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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2021-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04513834

Proton Pump Inhibitors Deprescription

COMPLETED NA

Feasibility Study of a Systematic Approach for Deprescribing of Statins and PPI's.

NCT04204590

Polypharmacy

COMPLETED NA

Engaging Patients to Promote Deprescribing

NCT04294901

Medical Overuse Inappropriate Prescribing Deprescriptions

COMPLETED NA

Deprescribing in Outpatient Internal Medicine Practices

NCT07226960

Deprescribing

RECRUITING NA

Intervention to Improve Prescribing in Elderly Patients

NCT02712268

Elderly Internal Medicine Patients

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Proton Pump Inhibitors Deprescription

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multi-faceted intervention

A patient education material on PPI deprescribing will be send to patients with long-term treatment with PPI (\>300DDD/patient/year).

Their general practitioner (GP) will receive a "dear doctor" letter with an algorithm related to PPI deprescribing.

Group Type EXPERIMENTAL

General practitioner and Patient receive informations related to PPI deprescribing.

Intervention Type 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)

"Dear doctor" letter of the GP

Only the GP will receive the "dear doctor" letter with the algorithm.

Their patients will not receive any patient education material.

Group Type EXPERIMENTAL

Only General practitioner receive informations related to PPI deprescribing.

Intervention Type OTHER

General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing.

Their patients will not receive any informations.

Control

Neither the patients nor their GP will receive information.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No