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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030468
Recruitment Status : Active, not recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Federico II University
University of Milano Bicocca
Information provided by (Responsible Party):
Elena Tragni, University of Milan

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.

Condition or disease Intervention/treatment Phase
Inappropriate Drug Prescription and Use Other: Educational intervention addressed to general practitioners Other: Informative intervention addressed to patients Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of Informative and/or Educational Interventions Aimed at Improving the Appropriate Use of Drugs Designed for General Practitioners and Their Patients
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
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

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Predictive factors of inappropriate prescribing [ Time Frame: 30-36 months ]
    Identification of predictors of poor prescription appropriateness

  2. Health Technology Assessment of intervention implemented [ Time Frame: 30-36 months ]
    HTA analysis

  3. GP's satisfaction [ Time Frame: 30-36 months ]
    Level of general practitioners (GPs) satisfaction by using ad hoc web-based questionnaire



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030468


Locations
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Italy
SEFAP, University of Milan
Milan, MI, Italy, 20133
Sponsors and Collaborators
University of Milan
Federico II University
University of Milano Bicocca
Investigators
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Principal Investigator: Alberico L Catapano University of Milan
Publications:

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Responsible Party: Elena Tragni, Researcher at Epidemiology and Preventive Pharmacology Centre, University of Milan
ClinicalTrials.gov Identifier: NCT04030468    
Other Study ID Numbers: FARM12KSBT
2017-002622-21 ( EudraCT Number )
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No