An Educational Intervention to Improve the Use of Antibiotics in Portuguese Health Professional

September 21, 2022 updated by: Maria Teresa Herdeiro, Aveiro University

An Educational Intervention to Improve the Use of Antibiotics in Portuguese Health Professional: Cluster-randomized Trial

This is a cluster randomised controlled trial covering all general practitioners working in the National Health System (SNS) and all pharmacists working in community pharmacies in the area covered by the Health Region Administration of Center (ARS-C) . A specific educative intervention, designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance, will be carried out on the intervention group. The control group will not receive any specific intervention.

Hypotheses:

  1. The attitudes and knowledge towards antibiotics generate habits of prescription by physicians
  2. The attitudes and knowledge towards to antibiotics generate propensity to dispense antibiotics without prescription by pharmacists
  3. The identification of the attitudes, knowledge and factors that generate habits of inadequate prescription will allow the design of specific educative interventions to improve the use of antibiotics
  4. The identification of the attitudes, knowledge and factors that generate propensity to dispense antibiotics without prescription will allow the design of specific educative interventions to antibiotic use
  5. The interventions designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance will improve the prescription and dispensation of antibiotics by physicians and pharmacists, respectively.
  6. The intervention will collaborate in the control of the bacterial resistance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intervention will consist of group outreach visits (40 minutes), and will be targeted at changing the knowledge-attitudes previously found to be associated with poor prescribing of antibiotics in the case of physicians and propensity to dispense antibiotics without medical prescription in the case of pharmacists.. An observational cohort study of a sample of 1100 primary care physicians and 1200 community pharmacists will be carried out to identify knowledge-attitudes associated with inappropriate prescribing of antibiotics. The independent variables (knowledge-attitudes) will be assessed by a self-administered postal questionnaire and dependent variables are some quantity and quality indicators of the prescribing antibiotics, and consumption data.

Study Type

Interventional

Enrollment (Actual)

2300

Phase

  • Not Applicable

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

No

Description

Inclusion Criteria:

  • All general practitioners working during the period of the study in the National System of Health (SNS)
  • All pharmacists working during the period study in the community pharmacies.

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
Experimental: Educational multifaceted intervention
Multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense, in physicians and pharmacists.
Other: Multidisciplinary and multifaceted educational intervention.
Outreach visits (40 minutes) which included a PowerPoint presentation and impress materials: poster; flyers; participation certificate and articles mentioned in the presentation. This outreach visit aimed to change the knowledge-attitudes previously identified in a previous study as being associated with poor prescribing of antibiotics in the case of physicians and propensity to dispense antibiotics without medical prescription in the case of pharmacists.
No Intervention: Control
Physicians and pharmacists that not received the multidisciplinary and multifaceted educational intervention about antibiotic prescription and dispense.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care
Time Frame: up to 18 months
To quantify antibiotic drug consumption, we used monthly sales data sourced from IMS Health® and we used the quality indicators validated by Coenen S et al., (2007) to calculate monthly prescribing rates.
up to 18 months
Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates.
Time Frame: May 2012- September 2014
antibiotic monthly sales data, obtained from IMS and quality indicators monthly prescribing rates, according to the ESAC indicators.
May 2012- September 2014

Collaborators and Investigators

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

Sponsor

Aveiro University

Collaborators

Fundação para a Ciência e a Tecnologia

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

May 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimated)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PTDC/SAU-ESA/105530/2008

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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