Multi-faceted intervention to improve antibiotic use in ambulatory care
ISRCTN | ISRCTN24158380 |
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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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Departamento de Salud Pública
Facultad de Medicina
San Francisco s.n
Santiago de Compostela
15782
Spain
Study information
Study design | Cluster randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Cluster randomised trial |
Study setting(s) | GP practice |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
Scientific title | Multi-faceted intervention to improve antibiotic use in ambulatory care: a cluster-randomised controlled trial |
Study acronym | INT-ATB-MED |
Study objectives | 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(s) | Spanish accredited Ethics Committee (Comité Ético de Investigación Clínica de Galicia), May 2007, ref: 2007/052 |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/12/2011 |
Completion date | 30/09/2013 |
Eligibility
Participant type(s) | Health professional |
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Age group | Adult |
Sex | Both |
Target number of participants | Estimated to include 3000 GPs (1500 at intervention group and 1500 at control group) |
Total final enrolment | 2610 |
Key inclusion criteria | 1. General practitioners working during the period of the study 2. Aged approximately 30 - 60 years old, female or male |
Key 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 |
Date of first enrolment | 02/12/2011 |
Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
15782
Spain
Sponsor information
Research organisation
C/Fortuny, 18
Madrid
28010
Spain
Website | http://www.mutua-mad.es/FundMM/jsp/Fhome.jsp |
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Research organisation
C/ Sinesio Delgado, 4 (entrada por Avda. Monforte de Lemos, 5)
Madrid
28029
Spain
oficina.informacion@isciii.es | |
Website | http://www.isciii.es/ISCIII/es/general/index.shtml |
Funders
Funder type
Research organisation
No information available
Results and Publications
Intention to publish date | 30/09/2018 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Other |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | 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. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.