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
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