Condition category
Not Applicable
Date applied
06/05/2016
Date assigned
23/06/2016
Last edited
23/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

GP practices

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/08/2015

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

General medical practices in NHS Ayrshire and Arran, NHS Highland, NHS Lanarkshire and NHS Lothian.

Participant type

Health professional

Age group

All

Gender

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

United Kingdom

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes