Deprescription, Proton Pump Inhibitors
Conditions
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 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.
Interventions
OTHERGeneral 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)
OTHEROnly 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.
Sponsors
Nantes University Hospital
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 (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PPI deprescribing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility analysis | 12 months | Incremental cost-utility ratio (cost by quality-adjusted life-years, QALY) of control group compared to the intervention. |
| GERD symptoms recurrence | 12 months | A short-form REFLUX-QUAL questionnaire will be assessed to a 10% patient sample in each arm (baseline and 12 months) |
| Attitudes of patients towards deprescribing | 12 months | Revised patients' attitudes toward deprescribing questionnaire will be assigned to a 10% patient sample in each arm (baseline and 12 months) |
Countries
France
Outcome results
None listed