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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nantes University Hospital
- Enrollment
- 25,000
- Locations
- 1
- Primary Endpoint
- PPI deprescribing
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Multi-faceted intervention
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 )
Intervention: GP will receive the educational outreach visit by a DAM (healthcare representative). (Other)
Multi-faceted intervention
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 )
Intervention: Patient education material on PPI deprescribing will be sent to the patients (Other)
Educational outreach visit to GPs
GP will receive the educational outreach visit by a DAM (healthcare representative). Their patients will not receive any patient education material.
Intervention: GP will receive the educational outreach visit by a DAM (healthcare representative). (Other)
Control
Neither the patients nor their GP will receive any information.
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)