Prescribing, Off-LabelCMO2018-9NCT03862794
CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9
A study testing new social norm feedback letter with bar chart and standard social norm feedback letter in people with Prescribing, Off-Label, run by Public Health England at 1 site in United Kingdom.
Trial summary
This trial aims to reduce unnecessary prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prescribing, Off-Label
- What is being tested?
- new social norm feedback letter with bar chart and standard social norm feedback letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- GP practices that prescribed more than 1.161 Antibacterial Items/STAR-PU for the twelve months (June 2017 - May 2018)
- GP practices that prescribed more than 0.965 Antibacterial Items/STAR-PU and also more than 10% broad spectrum items for the twelve months (June 2017 - May 2018).
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Behaviourally Informed Feedback Letters Sent by the Chief Medical Officer on the Amount of Antibiotics and the Percentage of Broad Spectrum Antibiotics Prescribed in Primary Care
This trial aims to reduce unnecessary prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels. Specifically the sample was GPs whose practices whose prescribed more than 1.161 items per STAR-PU or whose practices prescribed more that .965 items per STAR-PU and greater than 10% broad spectrum items. The intervention groups received a letter telling them they are among the highest prescribers of either their total or broad spectrum antibiotics, with a graph showing their prescribing compared to average prescribing ("their peers"). The letter also contained a leaflet to help GPs discuss self-care advice with patients and some advice to use delayed prescriptions. The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group, following the receipt of the letter.
- Conditions
- Prescribing, Off-Label
- Being tested
- new social norm feedback letter with bar chart, standard social norm feedback letter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new social norm feedback letter with bar chartBehavioural
letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
standard social norm feedback letterBehavioural
social norm feedback letter used as standard practice, without specific information about the prescribing percentile
| Study group | Role | What they receive |
|---|---|---|
| high total and high broad spectrum prescribing letter | Experimental | social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average Receives: Behavioral: new social norm feedback letter with bar chart |
| high total and high broad spectrum prescribing control | Active comparator | standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive the standard practice overall prescribing letter as a control Receives: Behavioral: standard social norm feedback letter |
| high total prescribing only intervention letter | Experimental | social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive a letter that has specific information about the percentile they are on for overall prescribing and a bar chart representing their overall prescribing compared to the average Receives: Behavioral: new social norm feedback letter with bar chart |
| high total prescribing control letter | Active comparator | standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive the standard practice overall prescribing letter as a control Receives: Behavioral: standard social norm feedback letter |
| moderate total prescribing and high broad spectrum letter | Experimental | social norm feedback letter with bar chart GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum will receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average Receives: Behavioral: new social norm feedback letter with bar chart |
| moderate total prescribing and high broad spectrum control | No intervention | GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive no letter, which is standard practice, as a control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 1 month
total broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
broad spectrum antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 1 month
percentage broad spectrum antibiotic prescribing in November for each GP practice
percentage broad spectrum antibiotic prescribing
Measured: 1 month
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
total overall antibiotic prescribing minus total broad spectrum antibiotic prescribing
Measured: 1 month
total antibiotic prescribing weighted by STAR-PU in December for each GP practice
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 2 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Measured: 2 months
percentage broad spectrum antibiotic prescribing in December for each GP practice
Measured: 2 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Measured: 2 months
total antibiotic prescribing in January weighted by STAR-PU for each GP practice
Measured: 3 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Measured: 3 months
percentage broad spectrum antibiotic prescribing in January for each GP practice
Measured: 3 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Measured: 3 months
total antibiotic prescribing weighted by STAR-PU in February for each GP practice
Measured: 4 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Measured: 4 months
percentage broad spectrum antibiotic prescribing in February for each GP practice
Measured: 4 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Measured: 4 months
total antibiotic prescribing weighted by STAR-PU in March for each GP practice
Measured: 5 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Measured: 5 months
percentage broad spectrum antibiotic prescribing in March for each GP practice
Measured: 5 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Measured: 5 months
total antibiotic prescribing weighted by STAR-PU in April for each GP practice
Measured: 6 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Measured: 6 months
percentage broad spectrum antibiotic prescribing in April for each GP practice
Measured: 6 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Nov 2018
- Primary completion30 Apr 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prescribing, Off-LabelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862794
- Sponsor's protocol ID
- R&D 193
- Acronym
- CMO2018-9
- Status last verified
- Dec 2018
- First submitted
- 27 Feb 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gold N, Sallis A, Saei A, Arambepola R, Watson R, Bowen S, Franklin M, Chadborn T. Using text and charts to provide social norm feedback to general practices with high overall and high broad-spectrum antibiotic prescribing: a series of national randomised controlled trials. Trials. 2022 Jun 18;23(1):511. doi: 10.1186/s13063-022-06373-y.
PubMed 35717262
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Behaviourally Informed Feedback Letters Sent by the Chief Medical Officer on the Amount of Antibiotics and the Percentage of Broad Spectrum Antibiotics Prescribed in Primary Care
- ClinicalTrials.gov ID
- NCT03862794
- Acronym / sponsor ID
- CMO2018-9 / R&D 193
- Conditions
- Prescribing, Off-Label
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to reduce unnecessary prescription of antibiotics and broad spectrum antibiotics by general practitioners (GPs) in England. Unnecessary prescriptions are defined as those that do not improve patient health outcomes. The intervention is to send GPs a letter from the Chief Medical Officer (CMO) that gives feedback on their practice's prescribing levels. Specifically the sample was GPs whose practices whose prescribed more than 1.161 items per STAR-PU or whose practices prescribed more that .965 items per STAR-PU and greater than 10% broad spectrum items. The intervention groups received a letter telling them they are among the highest prescribers of either their total or broad spectrum antibiotics, with a graph showing their prescribing compared to average prescribing ("their peers"). The letter also contained a leaflet to help GPs discuss self-care advice with patients and some advice to use delayed prescriptions. The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group, following the receipt of the letter.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| high total and high broad spectrum prescribing letter | Experimental | Behavioral: new social norm feedback letter with bar chartsocial norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average |
| high total and high broad spectrum prescribing control | Active comparator | Behavioral: standard social norm feedback letterstandard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive the standard practice overall prescribing letter as a control |
| high total prescribing only intervention letter | Experimental | Behavioral: new social norm feedback letter with bar chartsocial norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive a letter that has specific information about the percentile they are on for overall prescribing and a bar chart representing their overall prescribing compared to the average |
| high total prescribing control letter | Active comparator | Behavioral: standard social norm feedback letterstandard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive the standard practice overall prescribing letter as a control |
| moderate total prescribing and high broad spectrum letter | Experimental | Behavioral: new social norm feedback letter with bar chartsocial norm feedback letter with bar chart GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum will receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average |
| moderate total prescribing and high broad spectrum control | No intervention | –GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive no letter, which is standard practice, as a control. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- GP practices that prescribed more than 1.161 Antibacterial Items/STAR-PU for the twelve months (June 2017 - May 2018)
- GP practices that prescribed more than 0.965 Antibacterial Items/STAR-PU and also more than 10% broad spectrum items for the twelve months (June 2017 - May 2018).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| new social norm feedback letter with bar chartletter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average | Behavioural | high total and high broad spectrum prescribing letter, high total prescribing only intervention letter, moderate total prescribing and high broad spectrum letter |
| standard social norm feedback lettersocial norm feedback letter used as standard practice, without specific information about the prescribing percentile | Behavioural | high total and high broad spectrum prescribing control, high total prescribing control letter |
Primary outcome
total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice
Time frame: 1 month
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
total broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
Time frame: 1 month
broad spectrum antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
percentage broad spectrum antibiotic prescribing in November for each GP practice
Time frame: 1 month
percentage broad spectrum antibiotic prescribing
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice
Time frame: 1 month
total overall antibiotic prescribing minus total broad spectrum antibiotic prescribing
total antibiotic prescribing weighted by STAR-PU in December for each GP practice
Time frame: 2 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Time frame: 2 months
percentage broad spectrum antibiotic prescribing in December for each GP practice
Time frame: 2 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice
Time frame: 2 months
total antibiotic prescribing in January weighted by STAR-PU for each GP practice
Time frame: 3 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Time frame: 3 months
percentage broad spectrum antibiotic prescribing in January for each GP practice
Time frame: 3 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice
Time frame: 3 months
total antibiotic prescribing weighted by STAR-PU in February for each GP practice
Time frame: 4 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Time frame: 4 months
percentage broad spectrum antibiotic prescribing in February for each GP practice
Time frame: 4 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice
Time frame: 4 months
total antibiotic prescribing weighted by STAR-PU in March for each GP practice
Time frame: 5 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Time frame: 5 months
percentage broad spectrum antibiotic prescribing in March for each GP practice
Time frame: 5 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice
Time frame: 5 months
total antibiotic prescribing weighted by STAR-PU in April for each GP practice
Time frame: 6 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Time frame: 6 months
percentage broad spectrum antibiotic prescribing in April for each GP practice
Time frame: 6 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 35717262Gold N, Sallis A, Saei A, Arambepola R, Watson R, Bowen S, Franklin M, Chadborn T. Using text and charts to provide social norm feedback to general practices with high overall and high broad-spectrum antibiotic prescribing: a series of national randomised controlled trials. Trials. 2022 Jun 18;23(1):511. doi: 10.1186/s13063-022-06373-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new social norm feedback letter with bar chart and standard social norm feedback letter in people with Prescribing, Off-Label, run by Public Health England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice (time frame: 1 month). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03862794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.