Plain English Summary
Background
Since the discovery of the antibiotic penicillin, people have been prescribed a whole host of antibiotics treat whole host of infections. Different strains of bacteria change (mutate) over time, which can lead to strains which are resistant to antibiotics emerging. Strains of bacteria that are resistant to antibiotics have an advantage over those which are susceptible, and so these strains rapidly multiply. It is thought that the overuse of antibiotics in the past played a key role with the emergence of antibiotic resistant strains. In recent years, health organisations across the world, including the NHS in the UK, have been trying to reduce the amounts of antibiotics prescribed, especially for minor illnesses. It is thought that if antibiotics are only prescribed for serious complaints, then bacteria will have a lower chance of developing resistance as they are not exposed to antibiotics as much. The aim of this study is to try to reduce the amount of serious infections that are resistant to antibiotics by using promotional material in GP surgeries.
Who can participate?
General practitioner (GP) surgeries across England that do not take most bookings online and not already doing something similar to what is being tested in the study.
What does the study involve?
The first intervention (or test) is to add a message to the answer phone message which is usually played when patients phone up to make an appointment to see a doctor or nurse. The message tells patients that the doctors are committed to appropriate antibiotic prescribing and suggest that for colds and flu patients should first seek advice at their local pharmacy. The second intervention involves asking GPs to commit to appropriate antibiotic prescribing and make this commitment public by displaying a poster with their name and photo saying so. GP practices are randomly allocated to one of 4 groups. For those in group 1, the answer phone message is played. GP practices in group 2 display the posters. GP practices in group 3 play the answer phone message and display the poster. GP practices in group 4 carry on as normal (control group).
What are the possible benefits and risks of participating?
The benefits for the GP practices participating are likely to be reduced demand for appointments and for antibiotics and support to refuse antibiotics where they think it’s not appropriate to prescribe them. Patients will need to wait an extra 10 seconds before the phone is answered to book an appointment. The answer phone message will not be played outside of opening hours so that access to emergency numbers is not delayed.
Where is the study run from?
The majority of GP practices participating are from Commissioning Support Unit in the North East of England but other area are also taking part such as Bedfordshire, Kernow and Liverpool.
When is study starting and how long is it expected to run for?
February 2015 to March 2016
Who is the main contact?
Anna Sallis
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Impact of a mixed patient and GP intervention level intervention on antibiotic prescribing in GP practices in England: A cluster randomised controlled trial
Acronym
Study hypothesis
Antibiotic prescribing will be reduced by a call waiting intervention and/or a GP commitment poster compared to usual practice.
Ethics approval
London - Queen Square Research Ethics Committee, 16/09/2015, ref: 15/LO/1662
Study design
Cluster randomised controlled trial with a factorial design (3 intervention arms and 1 control arm)
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Antimicrobial resistance
Intervention
Randomisation of GP practices will be stratified by Clinical Commissioning Group (CCG) using an even-split-within-strata method, which ensures numerical balance within each CCG. Regression analysis will be used to check for balance on baseline measures of our outcome measure.
Brief recorded message on the GP surgery answer phone explaining to patients that GPs in this practice are committed to prescribing antibiotics prudently and directing patients to their pharmacy for self-care advice for infections that do not usually require antibiotics. This aims to address patient demand for appointments and ultimately reduce access to antibiotics by facilitating an expectation that inappropriate antibiotics will not be prescribed.
Display a ‘commitment poster’ in GP consulting rooms with a photo of the GP and a signed statement of their commitment to appropriate prescribing of antibiotics. This aims to provide a tool to support GPs, during the consultation, in their decision not prescribe antibiotics where it is not clinically appropriate and also to strengthen the GPs own commitment to appropriate prescribing through this public commitment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
EPACT data (STARPU adjusted) on filled antibiotic prescriptions per 1000 of the population for a baseline period of 3 months and the 4 month intervention period, and for the same intervention period the previous year.
Secondary outcome measures
Percentage of all filled antibiotic prescriptions that are for broad-spectrum antibiotics.
Measured at baseline for a period of 3 months and the 4 month intervention period and for the same intervention period the previous year.
Overall trial start date
02/02/2015
Overall trial end date
31/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All or the vast majority of GPs, practice nurses and non-medical prescribers are willing to take part in the study which may involve emailing a photograph and electronic signature
2. Can display the personalised posters in the GP consulting rooms
3. Can implement or amend an existing automated call-waiting message to record and play the AMR message (ideally first or last) and leave in place for the duration of the study
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
175
Participant exclusion criteria
1. Walk-in centres
2. More than 20% of our appointments bookings are made online
3. Those which already display AMR GP commitment posters or play AMR call waiting messages (other AMR related activity and posters are fine, including antibiotic guardian posters)
Recruitment start date
01/10/2015
Recruitment end date
01/11/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North & East London Commissioning Support Unit
75 Worship Street
London
TS17 6BL
United Kingdom
Trial participating centre
NHS Kernow
Sedgemoor Centre
Priory Road
Saint Austell
PL25 5AS
United Kingdom
Trial participating centre
Bedfordshire Clinical Commisioning Group
Capability House
Bedford
MK45 4HR
United Kingdom
Funders
Funder type
Government
Funder name
Public Health England
Alternative name(s)
PHE
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Study summaries sent to all participating practices
2. Conference presentations
3. Academic publication
Intention to publish date
31/10/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list