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

July 19, 2019 updated by: Elena Tragni, University of Milan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20133
        • SEFAP, University of Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Collaborators

Federico II University
University of Milano Bicocca

Investigators

  • Principal Investigator: Alberico L Catapano, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • FARM12KSBT
  • 2017-002622-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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