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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04513834
Acronym
DeprescrIPPDAM
Enrollment
25000
Registered
2020-08-14
Start date
2022-09-19
Completion date
2023-12-19
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deprescription, Proton Pump Inhibitors

Keywords

Proton pump inhibitors, Deprescription, Multi-faceted intervention, Patient-centered, Primary health care, Pharmacoepidemiology

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.

Interventions

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

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

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

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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PPI deprescribing12 monthsProportion 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

MeasureTime frameDescription
Characteristics of patients engaging in the deprescription process12 monthsSex, age, long-term illness, universal health insurance, complementary health insurance, medication

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026