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
- Conditions
- DeprescriptionProton Pump Inhibitors
- Interventions
- Other: GP will receive the educational outreach visit by a DAM (healthcare representative).Other: Patient education material on PPI deprescribing will be sent to the patients
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25000
-
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
-
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
- Arm && Interventions
Group Intervention Description Multi-faceted intervention GP will receive the educational outreach visit by a DAM (healthcare representative). Patient education material on PPI deprescribing will be sent to the patients and their general practitioner (GP) will receive an educational outreach visit by a Delegue d'Assurance Maladie (DAM, healthcare representative ) Multi-faceted intervention Patient education material on PPI deprescribing will be sent to the patients Patient education material on PPI deprescribing will be sent to the patients and their general practitioner (GP) will receive an educational outreach visit by a Delegue d'Assurance Maladie (DAM, healthcare representative ) Educational outreach visit to GPs GP will receive the educational outreach visit by a DAM (healthcare representative). GP will receive the educational outreach visit by a DAM (healthcare representative). 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 (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