Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.

Not Applicable

Completed

• Conditions: Proton Pump Inhibitors; Deprescription
• Interventions: Other: General practitioner and Patient receive informations related to PPI deprescribing.; Other: Only General practitioner receive informations related to PPI deprescribing.

• Registration Number: NCT04255823
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Study Start: 2020-09-29
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34000

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-faceted intervention	General practitioner and Patient receive informations related to PPI deprescribing.	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.
"Dear doctor" letter of the GP	Only General practitioner receive informations related to PPI deprescribing.	Only the GP will receive the "dear doctor" letter with the algorithm. Their patients will not receive any patient education material.

Primary Outcome Measures

Name	Time	Method
PPI deprescribing	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.

Secondary Outcome Measures

Name	Time	Method
Attitudes of patients towards deprescribing	12 months	Revised patients' attitudes toward deprescribing questionnaire will be assigned to a 10% patient sample in each arm (baseline and 12 months)
GERD symptoms recurrence	12 months	A short-form REFLUX-QUAL questionnaire will be assessed to a 10% patient sample in each arm (baseline and 12 months)
Cost-utility analysis	12 months	Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of control group compared to the intervention.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France