SRS289 - Optimising engagement and implementation in cluster randomised controlled trials: insights from CLARITY

Abstract Background Randomised controlled trials (RCTs) are the gold standard for evaluating clinical interventions. However, in practice, many RCTs face challenges achieving consistent delivery across sites, risking under-recruitment, protocol deviations, and reduced validity. Strategies to support effective implementation are therefore essential for optimising intervention uptake and producing reliable evidence in busy healthcare environments. As a pragmatic cluster RCT involving emergency surgical teams as participants, CLARITY presents an opportunity to assess these strategies. Aim We aimed to identify and characterise practical strategies for improving site engagement with CLARITY (ISRCTN: 16757238) to generate a transferable framework for implementing multicentre RCTs in complex clinical settings. Methods A structured virtual World Café was conducted with CLARITY site coordinators, principal and associate investigators, and regional leads to explore experiences of trial delivery (n = 11). Breakout discussions were recorded and analysed using Braun and Clarke’s reflexive thematic analysis. Coding was guided deductively by the Consolidated Framework for Implementation Research and supplemented by inductive analysis to capture emergent, site-specific strategies. Results Discussions generated a framework emphasising embedding socially-mediated, low cognitive-load strategies into clinical routines. Role-specific tailoring strategies, distributed leadership, and informal communication channels sustained engagement, while ‘local champions’ anchored delivery. Interdepartmental collaboration was strengthened by staffing continuity, confidence in intervention value, and flexibility to context. Recruitment and data processes benefitted from diverse team structures, workflow alignment, and accessible support mechanisms. Conclusions This co-produced framework demonstrates that successful multicentre RCTs require deliberate and context-sensitive engagement strategies. These insights provide transferable guidance for enhancing fidelity, scalability, and engagement across diverse trial settings.