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)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Deprescription; Proton Pump Inhibitors

Treatments: 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

Funder types: Other

Identifiers

NCT04513834

RC20_0339

Details and patient eligibility

About

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.

Enrollment: 25,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25,000 participants in 3 patient groups

Multi-faceted intervention

Experimental group

Description:

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 )

Treatment:

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

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

Educational outreach visit to GPs

Active Comparator group

Description:

GP will receive the educational outreach visit by a DAM (healthcare representative). Their patients will not receive any patient education material.

Treatment:

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

Control

No Intervention group

Description:

Neither the patients nor their GP will receive any information.