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.

RATIONALE: 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.

Duke Scholars

Author Hayden Barry Bosworth Population Health Sciences