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

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.

Official Title
-----------------
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
-----------------
Proton Pump Inhibitors, Deprescription

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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. 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-faceted intervention<br>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 ) | Other: GP will receive the educational outreach visit by a DAM (healthcare representative).<br>* GP will receive the educational outreach visit by a DAM (healthcare representative).<br>Other: Patient education material on PPI deprescribing will be sent to the patients<br>* Patient education material on PPI deprescribing will be sent to the patients<br>|
| Active Comparator: Educational outreach visit to GPs<br>GP will receive the educational outreach visit by a DAM (healthcare representative). Their patients will not receive any patient education material. | Other: GP will receive the educational outreach visit by a DAM (healthcare representative).<br>* GP will receive the educational outreach visit by a DAM (healthcare representative).<br>|
| No Intervention: Control<br>Neither the patients nor their GP will receive any information. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPI deprescribing | 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of patients engaging in the deprescription process | Sex, age, long-term illness, universal health insurance, complementary health insurance, medication | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proton pump inhibitors, Deprescription, Multi-faceted intervention, Patient-centered, Primary health care, Pharmacoepidemiology