A practice level intervention to reduce antibiotic prescribing for self-limiting infections in primary care
| ISRCTN | ISRCTN83322985 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83322985 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/09/2015
- Registration date
- 30/09/2015
- Last edited
- 17/08/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
80 London Road
London
SE1 6LH
United Kingdom
Study information
| 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 |
| 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 | Impact of a mixed patient and GP intervention level intervention on antibiotic prescribing in GP practices in England: A cluster randomised controlled trial |
| Study objectives | Antibiotic prescribing will be reduced by a call waiting intervention and/or a GP commitment poster compared to usual practice. |
| Ethics approval(s) | London - Queen Square Research Ethics Committee, 16/09/2015, ref: 15/LO/1662 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 02/02/2015 |
| Completion date | 31/03/2016 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 175 |
| Total final enrolment | 196 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2015 |
| Date of final enrolment | 01/11/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
TS17 6BL
United Kingdom
Priory Road
Saint Austell
PL25 5AS
United Kingdom
Bedford
MK45 4HR
United Kingdom
Sponsor information
Government
80 London Road
London
SE1 6LH
United Kingdom
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- PHE
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Study summaries sent to all participating practices 2. Conference presentations 3. Academic publication |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/08/2020 | 17/08/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/08/2020: Publication reference and total final enrolment number added.
31/05/2018: No publications found, verifying study status with principal investigator.
