NCT04030468

Educational and Informative Interventions to Tackle Inappropriate Use of Drugs in Italy

Effectiveness of Informative and/or Educational Interventions Aimed at Improving the Appropriate Use of Drugs Designed for General Practitioners and Their Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,840 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

Pharmacological intervention is an essential step in health promotion. However, lots of drugs are often used in inappropriate ways, especially in elderly patients. This study is aiming at evaluating the effectiveness of educational and/or informative interventions addressed to general practitioners and their adult patients in Italy, in order to improve appropriateness of prescribing in primary care.

Detailed description

EDU.RE.DRUG project is a prospective, multicentre, open-label, parallel-arm, controlled, pragmatic trial directed to general practitioners (GPs) and their patients from two Italian regions (Campania and Lombardy), with the objective of investigating the practice of prescribing among GPs to highlight the most frequent events of inappropriateness and to implement ad hoc interventions for GPs and patients. Appropriateness of prescribing in general practice will be assessed by evaluating selected prescribing, consumption and adherence indicators, using Regional administrative pharmaceutical prescription databases. Primary care physicians and their patients will be assigned to four trial arms: informative intervention (leaflets and posters for patients), educational intervention (feedback reports and online CME courses for GPs), combined interventions, or no intervention. Intervention effectiveness will be assessed measuring the variation in rates of inappropriate prescription indicators after 1-year of follow-up. EDU.RE.DRUG project will provide with improvements in the prescribing performance of GPs and in patients' adherence to treatment, with relevant clinical implications in terms of rational and safe use of drugs and optimized patient care, and with economic benefits (optimization of available resources use and savings in direct and indirect health costs).

Conditions

• Inappropriate Drug Prescription and Use

Interventions

Type	Name	Description
OTHER	Educational intervention addressed to general practitioners	* feedback reports regarding the status of their patients according to the appropriateness indicators determined at baseline and the pooled prevalences for their patients, Local Health Units, and region * Continuous Medical Education (CME) course
OTHER	Informative intervention addressed to patients	• leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use

Timeline

• Start date: 2017-04-20
• Primary completion: 2019-10-01
• Completion: 2020-04-01
• First posted: 2019-07-24
• Last updated: 2019-07-24

Locations

1 site across 1 country: Italy