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

NCT04255823 | Completed

• 1 other identifier: RC19_0460
• Study Type: interventional
• Target: 34,000
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Proton Pump Inhibitors; Deprescription

Keywords

Proton pump inhibitors; Deprescription; Multi-faceted intervention; Patient-centered; Primary health care; Pharmacoepidemiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cost-utility analysis

  12 months

• GERD symptoms recurrence

  12 months

• Attitudes of patients towards deprescribing

  12 months

Study Arms (3)

Multi-faceted intervention

EXPERIMENTAL

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.

"Dear doctor" letter of the GP

EXPERIMENTAL

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.

Control

NO INTERVENTION

Neither the patients nor their GP will receive information.

Interventions

General practitioner and Patient receive informations related to PPI deprescribing. OTHER

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)

Multi-faceted intervention

Only General practitioner receive informations related to PPI deprescribing. OTHER

General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing. Their patients will not receive any informations.

"Dear doctor" letter of the GP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

Related Publications (1)

• 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.

  PMID: 35177042 DERIVED

MeSH Terms

Interventions

General Practitioners

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: September 29, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)