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

Proton Pump Inhibitors Clinical Trial

— DeprescrIPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255823
• Other study ID #: RC19_0460
• Status: Completed
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: December 15, 2021

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34000
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deprescription
• Proton Pump Inhibitors

Intervention

Other:
• General practitioner and Patient receive informations related to PPI deprescribing.
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.
General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing. Their patients will not receive any informations.

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.	12 months
Secondary	Cost-utility analysis	Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of control group compared to the intervention.	12 months
Secondary	GERD symptoms recurrence	A short-form REFLUX-QUAL questionnaire will be assessed to a 10% patient sample in each arm (baseline and 12 months)	12 months
Secondary	Attitudes of patients towards deprescribing	Revised patients' attitudes toward deprescribing questionnaire will be assigned to a 10% patient sample in each arm (baseline and 12 months)	12 months