Exploring factors influencing implementation across the explanatory-to-pragmatic trial continuum: a sequential...

Many innovations with proven efficacy in randomized controlled trials encounter significant barriers to real-world implementation. Using an example from delivery of a higher-intensity walking exercise protocol within inpatient stroke rehabilitation, we explored factors influencing implementation when moving from an explanatory trial under ideal conditions to a more pragmatic trial under real-world conditions. We identified implementation strategies and practical actions for implementation into routine inpatient stroke rehabilitation.

Context and perspectives of delivering higher-intensity walking exercise in the Walk 'n Watch (WnW) pragmatic trial were compared and contrasted with its predecessor, the Determining Optimal post-Stroke Exercise (DOSE) trial. The PRECIS-2 tool was used to quantify trials along the explanatory-to-pragmatic continuum. A sequential qualitative integrative approach compared perspectives from semi-structured interviews conducted with therapists and managers in the WnW trial (n = 18) to previously published therapist perspectives from the DOSE trial (n = 15). The Consolidated Framework for Implementation Research (CFIR) was used deductively. The CFIR-Expert Recommendations for Implementing Change (ERIC) matching tool was used retrospectively to identify key implementation strategies, operationalizing to practical actions employed during WnW protocol implementation.

PRECIS-2 analysis demonstrated a shift towards greater pragmatism (mean (SD) domain score 2.8 (1.4) vs 4.3 (0.7)). In both trials, therapists were motivated to deliver the protocol, despite differing belief systems and staffing challenges. In the WnW trial, therapists demonstrated greater readiness for change, actively implementing protocol principles whilst modifying delivery to meet needs. Managers and champions played an important role in supporting decision-making and systems-level compatibility. Ten ERIC strategies were identified focusing on evaluating needs, ensuring team readiness, promoting adaptability and ongoing engagement. Practical actions included optimizing innovation-context fit, fostering a collective commitment and focusing on communication.

Capitalizing on a unique longitudinal opportunity, we report consistent, evolving and emerging factors that influenced implementation, highlighting the importance of iterative consideration of context and perspectives along the explanatory-to-pragmatic continuum. Our example indicates that higher-intensity walking exercise protocols hold promise for widespread adoption in stroke rehabilitation, with local modifications for optimizing innovation-context fit. Leveraging our relatively rare pragmatic trial, we identified implementation strategies and practical actions to provide tangible support for future implementation efforts. For long-term sustainability, economic factors require consideration.

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gov ID: NCT01915368. www.

gov ID: NCT04238260.