Role of Clinical Trials in Implementation Science and Organization Change: An Overview of Cluster, Stepped-Wedge, and Hybrid Effectiveness-Implementation Studies.

Coughlan, Kelly; Fasugba, Oyebola; Dale, Simeon; Straiton, Nicola; Ferguson, Caleb; D'Este, Catherine; Middleton, Sandy · Stroke · 2026

review · Level V

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Abstract

Implementation science plays a pivotal role in advancing organizational change within stroke healthcare settings by systematically evaluating and facilitating the adoption of evidence-based practices. This topical review examines the use of key trial designs relevant to implementation science research that aim to change organizational practice, highlighting their unique design features and methodological considerations. It also provides case studies of stroke research that have used each of the methods discussed demonstrating the practical applications in real-world environments. This overview aims to guide researchers and clinicians in selecting appropriate trial designs to optimize the translation of research into sustainable organizational systems and processes.