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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Deprescription; Proton Pump Inhibitors

Treatments: Other: Only General practitioner receive informations related to PPI deprescribing.; Other: General practitioner and Patient receive informations related to PPI deprescribing.

Study type: Interventional

Funder types: Other

Identifiers

NCT04255823

RC19_0460

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 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.

Enrollment: 34,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34,000 participants in 3 patient groups

Multi-faceted intervention

Experimental group

Description:

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.

Treatment:

Other: General practitioner and Patient receive informations related to PPI deprescribing.

"Dear doctor" letter of the GP

Experimental group

Description:

Only the GP will receive the "dear doctor" letter with the algorithm. Their patients will not receive any patient education material.

Treatment:

Other: Only General practitioner receive informations related to PPI deprescribing.

Control

No Intervention group

Description:

Neither the patients nor their GP will receive information.