DepRescribing inapprOpriate Proton Pump InhibiTors - the DROPIT Trial: a Cluster Randomized Controlled Trial in Primary Care Setting
Led by University of Bern · Updated on 2026-05-14
400
Participants Needed
2
Research Sites
35 weeks
Total Duration
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U
University of Bern
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate an intervention to guide the deprescribing of inappropriate proton pump inhibitors (PPIs) in adult patients within a Swiss primary care setting. The study investigates whether this intervention can safely reduce inappropriate PPI prescriptions compared to usual care, while also assessing its impact on clinical outcomes, implementation factors, and cost-effectiveness. PPIs are commonly used for gastric acid-related disorders, but concerns exist about their long-term inappropriate use and associated risks such as nutritional deficiencies and infections.
The trial is an interventional, open-label, cluster-randomized controlled study involving general practitioners (GPs) and their adult patients who have been using PPIs daily for at least 8 weeks at specified doses. Patients are assigned by GP clusters to either receive the deprescribing intervention, which includes educational materials and guidance for both GPs and patients, or to continue with usual care without the intervention. The study follows participants for 12 months to monitor PPI use and safety outcomes.
Participants will be involved in regular follow-up over 12 months to evaluate PPI dosage changes, gastrointestinal symptoms, quality of life, medication use, and safety events. Data will be collected on PPI dose reductions, discontinuations, switches to on-demand use, and alternative treatments. The study also includes assessments of the intervention's implementation quality, acceptance by patients and GPs, and cost-effectiveness. Safety and effectiveness will be analyzed using statistical models accounting for cluster randomization and baseline measures.
Patient of a participating general practitioner (GP).
Age 18 years or older.
Daily proton pump inhibitor (PPI) use for at least 8 weeks.
PPI dose at or above specified thresholds (e.g., 40mg/day pantoprazole, 40mg/day omeprazole, more than 30mg/day lansoprazole or dexlansoprazole, more than 20mg/day esomeprazole or rabeprazole).
Sufficient knowledge of German to understand the trial and follow-up as assessed by GP.
You will not qualify if you...
Limited life expectancy less than 12 months as judged by GP.
Unable to provide informed consent.
Appropriate PPI dose with established indication for long-term use (e.g., bleeding ulcer history, Barrett's oesophagus, severe erosive reflux disease, oesophageal ulcer or stricture, Zollinger-Ellison syndrome, eosinophilic esophagitis, chronic pancreatitis, idiopathic pulmonary fibrosis).
Concurrent use of two or more of certain medications (NSAIDs for more than 7 days, antiplatelet therapy, anticoagulants, systemic steroids over 1 month), or one medication plus one or more specified risk factors.
Risk factors including history of gastrointestinal ulcer, age 75 or older, use of SSRIs or SNRIs, or severe concomitant disease increasing GI bleeding risk as assessed by GP.
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Intervention
Duration - 12 months
Participants in the intervention group receive a patient-centred PPI deprescribing tool to guide general practitioners and patients through safely deprescribing inappropriate proton pump inhibitors. Participants in the control group receive usual care without this intervention.