ISRCTN ISRCTN70810031
DOI https://doi.org/10.1186/ISRCTN70810031
Secondary identifying numbers 1.0
Submission date
06/05/2016
Registration date
23/06/2016
Last edited
25/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Mr William Malcolm
Scientific

NHS National Services Scotland
4th Floor, Meridian Court
5 Cadogan Street
Glasgow
G2 6QE
United Kingdom

Phone +44 (0)141 300 1174
Email w.malcolm@nhs.net

Study information

Study designInterventional cluster randomised controlled study
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typeOther
Scientific titleFeedback of Antibiotic Prescribing to Primary Care (FAPPC): A cluster randomised controlled trial using nationally held prescribing data
Study acronymFAPPC
Study objectivesA 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.
Health condition(s) or problem(s) studiedAntibiotic prescribing in primary care
InterventionThe 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 typeOther
Primary outcome measureRate 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 measures1. 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 date01/08/2015
Completion date30/06/2017

Eligibility

Participant type(s)Health professional
Age groupAll
SexBoth
Target number of participantsNumber of practices enrolled 183
Key inclusion criteriaGeneral medical practices in NHS Ayrshire and Arran, NHS Highland, NHS Lanarkshire and NHS Lothian.
Key exclusion criteria1. 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
Date of first enrolment01/04/2015
Date of final enrolment01/04/2015

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

NHS National Services Scotland
G2 6QE
United Kingdom

Sponsor information

NHS National Services Scotland
Other

Gyle Square
Edinburgh
EH12 9EB
United Kingdom

ROR logo "ROR" https://ror.org/04za2st18

Funders

Funder type

Government

Scottish Government

No information available

Results and Publications

Intention to publish date30/06/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration.
IPD sharing plan

Editorial Notes

25/05/2021: Proactive update review. No publications found. Search options exhausted.
18/10/2017: Internal review.