Plain English Summary
Background and study aims
Antibiotics are vital for treatment of bacterial infections. The main driver for development of antimicrobial resistance is exposure to antibiotics and resistance is greatest where use is greatest. Resistance is a natural consequence of using antibiotics but overuse and inappropriate use can unnecessarily increase the rate of resistance development.
The aim of this study is to test whether e-mail feedback of a practices antibiotic prescribing together with action orientated goal setting information can reduce antibiotic prescribing.
Who can participate?
General practices in NHS Ayrshire & Arran, NHS Highland, NHS Lanarkshire and NHS Lothian.
What does the study involve?
Participating general practices are randomly allocated to one of two groups. Those in the first group receive quarterly reports for a year containing information about the amount of antibiotics they are prescribing compared to a benchmark for their NHS board and Scotland as a whole. The report also contains suggested actions that practices can take and details of the support resources that are available. Those in the second group continue with their usual practice and do not receive any reports. One year after the final report, the rate of prescribing antibiotics in general and to different age groups, as well as the rate of prescribing different antibiotics in all the practices is recorded.
What are the possible benefits and risks of participating?
Practices in the feedback arm will benefit from having access to reports containing the amount of antibiotics they are prescribing. There are no notable risks involved with participating in this study.
Where is the study run from?
The study is run from NHS National Services Scotland and takes place in 183 general practices in Scotland (UK)
When is study starting and how long is it expected to run for?
August 2015 to June 2017
Who is the main contact?
William Malcolm
w.malcolm@nhs.net
Study website
Contact information
Type
Scientific
Contact name
Mr William Malcolm
ORCID ID
Contact details
NHS National Services Scotland
4th Floor
Meridian Court
5 Cadogan Street
Glasgow
G2 6QE
United Kingdom
+44 (0)141 300 1174
w.malcolm@nhs.net
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
Feedback of Antibiotic Prescribing to Primary Care (FAPPC): A cluster randomised controlled trial using nationally held prescribing data
Acronym
FAPPC
Study hypothesis
A report containing feedback of antibiotic prescribing data plus action orientated goal setting text delivered by email to primary care medical practices will reduce antibiotic prescribing compared to practices which do not receive the reports.
Ethics approval(s)
Ethical approval was not required as the study is an assessment of the impact of a service development using nationally held prescribing data and no patient identifiable information provided.
Study design
Interventional cluster randomised controlled study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
GP practice
Study type
Other
Patient information sheet
Condition
Antibiotic prescribing in primary care
Intervention
The intervention is feedback of antibiotic prescribing data plus action orientated goal setting text
Practices in the feedback arm will receive quarterly feedback of practice rates of antibiotic prescribing compared to a benchmark of the 25th percentile at local and national together with suggested actions that practices can take and details of the support resources that are available.
Comparators will receive usual care (no report)
Intervention type
Other
Primary outcome measure
Rate of prescribing of systemic antibacterials is calculated as the number of antibacterial prescriptions per 1000 registered patients per day measured one year after the final intervention.
Secondary outcome measures
1. Number of antibacterials defined daily doses per 1000 registered patients per day measured 1 year after the final intervention
2. Number of antibacterial prescriptions per 1000 registered patients aged 0-4 years per day measured 1 year after the final intervention
3. Number of antibacterial prescriptions per 1000 registered patients aged 5-64 years per day measured 1 year after the final intervention
4. Number of antibacterial prescriptions per 1000 registered patients aged ≥65 years per day measured 1 year after the final intervention
5. Number of amoxicillin prescriptions per 1000 registered patients per day measured 1 year after the final intervention
6. Number of phenoxymethylpenicillin prescriptions per 1000 registered patients per day measured 1 year after the final intervention
7. Number of flucloxacillin prescriptions per 1000 registered patients per day measured 1 year after the final intervention
8. Number of co-amoxiclav prescriptions per 1000 registered patients per day measured 1 year after the final intervention
9. Number of doxycycline prescriptions per 1000 registered patients per day measured 1 year after the final intervention
10. Number of clarithromycin and erythromycin prescriptions per 1000 registered patients per day measured 1 year after the final intervention
11. Number of trimethoprim prescriptions per 1000 registered patients per day measured 1 year after the final intervention
12. Number of nitrofurantoin prescriptions per 1000 registered patients per day measured 1 year after the final intervention
13. Number of ciprofloxacin prescriptions per 1000 registered patients per day measured 1 year after the final intervention
14. Number of cefalexin prescriptions per 1000 registered patients per day measured 1 year after the final intervention
15. Number of prescriptions commonly used for respiratory tract infections (amoxicillin, doxycycline, phenoxymethylpencillin) per 1000 registered patients per day measured 1 year after the final intervention
16. Number of prescriptions commonly used for urinary tract infections (trimethoprim, nitrofurantoin, ciprofloxacin, cefalexin, co-amoxiclav) per 1000 registered patients per day measured 1 year after the final intervention
17. Number of prescriptions commonly used for long term skin infections (oxytetratcycline, lymecycline, minocycline ) per 1000 registered patients per day measured 1 year after the final intervention
18. Number of hospital admissions with mastoiditis, peritonsillar abscess, pneumonia, exacerbation of COPD
Overall study start date
01/08/2015
Overall study end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
General medical practices in NHS Ayrshire and Arran, NHS Highland, NHS Lanarkshire and NHS Lothian.
Participant type(s)
Health professional
Age group
All
Sex
Both
Target number of participants
Number of practices enrolled 183
Participant exclusion criteria
1. Practices with <250 registered patients
2. Practices which cease to exist during the trial
3. Practices which merge with another practice where the merging practices are in different arms
Recruitment start date
01/04/2015
Recruitment end date
01/04/2015
Locations
Countries of recruitment
Scotland, United Kingdom
Study participating centre
NHS National Services Scotland
G2 6QE
United Kingdom
Sponsor information
Organisation
NHS National Services Scotland
Sponsor details
Gyle Square
Edinburgh
EH12 9EB
United Kingdom
Sponsor type
Other
Website
ROR
Funders
Funder type
Government
Funder name
Scottish Government
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration.
Intention to publish date
30/06/2018
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|