Condition category
Not Applicable
Date applied
05/11/2008
Date assigned
05/02/2009
Last edited
06/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adolfo Figueiras

ORCID ID

Contact details

Departamento de Salud Pública
Facultad de Medicina
San Francisco s.n
Santiago de Compostela
15782
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FMM-2008-FF

Study information

Scientific title

Multi-faceted intervention to improve antibiotic use in ambulatory care: a cluster-randomised controlled trial

Acronym

INT-ATB-MED

Study hypothesis

Antibiotic resistance is one of the principal public health problems world-wide. Inappropriate use of antibiotics is currently regarded as the main determinant of such resistance.

Hypotheses:
1. The attitudes and knowledge towards antibiotics generate habits of prescription
2. 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
3. The intervention designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance will improve the prescription of antibiotics
4. The intervention will collaborate in the control of the bacterial resistance

Ethics approval

Spanish accredited Ethics Committee (Comité Ético de Investigación Clínica de Galicia), May 2007, ref: 2007/052

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Antibiotics prescriptions

Intervention

This is a cluster randomised controlled trial covering all general practitioners in a northwest region of Spain (Galicia). 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.

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. An observational cohort study of a sample of 1500 primary care physicians 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Current primary outcome measure as of 06/09/2018:
Quality indicators for antibiotic prescribing drawn up by the European Surveillance of Antimicrobial Consumption Network (ESAC-Net), measured monthly from the last intervention to the end of study

Previous primary outcome measure:
Various quality indicators of the prescribing of antibiotics, assessed based on Infectious Diseases Clinical guidelines in Primary Care, measured monthly from the last intervention to the end of study

Secondary outcome measures

Various quantity indicators of the prescribing of antibiotics, measured monthly from the last intervention to the end of study.

Overall trial start date

01/12/2011

Overall trial end date

30/09/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. General practitioners working during the period of the study
2. Aged approximately 30 - 60 years old, female or male

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Estimated to include 3000 GPs (1500 at intervention group and 1500 at control group)

Participant exclusion criteria

General practitioners who work for private insurances during the period of the study

Added 06/09/2018:
Temporary staff and medical residents in training physicians exclusively assigned to emergencies

Recruitment start date

02/12/2011

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Departamento de Salud Pública
Santiago de Compostela
15782
Spain

Sponsor information

Organisation

The Foundation for Medical Research Mutua Madrileña (Fundación de Investigación Médica Mutua Madrileña) (Spain)

Sponsor details

C/Fortuny
18
Madrid
28010
Spain

Sponsor type

Research organisation

Website

http://www.mutua-mad.es/FundMM/jsp/Fhome.jsp

Organisation

Instituto de Salud Carlos III

Sponsor details

C/ Sinesio Delgado
4 (entrada por Avda. Monforte de Lemos
5)
Madrid
28029
Spain
-
oficina.informacion@isciii.es

Sponsor type

Research organisation

Website

http://www.isciii.es/ISCIII/es/general/index.shtml

Funders

Funder type

Research organisation

Funder name

The Foundation for Medical Research Mutua Madrileña (Fundación de Investigación Médica Mutua Madrileña) (Spain) - grant received

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date. The datasets include global antimicrobial prescriptions in the Health Care System of Galicia (NHS). The data was provided by the NHS of Galicia, so their authorization is needed before sharing it.

Intention to publish date

30/09/2018

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/09/2018: The following changes were made to the trial record: 1. The overall trial start date was changed from 01/10/2007 to 01/12/2011. 2. The overall trial end date was changed from 31/10/2010 to 31/09/2013. 3. The co-sponsor Instituto de Salud Carlos III was added. 4. IPD sharing statement and intention to publish date added. 5. The primary outcome measure and the exclusion criteria were updated.