Multi-faceted intervention to improve antibiotic use in ambulatory care

ISRCTN ISRCTN24158380
DOI https://doi.org/10.1186/ISRCTN24158380
Secondary identifying numbers FMM-2008-FF
Submission date
05/11/2008
Registration date
05/02/2009
Last edited
26/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Adolfo Figueiras
Scientific

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

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet
Scientific titleMulti-faceted intervention to improve antibiotic use in ambulatory care: a cluster-randomised controlled trial
Study acronymINT-ATB-MED
Study objectivesAntibiotic 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(s)Spanish accredited Ethics Committee (Comité Ético de Investigación Clínica de Galicia), May 2007, ref: 2007/052
Health condition(s) or problem(s) studiedAntibiotics prescriptions
InterventionThis 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 typeOther
Primary outcome measureCurrent 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 measuresVarious quantity indicators of the prescribing of antibiotics, measured monthly from the last intervention to the end of study.
Overall study start date01/12/2011
Completion date30/09/2013

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participantsEstimated to include 3000 GPs (1500 at intervention group and 1500 at control group)
Total final enrolment2610
Key inclusion criteria1. General practitioners working during the period of the study
2. Aged approximately 30 - 60 years old, female or male
Key exclusion criteriaGeneral 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
Date of first enrolment02/12/2011
Date of final enrolment30/09/2012

Locations

Countries of recruitment

  • Spain

Study participating centre

Departamento de Salud Pública
Santiago de Compostela
15782
Spain

Sponsor information

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

C/Fortuny, 18
Madrid
28010
Spain

Website http://www.mutua-mad.es/FundMM/jsp/Fhome.jsp
Instituto de Salud Carlos III
Research organisation

C/ Sinesio Delgado, 4 (entrada por Avda. Monforte de Lemos, 5)
Madrid
28029
Spain

Email oficina.informacion@isciii.es
Website http://www.isciii.es/ISCIII/es/general/index.shtml

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date30/09/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planNot provided at time of registration
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 07/12/2020 26/01/2021 Yes No

Editorial Notes

26/01/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
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.