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 (DeprescrIPPDAM)

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 Overview

• Status: Completed
• 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

• Study Type: Interventional
• Enrollment (Actual): 25000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 )	Other: GP will receive the educational outreach visit by a DAM (healthcare representative).; 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; Patient education material on PPI deprescribing will be sent to the patients
Active Comparator: 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.	Other: GP will receive the educational outreach visit by a DAM (healthcare representative).; GP will receive the educational outreach visit by a DAM (healthcare representative).
No Intervention: Control; 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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): December 19, 2023

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Primary health care; Pharmacoepidemiology; Proton pump inhibitors; Deprescription; Multi-faceted intervention; Patient-centered
• Other Study ID Numbers: RC20_0339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No