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

NCT04513834 | Completed

• 1 other identifier: RC20_0339
• Study Type: interventional
• Target: 25,000
• 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 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.

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 (estimated with reimbursement databases)

  12 months

Secondary Outcomes (1)

• Characteristics of patients engaging in the deprescription process

  12 months

Study Arms (3)

Multi-faceted intervention

EXPERIMENTAL

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).; Other: Patient education material on PPI deprescribing will be sent to the patients

Educational outreach visit to GPs

ACTIVE COMPARATOR

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).

Control

NO INTERVENTION

Neither the patients nor their GP will receive any information.

Interventions

GP will receive the educational outreach visit by a DAM (healthcare representative). OTHER

GP will receive the educational outreach visit by a DAM (healthcare representative).

Educational outreach visit to GPs; Multi-faceted intervention

Patient education material on PPI deprescribing will be sent to the patients OTHER

Patient education material on PPI deprescribing will be sent to the patients

Multi-faceted intervention

Eligibility Criteria

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

You may qualify if:

• 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

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
• Patients under legal protection

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

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: August 12, 2020
• First Posted: August 14, 2020
• Study Start: September 19, 2022
• Primary Completion: September 19, 2023
• Study Completion: December 19, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)