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Completed

NCT Number: NCT02173509

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidisciplinary and multifaceted educational intervention.

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2017
First posted
Jun 25, 2014
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.