Health TrialsbyHealthPanel

Deprescribing Inappropriate Proton Pump Inhibitors

ConditionsInappropriate PrescribingReflux DiseaseProton Pump Inhibitors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient of a participating GP.

Age: minimum 18 years old.

Daily PPI intake for minimum 8 weeks.

minimum 40mg/day pantoprazole;

Disqualifiers

Limited life expectancy according to GP judgement (patients with terminal disease and a life expectancy of less than 12 months.

Unable to provide informed consent.

History of bleeding ulcer.

Peptic ulcer due to cause other than NSAID or H. Pylori.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proton Pump Inhibitor deprescribing tool

    Other intervention

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: DROPIT InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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).

Time frame
12 months

Secondary outcomes

1

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

Time frame
12 months
2

Occurrence of PPI discontinuation

Stop in PPI prescription as indicated by the general practitioner (GP)

Time frame
12 months
3

Occurrence of PPI sustained discontinuation

3 months without prescribed PPI

Time frame
12 months
4

Occurrence of a switch to prescription for on-demand use

Time frame
12 months

Other outcomes

1

Serious adverse events (SAE)

A Serious Adverse Event (SAE) (ClinO, Art. 63) is any untoward medical occurrence that results in death or is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or causes a congenital anomaly or birth defect. Upon a SAE, the GP makes the severity assessment of the event following the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Time frame
12 months
2

Mortality

Time frame
12 months
3

Patients' satisfaction with the trial participation

Measured by the Study Participant Feedback Questionnaire (SPFQ), handed to at the beginning (baseline), middle (6-month) and end of trial (12-month).

Time frame
12 months
4

Use of alternative anti-reflux treatments (medication)

After PPI discontinuation and after PPI sustained discontinuation

Time frame
12 months

Sponsors and contacts

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University of Bern

Lead sponsor

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

Source ClinicalTrials.gov
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