Deprescribing Inappropriate Proton Pump Inhibitors

NCT06129474 | Recruiting DMC

• 1 other identifier: DROPIT Trial_v1.0
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Inappropriate Prescribing; Reflux Disease; Proton Pump Inhibitors

Keywords

Deprescribing; Proton pump inhibitors

Outcome Measures

Primary Outcomes (2)

• Effectiveness co-primary endpoint: prescribed PPI dose over 12 months follow-up (superiority endpoint).

  12 months

• Safety co-primary endpoint: upper gastrointestinal symptoms (Non-inferiority endpoint)

  Co-primary endpoints measured by the Reflux Disease Questionnaire (RDQ), considering the worst of the subscales dyspepsia and gastroesophageal reflux disease (GERD) (i.e.,regurgitation and heartburn subscales combined).

  12 months

Secondary Outcomes (13)

• Occurrence of reduction of at least 50% of the prescribed PPI dose over the follow-up time.

  12 months

• Occurrence of PPI discontinuation

  12 months

• Occurrence of PPI sustained discontinuation

  12 months

• Occurrence of a switch to prescription for on-demand use

  12 months

• Occurrence of use of alternative anti-reflux treatments

  12 months

Other Outcomes (5)

• Serious adverse events (SAE)

  12 months

• Mortality

  12 months

• Patients' satisfaction with the trial participation

  12 months

Study Arms (2)

DROPIT Intervention

EXPERIMENTAL

The study intervention is a patient-centred PPI deprescribing intervention aiming to guide GPs and patients through the process of safely deprescribing inappropriate PPIs.

Other: Proton Pump Inhibitor deprescribing tool

Usual Care

NO INTERVENTION

The reference or control arm will receive usual care. This means that the GPs and patients in this group will conduct their clinical practice as per usual, without receiving the intervention from the study team.

Interventions

Proton Pump Inhibitor deprescribing tool OTHER

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.

DROPIT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Bern: lead
• Swiss National Science Foundation: collaborator
• University of Zurich: collaborator
• University of Basel: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Patientenstelle Zürich: collaborator
• Patientenstelle Basel: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (2)

Prof. Dr. med. Dr. phil. Sven Streit

Bern, 3012, Switzerland

NOT YET RECRUITING

University of Bern

Bern, 3012, Switzerland

RECRUITING

Related Publications (1)

• Schulthess-Lisibach AE, Luthold RV, Tombez C, Weir KR, Zangger M, Chan S, Jenal F, Roumet M, Mattmann Y, Bieri C, Aubert CE, Rodondi N, Zambrano Ramos SC, Trelle S, Neuner-Jehle S, Juillerat P, Barbier M, Inauen J, Streit S, Jungo KT, Vallejo-Yague E. DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care. BMJ Open. 2025 Jan 20;15(1):e094495. doi: 10.1136/bmjopen-2024-094495.

  PMID: 39832992 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sven Streit, Prof. Dr. med. Dr. phil

  University of Bern, Institute of Primary Health Care (BIHAM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Streit, Prof. Dr med. Dr. phil.

CONTACT

+41 31 684 58 75; sven.streit@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Even though this is an open label study, the investigators have measures in place to mask the participants as much as possible. Patients of both groups will receive a description of the trial, which mentions inappropriate prescription of medications but not PPI, which keeps them blinded. However, GPs and patients in the intervention group may not necessarily remain blinded, since they may be questioned about the intervention as part of the integrated process evaluation of the intervention. The control group will remain unaware of the detailed nature of the intervention. In case more than one GP from a group practice takes part in this trial, GPs are instructed to keep trial-related communication and exchanges to a minimum. Team members collecting data will remain blinded to the group allocation of the patients.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this trial, adult patients with inappropriate PPI prescription will be recruited by GPs in the German speaking part of Switzerland. Based on 1:1 cluster randomization of GPs, patients will be assigned to either the control group or to the group receiving an intervention to guide deprescribing of inappropriate PPIs. The control group will receive usual care.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 13, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CH (2)