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

Not Applicable

• Conditions: Inappropriate Drug Prescription and Use

• Registration Number: NCT04030468
• Lead Sponsor: University of Milan

Brief 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).

Study Timeline

• Study Start: 2017-04-20
• Status Verified: 2019-07
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-19
• Study First Posted: 2019-07-24
• Last Update Posted: 2019-07-24
• Primary Completion: 2019-10
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4840

Inclusion Criteria

• general practitioners of the Italian National Health System (NHS) operating at December 31, 2016 belonging to the 8 Local Health Units involved in the project

Exclusion Criteria

• primary care pediatricians

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inappropriate drug prescription and use indicators	30 months	Changes in prevalences of selected potentially inappropriate prescribing (including drug-drug interactions, duplicate therapies, inappropriate drugs in older people and drugs with high anticholinergic and sedative burden), consumption and adherence indicators between baseline and after the intervention

Secondary Outcome Measures

Name	Time	Method
GP's satisfaction	30-36 months	Level of general practitioners (GPs) satisfaction by using ad hoc web-based questionnaire
Health Technology Assessment of intervention implemented	30-36 months	HTA analysis
Predictive factors of inappropriate prescribing	30-36 months	Identification of predictors of poor prescription appropriateness

Trial Locations

Locations (1)

SEFAP, University of Milan; 🇮🇹 Milan, MI, Italy