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Completed

NCT Number: NCT04255823

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

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.

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Key information

Conditions

Proton Pump Inhibitors Deprescription

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Nantes, 44000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Primary outcomes

  1. PPI deprescribing

    Time frame: 12 months

    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.

Secondary outcomes

  1. Cost-utility analysis

    Time frame: 12 months

    Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of control group compared to the intervention.

  2. GERD symptoms recurrence

    Time frame: 12 months

    A short-form REFLUX-QUAL questionnaire will be assessed to a 10% patient sample in each arm (baseline and 12 months)

  3. Attitudes of patients towards deprescribing

    Time frame: 12 months

    Revised patients' attitudes toward deprescribing questionnaire will be assigned to a 10% patient sample in each arm (baseline and 12 months)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: DeprescrIPP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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