Promoting the use of evidence (PROMOTE) in upper limb stroke rehabilitation: protocol for a multicentre, cluster-randomised, phase IV implementation trial

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INTRODUCTION: Fewer than half of patients receive evidence-based upper limb rehabilitation after stroke. Implementation science interventions may improve use of guidelines by clinicians; however, it is not yet known whether they lead to evidence-based stroke rehabilitation practice. We aim to determine the effect and cost-effectiveness of a champion-led implementation package (PROMOTE) to increase adherence to best practice guidelines for upper limb rehabilitation after stroke. METHODS AND ANALYSIS: A multistate, multicentre, cluster-randomised, implementation phase IV trial with concealed allocation, blinded measurement and intention-to-treat analysis will be conducted. The PROMOTE package includes appointing an internal champion, local audit and feedback, interactive education tailored to gaps in knowledge and skill, and a decision-aid to support intervention selection. To be eligible, centres delivered rehabilitation to at least 20 stroke patients in the preceding year. Assuming 35% baseline adherence to guidelines, 14 centres (n=238) will be recruited to provide 80% power to detect a 30% absolute difference with a two-sided α=0.05. An embedded process evaluation and economic analysis will assess implementation and costs. The primary outcome is the proportion of people with stroke who are documented to receive guideline-recommended upper limb rehabilitation interventions by 6 months. Secondary outcomes include self-reported clinician behaviour change, upper limb therapy outcomes at the end of intervention, costs and cost effectiveness (eg, incremental cost per quality adjusted life year). Process evaluation outcomes include reach, adoption, implementation and maintenance (sustainability). ETHICS AND DISSEMINATION: Ethical approval was obtained from the Alfred Hospital Human Research Ethics Committee (approval number 89725 (NMA), 26 April 2023) with each participating site providing ethical clearance prior to the commencement of the trial. Findings will be reported in accordance with the Consolidated Standards of Reporting Trials extended for cluster-randomised trials and in peer-reviewed journals, and communicated to stakeholders and the public. Understanding and characterising the active ingredients of effective implementation will inform scalable strategies to improve stroke rehabilitation practice, health outcomes and the equitable delivery of evidence-based care. TRIAL REGISTRATION NUMBER: The trial is currently recruiting and is registered at https://www.anzctr.org.au/.ID: ANZCTR 12623000608662 (UTN U1111-1292-8705), 2 June 2023.

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