A Framework to Decipher and Report Implementation Strategies and Pragmatic Attributes of Trial Design Domains From Pre-Implementation Studies Identified From a Systematic Review: A Methodological Study.
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2026-03
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Telemedicine has strong potential to improve hypertension management, yet its uptake into routine care remains limited. Implementation strategies (IS) enhance evidence-based intervention (EBI) use. Identifying IS used in pre-implementation trials and understanding whether these trials are explanatory or pragmatic can inform the expedited translation of EBI. Despite the availability of tools to evaluate trial design and report IS, clinical researchers often face challenges in systematically describing IS from pre-implementation studies.Methods
Using the Pragmatic Implementation Strategy Reporting tool (PISRT), we describe a step-by-step approach to retrospectively report IS from 13 telemedicine trials of hypertension management identified from a systematic review. For each trial, we also mapped nine trial design domains along efficacy to effectiveness spectrum using the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool. Three clinical researchers new to implementation science underwent short training on implementation science methods including the Expert Recommendation for Implementation Change (ERIC) project, supervised by a fourth clinical researcher with working implementation science knowledge. The clinical researchers clarified important implementation science concepts, terminologies, PRECIS-2 domains and data harmonizing approaches across trials guided by published literature, lectures and group discussions during pilot coding sessions. After individual data extraction, the clinical researchers met to select and operationalize IS and trial design domains along the efficacy to effectiveness spectrum using consensus achieved through group discussions. We partnered with two implementation science experts to refine our approach and elaborated each ERIC IS by providing relevant examples in implementing IS in telemedicine management of hypertension intervention. We also defined intervention components for each trial to help distinguish EBI from IS.Discussion
We describe a practical manual for systematically reporting IS and attributes of trial designs from efficacy and effectiveness telemedicine trials for hypertension management. We provide a step-by-step approach to support clinical researchers in reporting IS and assessing the readiness of trials evaluating an EBI for real-world use. Future work should evaluate the effectiveness of our methods, including implementation science experts evaluating any discordance with our IS reporting.Type
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Ajja, Rahma, Vidhya Suresh, Sean Wang, Adrianna Elashker, Catalina Ordorica, Hayden B Bosworth, Justin B Moore, Brittany N Rudd, et al. (2026). A Framework to Decipher and Report Implementation Strategies and Pragmatic Attributes of Trial Design Domains From Pre-Implementation Studies Identified From a Systematic Review: A Methodological Study. Journal of evaluation in clinical practice, 32(2). p. e70403. 10.1111/jep.70403 Retrieved from https://hdl.handle.net/10161/34915.
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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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