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

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.

Study Overview

• Status: Completed
• Conditions: Proton Pump Inhibitors; Deprescription
• Intervention / Treatment: Other: General practitioner and Patient receive informations related to PPI deprescribing.; Other: Only General practitioner receive informations related to PPI deprescribing.

• Study Type: Interventional
• Enrollment (Actual): 34000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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; 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.; 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)
Experimental: "Dear doctor" letter of the GP; 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.; General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing. Their patients will not receive any informations.
No Intervention: Control; Neither the patients nor their GP will receive 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.	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Publications and helpful links

General Publications

• Nguyen-Soenen J, Rat C, Gaultier A, Schirr-Bonnans S, Tessier P, Fournier JP. Effectiveness of a multi-faceted intervention to deprescribe proton pump inhibitors in primary care: protocol for a population-based, pragmatic, cluster-randomized controlled trial. BMC Health Serv Res. 2022 Feb 17;22(1):219. doi: 10.1186/s12913-022-07496-3.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 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: RC19_0460

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