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

Proton Pump Inhibitors Clinical Trial

— DeprescrIPPDAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04513834
• Other study ID #: RC20_0339
• Status: Completed
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: December 19, 2023

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25000
• Est. completion date: December 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deprescription
• Proton Pump Inhibitors

Intervention

Other:
• GP will receive the educational outreach visit by a DAM (healthcare representative).
GP will receive the educational outreach visit by a DAM (healthcare representative).
• Patient education material on PPI deprescribing will be sent to the patients
Patient education material on PPI deprescribing will be sent to the patients

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPI deprescribing	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)	12 months
Secondary	Characteristics of patients engaging in the deprescription process	Sex, age, long-term illness, universal health insurance, complementary health insurance, medication	12 months