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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04030468
Acronym
EDUREDRUG
Enrollment
4840
Registered
2019-07-24
Start date
2017-04-20
Completion date
2020-04-30
Last updated
2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inappropriate Drug Prescription and Use

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).

Interventions

OTHEREducational 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

OTHERInformative intervention addressed to patients

• leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use

Sponsors

Federico II University
CollaboratorOTHER
University of Milano Bicocca
CollaboratorOTHER
University of Milan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

According to the Local Health Unit (LHU), general practitioners (GPs) with their patients will be assigned to one of the following intervention arms: 1. intervention on GPs (LHUs of Napoli 1 Nord and Bergamo) 2. intervention on patients (LHUs of Avellino and Val Padana-Mantova District) 3. intervention on GPs and patients (LHUs of Napoli 2 Centro and Brianza-Lecco District) 4. no intervention (LHUs of Caserta and Brianza-Monza Brianza District)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Inappropriate drug prescription and use indicators30 monthsChanges 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

MeasureTime frameDescription
Predictive factors of inappropriate prescribing30-36 monthsIdentification of predictors of poor prescription appropriateness
Health Technology Assessment of intervention implemented30-36 monthsHTA analysis
GP's satisfaction30-36 monthsLevel of general practitioners (GPs) satisfaction by using ad hoc web-based questionnaire

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026