Deprescribing Inappropriate Proton Pump Inhibitors
DepRescribing inapprOpriate Proton Pump InhibiTors - the DROPIT Trial: a Cluster Randomized Controlled Trial in Primary Care Setting
University of Bern
400 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
Summary
The DROPIT Trial is an interventional, open-labelled, cluster-randomized controlled trial conducted in the Swiss primary care setting. It aims to evaluate an intervention to guide the deprescribing of inappropriate proton-pump inhibitors (PPIs). Therefore, the trial investigates whether the study intervention leads to the deprescribing of inappropriate PPI prescription while ensuring noninferiority safety, in comparison to usual care. Additionally, the trail aims to investigate the intervention's impact on other clinical aspects, as well as addressing features of the implementation of the intervention and its cost-effectiveness.
Eligibility
Inclusion Criteria11
- Patient of a participating GP.
- Age ≥18 years old.
- Daily PPI intake for ≥8 weeks.
- PPI in one of the following doses:
- ≥40mg/day pantoprazole;
- ≥40mg/day omeprazole;
- >30mg/day lansoprazole;
- >30mg/day dexlansoprazole;
- >20mg/day esomeprazole;
- >20mg/day rabeprazole.
- Sufficient knowledge of German language to understand the trial and follow-up according to GP assessment.
Exclusion Criteria21
- Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy < 12 months.
- Unable to provide informed consent.
- PPI in an appropriate dose (see Appendix Table A1) and with an established indication for long-term PPI, such as:
- History of bleeding ulcer.
- Peptic ulcer due to cause other than NSAID or H. Pylori.
- Barrett's oesophagus.
- Severe erosive reflux disease (Los Angeles grade C/D).
- GERD with symptoms or complications (oesophageal ulcer, peptic stricture).
- Other indications (i.e., Zollinger-Ellison-Syndrome, PPI-sensitive eosinophilic esophagitis, chronic pancreatitis with steatorrhea refractory to enzyme replacement therapy, idiopathic pulmonary fibrosis.)
- Two or more of the following medications, or one of the following medications and one or more of the below risk factors.
- Medications (any dose):
- Daily use of non-steroidal anti-inflammatory drug (NSAID) >7 days.
- Antiplatelet therapy.
- Additional antiplatelet therapy (e.g., ticagrelor or similar).
- Anticoagulant(s).
- Systemic steroid(s) >1 month.
- Risk factors:
- History of gastrointestinal ulcer.
- Age ≥75 years.
- Selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) use.
- Severe concomitant disease with increased risk of GI bleeding according to the GP's assessment (e.g., severe liver disease, neoplasia, nicotine or alcohol abuse).
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Interventions
The intervention is targeted to the Swiss Primary care practice. It involves educational material and resources to guide the safe deprescribing of inappropriate PPIs, for both general practitioners and patients.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06129474