Pétein Catherine, Chevallereau Tina, Aikpitanyi Josephine, Evrard Perrine, Tubeuf Sandy, Henrard Séverine, Spinewine Anne
Clinical Pharmacy and Pharmacoepidemiology research group, UCLouvain Louvain Drug Research Institute, Brussels, Belgium.
Institute of Health and Society (IRSS), UCLouvain, Brussels, Belgium.
BMJ Open. 2025 Mar 4;15(3):e085434. doi: 10.1136/bmjopen-2024-085434.
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.
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.
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.
NCT05929417.
需要采取苯二氮䓬受体激动剂（BZRA）减药干预措施来解决老年人群中BZRA的高使用量问题。本研究旨在评估从加拿大改编至比利时社区环境的D-PRESCRIBE干预措施的可行性。这项由药剂师主导的干预措施包括一份患者教育手册和一种药剂师与开处方者之间的沟通工具。
我们将进行一项整群随机对照试验的可行性研究，涉及8 - 10家社区药房（群组），目标是招募56 - 80名患者（≥65岁）。干预药房将实施改编后的D-PRESCRIBE干预措施，对照药房提供常规护理。患者将对分组情况不知情。将在基线、3个月和6个月时通过患者和药剂师问卷收集定量数据，目的是：（1）测试干预措施的可行性，（2）测试评估该干预措施所需研究设计的可行性，以及（3）进行探索性成本效益分析。因此，将收集有关实施结果、影响机制（即干预措施预期有效的机制）和背景因素的数据。还将收集以患者为中心的结果，就如同在全面成本效益试验中那样。将通过参与率、数据完整性以及在6个月数据收集后向参与者发送的满意度调查来评估研究设计的可行性。将使用描述性统计方法分析数据。为了更深入地了解药剂师和患者对干预措施的体验，将在6个月数据收集后进行访谈，并将理论领域框架用作演绎分析框架。
本研究已获得那慕尔大学中心医院伦理委员会批准（编号：B0392023000036）。参与者将收到结果摘要。结果还将通过组织当地研讨会和同行评审出版物进行传播。
NCT05929417。
