Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.
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2024-01
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In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.
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Green, Terren, Hayden B Bosworth, Gloria D Coronado, Lynn DeBar, Beverly B Green, Susan S Huang, Jeffrey G Jarvik, Vincent Mor, et al. (2024). Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review. Journal of general internal medicine. 10.1007/s11606-023-08593-7 Retrieved from https://hdl.handle.net/10161/29791.
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Scholars@Duke
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
Kevin Phillip Weinfurt
Kevin P. Weinfurt, PhD, is Professor and Vice Chair of Faculty in the Department of Population Health Sciences at Duke University Medical Center and a faculty member of the Duke Clinical Research Institute. He holds secondary appointment as a Professor of Psychology and Neuroscience, Professor of Psychiatry and Behavioral Sciences, Professor of Biostatistics and Bioinformatics, and a Faculty Associate of the Trent Center for Bioethics, Humanities & History of Medicine. Dr. Weinfurt also co-directs the Center for Health Measurement at Duke and is co-director of the Clinical Research Training Program (Masters degree offered through the School of Medicine). Dr. Weinfurt worked as a Special Governmental Employee for the U.S. Food and Drug Administration for four years, helping to create the Patient-Focused Drug Development guidance series. He is also a member of the Secretary's Advisory Committee for Human Research Protections.
Dr. Weinfurt conducts research on measuring patient-reported outcomes, medical decision making, and bioethics. In addition to conducting research, Dr. Weinfurt has taught undergraduate courses in introductory psychology, judgment and decision making, and the psychology of medical decision making; and graduate courses in multivariate statistics, patient-reported outcomes, and research ethics.
Areas of Expertise: Bioethics, Health Measurement, Health Services Research, and Health Behavior
Devon Karnes Check
Devon Check, PhD is a health services and implementation researcher whose primary research interests include quality of care and the implementation of evidence-based and guideline-recommended practices in oncology. Her projects use large secondary data analysis as well as qualitative and mixed methods to investigate variation and inequities in cancer care, the experiences of patients and clinicians, and multi-level factors that impact cancer treatment and outcomes. She has a specific interest in supportive cancer care, and within that area, she has a growing portfolio of research projects focused on pain and symptom management in cancer.
Dr. Check also has methodological expertise in implementation science. She has served as the implementation research methods expert on several behavioral intervention trials that use a hybrid effectiveness-implementation design. She also co-leads the Implementation Science Core Working Group as part of the Coordinating Center for the NIH Pragmatic Trials Collaboratory and the NIH HEAL Collaboratory.
Dr. Check received her PhD in Health Policy and Management from the Gillings School of Global Public Health at UNC-Chapel Hill. Prior to joining the Department of Population Health Sciences at Duke, she completed a postdoctoral fellowship in Delivery Science at Kaiser Permanente Northern California's Division of Research.
Areas of Expertise: Implementation Science and Health Services Research
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