Collection of implementation-related data in pragmatic clinical trials: a cross-sectional study from the NIH Pragmatic Trials Collaboratory.
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2026-02
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Abstract
Background
Embedded pragmatic clinical trials (ePCTs) are conducted as part of routine care, which provides researchers and health systems multiple opportunities to study implementation processes and outcomes.Methods
We conducted a cross-sectional survey of 32 ePCTs associated with the NIH Pragmatic Trials Collaboratory to assess the implementation-related outcomes that were measured or were planned to be measured, including reach (number and percent of eligible patients who participate in an intervention and the representativeness of those patients), patient engagement in or adherence to the intervention, adoption (number and percent of eligible organizations or clinicians that decide to take up or use an intervention), fidelity (clinician's delivery of an intervention as intended), adaptations (changes or modifications to an intervention), sustainability (potential for an intervention to be maintained or institutionalized after a trial concludes), sustainment (actual maintenance or institutionalization of an intervention after a trial concludes), and costs. The trials represented different phases of progress (planned, ongoing, or completed).Results
91% of study teams completed the survey, and most (86%) reported measuring reach. The total number of teams measuring other outcomes was 76% for adherence, 45% for clinician adoption, 93% for fidelity, 69% for adaptations, 24% for sustainability, 38% for sustainment, and 31% for costs.Conclusion
There is an opportunity for growth in measuring clinician adoption of the intervention, sustainability, sustainment, and associated costs. Measurement of these constructs in future ePCTs could result in development of improved implementation strategies to increase the likelihood of effective implementation leading to equitable, sustainable, and scalable improvement in practice.Type
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Trinkley, Katy E, Shruti Gohil, Stacie A Salsbury, Diana J Burgess, Ardith Z Doorenbos, Brian S Mittman, Wynne E Norton, Hayden B Bosworth, et al. (2026). Collection of implementation-related data in pragmatic clinical trials: a cross-sectional study from the NIH Pragmatic Trials Collaboratory. Implementation science communications. 10.1186/s43058-026-00868-4 Retrieved from https://hdl.handle.net/10161/34213.
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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
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