Reducing antibiotic use in primary care: a pharmacist-led educational and audit & feedback strategy
| ISRCTN | ISRCTN11175879 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11175879 |
- Submission date
- 25/11/2024
- Registration date
- 11/12/2024
- Last edited
- 21/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to improve how general practitioners (GPs) prescribe antibiotics by providing them with educational support and feedback. The goal is to ensure antibiotics are used correctly to combat resistance and improve patient care.
Who can participate?
All general practitioners (GPs) working in primary health care centers in three Spanish Health Care Districts: Mallorca (Balearic Islands), Paterna (Valencia), and Tarragona-Reus (Catalonia) will participate. A total of 112 GPs are required for the study.
What does the study involve?
GPs will receive personalized feedback on their antibiotic prescribing habits, including information on selection, dosage, duration, and the conditions treated. Those who request additional help or are in the highest prescribing quartile will get one-on-one support from a study pharmacist. This includes setting goals, creating action plans, and discussing specific cases. Participants will also have access to an online educational course.
What are the possible benefits and risks of participating?
The main benefit is improved antibiotic prescribing practices, which can lead to better patient outcomes and reduced antibiotic resistance. There are no significant risks for the GPs participating in this study.
Where is the study run from?
The study is conducted in three Spanish Health Care Districts: Mallorca (Balearic Islands), Paterna (Valencia), and Tarragona-Reus (Catalonia).
When is the study starting and how long is it expected to run for?
January 2023 to December 2026
Who is funding the study?
The study is funded by the Carlos III Institute of Health (PI22/01742) (Spain)
Who is the main contact?
1. Dr Laura Gallardo, laura.gallardo@ibsalut.es
2. Aina Soler, aina.soler@ibsalut.es
Contact information
Public, Principal Investigator
c/Escola Graduada, 3
Palma
07002
Spain
 ORCID ID |
0000-0002-5769-706X |
|---|---|
| Phone | +34 971 17 58 97 |
| laura.gallardo@ibsalut.es |
Scientific
c/Escola Graduada, 3
Palma
07002
Spain
| Phone | +34 971 17 58 97 |
|---|---|
| aina.soler@ibsalut.es |
Study information
| Study design | Multicenter parallel randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | A pharmacist-led educational intervention and audit & feedback approach to reduce antibiotic prescriptions in primary care |
| Study acronym | AFA study |
| Study objectives | Current study hypothesis as of 06/01/2025: An Audit & Feedback intervention targeting general practitioners (GP), which includes individualized graphical data on antibiotic prescriptions (covering antibiotic selection, dosages, treatment duration, and associated conditions) combined with a pharmacist-led educational intervention consisting of an individualized, face-to-face session with a primary care pharmacist for GPs with significant potential for improvement in their prescribing practices (above the 75th percentile), along with an online educational component, reduces antibiotic prescriptions by at least 1 point in the ratio of total antibiotic prescriptions per 100 visits, for individuals aged 14 years and older. Previous study hypothesis: An Audit & Feedback intervention targeting general practitioners (GP), which includes individualized graphical data on antibiotic prescriptions (covering antibiotic selection, dosages, treatment duration, and associated conditions) combined with a pharmacist-led educational intervention consisting of an individualized, face-to-face session with a primary care pharmacist for GPs with significant potential for improvement in their prescribing practices (above the 75th percentile), along with an online educational component, reduces antibiotic prescriptions by at least 4 daily doses per 1,000 inhabitants per day (DHD) in individuals over 14 years of age. |
| Ethics approval(s) |
Approved 14/07/2023, Balearic Islands Ethics Committee (c/Calçat, 2A, 2n, Palma, 07011, Spain; +34 971177378; ceic_ib@caib.es), ref: IB 5219/23 PI |
| Health condition(s) or problem(s) studied | Reduction of antibiotic prescription in primary care |
| Intervention | The method of randomization is simple random sampling. General practitioners (GPs) in the intervention arm will receive individualized monthly information about their antibiotic prescription (incorporating graphical data, including antibiotic selection, dosages, treatment duration, and associated conditions), combined with an individualized, face-to-face intervention by a primary care pharmacist for GPs with significant potential for improvement in their prescribing practices (above the 75th percentile), along with an online educational component. GPs in the control group will receive an intervention to reduce potentially inappropriate medication use (benzodiazepines, proton pump inhibitors and antipsychotics in patients with dementia) in patients over 65 years old. The follow-up of the intervention is 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 06/01/2025: The efficacy of the interventions on the prescription of antibiotics in the primary care area, measured using the number of antibiotic prescriptions extracted from the e-prescription databases of each health district at 12-month follow-up. The primary outcome will be measured as the total number of antibiotic prescriptions per 100 visits. Previous primary outcome measure: The efficacy of the interventions on the prescription of antibiotics in the primary care area, measured using the number of antibiotic prescriptions extracted from the e-prescription databases of each health district at 12-month follow-up |
| Secondary outcome measures | Current secondary outcome measures as of 07/05/2025: 1. Percentage of patients who start antibiotic treatment measured using the number of antibiotic prescriptions extracted from the e-prescription databases of each health district at 12-month follow-up. 2. Antibiotic prescription according to therapeutic group of antibiotics measured using number of antibiotic prescriptions according to therapeutic group (beta-lactams, glycopeptides, macrolides, aminoglycosides, tetracyclines, quinolones and fluoroquinolones, sulfonamides, lincosamides, oxazolidinones, polymyxins, rifamycins, nitroimidazoles, nitrofurans, fosfomycin) extracted from the e-prescription databases of each health district at 12-month follow-up. 3. Antibiotic prescription according to prescription pathology measured using the number of antibiotic prescriptions and their associated pathology (lower and upper respiratory infections, lower and upper urinary tract infections, sexually transmitted infections, skin and soft tissue infections, oral and odontogenic infections) at 12-month follow-up. 4. Antibiotic prescription according to gender measured using the number of antibiotic prescriptions extracted from the e-prescription databases of each health district, considering the gender of the GP and gender of the patient at 12-month follow-up. 5. The reach, engagement, adoption, fidelity and maintenance of the intervention. Reach will be defined as the percentage of participating GPs relative to the total number of eligible GPs. Engagement will measure the degree of active involvement in the intervention, including use of the feedback reports, participation in pharmacist-led sessions, and integration of recommendations into clinical practice. Adoption will be measured at the organizational level as the percentage of healthcare management units that have agreed to implement the intervention. Fidelity to the intervention will be assessed through audits of adherence to the planned feedback delivery process. This includes consistency in the timing and content of reports, implementation of pharmacist consultations, and completion of online training modules. Maintenance of the intervention will be assessed at 6 and 12 months post-intervention, focusing on the degree to which the intervention becomes institutionalized within the healthcare system. Previous secondary outcome measures: 1. Percentage of patients who start antibiotic treatment measured using the number of antibiotic prescriptions extracted from the e-prescription databases of each health district at 12-month follow-up. 2. Antibiotic prescription according to therapeutic group of antibiotics measured using number of antibiotic prescriptions according to therapeutic group (beta-lactams, glycopeptides, macrolides, aminoglycosides, tetracyclines, quinolones and fluoroquinolones, sulfonamides, lincosamides, oxazolidinones, polymyxins, rifamycins, nitroimidazoles, nitrofurans, fosfomycin) extracted from the e-prescription databases of each health district at 12-month follow-up. 3. Antibiotic prescription according to prescription pathology measured using the number of antibiotic prescriptions and their associated pathology (lower and upper respiratory infections, lower and upper urinary tract infections, sexually transmitted infections, skin and soft tissue infections, oral and odontogenic infections) at 12-month follow-up. 4. Antibiotic prescription according to gender measured using the number of antibiotic prescriptions extracted from the e-prescription databases of each health district, considering the gender of the GP and gender of the patient at 12-month follow-up. 5. The reach of the intervention as well as the fidelity of the intervention execution. The reach of the intervention will be measured using the percentage of patients assigned to GPs, with any antibiotic prescription and eligible to receive the intervention at 12 months follow-up. The fidelity will be measured using a comprehensive record with a detailed description of the execution process and any adaptations made in each intervention, as well as the strategies they comprise at the 12-month follow-up. |
| Overall study start date | 01/01/2023 |
| Completion date | 12/12/2026 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 112 |
| Key inclusion criteria | All GPs with assigned patients in their primary care health center will be included |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/05/2025 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Spain
Study participating centres
Palma
07002
Spain
46980
Spain
43480
Spain
Sponsor information
Government
Carrer Escola Graduada, 3
Palma
07002
Spain
| Phone | +34 971175888 |
|---|---|
| gapm.investigacio@ssib.es | |
| Website | https://www.ibsalut.es/es/servicio-de-salud/organizacion/gerencias-ibsalut/gerencia-de-atencion-primaria-mallorca |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | 1. The effectiveness of the intervention will be published in a Primary Care/General Medicine journal 2. The factibility, feasibility and fidelity will be published in a Primary Care journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publicly available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 19/07/2025 | 21/07/2025 | Yes | No |
Editorial Notes
21/07/2025: Publication reference added.
07/05/2025: Secondary outcome measures updated.
24/03/2025: The recruitment start date was changed from 01/02/2025 to 01/05/2025.
06/01/2025: The following changes were made to the study record:
1. The study hypothesis and primary outcome measure were updated.
2. The target number of participants was changed from 256 to 112.
25/11/2024: Trial's existence confirmed by Instituto de Salud Carlos III.
