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

University of Milan

Status: Unknown

Conditions: Inappropriate Drug Prescription and Use

Treatments: Other: Informative intervention addressed to patients; Other: Educational intervention addressed to general practitioners

Study type: Interventional

Funder types: Other

Identifiers

NCT04030468

FARM12KSBT

2017-002622-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4,840 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,840 participants in 4 patient groups

General practitioners

Experimental group

Description:

Educational intervention

Treatment:

Other: Educational intervention addressed to general practitioners

Patients

Experimental group

Description:

Informative intervention

Treatment:

Other: Informative intervention addressed to patients

General practitioners and patients

Experimental group

Description:

Combined strategy

Treatment:

Other: Educational intervention addressed to general practitioners

Other: Informative intervention addressed to patients

Control

No Intervention group

Description:

No intervention