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OpenTrials
Completed

NCT Number: NCT04513834

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

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.

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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 (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

Treatment and study plan

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).

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

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 (estimated with reimbursement databases)

Secondary outcomes

  1. Characteristics of patients engaging in the deprescription process

    Time frame: 12 months

    Sex, age, long-term illness, universal health insurance, complementary health insurance, medication

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: DeprescrIPPDAM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 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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