Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.

Study Overview
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Brief Summary
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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 is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.

Official Title
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Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.

Conditions
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Proton Pump Inhibitors, Deprescription

Intervention / Treatment
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* Other: General practitioner and Patient receive informations related to PPI deprescribing.
* Other: Only General practitioner receive informations related to PPI deprescribing.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General practitioners (GPs): • All GPs settled in the 2 departments of Loire-Atlantique and Vendée with more than 100 patients in the year before baseline, will be eligible. Patients: aged over 18 years affiliated to the French health insurance system (CPAM) treated with PPI with more than 300 DDD/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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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>A patient education material on PPI deprescribing will be send to patients with long-term treatment with PPI (>300DDD/patient/year). Their general practitioner (GP) will receive a dear doctor letter with an algorithm related to PPI deprescribing. | Other: General practitioner and Patient receive informations related to PPI deprescribing.<br>* General practitioner will receive a sensibilization and an algorithm related to PPI deprescribing. Their patients will receive any informations (patient information material on PPI deprescribing)<br>|
| Experimental: Dear doctor letter of the GP<br>Only the GP will receive the dear doctor letter with the algorithm. Their patients will not receive any patient education material. | Other: Only General practitioner receive informations related to PPI deprescribing.<br>* General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing. Their patients will not receive any informations.<br>|
| No Intervention: Control<br>Neither the patients nor their GP will receive information. | |

What is the study measuring?
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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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-utility analysis | Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of control group compared to the intervention. | 12 months | 
| GERD symptoms recurrence | A short-form REFLUX-QUAL questionnaire will be assessed to a 10% patient sample in each arm (baseline and 12 months) | 12 months | 
| Attitudes of patients towards deprescribing | Revised patients' attitudes toward deprescribing questionnaire will be assigned to a 10% patient sample in each arm (baseline and 12 months) | 12 months | 

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