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Clinical Trials/NCT04513834
NCT04513834
Completed
Not Applicable

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

Nantes University Hospital1 site in 1 country25,000 target enrollmentSeptember 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proton Pump Inhibitors
Sponsor
Nantes University Hospital
Enrollment
25000
Locations
1
Primary Endpoint
PPI deprescribing
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2022
End Date
December 19, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.
  • 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
  • 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

Outcomes

Primary Outcomes

PPI deprescribing

Time Frame: 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 Outcomes

  • Characteristics of patients engaging in the deprescription process(12 months)

Study Sites (1)

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