Pragmatic Evaluation of Effectiveness and Acceptability of the Bristol Medication Review Toolkit (BRISMED) Protocol for a multicentre cluster randomised trial

Introduction Medicines are a key healthcare intervention. Medicines optimisation aims to ensure safe and effective use of medicines, with medication reviews a critical component. However, evidence around how reviews should be structured and delivered is limited. The Bristol Medication Review Toolkit comprises a review model and practical supporting materials to facilitate comprehensive, patient-centred, structured medication reviews. The BRISMED trial aims to evaluate the clinical effectiveness and acceptability of the Toolkit compared with standard general practice care. Methods BRISMED is a multicentre, open-label, cluster-randomised controlled trial, with two parallel groups. General practices within the Oxford RCGP Research Surveillance Centre (RSC) network will be selected to participate, representing 500 primary care networks (PCNs) in England. Randomisation will occur at PCN level. The intervention will take place at the practice level, with no patient-level recruitment. Practices will either undertake usual care (control group, 250 PCNs) or receive the BRISMED Toolkit (intervention group, 250 PCNs) over the same 12-month intervention delivery period. The primary outcome will be potentially inappropriate prescribing (PIP), defined as the proportion of patients with ≥1 STOPP/START indicator at 12 months (binary outcome per patient). Secondary outcomes will include additional prescribing metrics and healthcare utilisation. Outcomes will be determined using routinely collected electronic health data. The primary analysis will use mixed-effects logistic regression, on an intention-to-treat basis. A parallel mixed-methods process evaluation in a subset of practices will examine intervention implementation and provide context for interpretation of the trial findings, alongside a cost consequence analysis. Findings will be disseminated through publications, conferences and stakeholder engagement. Patients and the public will contribute throughout the study, supporting research delivery and dissemination. Ethics and registration The study has received approval from the West of Scotland NHS Research Ethics Committee 1 (reference 24/WS/0031). The trial is prospectively registered with ISRCTN (reference 12979016, registration date 3/6/2024).