Protocol to evaluate the feasibility of the D-PRESCRIBE intervention adapted to the Belgian community setting (END-IT CS study).

Abstract

Introduction: Benzodiazepine receptor agonists (BZRA) deprescribing interventions are needed to tackle high BZRA use in the older population. This study aims to assess the feasibility of the D-PRESCRIBE intervention, adapted from Canada to the Belgian community setting. This pharmacist-led intervention comprises a patient educational brochure and a pharmacist-to-prescriber communication tool.

Methods and analysis: We will conduct a feasibility study of a cluster randomised controlled trial involving 8-10 community pharmacies (clusters) and aiming to recruit 56-80 patients (≥65 years). Intervention pharmacies will deliver the adapted D-PRESCRIBE intervention and control pharmacies, usual care. Patients will be blinded to group allocation. Quantitative data will be collected at baseline, 3 months and 6 months through patients' and pharmacists' questionnaires, aiming: (1) to test the feasibility of the intervention, (2) to test the feasibility of the study design needed for its evaluation and (3) to perform an exploratory cost-effectiveness analysis. Hence, data about implementation outcomes, mechanisms of impact (ie, mechanisms through which the intervention is supposed to be effective) and contextual factors will be gathered. Patient-centred outcomes will also be collected as they would be in a full cost-effectiveness trial. The feasibility of the study design will be assessed through participation rate, completeness of the data and a satisfaction survey, sent to participants after the 6-month data collection. Data will be analysed using descriptive statistics. To gain a deeper understanding of pharmacists and patients' experience with the intervention, interviews will be conducted after the 6-month data collection and the Theoretical Domains Framework will be used as a deductive framework for analysis.

Ethics and dissemination: This study was approved by the Ethics Committee of CHU UCL Namur (NUB: B0392023000036). Participants will receive a summary of the results. Results will also be disseminated through the organisation of a local symposium and a peer-reviewed publication.

Trial registration number: NCT05929417.