Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34,000
- 试验地点
- 1
- 主要终点
- PPI deprescribing
研究概览
简要总结
Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.
DeprescrIPP is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General practitioners (GPs):
- •All GPs settled in the 2 departments of Loire-Atlantique and Vendée with more than 100 patients in the year before baseline, will be eligible.
- •Patients:
- •aged over 18 years
- •affiliated to the French health insurance system (CPAM)
- •treated with PPI with more than 300 DDD/year in the year before baseline, estimated with reimbursement databases.
- •whose GP is included in the study
排除标准
- •General practitioners (GPs):
- •Participation refusal
- •Patients :
- •Participation refusal
- •Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and over 65 years old or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors
研究组 & 干预措施
Multi-faceted intervention
A patient education material on PPI deprescribing will be send to patients with long-term treatment with PPI (>300DDD/patient/year).
Their general practitioner (GP) will receive a "dear doctor" letter with an algorithm related to PPI deprescribing.
干预措施: General practitioner and Patient receive informations related to PPI deprescribing. (Other)
"Dear doctor" letter of the GP
Only the GP will receive the "dear doctor" letter with the algorithm.
Their patients will not receive any patient education material.
干预措施: Only General practitioner receive informations related to PPI deprescribing. (Other)
Control
Neither the patients nor their GP will receive information.
结局指标
主要结局
PPI deprescribing
时间窗: 12 months
Proportion of patients achieving a 50% decrease in their reimbursement of PPI (Defined Daily Dose (DDD)/year) at the end of the intervention compared to baseline.
次要结局
- Attitudes of patients towards deprescribing(12 months)
- GERD symptoms recurrence(12 months)
- Cost-utility analysis(12 months)