Effectiveness of Informative and/or Educational Interventions Aimed at Improving the Appropriate Use of Drugs Designed for General Practitioners and Their Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Milan
- Enrollment
- 4,840
- Locations
- 1
- Primary Endpoint
- Inappropriate drug prescription and use indicators
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts 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
Arms & Interventions
Control
No intervention
General practitioners and patients
Combined strategy
Intervention: Educational intervention addressed to general practitioners (Other)
General practitioners and patients
Combined strategy
Intervention: Informative intervention addressed to patients (Other)
General practitioners
Educational intervention
Intervention: Educational intervention addressed to general practitioners (Other)
Patients
Informative intervention
Intervention: Informative intervention addressed to patients (Other)
Outcomes
Primary Outcomes
Inappropriate drug prescription and use indicators
Time Frame: 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 Outcomes
- GP's satisfaction(30-36 months)
- Health Technology Assessment of intervention implemented(30-36 months)
- Predictive factors of inappropriate prescribing(30-36 months)
Investigators
Elena Tragni
Researcher at Epidemiology and Preventive Pharmacology Centre
University of Milan