Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 8:50 AM
Study NCT ID:
NCT04637750
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2020-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proton Pump Inhibitors (PPI): a Study to Improve Appropriate Prescriptions in the Elderly
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAPTOP-PPI
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: