report.pdf Donabedian, A. 1966. “Evaluating the Quality of Medical Care.” Milbank Memorial Fund Quarterly 44 (3, Pt.2): 166–203. ———. 1988. “The Quality of Care: How Can It Be Assessed?” Journal of the American Medical Association 260 (12): 1743–48. ———. 1989. “The End Results of Health Care: Ernest Codman’s Contribution to Quality Assessment and Beyond.” The Milbank Quarterly 67 (2): 233–56. ———. 1990. “The Seven Pillars of Quality.” Archives of Pathology & Laboratory Medicine, 114 (11): 1115–18. Elshaug, A., J. Hiller, S. Tunis, and J. Moss. 2007. “Challenges in Australian Policy Processes for Disinvestment from Existing, Ineffective Health Care Practices.” Australia and New Zealand Health Policy 4:23. Elshaug, A., A. Watt, L. Mundy, and C. Willis. 2012. “Over 150 Potentially Low-value Health Care Practices: An Australian Study.” Medical Journal of Australia 197 (10): 556–60. Euroqol. 2017. EQ-5D. https://euroqol.org Evans, R. G., and G. L. Stoddart. 1990. “Producing Health, Consuming Health Care.” Social Science and Medicine 31 (12): 1347–63. Field, M., and K. Lohr, eds. 1990. Clinical Practice Guidelines: Directions for a New Program. Washington, DC: National Academy Press. Finance Canada. 2007. Aspire to a Stronger, Safer, Better Canada. The Budget Plan 2007. http://www.budget.gc.ca/2007/pdf/bp2007e.pdf Gottlieb, L., C. Margolis, and S. Schoenbaum. 1990. “Clinical Practice Guidelines at an HMO: Development and Implementation in a Quality Improvement Model.” QRB. Quality Review Bulletin 16 (2): 80–86. Health Council of Canada. 2012. “A Background Note on Benchmarks for Wait Times.” http://publications.gc.ca/collections/collection_ 2012/ccs-hcc/H174-34-2005-eng.pdf Institute of Medicine. 2001. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press.

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Institute of Medicine. 2014. Capturing Social and Behavioral Domains and Measures in Electronic Health Records. Phase 2. https://www.nap.edu/ download/18951 Ipsos Public Affairs. 2017. Priority National Issues. Ottawa. Kasper, J., A. Mulley, and J. Wennberg. 1992. “Developing Shared Decision-making Programs to Improve the Quality of Health Care.” QRB. Quality Review Bulletin 18 (6): 183–90. Kyte, D., P. Cockwell, M. Lencioni, M. Skrybant, M. von Hildebrand, G. Price, et al. 2016. “Reflections on the National Patient-reported Outcomes Measures (PROMs) Programme: Where Do We Go from Here?” Journal of the Royal Society of Medicine 109 (12): 441–45. Liberal Party of Canada. 2004. Moving Canada Forward: The Paul Martin Plan for Getting Things Done. Ottawa. Linton, A., and D. Peachey. 1990. “Guidelines for Medical Practice: 1. The Reasons Why.” Canadian Medical Association Journal 143 (6): 485–90. Marsh, Leonard. 1943. Report on Social Security for Canada. Ottawa: King’s Printer. Marsh, Leonard, Albert Grant Fleming, and C. F. Blackler. 1938. Health and Unemployment: Some Studies of their Relationships. Toronto: Oxford University Press. National Steering Committee on Patient Safety. 2002. “Building a Safer System: A National Integrated Strategy for Improving Patient Safety in Canadian Health Care.” http://www.royalcollege.ca/portal/ page/portal/rc/common/documents/advocacy/building_a_saf er_system_e.pdf Naylor, C. David, Francine Girard, Jack Mintz, Neil Fraser, Toby Jenkins, and Christine Power. 2015. Unleashing Innovation: Excellent Healthcare for Canada. Report of the Advisory Panel on Healthcare Innovation. Ottawa: Health Canada. http://www.healthycanadians.gc.ca/pub lications/health-system-systeme-sante/report-healthcare-innova tion-rapport-soins/alt/report-healthcare-innovation-rapport-so ins-eng.pdf NHS Digital. 2017. Provisional Quarterly Patient Reported Outcome Measures (PROMs) in England—April 2016 to December 2016. http://con tent.digital.nhs.uk/catalogue/PUB23909 Niven, D., K. Mrklas, J. Holodinsky, S. Straus, B. Hemmelgarn, L. Jeffs, and H. Stelfox. 2015. “Towards Understanding the De-adoption of Low-value Clinical Practices: A Scoping Review.” BMC Medicine 13: 255. Ontario Ministry of Health. 2005. “First Ever Common Benchmarks

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Will Allow Canadians to Measure Progress in Reducing Wait Times.” Toronto, 12 December. https://news.ontario.ca/archive/ en/2005/12/12/First-ever-common-benchmarks-will-allow-Cana dians-to-measure-progress-in-reducin.html Ontario Ministry of Labour. 2017. “Backgrounder: Proposed Changes to Ontario’s Employment and Labour Laws.” https://news.on tario.ca/mol/en/2017/05/proposed-changes-to-ontarios-employ ment-and-labour-laws.html Ottawa Hospital Research Institute. 2017. “Patient Decision Aids.” https://decisionaid.ohri.ca/ Peachey, D., and A. Linton. 1990. “Guidelines for Medical Practice: 2. A Possible Strategy.” Canadian Medical Association Journal 143 (7): 629–32. Postl, Brian D. 2006. “Final Report of the Federal Advisor on Wait Times. Ottawa, June. https://www.canada.ca/content/dam/hc-sc/ migration/hc-sc/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006wait-attente/index-eng.pdf Quebec Medical Association. 2014. “Overdiagnosis: Findings and Action Plan.” http://www.preventingoverdiagnosis.net/2014presen tations/surdiagnostic-plan-action-en%20(Abs57).pdf Romanow, Roy. 2002. Building on Values: The Future of Health Care in Canada. http://publications.gc.ca/collections/Collection/CP32-852002E.pdf Scott, I., and S. Duckett. 2015. “In Search of Professional Consensus in Defining and Reducing Low-value Care.” Medical Journal of Australia 203 (4): 179–81e.1 Standing Senate Committee on Social Affairs, Science and Technology. 2009. A Healthy, Productive Canada: A Determinant of Health Approach. Ottawa. ———. 2017. “Study on the Role of Robotics, 3D Printing and Artificial Intelligence in the Healthcare System.” https://sencanada.ca/Content/SEN/Committee/421/SOCI/pdf/14issue.pdf Toward Optimized Practice. 2017. “Clinical Practice Guidelines.” http://www.topalbertadoctors.org/cpgs/ Townsend, Peter, and Nick Davidson. 1982. Inequalities in Health: The Black Report. London: Penguin Books. Upstream. 2017. “About Upstream.” http://www.thinkupstream.net/ about_upstream Vail, Stephen. 2001. “Canadians’ Values and Attitudes on Canada’s Health Care System: A Synthesis of Survey Results.” Ottawa: Confer-

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ence Board of Canada. Wait Time Alliance. 2005. “It’s About Time: Achieving Benchmarks and Best Practice in Wait Time Management.” Ottawa, August. http:// www.waittimealliance.ca/wp-content/uploads/2014/05/2005_Its_ About_Time.pdf Wait Time Alliance. 2006. “Wait Time Alliance Interim Report Card 2006.” http://www.waittimealliance.ca/wp-content/up loads/2014/05/2006_Report_Card.pdf ———. 2015. “Eliminating Code Gridlock in Canada’s Health Care System: 2015 Wait Time Alliance Report Card.” http://www.waittimeal liance.ca/wp-content/uploads/2015/12/EN-FINAL-2015-WTA-Re port-Card_REV.pdf Watson, Diane E., Morris L. Barer, Heidi M. Matkovich, and Michelle L. Gagnon. 2007. “Wait Time Benchmarks, Research Evidence and the Knowledge Translation Process.” Healthcare Policy 2 (3): 56–62. Western Canada Waiting List Project. 2005. “Moving Forward. Final Report, 28 February 2005.” Wise, A. 2017. A Health Outcomes Fund for Canada. https://www. marsdd.com/wp-content/uploads/2017/02/A-Health-OutcomesFund-for-Canada.pdf.

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Educating for Innovation in Medicine Eve Purdy and Richard Reznick

If we are to transform the Canadian healthcare system, we cannot underestimate the importance of empowering the people working within it. Students are the future of our healthcare workforce. While our essential mandate is to prepare students to work meaningfully in society, we must go beyond this if we want to improve the system. We need to graduate students who have the skills to engage creatively in issues of complexity, and who are prepared and willing to bring forth significant, positive change. We must graduate innovators. Innovation can be taught and learned. Of course, some may have a natural tendency towards innovation, in the same way that certain individuals are musically gifted, but the skills can be learned and they absolutely must be fostered. In his research on educating for innovation, Tony Wagner identified key qualities of innovators including curiosity, collaboration, integrative thinking, and a bias towards action (Wagner 2012, 16). He shows that in the educational environment these qualities can be nurtured and taught. If neglected, they can be forgotten. Even worse, the skills for innovation can be actively discouraged. For some time now, many engineering programs, elementary schools, and even military training programs, have been making efforts to give their learners the skills and mindset to be innovators (Cropley 2015; Sawyer 2006; TRADOC 2011; Wagner 2012). This shift has required deliberate and often radical changes in curricula, culture and the definition of what is meant by success in the program. These groups’ educational approaches have changed to adapt to society’s need for individuals A Canadian Healthcare Innovation Agenda: Policy, Governance, and Strategy, edited by A. Scott Carson and Kim Richard Nossal. Montréal and Kingston: McGill-Queen’s University Press, Queen’s Policy Studies Series. © 2018 The School of Policy Studies, Queen’s University at Kingston. All rights reserved.

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prepared to approach problems creatively. It is time that medicine do the same. In this chapter we will explore innovation as it relates specifically to the medical education paradigm. However, we anticipate that there will be parallels to other health professional training systems and encourage application and discussion of this work broadly. First we will outline the current inertia within the structure of medical education. Next, through a narrative we will explore some of the challenges and opportunities related to innovation in medical education. Finally, we will reflect on what successful changes might look like. We hope that in reading this chapter you might be inspired to engage in, and inspire innovation with, those with whom you work and teach. Inertia in the Structure of Medical Education While there have been many changes in medicine that reflect advances in science and technology, we still approach medical education as we did a century ago. The current model of training is based on suggestions featured in a report written by Abraham Flexner (Flexner and Pritchet 1910). At the time, medical training across Canada and the United States varied significantly in duration, structure, and content. As a result, the quality of those entering the workforce was variable. The Flexner report stressed the need for a strong foundation in biomedical sciences, followed by clinical exposure and a regulatory structure that could ensure minimum standards were being met. Flexner’s report revolutionized medical education leading towards the model we know today (see Figure 12.1)—what physicians should know, and how they should be taught became standardized (Beck 2004). When the Flexner report was released, the understanding of diseases, treatments available, and the model of our healthcare system were simpler. The average life expectancy was 49. Antibiotics did not yet exist. Learning everything about medicine was possible and that indeed was the goal. In the historical context, Flexner’s efforts undoubtedly improved the educational milieu. However, in response to society’s changing needs and available technologies, medical education should look different than it did after Flexner’s changes were instituted (Cooke et al. 2009; Pershing and Fuchs 2013). In fundamental ways it has remained the same. As we were recently told in a conversation about innovation as an educational goal, “Trainees don’t need to think creatively about heart failure; they need to learn the guidelines on how to treat

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Figure 12.1

Traditional Medical Education

Source: Author’s compilation.

it.” That attitude is quite troubling and highlights a tension that exists between the comfort with the status quo and the optimism that we can educate for so much more than that. Despite neophobic tendencies, key groups in medical education have started to recognize that innovation might be an important educational target. A recent reevaluation of Flexner’s report, coordinated by the Carnegie Foundation for the Advancement of Teaching, challenges what medical trainees should know, how they should be assessed, and how we might promote a commitment to excellence (Cooke et al. 2009). In the updated Royal College of Physicians and Surgeons’ CanMEDS 2015 Framework—a document that guides the principles of Canadian specialist resident education—“leader” is one of seven primary roles that a physician-in-training must learn to fulfill. Key competencies that could incorporate innovation in the leader role are “contributing

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Figure 12.2

Residency in Competence by Design

Source: Adapted from the Royal College of Physicians and Surgeons (2014).

to the improvement of health care delivery in teams, organizations, and systems” and “facilitating change in health care to enhance services and outcomes” (Dath 2015). The terms leader and innovator are by no means synonymous but we are optimistic that in an educational model that values leadership, innovation could have the opportunity to flourish. Currently, residency training in Canada is being re-imagined as programs across the country move towards a form of competency-based medical education (CBME). The Royal College of Physicians and Surgeons (2014) is spearheading this transition through their initiative, Competence by Design (see Figure 12.2). Instead of focusing on time in program, and being overly reliant on high stakes examinations to determine fitness to practice, Competence by Design will be focused on trainees demonstrating the essential skills to practice within a given field through the use of frequent and multi-modal assessment. As we will explore later in this chapter, many of the features of this new model will help cultivate desired traits, but some aspects will create new barriers to developing innovators. As we

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move into a post-Flexnarian era, we must consider how to prioritize and authentically support the development of innovation in medical learners. Physicians should be innovators because of their education, not in spite of it. Admissions for Innovation Dee Hock, echoing numerous organizational theorists, has reminded us that “An organization, no matter how well designed, is only as good as the people who live and work in it” (Tansey 2014). Before we consider the state of educating for innovation we must first comment on how individuals end up in medicine. The medical school admissions process is critical for shaping the physician workforce. With very few exceptions, admitted medical students will complete their training and practice medicine in Canada. If we want physicians who are capable of leading positive change in dynamic environments then we must ask whether our current admissions process mindfully selects for those with innovative potential. Jennifer decided during high school that she wanted to be a physician and since that time had worked deliberately towards the goal. She applied with a 3.98 GPA from an undergraduate health sciences program at a respected Canadian university. She opted not to take many of the electives she was interested in, including English and Cognitive Science courses, because she was concerned that taking these courses might risk decreasing her GPA. One summer she exclusively studied for the Medical College Admission Test (MCAT) and was rewarded with a 36T, widely recognized as a stellar score. She worked as research assistant on a number of projects, electing to play a minor role on a number of her supervisor’s projects to ensure publication. Jennifer received multiple interviews across the country. She prepared diligently for the multiple mini interview and panel interviews, even employing a tutor to give her advice on the process. She was one of the successful 100 students of the 4,686 applicants to be admitted to Queen’s University.

Medical school admissions committees are charged with the task of selecting students with the desirable academic and nonacademic factors predictive of success. Though the admissions process has evolved over time to become more holistic, the current system might still be improved (Mahon, Henderson, and Kirch 2013; Monroe et al. 2013). It relies on a combination of elements, including GPA, MCAT scores, per-

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sonal statements, letters of recommendation, and interviews. The processes across the country vary: thirteen of seventeen Canadian medical schools require the MCAT, for example, and there are different structures to the interview practice. Regardless of the exact data collected, schools quantify these variables which then act as inputs to formulae, the output of which influences the future of the national physician workforce. The GPA and MCAT components are designed to provide a reasonable degree of assurance of academic fitness for medical studies. These requirements were put in place to ensure that applicants have the ability to learn concepts expected of physicians. When considering the necessary qualities of a doctor, it is reasonable to select for a baseline degree of academic capability. However, rather than serving as a cutoff, the need for unnecessarily high GPA and MCAT scores has rapidly become the norm for applicants wishing to remain competitive. Many schools select classes with a mean GPA of greater than 3.9 and MCAT scores in the 95th percentile, highlighting the centrality of these two factors in the selection process (AFMC 2015). At face value, admitting the smartest people to medical school seems sensible. However, as we can see from Jennifer’s narrative above, there is an associated cost. When selecting courses, Jennifer opted for classes that she was confident she could ace. Instead of welcoming a new learning opportunity, one that might give her new skills or offer new perspectives on her world, she decided to take a course in which she could guarantee success. She was unwilling to risk not getting a perfect grade. The admissions process rewarded her and continues to reward thousands of other applicants for that choice. Sadly, thousands of students across Canada who graduate with a GPA of less than 3.7 never get their files read, as the high numbers of applicants dictate setting arbitrary cut-off scores as a first filter in the application process. It wouldn’t matter if an applicant had demonstrated extraordinary achievements in innovation, a GPA of less than 3.7 will normally sink an application. Jennifer spent an entire summer, and thousands of dollars, studying for the MCAT. She did very well. The test is a multi-part standardized exam that was implemented in 1928 in an effort to combat a medical school attrition rate of 50 per cent during that era. While the exam has seen multiple iterations, most recently an overhaul in 2015 which led to the inclusion of elements of sociology and reasoning, it has always focused on basic sciences. An entire industry has developed to prepare students to take this exam, with over 43 per cent of those who take

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the exam using a commercial preparatory course (AAMC 2016). MCAT scores have been weakly correlated to success on academic measures such as standard licensing exams, but have not been associated with other definitions of professional success (Gauer, Wolff, and Jackson 2016). The continued focus on the MCAT in medical school admissions processes signals to students that we value their ability to succeed on standardized examinations. If we are not careful, with our continued emphasis, they may start to internalize that value more than other qualities that would make them strong physicians. Fortunately, the admissions process has evolved to include more holistic components, including personal statements, letters of reference, and interviews. Exciting developments such as the incorporation of the multiple mini interview, which has been shown to be more reliably predictive of success in non-cognitive domains have positively shaped the admissions environment in Canada (Knorr and Hissbach 2014; Pline et al. 2016; Reiter et al. 2007). The Association of American Medical Colleges has published a list of desirable non-cognitive competencies including service orientation, cultural competence, team work, communication, ethical responsibility, reliability, resilience, and critical thinking (Mahon et al. 2013). A similar environmental scan of Canadian admissions processes shows that while there is agreement that assessing applicants on non-cognitive factors is essential, there is little consensus about which of these factors should be present at the time of admission and how they might be reliably assessed (Bandiera et al. 2015). In the discussion of identifying and assessing non-cognitive factors, while some of the identified traits are related to innovation, there has been no overt reference to selecting for those with a propensity for it. In short, the current medical school admissions process does not purposefully select for innovators. At worst, the process may actually handicap or deter applicants with an innovative spirit. We are most definitely selecting against accepting students who, in any way, have “dared to fail” by taking risks in course selection or the extra-curricular avenues they choose to explore. This is particularly problematic when, in Canada, admissions committees have made social accountability a key part of their mandate (Hanson et al. 2016). Up to this point, efforts to be socially accountable in admissions have focused on ethnic, geographic, and socioeconomic diversity. While we believe that these efforts should most certainly continue, we urge medical schools to add the innovative potential of applicants in their understanding of social

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accountability. The future challenges of our healthcare system must be met by individuals and teams willing to creatively engage—and having those people join the healthcare workforce is the first step. Conveniently, we are at a critical juncture for medical school admissions in Canada. The Association of Faculties of Medicine of Canada’s “Future of Medical Education in Canada Project” requested an in-depth evaluation of medical school admissions processes in 2010 (AFMC 2010). The resulting working group has started necessary debates about a wide range of topics from the utility of the MCAT to the relevance of school prestige (Bandiera et al. 2015; Eskander, Shandling, and Hanson 2013). They have identified barriers to nationwide collaboration but suggest that mutually defining a set of shared values around how to select candidates who can respond to our country’s changing health priorities is a necessity (Hanson et al. 2016). The national conversation on how admissions processes can evolve is about to begin—the urgent need to attract and identify innovative minds must be on the agenda. To guide this discussion, we should look to other fields which have defined innovation as a top priority. Just as we have identified admissions to medical school as a crucial step, companies such as Apple, Google, and Xerox feel that hiring the right people is central to their innovative successes (Berger and Brem 2016). In a study of the elements perceived to influence Google’s innovativeness, the selection of individuals to work for the company was identified as the most crucial factor (Steiber and Alänge 2013). The selection process broadly focuses on four key factors including cognitive ability, role-related knowledge, leadership, and “Googliness.” The goal for these companies is to hire smart, creative individuals who demonstrate flexibility, playfulness, risk-taking, energy, and tolerance of ambiguity (Berger and Brem 2016). Hiring the right people, however, is no simple task. Admittedly there are differences between hiring an employee to fill a current position and selecting an individual for an educational track with the guarantee of a job several years down the line. These differences should not deter us from consulting experts outside of medicine to help us advance our admissions practices. Table 12.1 provides a list of key questions that those involved in admissions processes might consider to improve innovation through admissions.

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Table 12.1 Key Questions for Admissions for Innovation How does the medical school admission process affect the pre-medical education experience of those applying? How do the MCAT and GPA cut-offs affect the ability to attract and identify innovators? How might the admissions process facilitate admitting those with atypical paths? How might we identify applicants with a propensity for innovation? Source: Author’s compilation

Education for Innovation Challenging the admissions process to select innovators is an important goal, but we must also consider how the current model of training supports or inhibits the development of innovators. Do we cultivate innovative thinking in those who walk through our doors? If not, how might we? Tony Wagner, of Harvard’s Innovation Lab, spent years studying young innovators from a variety of industries. His goal was to understand how innovation is cultivated. In Creating Innovators, Wagner presents a framework, adapted from earlier work on creativity, for developing the capacities of young people to be innovators (Wagner 2012, 24; Amabile 1998). We have applied this framework, the intersection of expertise, motivation, and creative thinking, to understand the current state and future possibilities for cultivating innovation in medical training. Expertise Expertise is an essential component of innovation. It is likely the aspect of this framework that readers feel most familiar with and the factor that medical educators most excel at providing. “You cannot innovate from nothing” (Wagner 2012, 24). Innovators must bring unique knowledge, technical skills, or intellectual abilities to the table. For physicians, that unique expertise has traditionally been the possession of scientific knowledge, clinical reasoning abilities, social and communication skills, and technical ability. Through medical school and residency, trainees

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Figure 12.3 Components Necessary for Creating Innovators in Medicine

Source: Adapted from How to Kill Creativity and Creating Innovators (Amabile 1998; Wagner 2012, 24)

acquire the medical knowledge to which others do not have access. They intuitively organize this discrete knowledge in a way that allows them to reason through familiar and new clinical problems. They develop skills in communicating effectively with patients and colleagues. Some physicians acquire complex procedural skills. The development of accreditation standards of medical schools and residency programs have ensured that expertise in these domains is acquired throughout medical training. There is no doubt that Canadian medical programs

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graduate individuals with some requisite expertise. However, the components of this expertise should be continuously re-examined in our modern context, and necessary changes appropriately reflected in our educational model. The component of physician expertise most urgently in need of re-imagining is that of knowledge possessor. Jennifer was excited to begin medical school! She was finally going to realize her dream. Two months into the semester she was entirely overwhelmed. Midterms were approaching and she was staying up until 2 a.m. each night trying to cover all of the material she needed to know. There was anatomy, physiology, and research skills. She hadn’t even reached the clinical content. She began to wonder whether she would be able to keep up. Her friends started to worry; they hadn’t seen her in weeks.

Medical school curriculum committees invariably quarrel about what medical students need to be taught. Cardiologists believe that a segment on cardiac risk assessment is absolutely fundamental, while geriatricians fight to include a session on falls prevention. These arguments ensue because educators are passionate and there is limited curricular time. In 2011, the year that Jennifer started medical school, medical knowledge doubling time was three and a half years (Densen 2011). By the time Jennifer finishes her fellowship training in 2020 the volume of medical knowledge will have doubled at least four times over. Fights over curricular space are going to become more common as the amount and complexity of information increases, unless we fundamentally rethink what students need to know. Jennifer cannot know everything. Educators and students need to be comfortable with this reality. In the context of baseline understanding of physiology, homeostatic mechanisms, clinical skills, and the healthcare system—which could be nationally decided upon and collaboratively delivered—the knowledge aspect of expertise that Jennifer and her colleagues must bring to the table are skills in readily accessing and applying information. Most Canadian schools have some curricula in critical appraisal but these courses are often research focused and separate from core clinical content. While a starting point, they do not focus on accessing information at the point of care or developing strategies for managing and applying the future volumes of information. When they access a web resource in clinic or during a class session, students often feel that they are cheating. We test students on what they know, not on what they are able to know. Exams at all levels are closed-book,

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closed-phone, and closed-computer. Educators need to ask whether this makes any sense in our technologic world and with a future of unknowably vast amounts of information on the horizon. The ability to access information quickly and reliably is going to be a key component of physicians’ expertise in the future, yet this is largely not a focus of our medical teaching or embedded in our assessment structures. This is but one example of a curricular gap in anticipated necessary future expertise. In all domains we need to reconsider what unique skills might be helpful for the physician of the future? Are we helping our physicians of tomorrow develop them? The medical community’s reaction to the immense amount of new medical knowledge has been specialization and sub-specialization. In 1971, the earliest date for which residency matching data is available from the Canadian Resident Matching Service (CaRMS), the vast majority of residents completed rotating internships while the minority matched to one of seven straight entry programs (CaRMS 1971). In 2016, students must match to one of thirty-one straight entry programs, as the rotating internship has long since disappeared (CaRMS 2016). Decisions related to career specialization have been pushed back to medical school. This, associated with the increasing perceived competiveness of the residency application process, means that medical students like Jennifer are effectively pigeonholing themselves early in the learning process to seem attractive to prospective residency programs. Early in second-year medical school Jennifer was involved in a conversation with a couple of her classmates. They were discussing their career interests. Jennifer mentioned casually that she was interested in emergency medicine. Her friend responded by saying that getting into a residency program in that specialization would be very competitive and to be successful she would have to do research in emergency medicine and set up all of her electives in the field.

Our current rigid educational path assumes a single starting point for learners and a single best path to the development of expertise. We assume that early in medical school, trainees will identify a specialty that they wish to pursue, then after a set period of time will begin training for that future. There are good reasons for specialization. As Wagner points out, most patients would prefer that a neurosurgeon, maybe even a subspecialized neurosurgeon, perform their craniotomy rather than an emergen-

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cy physician (Wagner 2012, 173). That neurosurgeon will have specific expertise that is likely to make the operation more successful; he or she will possess expertise that will allow innovation in further neurosurgical domains. We do need specialists. However, in efforts to cultivate innovation, early specialization may not be right for every learner. The issues facing the healthcare system are intertwined and messy. They require the breaking down of walls, not the reinforcement of silos. The capacity to understand, empathize, incorporate, and capitalize on multiple perspectives is a key ability of innovators. This requires broad, open-minded exposures. Experience for experience’s sake and knowledge for knowledge’s sake, while not perceived as efficient, are sometimes exactly what is required for innovators to develop a networked web of understanding from which innovative ideas can flourish (Wagner 2012, 41). It is hard to predict what experiences will be fodder for innovation down the line. Broad-based learning is often necessary for producing a foundation for individuals who are capable of recognizing opportunities for improvement and innovation. The next wave in Canadian specialist residency education, Competence by Design, will further target learning experiences during residency to those most relevant for a particular specialty. As we continue to move in the direction of universal, early, and targeted specialization of expertise, we must do so with the awareness that we could be compromising physicians’ capacity to be innovators at a systems level. We urge the medical education community to consider ways that we might mitigate this unintended consequence. In reality there are many different types of learners who enter medical school. Some begin with a well-defined understanding of the path they wish to pursue. We should support, rather than hold them back from their destined future while offering a variety of flexible exit strategies should they change their mind. This path could result in early specialization. Others, like Jennifer, have interests but not a specific calling. These students require different exposures and opportunities for career development than the students who are confident about what they wish to pursue. There is one further group: students who have no idea what specialty of medicine they wish to pursue. In our current system, which requires early identification of specialty, these students can experience significant stress and anxiety related to their uncertainty. These students would benefit from a modified educational plan that supports exploration. We strongly believe that in order to foster innovation, individualized

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Table 12.2 Key Questions for Fostering Expertise How do we define a physician’s expertise? How does education need to evolve to manage increasing volumes of information? How can a student’s development of expertise be personalized? Source: Author’s compilation.

rather than homogenized paths to expertise, should be a key goal for the future for medical education. Table 12.2 provides key questions for those involved in fostering expertise of medical trainees to consider. Creative Thinking Creative thinking is a second crucial component of innovation identified by Wagner (2012, 24). Creative thinkers can approach old problems with new perspectives and tolerate ambiguity because of flexibility in their mental processes. Interestingly, cognitive scientists tend to agree that babies and young children are more expert at this domain of skills than are adults (Gopnik 2010). Jennifer left her class on upper urinary tract problems frustrated. She couldn’t believe that the professor refused to give the class access to the PowerPoint slides that he used during the lecture. In most classes the questions on the exam are taken from content covered in class. How was she supposed to study for the exam?

Educational programs that dictate right from wrong and that impart knowledge, rather than encouraging creation, systematically reduce creative thinking abilities. Teaching and fostering creativity has become a paramount issue in education. In search of best practices, the Organisation for Economic Co-Operation and Development (OECD) is undertaking a study across fifteen countries on how creativity is fostered, taught, assessed, and incentivized (Vincent-Lancrin 2015). In the meantime, educators of all varieties continue to scramble to understand how they might foster, rather than inhibit, creative thinking in their students. Medical educators need to be focused on ways to educate for

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creativity, especially given that the history of medical education has been to reward the volume of memorized knowledge, over and above the capacity to deal with uncertainty. The facility to incorporate creative thinking has expanded in medical schools recently. Just ten years ago, the vast majority of material was delivered to students through lecture. Students sat, listened, read text books, then regurgitated learned facts on a test. As Jennifer’s narrative shows, despite some advances, this type of learning and assessment still predominates in medical training. The black and white nature of teaching and assessment explains the discomfort that medical students have with ambiguity, a discomfort that Simpkin eloquently advises, needs urgently to be remedied for the good of our patients and healthcare system (Caulfield et al. 2014; Simpkin and Schwartzstein 2016). Approaches, such as problem-based learning pioneered at McMaster University, that create uncertainty and encourage creative reasoning, are becoming more common (Barrows 1996). When facilitated well, these methods do have the capacity to ripen creative minds. A variety of other courses that motivate creative thinking such as the Critical Enquiry course at Queen’s University which sees students apply basic research knowledge to design a research project, are cropping up across the country (Queen’s School of Medicine 2016). Furthermore, some students are developing their creative thinking abilities outside of class time through involvement in any number of projects ranging from research to podcast development. Through such educational and self-created experiences, medical students and residents informally learn creative thinking but to our knowledge it is not an explicit goal at any level of medical education. In addition to supporting courses and personal endeavours that informally promote the development of creative thinking, medical educators could consider adopting a formal curriculum. Roberta Ness, dean of the University of Texas School of Public Health and a leader in innovation science, presents a convincing case for such a program (Ness 2011). Ness’s course adapts evidence-based pedagogies from other fields to provide instruction in divergent thinking, problem solving, creative production, and cognitive frames. A meta-analysis of seventy similar creativity training programs showed that with instruction, creative thinking abilities of participants can be enhanced (Scott, Leritz, and Mumford 2004). A deliberate creative reasoning curriculum could be integrated into existing problem-based learning structures or residency training to enhance the creative capacity of the next generation of physicians. We encourage readers to reflect on the questions

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Table 12.3 Key Questions for Fostering Creative Thinking Do we teach students creative thinking? Do our students tolerate ambiguity and engage positively with uncertainty? If not, why? How can we help them? Do we, as educators, feel comfortable with ambiguity and engage positively with uncertainty? If not, why? Source: Author’s compilation.

provided in Table 12.3. Motivation While expertise and creative thinking skills are necessary for innovation they are not enough. Innovation requires steadfast effort, persistence in the face of adversity, and unwavering belief in the goal. These qualities do not come from the expertise or intellectual abilities that we have discussed up to this point. These qualities come from motivation (Wagner 2012, 56). There are many theories for understanding motivation (Pink 2011; Ryan and Deci 2000). Most theories suggest that both extrinsic factors (i.e., money, grades, titles, and punishments) and intrinsic factors (i.e., desire, interest) contribute to overall drive. While extrinsic factors can sometimes be harnessed, usually in the short-term, intrinsic factors are much more powerful motivators. Intrinsic motivation is particularly important in the context of innovation, a process during which individuals fail often and are met with barriers to their efforts. A recent review suggests that motivation theory is underutilized in the development of medical education curricula (Kusurkar et al. 2012). Effectively fostering intrinsic motivation throughout the six to ten plus years of medical training is essential to ensuring that innovators come out at the other end. Despite issues with admissions processes addressed earlier in this chapter, there is no doubt that schools do succeed in identifying motivated students. Students entering medical school have devoted years to achieving that goal; they come to medical school with an intrinsic desire to care for patients and improve the health of our populations. Maintaining this motivation is the key task for educators. In the tradi-

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tional model we distance these highly motivated students from the patients they want to care for by sequestering them in a classroom for the first several years of their medical education. This does not make sense. By contrast, new innovative vertical curricula, and programs that prioritize early clinical exposure, such as the Harvard Pathways Curriculum or the Queen’s University First Patient Program, tap into learners’ initial enthusiasm (Harvard Medical School 2015; Pinchin 2012). That enthusiasm enhances learning and fosters the maintenance of intrinsic motivation (Ten Cate, Kusurkar, and Williams 2011). We must ask— with considerable skepticism—whether an undergraduate model of classroom-based pre-clerkship, followed by a clinical clerkship, is still best practice. To further understand how educational practices affect motivation we can apply some of the more basic aspects of self-determination theory. The psychological need for autonomy, competence, and relatedness have been identified as necessary factors for the maintenance of intrinsic motivation (Ryan and Deci 2000).1 Jennifer worked a period in clerkship for fifty weeks without vacation and had available only five personal days. While on rotations, as the most junior learner, she had no control over her schedule. She was told what clinics she was to attend, and which patients she was to look after. Her standardized exams dictated what she should learn in her time outside the hospital. On a number of her rotations, Jennifer felt she had to ask to take a break just to go to the washroom. In February, she was hoping to attend a conference on wilderness medicine, to combine her passion of outdoor pursuits with her medical training, but her request for additional time off was denied.

Humans seek independence and the freedom to self-regulate. Autonomy is the ability to feel free from external control. The need for autonomy likely stems from the fact that actions are an outward portrayal of self. Without the ability to behave independently, humans experience a compromised sense of self, a sure path to amotivation (Ryan and Deci 2000). The introduction of problem-based learning, asynchronous content delivery, and independently motivated exercises have increased autonomy in pre-clerkship. Technologic advances including the exponential production and use of open-access online medical education 1 For an in-depth review of this interesting topic, see Ten Cate et al. 2011.

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resources should continue to make guided, but autonomous, learning outside of the clinical setting increasingly feasible (Cadogan et al. 2014; Purdy et al. 2015). Early clinical training, however, quite consistently strips away autonomy. The medical hierarchy has an extraordinary tendency to stultify independence by frequently treating well-educated, adult, first-year residents as if they were in kindergarten. While most residency training experiences offer some limited elective time, for the most part, the curriculum is rigidly defined and learners often feel powerless to adapt their education to reflect their own interests. As we see from Jennifer’s narrative, the exertion of control can be at even the most basic human level. Such control could easily cause her to disengage. Providing faculty development on how to incorporate autonomy-supporting methods rather than control-exerting behaviours should be a priority (Ten Cate et al. 2011). Furthermore, a curricular structure that reflects a commitment to learner self-determination and that helps students develop metacognitive and self-regulation skills, is essential to maintaining intrinsic motivation. Jennifer graduated from medical school and was matched to her first choice residency program in emergency medicine. As a mandatory component of her emergency medicine training, she was required to rotate through other services. During her general surgery rotation, she just felt like she was in the way. While suturing in the OR one day she could tell her chief resident was becoming impatient. He then said, “Could you sew any slower?” and took the surgical instruments from her and finished closing. After that interaction she avoided the operating theatre.

Humans want to be useful. In self-determination theory, this is known as competence, but we will refer to it as mastery (a term that Daniel Pink coined to describe the same concept) so as not to confuse with terminology related to competency-based medical education. The feeling of mastery contributes to motivation because individuals will then commit to maintaining and enhancing their skills (Pink 2011; Ten Cate et al. 2011). This does not mean that we should make learners think they can act in ways for which they are not well equipped. Instead we must appreciate that trainees at every level are capable of taking on some task independently, even if it seems insignificantly small. In the first experience with a trauma patient as a medical student, Jennifer was assigned the task of finding warm blankets for the patient by an astute trauma team leader and educator. She had

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previously learned that hypothermia had dangerous consequences and so she took the seemingly simple task of keeping the patient warm very seriously. As the case progressed towards a positive outcome, she felt as though she had played a role in the team’s success. She left the department exhilarated and started dedicating time to learning about the more complicated aspects of trauma management.

Identifying the appropriate baseline task and then helping learners evolve so that they can take on a slightly more involved assignment next time allows learners to sense mastery while facilitating progression. Essential to maintaining intrinsic motivation towards improving the medical system as a whole is ensuring that learners feel mastery within the hospital structures and the broader environments in which they work. Learners are systematically involved in patient care issues. However, they are seldom involved in administrative or systems issues. Involving learners in small but meaningful ways, in contributing to the system, whether at the local hospital level or at the regional level, is likely an important step in fostering motivation towards future involvement in groups that are vital to approaching systems level issues. Humans also crave relatedness: being connected with others, having a sense of belonging, being accepted and valued (Ryan and Deci 2000; Ten Cate et al. 2011). Jennifer’s familiar narrative depicts her as a transient. She is a visitor on a different team every month. The learner as an evanescent being is a critical drawback of our current educational structure. Especially at large academic centres, trainees’ interactions with their peers, allied health staff, and teaching faculty are usually short-lived. Relationships between learners and patients are seemingly ephemeral. Programs that provide continuity through longitudinal experiences or that aim to provide regular mentorship may be effective at targeting the issue of relatedness in clinical education (Ogur and Hirsh 2009; Ten Cate et al. 2011; Thistlethwaite et al. 2013). We are tremendously optimistic that the move towards CBME will foster intrinsic motivation in resident learners. Competence by Design, a system of training being created by the Royal College of Physicians and Surgeons of Canada, will directly address issues related to autonomy and mastery. In this model trainees will play a key role in identifying how they can meet the objectives of their training. Significant responsibility will be transferred from educators to trainees and with that the autonomy to track and direct their learning. Residents will

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have an academic adviser working with them to set goals and facilitate progress. Entrustable professional activities (EPAs)—a nationally agreed upon set of skills that a graduate of each specialty should be able to independently perform—will be the currency of training. For an obstetrics and gynecology resident an EPA might be the ability to perform a cesarean section, for an emergency medicine resident it would be leading a resuscitation of a critically ill patient. Once a trainee has demonstrated mastery of a component of an EPA (a milestone) or an entire EPA they can take responsibility for that task in the future. At each milestone along the way to the EPA the trainee will feel mastery—in the self-determination theory sense. The transition of medical education to CBME is occurring primarily at the level of residency training. However, many medical educators feel that competency-based training will be equally beneficial to undergraduate medical programs as well as to continuing professional development. In a system that truly prioritizes intrinsic motivation, we envision a fluid continuum from newly accepted student to ready-to-practice physician to lifelong learning professional. However, there are risks that must be considered when implementing Competence by Design. We are concerned about a homogenization of graduates given the reductionist approach to curriculum development and assessment inherent to CBME. Efforts to carefully define a status quo of competence may stifle innovators. We again stress the importance of personalized education with the flexibility to pursue unique, self-directed learning opportunities—not just those that fit in the boxes of pre-defined requirements. Room for personalization is important not only for the development of unique expertise, as discussed earlier, but is also essential for fostering autonomy. Furthermore, there will be ongoing threats to relatedness for learners in the academic environment. To mitigate, programs have designed an initial transition from medical school to discipline period in which new trainees will interact intensely with faculty and colleagues in their specialty. They will develop a home base. They will belong. Ongoing attention to the degree of relatedness learners experience throughout their training should be a priority. Queen’s University will be the first Canadian institution to transition all specialty residency programs to CBME in 2017. This transition is exciting and presents the opportunity for scholarly activity across many domains. As it relates so centrally to innovation, we recommend an evaluation of measures related to intrinsic motivation be considered in analyses at Queen’s and across the country as other programs join the

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Table 12.4 Key Questions for Fostering Motivation Does our curriculum capitalize on the intrinsic motivation that students enter medical school with? Can we provide learners with more autonomy? How can this learner be useful and feel valued? Can we strengthen our relationships with learners? Source: Author’s compilation.

Figure 12.4 Components and Cultural Milieu Needed to Create Innovators in Medicine

Source: Adapted from How to Kill Creativity and Creating Innovators (Amabile 1998; Wagner 2012, 58)

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ranks. We encourage all educators to think about fostering motivation in trainees and have provided prompting questions in Table 12.4 for reflection. A Culture of Innovation Wagner’s model builds on previous frameworks for creativity by overlaying culture as an influencer as seen in Figure 12.4 (Wagner 2012, 58). Culture, yet another nebulous word, refers to a group’s shared set of values, beliefs, and behaviours. Culture is learned. Just as trainees learn to identify a stroke, they learn the culture of the profession. If we are to create innovators they need to exist in a culture that values innovation. Too often, this is far from reality. Addressing cultural barriers to innovation is an imperative not just for learners but for the healthcare system. We believe that targeting the culture of innovation in educational environments, so that those graduating and entering the workplace have positive attitudes towards innovation, may be the most efficient way to produce change at a systems level. Physicians, by and large, do not view themselves as innovators. While Mylopoulos and Scardamalia showed that physicians consistently improve and change practice in response to challenges—in other words, they engage in small-scale innovation—they themselves do not see this process as innovation (Mylopoulos and Scardamalia 2008). Physicians are unlikely to share such advances beyond their own practices, limiting the potential for advancement and iteration. In practice, physicians, for the most part, see themselves as knowledge users but not knowledge producers and feel that innovation is something that happens only at higher levels or in research. This attitude is in direct contrast to the cultures of innovation at the most progressive companies. At Google, for example, there is an underlying belief held by all employees that products can be better, that the world can be re-imagined, and that they play an important role in that process (Steiber and Alänge 2013). Childlike energy and irrational optimism channeled towards the belief that we can improve healthcare needs to be the norm. If physicians do not see themselves as innovators, they will not be innovators. Though challenging from the perspective of practicality, medical schools should deliberately expose learners to people and groups who value innovation while limiting interaction or consciously debriefing experiences with those who do not.

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Jennifer had been on call overnight on cardiology. She stayed awake all night caring for a sick patient who had atrial fibrillation (a fast heart rate). Overnight, she spoke with her senior resident, who suggested she treat the condition with a medication to slow the rate, one of two options for the treatment of such a condition. The next morning, however, the staff doctor humiliated her in front of the team, aggressively chastising the decision to use a medication instead of the delivery of a shock to the patient. The senior resident who had advised her to give her patient medication remained silent and did not step in to take any of the blame. Jennifer was holding back tears so she was unable to clarify why delivering a shock would have been a better choice.

Doctors are not supposed to fail; but innovators often fail. The stigmatization of failure, though decreasing, continues to plague medicine. A distaste for failure, given the life-and-death consequences of our work, is understandable—but it can paralyze progress by creating an apprehensive mindset that transcends clinical and non-clinical domains. The interaction that Jennifer experienced contributes to a perpetuated understanding that failure is because of irreparable deficiencies, represents personal weakness, and is inherently negative. This interaction signaled to Jennifer that she must avoid future failure at all costs. Beyond contributing to significant psychological distress and jeopardizing patient safety, the stigmatization of failure threatens innovation (Loewe and Dominiquini 2006; Tomlinson 2016; Williams et al. 2007). A culture that does not frame failure as an opportunity for growth is one that actively suppresses innovation. For trainees to develop a tolerance for failure it is critical that educators allow learners to fail. They should fail safely, across multiple domains, many times. The failure should be explored and opportunities for development identified. An excellent example of how failure can be safe can be found in the growing use of simulation laboratories for teaching procedural and cognitive skills. Simulated environments provide an excellent vehicle for allowing learners to fail and indeed learn by those mistakes. Imagine the pedagogical value proposition of learning how to connect two pieces of bowel in a simulation laboratory, where one can perfect how to do it, compared to learning in the high-stakes environment of a real operating room. We anticipate that frequent and positive exposures to failure will allow the healthcare professionals of tomorrow to hold a more enlightened understanding of what it means to fail. This new relationship with failure will make them more capable of supporting innovation.

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Innovation also requires a certain degree of disobedience. As Wagner eloquently writes, “innovation demands that both assumptions about what is necessary or possible, and the authority that defends those assumptions be challenged” (Wagner 2012, 241). As a third year resident Jennifer was leading a trauma resuscitation for a patient with internal bleeding who was also hemodynamically unstable. Jennifer recognized this as a situation where the patient should go directly to the operating room, however the staff surgeon wanted to get a CT-scan first. This decision made Jennifer uncomfortable because it would delay necessary treatment by at least fifteen minutes. She voiced her concern by saying, “I am quite worried that things will get much worse if we go to CT. I don’t think we have time.” The surgeon curtly asked, “Are you the one operating?” Some days later, Jennifer was called to her program director’s office because he had received a complaint that Jennifer had been rude to the surgeon.

Jennifer’s experience shows that medicine’s hierarchal culture does not tolerate disobedience particularly well. In clinical settings, trainees rarely challenge the decisions of their superiors. When they do, like Jennifer, the challenge can be met with resistance and sometimes even contempt. Just as she acquired a fear of failure, Jennifer learned to become compliant throughout her training. The pervasive sense of the need for conformity affects her approach in both clinical and non-clinical domains and may negatively affect her ability to innovate down the road. There is no doubt that the experience of those more senior should be highly valued and harnessed but if we are committed to educating for innovation we must rethink how that authority is enacted (Wagner 2012, 240). Authority needs to welcome hard questions, empower others to solve problems, and embolden occasional disobedience. Medicine is not the only high-stakes, hierarchical field looking to undergo a transition towards educating their students for innovation. The United States Army has already adopted the Army Learning Model, a mission for their educational programming from basic training, to officer courses, to professional development. The concept document is worth reading (TRADOC 2017; Wagner 2012, 234). Their goal is to educate for uncertainty, complexity, operational adaptability, and lifelong learning. The stated impetus for these changes is to build the capacity to innovate more quickly than their enemies allowing “cohesive teams to win in complex worlds” (TRADOC 2017). Though we have a different “ad-

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versary,” medical educators should be adapting our efforts to prepare trainees with the same goals of innovation in mind, and with the same striking resolve. When it comes to fostering innovation, medical education has a culture problem. We have touched on just a few of the cultural inhibitors to innovation. There are, however, other obstacles. These include tribalism, rigidity, emphasis on acute care, preoccupation with assessment, and disregard for personal wellness. Furthermore, we cannot underestimate the effects that factors such as overcrowding, hospital bureaucracy, availability of funding, and staff morale have on the ability to foster innovation. These issues, and many others, have been explored in The Medical Education in Cases Series which uses an innovative online international discussion forum, curated commentary, and expert reviews to explore non-medical domains of medical training (Chan et al. 2016; Chan et al. 2015). We also recognize that culture is local. In translating the principles of fostering innovation to the realities of a specific program, it is critical that the cultural milieu of the local unit be evaluated. Some of the issues that we raised will resonate, others may not. Some readers will likely identify issues that we did not touch on. We recognize that there are people championing improvement of the learning environment across the country, and as such there may be programs that do so already in place. We anticipate that programs developed with the specific goal of cultivating innovation will synergistically improve the learning experience in other important ways. The Way Forward for Medical Education To serve as an example for medical trainees, it is imperative that medical education itself and those who provide it live the spirit of innovation. We must consider how medical education can change to support the development of innovators. To do so, we must innovate. There are different models for understanding innovation. One model, somewhat simplified, puts incremental innovation and disruptive innovation on opposite ends of a spectrum (Christensen 2003; Yu and Hang 2010). To understand the difference, we can consider the iPhone. The introduction of the iPhone to the cellular market in 2007 was highly disruptive. This product was dramatically different than any other existing technology. The introduction of the smartphone reshaped the way that we communicate with each other and see the world. It fundamentally changed our society. Conversely, incremental innovations are achieved

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Figure 12.5 Innovations in Medical Education

Source: Adapted from D. Yu and C. C. Hang (2010) and C. Christensen (2003).

through changes to an existing product that result in noticeable improvement. The iPhone 2 iterated on the original iPhone but it was the same basic device. Through a series of incremental innovations we now have subsequent iterations that look and function differently than the original product—but the change was gradual. Incremental innovation is safe. Disruptive innovation offers the potential for profound change. Both are worthy targets. Over the past century there have certainly been innovations in medical education. Most of these innovations, depicted in Figure 12.5, fall on the incremental side with a few outliers such as the introduction of problem-based learning, the upcoming transition to CBME, and recent production and distribution of free, open access, medical educational resources, inching closer but not quite reaching the disruptive end of the spectrum (Cadogan et al. 2014). We encourage educators to continue to find incremental ways to change education to foster innovation. While researching this chapter, we have come across many exciting incremental changes. Within the strict accreditation struc-

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ture, given the many successes of our current model, and in medicine’s innovation-reluctant culture, incremental changes are more feasible and certainly worthy of continued effort and energy. Indeed, the accreditation framework for both medical school and residency is quite rigid, and in and of itself can stultify innovation. As such, we encourage educators to share what works, and what doesn’t, with a view to advancing and disseminating knowledge of advances in the process of medical education that promote innovation in our learners. But maybe—just maybe—in order to create innovators, medical education needs to be reimagined entirely. Perhaps enrollment at a single institution is unnecessary. Could physicians and allied health students be educated together? Perhaps medical school, residency, and ongoing professional development should be indistinguishable entities. There could be a different structure, a better structure, that current educators cannot possibly conceive. Does our system have the capacity and attitude to allow for wholesale, disruptive change? The underlying tensions that inhibit innovation in medical education are the same tensions that prevent disruptive innovation in healthcare— the satisfaction with the way we do things now and the perception that if we get things wrong there will be catastrophic consequences. The contentment with status quo combined with a fear of failure not only paralyzes individuals like Jennifer but our education structures too. The changes that ushered in standardized medical education during Flexner’s era were, in the historical context, a disruptively innovative response to the desperate need for consistency at the time. Flexner would agree that medical education once again requires dramatic changes, but this time the urgent need is to graduate innovators and doctors with an augmented capacity for adaptation and being part of Table 12.5 Key Questions for Culture in Innovation Do we think we can do better? Do we consider ourselves innovators? How do we manage failure? What hierarchical structures exist? What purpose do they serve? What do we need to change? Source: Author’s compilation.

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an adaptive system. The power structures in place regulating medical education and licensure have evolved to guarantee consistency, which they do well, but in doing so might be preventing substantial changes that are necessary to produce the types of innovators our healthcare system needs. We know that the demand to guarantee a standard product and the desire to allow room for change will be an ongoing struggle. These two needs are not easily reconciled. As the capacity for innovation in education evolves, we encourage the engagement in incrementally or disruptively redefining expertise, cultivating creative thinking, fostering intrinsic motivation, and optimizing culture. We encourage you to start by reflecting on the questions in Table 12.5. Conclusion: Measuring Success Defining the success of educational interventions designed to create innovators might actually be more difficult than imagining and implementing the interventions themselves. Traditionally, assessment revolves around a measurement of how well students have learned the concepts that we teach. There are ways to assess the components of innovation. We can test creative thinking abilities and we can measure intrinsic motivation. Such assessment strategies may seem attractive but there is a worry that a reductionist approach to assessing innovation entirely misses the point. The definition of success needs to be holistic. In evaluating our success at cultivating innovators, we believe that educators should be reflexive. We should answer key questions: Have admission criteria been restructured to identify innovators? Have we incorporated new understandings of expertise and have we committed to reevaluating the role of expertise often? Are strategies in place to promote creative thinking? Do we capitalize on intrinsic motivation by increasing learner autonomy, competence and relatedness? Is our culture one that does not stigmatize failure and that reshapes hierarchy? Do our educational power structures support both incremental and disruptive innovation? These are questions that we need to ask often. These measures of our education system, not of our learners, should be the focus of defining success. If our health professions’ education system does indeed succeed at creating innovators, we will have a workforce willing and capable of adapting to unforeseen challenges. If we succeed in creating innovators, our healthcare system will be able to sustainably provide Canadians with the healthcare they deserve. If we succeed in creating innovators,

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