Clinical trial NCT04637750: Proton Pump Inhibitors (PPI): a Study to Improve Appropriate Prescriptions in the Elderly
Official title: Evaluation of the Effectiveness of a Low-cost Informative Intervention to Improve the Appropriate Prescription of Proton Pump Inhibitors in Older People in Primary Care: a Cluster- Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proton Pump Inhibitor
Primary Care
Keywords: Proton pump inhibitors
prescription appropriateness
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: IRCCS Multimedica
name: Federico II University
First posted: 2020-11-20
Enrollment: 800
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proton Pump Inhibitors(PPIs) are the leading evidence-based therapy for upper gastrointestinal disorders and prevention of antiplatelet or non-steroidal anti-inflammatory drugs induced ulcer. In Italy in 2015 nearly 3,5 millions of people were treated with PPI. Despite the extensive literature regarding PPI adverse event, their inappropriate prescription rate is still increasing, and Campania and Lombardy region are at the highest level. For this reason a cluster-randomised controlled trial will be performed, in order to evaluate if a low-cost informative intervention addressed to GPs is effective in improving PPIs prescription in older people. The threshold will be defined according to the distribution of the rate of appropriate PPI prescriptions for a 6 months lag time starting 1 year before randomisation (baseline assessment).

Detailed description: A cluster-randomized controlled trial will be performed in order to evaluate if a low-cost informative intervention addressed to GPs is effective in improving PPIs prescription in older people. All GPs of the Local Health Unit (LHU) of Caserta (southern Italy) and Bergamo (northern Italy) will be invited to participate to the study, because Caserta and Bergamo represent the areas with the highest level of inappropriate PPI prescription rate. All GPs involved in the study will receive an invitation letter illustrating the study purpose and containing information about aggregated data on PPI prescriptions out of AIFA reimbursement criteria in Italy and their local area. The GPs randomized to the intervention arm will also receive a feedback informing on their absolute number of patients treated with at least one PPI during the baseline period and if they have been prescribed above or below the median of appropriate prescriptions rate in their local area. They will be also provided with a scientific document including technical details on AIFA reimbursement criteria (NOTA 1 and 48), short hints about adverse events related to PPI long- term use in older patients and recommendation on how to discontinue PPI. After 4 months GPs will also receive a patient-focused intervention leaflet and poster for patients about their medicines: what are the PPI and their possible side effects, nutritional and behavioral advices to prevent gastric and reflux problems and how to step down the treatment. The appropriateness of PPI prescriptions will be defined according to the Italian Medicines Agency (AIFA) reimbursement rules (NOTA 1 and 48).

Eligibility criteria: All the GPs in Caserta and Bergamo will be invited to participate to the study by the local authorities.

Inclusion Criteria for GPs patients:

* user of Proton Pump Inhibitors (at least one prescriptions in the period of interest)
* aged 65 or above

Exclusion Criteria:

- nursing homes residents

Primary outcomes:
measure: Short-term effectiveness
timeFrame: 6 months
Secondary outcomes:
measure: Long-term effectiveness
timeFrame: 12-18 months
Other outcomes:
measure: Rate of 'paradoxical effect'
timeFrame: 12-18 months
Locations:
city: Sesto San Giovanni
country: Italy
facility: IRCCS MultiMedica- MultiMedica Spa
state: Milan
city: Milan
country: Italy
facility: Mario Negri Institute for Pharmacological Research
city: Napoli
country: Italy
facility: Università degli studi di Napoli Federico II
Study officials:
affiliation: Mario Negri Institute for Pharmacological Research
name: Carlotta Franchi, PhD
role: PRINCIPAL_INVESTIGATOR
References: