Electronically delivered, multi-component intervention to reduce unnecessary antibiotic prescribing in primary care

ISRCTN	ISRCTN95232781
DOI	https://doi.org/10.1186/ISRCTN95232781
Secondary identifying numbers	13/88/10

Submission date: 11/11/2014
Registration date: 18/11/2014
Last edited: 25/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Antibiotics are vitally important medicines. They are used to treat infections caused by bacteria, some of which would otherwise kill the person affected. In recent years, however, antibiotic resistance, a situation where an antibiotic no longer works against one or more bacteria, has become a major problem. It has been caused by a number of factors, including general practitioners (GPs) prescribing them for minor illnesses that do not need them or for conditions that antibiotics cant cure (such as the common cold). Here, we are going to test whether an electronically delivered, multi-component intervention can reduce the number of unnecessary antibiotic prescriptions given to patients that go to their GP about a respiratory tract infection (RTI an infection of the sinuses, throat, airways or lungs).

Who can participate?
General practices that contribute up-to-standard data to the Clinical Practice Research Datalink (CPRD), the NHS observational data and interventional research service.

What does the study involve?
Participating CPRD general practices are randomly allocated into one of two groups. Those in the control group continue with their usual clinical care. Those in the interventional group receive an intervention made up of a number of parts. These include feedback on their rate of antibiotic prescribing compared to other GP practices, educational and decision support tools to support the none prescribing or delayed prescribing of antibiotics, and three minute webinars that explain and promote the use of the materials they are given. The study is run for 12 months, after which the antibiotic prescribing rates between the intervention and control groups are made, along with other outcome measures such as RTI consultation rate, health care costs, number of cases of pneumonia and lower respiratory tract infections and hospital admissions.

What are the possible benefits and risks of participating?
This research looks at inappropriate and unnecessary prescribing of antibiotics to patients with respiratory tract infections (RTIs) in general practice. All management decisions for individual patients remain at the discretion of individual general practitioners. Therefore, we do not anticipate any potential serious adverse events that could be directly caused by the intervention. However, we will ask general practitioners at participating general practices to tell us of any possible adverse events.

Where is the study run from?
Kings College London (UK)

When is the study starting and how long is it expected to run for?
January 2015 to December 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Professor Martin Gulliford

Contact information

Prof Martin Gulliford
Scientific

King's College London
Department of Primary Care and Public Health Sciences
Capital House
52 Weston Street
London
SE1 3QD
United Kingdom

Phone	+44 (0)2078486631
Email	martin.gulliford@kcl.ac.uk

Study information

Study design	Cluster randomised trial with general practices as the unit of allocation
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	GP practice
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Electronically delivered, multi-component intervention to reduce unnecessary antibiotic prescribing in primary care. Cluster randomised trial using electronic health records (eCRT2)
Study acronym	eCRT2
Study objectives	To test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multi component interventions to reduce unnecessary antibiotic prescribing when patients consult for respiratory tract infections (RTI) in primary care.
Ethics approval(s)	NRES London Dulwich, 08/10/2014, ref. 14/LO/1730.
Health condition(s) or problem(s) studied	Antibiotic prescribing/respiratory tract infections
Intervention	There will be two trial arms. 1. The control trial arm practices will continue with usual clinical care. 2. Practices in the Intervention trial arm will receive complex multi-component interventions, delivered remotely, as follows: 2.1. Feedback of each practices antibiotic prescribing results in relation to peers, through monthly updated antibiotic prescribing reports estimated from CPRD data 2.2. Delivery of educational and decision support tools to support policies of no-antibiotic prescribing or delayed prescribing 2.3. Three minute webinars to explain and promote effective utilisation of the intervention materials. The intervention will continue for 12 months.
Intervention type	Other
Primary outcome measure	Number of antibiotic prescriptions for RTI per 1,000 registered patient years at 12 months follow-up
Secondary outcome measures	1. Number of consultations for RTI with antibiotic prescribed / Total RTI consultations (%) at 12 months follow-up 2. Consultations and prescriptions as defined above during 14 days after the index consultation at 12 months follow-up 3. Number of consultations for RTI per 1,000 registered patient years 12 months follow-up 4. All antibiotic prescriptions per 1,000 registered patient years at 12 months follow-up 5. Number of hospital admission (by category) per 1,000 registered patient years at 12 months follow-up 6. Estimated costs of all health care utilisation per 1,000 registered patient years at 12 months follow-up 7. Broad categories of RTI subgroups including colds, sore throat, cough and bronchitis, otitis media and rhino-sinusitis (NICE, 2008) at 12 months follow-up 8. Number of adverse events ((peritonsillar abscess, mastoiditis, skin infections and bacterial infections) (by category) per 1,000 registered patient years over at 12-months follow-up
Overall study start date	01/01/2015
Completion date	31/12/2018

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	120
Key inclusion criteria	General practices will be included in the trial if: 1. They presently contribute up-to-standard data to CPRD 2. Consent to participation in the trial 3. Are located in areas that have given research governance approval for the study Data for non-trial CPRD practices will be eligible for observational data analysis to gauge the representativeness of practices and patients participating in the trial. Data for individual participants will be included if they are currently registered with CPRD general practices
Key exclusion criteria	No other exclusion criteria
Date of first enrolment	01/01/2015
Date of final enrolment	30/09/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

King's College London

London
SE1 3QD
United Kingdom

Sponsor information

National Institute for Health Research (UK)
Government

Evaluation, Trials and Studies Coordinating Centre
University of Southampton
Alpha House, Enterprise Road
Southampton
SO16 7NS
United Kingdom

Website	http://www.nets.nihr.ac.uk/programmes/hta
"ROR"	https://ror.org/0187kwz08

Funders

Funder type

Government

Health Technology Assessment Programme (Ref: 13/88/10)
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	04/08/2016		Yes	No
Results article	results	01/03/2019		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

25/03/2019: Publication reference added.
08/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 31/12/2018 to 30/09/2018.
2. The intention to publish date has been set to 31/12/2019.
08/08/2016: Publication reference added.