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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Inappropriate Drug Prescription and Use

Intervention / Treatment
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* Other: Educational intervention addressed to general practitioners
* Other: Informative intervention addressed to patients


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: intervention on GPs (LHUs of Napoli 1 Nord and Bergamo) intervention on patients (LHUs of Avellino and Val Padana-Mantova District) intervention on GPs and patients (LHUs of Napoli 2 Centro and Brianza-Lecco District) no intervention (LHUs of Caserta and Brianza-Monza Brianza District)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: General practitioners<br>Educational intervention | Other: Educational intervention addressed to general practitioners<br>* 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<br>|
| Experimental: Patients<br>Informative intervention | Other: Informative intervention addressed to patients<br>* • leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use<br>|
| Experimental: General practitioners and patients<br>Combined strategy | Other: Educational intervention addressed to general practitioners<br>* 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<br>Other: Informative intervention addressed to patients<br>* • leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inappropriate drug prescription and use indicators | 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 | 30 months | 

Secondary Outcome Measures

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