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September 2019 (Volume 97)
Milbank Quarterly Classics
Donald M. Berwick
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On March 19, 2019, the firmament of expertise on the improvement of quality in complex systems lost one of its brightest stars with the death of Tom Nolan, PhD. A protégé of Dr. W. Edwards Deming, Nolan worked in many industries, but in the last two decades of his life, his primary focus was on improving health care, to the benefit of countless patients, families, and communities worldwide.
Nolan contributed many important concepts and frameworks to the health care quality movement, but one of his most important was also one of the simplest. “What are the necessary and sufficient conditions for improvement in large systems?” he asked. His answer was threefold: “Will, ideas, and execution.” He regarded the assurance of these conditions as a fair description of the duties of boards, executives, and senior leaders who wished to foster change at scale.1
Providing will refers to the tasks of fostering discomfort with the status quo and attractiveness for the as-yet-unrealized future. Providing ideas means assuring access to alternative designs and ideas worth testing, as opposed to continuing legacy systems. And execution was his term for embedding learning activities and change in the day-to-day work of everyone, beginning with leaders.
Nolan’s simple framework launched never-ending debates among aficionados of improvement as to which of the three conditions is toughest to supply. Of course, all three are. But, in my experience, the sleeper, apparently easy, but really not easy at all, is ideas.
Without change, there is no improvement. Therefore, here is the task: to find or create new models of a system that can outperform the existing system, and then to offer those models to the people without whom they cannot be put to use—the workforce. In health care, ideas can come from a fire hose of suppliers. One is the vast published medical literature. As of April 19, 2019, the US National Library of Medicine’s ClinicalTrials.gov website listed 311,636 studies from 50 states and 209 countries.2 Another is the variation among health systems, such as among hospitals, clinical practices, or nations, that, if studied and assessed, can yield fruitful notions for further trial. Yet another is the intelligence and suggestions of the health care workforce, patients, and families.
Finding and codifying ideas—promising alternatives to the current system—is itself an art form, demanding a fine balance between overspecification and vagueness. The more generalized an idea (for example, “shared decision-making”), the less helpful it is in a local context (“What exactly does that mean here?”). However, the more specific and detailed (for example, “Use this script when talking with a patient”), the less likely an idea is to fit well into important local conditions of context and mechanisms.
Nolan and his colleagues offered the notion of a change concept to strike the right balance3—an idea with enough pedigree to merit confidence that it was evidence-based but also flexible enough to invite local adaptation. At their best, change concepts come in the form of frameworks—collections of change concepts constituting a new, overall system, with full respect for their interactions and synergies.
I had the privilege of teaching with Tom Nolan. When we searched for an example to explain what great ideas look like in the “Will-Ideas-Execution” model, we turned time and again to the breakthrough model of chronic disease management—the Chronic Care Model (CCM)—of Wagner and colleagues, first published in these pages in 19964 and then issued in revised form in 1998.5
Edward H. Wagner, Brian T. Austin, Michael Von Korff
The CCM brilliantly hit the mark, balancing evidence-based general components with lots of room for local adaptation. With many months of hard work,Wagner and colleagues did what no single clinician could possibly do: digest a vast experimental and theoretical literature into components of a comprehensive new system of care. The 1996 paper had 132 citations, many of which were themselves summaries of multiple papers. Even a quick scan of the 1998 model diagram (Figure 2 in the commentary by Wagner in this issue) shows how accessible this systems view is—just six major components (Community Resources and Policies, Health Care Organization, Self-Management Support, Delivery System Design, Decision Support, and Clinical Information Systems) supplemented by extensive exploration of the substructures and examples of each component. Imagine a health care leadership team that sets about to perfect chronic disease care. The CCM almost immediately suggests a way to organize that journey, and even what assignments to give to managers.
That is precisely what happened when, with Wagner and his team, Tom Nolan and colleagues from the Institute for Healthcare Improvement (including me) had a chance to test the CCM in real-world applied “Breakthrough Series Collaboratives” over four years in hundreds of primary care settings,6 federally qualified community health centers, the Indian Health Service, and other organizations.7 It was easy, and inspiring, to see local teams grasp the scientific essence of the CCM, and then mold local trials to adapt those ideas as needed. With their model, Wagner and colleagues democratized scientific knowledge.
Remarkably, more than 20 years after Wagner and colleagues first presented the CCM, it remains very much fit for use. The nuances of meaning for each category have changed: for example, decision support has a whole new frontier now in artificial intelligence and telemedicine; self-care can embrace wearable devices; clinical information systems now include widespread use of electronic health records; and community resources and policies invoke value-based payment. But, at the conceptual level of change concepts, the model still holds.
That, of course, turns the spotlight on the other two of Nolan’s triad of components for change: not just ideas, but will and execution. In these, the American health care system still appears wanting. For all the rhetoric today about high cost, high use patients and such, evidence of fragmentation and suboptimal care still abounds, with hospitals, addicted to revenue-driven business plans and maintaining occupancy rates, still seeming ambivalent about the financial implications of the CCM. And execution, the hard, daily work of system change, is in the back seat of a car driven mostly by old ways of working.
Nonetheless, if the will were there and the work of change embraced, the whole world’s community of health care leaders and practitioners have in the CCM one of the most comprehensive, powerful, and scientifically grounded blueprints for truly new care that health services research has yet produced. Tom Nolan would smile at this celebration of intellectual achievement, and then he would tell us, please, to get on with the job of change.
Published in 2019 Volume 97, Issue 3 (pages 664-668) DOI: 10.1111/1468-0009.12414
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