Schulthess-Lisibach Angela Edith, Lüthold Renata Vidonscky, Tombez Clémentine, Weir Kristie Rebecca, Zangger Martina, Chan Samantha, Jenal Flurina, Roumet Marie, Mattmann Yvonne, Bieri Christof, Aubert Carole Elodie, Rodondi Nicolas, Zambrano Ramos Sofia Carolina, Trelle Sven, Neuner-Jehle Stefan, Juillerat Pascal, Barbier Michaela, Inauen Jennifer, Streit Sven, Jungo Katharina Tabea, Vallejo-Yagüe Enriqueta
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
Institute of Psychology, University of Bern, Bern, Switzerland.
BMJ Open. 2025 Jan 20;15(1):e094495. doi: 10.1136/bmjopen-2024-094495.
Proton pump inhibitors (PPIs) are widely prescribed medications and commonly used for the treatment of gastric acid-related disorders. Nevertheless, PPIs are often overused leading to potential adverse effects and unnecessary healthcare costs. Deprescribing strategies have emerged to safely reduce or substitute inappropriate PPIs and optimise patient care in an evidence-based manner. This protocol describes a study to evaluate the effectiveness of a PPI deprescribing intervention in comparison to usual care in the Swiss primary care setting.
An open-label, cluster randomised controlled trial.
Swiss primary care settings.
Included participants will be adults with inappropriate PPI treatment and will be recruited by general practitioners (GPs). Participants treated by the same GP constitute a cluster. Clusters are randomised 1:1 to either the intervention group or the control group.
The intervention components consist of deprescribing tools including educational material, decision aids for both participants and GPs, and additional trainings for GPs only. Patients in the control group will receive usual care. Data will be collected at baseline, 3-, 6-, 9- and 12-month follow-up time through online surveys or a phone call for both GPs and participants.
The first co-primary endpoint is the effectiveness of the deprescribing intervention measured by the change of prescribed PPI dose. The second co-primary endpoint is safety, which is measured with the Reflux Disease Questionnaire assessing change in gastrointestinal symptoms. There are several secondary endpoints, such as the total number of prescribed medications, occurrences of changes in prescription patterns, PPI discontinuation and cost-effectiveness.
The findings from this study will provide evidence on the effectiveness and safety of a PPI deprescribing intervention for patients and GPs. Successful implementation of our PPI deprescribing strategy has the potential to improve patient outcomes and lower costs.
NCT06129474.
质子泵抑制剂（PPIs）是广泛处方的药物，常用于治疗胃酸相关疾病。然而，PPIs经常被过度使用，导致潜在的不良反应和不必要的医疗费用。减药策略已出现，以安全地减少或替代不适当的PPIs，并以循证方式优化患者护理。本方案描述了一项研究，以评估在瑞士初级保健环境中，与常规护理相比，PPI减药干预的有效性。
开放标签、整群随机对照试验。
瑞士初级保健机构。
纳入的参与者将是接受不适当PPI治疗的成年人，由全科医生（GPs）招募。由同一位全科医生治疗的参与者构成一个群组。群组以1:1的比例随机分配到干预组或对照组。
干预组成部分包括减药工具，如教育材料、针对参与者和全科医生的决策辅助工具，以及仅针对全科医生的额外培训。对照组的患者将接受常规护理。数据将在基线、3个月、6个月、9个月和12个月随访时，通过在线调查或电话收集，涉及全科医生和参与者。
第一个共同主要终点是通过规定的PPI剂量变化衡量的减药干预的有效性。第二个共同主要终点是安全性，通过反流疾病问卷评估胃肠道症状变化来衡量。有几个次要终点，如规定药物的总数、处方模式变化的发生率、PPI停药情况和成本效益。
本研究的结果将为PPI减药干预对患者和全科医生的有效性和安全性提供证据。成功实施我们的PPI减药策略有可能改善患者结局并降低成本。
NCT06129474。
