Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial

Not Applicable

Completed

• Conditions: Deprescription; Proton Pump Inhibitors

• Registration Number: NCT04513834
• 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 DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) to deprescribe PPI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-14
• Study Start: 2022-09-19
• Primary Completion: 2023-09-19
• Study Completion: 2023-12-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

• General practitioners (GP)

  • All GP settled in the French region Pays-de-la-Loire having seen more than 100 different patients in the year before baseline, will be eligible.

• Patients

  • Aged more than 18 years old
  • Affiliated to the French health insurance CPAM
  • Treated with PPI> 300DDD/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
  • Patients under legal protection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 (estimated with reimbursement databases)

Secondary Outcome Measures

Name	Time	Method
Characteristics of patients engaging in the deprescription process	12 months	Sex, age, long-term illness, universal health insurance, complementary health insurance, medication

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France