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

NCT ID: NCT04513834

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2023-12-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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 )

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Control

Neither the patients nor their GP will receive any information.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC20_0339

Identifier Type: -

Identifier Source: org_study_id