Prescribing, Off-LabelNCT04051281
CMO Letter to Reduce Inappropriate Antibiotic Prescribing Winter 2019/2020
A study testing 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 inappropriate 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 age
- Conditions the study is for
- Prescribing, Off-Label
- What is being tested?
- Letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,963 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Aug 2019to 30 Aug 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GP practices that prescribed more than 0.919 Antibacterial Items/STAR- PU (5% under the target of 0.965) for the twelve months April 2018 - March 2019
Who cannot join
- Practices in the 99th percentile of prescribers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Letter From the CMO in England to Reduce Antibiotic Prescribing in General Practice: A Randomized Controlled Trial Comparing Monitoring and Feedback (With and Without Graphs), and Social Norms Feedback (Without and Without a Specific Case Study of Patient Harm)
This trial aims to reduce inappropriate 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.
There will be three intervention samples:
- practices whose prescribing in the past year was under the new target of 0.965 items per STAR-PU but who would exceed the target if they had a 5% increase in prescribing; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing is just under the new target to that of practices that are not sent a letter
- Practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing exceeds the new target to practices who get a letter that includes a graph showing their prescribing relative to the target and to practices that are not sent a letter
- Practices that are currently in the top 20% of prescribers; trial compares effect on prescribing of a feedback letter with a social norms message (current standard practice for this group) to a letter informing GPs that their practice's prescribing exceeds the new target and to a letter with a social norms message, that includes a specific example of a case of patient harm caused by antimicrobial resistance.
Read the detailed description
The study will involve three trials, each conducted as non-blinded randomised controlled trial, with GP practices as the unit of randomisation.
Trial 1 Targeting practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing
- Control: No letter
- Intervention: Letter informing them that their practice's prescribing is just under the new target (Letter A) Trial hypothesis: Sending a letter to GPs whose practices are just under the new prescribing target will reduce antibiotic prescribing
Trial 2 Targeting practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers
- Control: No letter
- Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1)
- Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2) Hypotheses: (i) Sending a letter to GPs whose practices missed the new prescribing target will reduce their prescribing; (ii) A letter with a graph will be more effective than a letter without a graph.
Trial 3 Targeting practices that are currently in the top 20% of prescribers
- Control: Current standard practice, a social norms message, that their practice is in the top 20% of prescribers (Letter C1)
- Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter C2)
- Intervention 2: Social norms message, that they are in the top 20%, with a specific example of a case of patient harm caused by antimicrobial resistance (Letter C3)
Hypotheses: (i) A letter with a social norms message and a specific example of a case where a patient came to harm will be more effective than a feedback letter without a specific example; (ii) A letter telling GPs that they missed the prescribing target will be no less effective than a letter with social norms feedback
For each letter, there will be two versions, one for practices whose prescribing has increased by > 5% in the previous year, informing them of that their prescribing has increased since the previous year, and one for practices whose prescribing has not been increasing.
The letters will signpost GPs to resources to help address patient demand for inappropriate antibiotic prescribing, recognising that many GPs feel that patients expect antibiotics and that GPs may find it difficult to have the necessary patient conversations, especially within a short consultation. As with previous letters, these letters will advise GPs of actions that they can take to reduce inappropriate prescribing, supporting them to have conversations with patients, and there will be TARGET leaflets enclosed.
Power calculation All trials are powered to detect a 2% reduction in prescribing at a significance level of 0.05 with a power of 80%.
Statistical analysis plan In order to test our hypotheses, the investigators will use a fixed effects panel regression model, with time trends accounting for seasonal effects, to estimate the effect of treatment status on prescribing. The investigators will also run ANCOVAs for each month separately and one covering the whole six months of the trial. Analysis will control for baseline prescribing rates and for whether practices got the version of the letter saying that their prescribing has been increasing.
- Conditions
- Prescribing, Off-Label
- Being tested
- Letter
- Keywords
- antimicrobial resistance, social norms feedback, behavioural science, feedback and monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetterBehavioural
Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)
| Study group | Role | What they receive |
|---|---|---|
| Just under target control | No intervention | Practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing; no letter sent. |
| Just under target letter | Experimental | Practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing: receive a letter informing of this.
Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter Receives: Behavioral: Letter |
| Over target control | No intervention | Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; no letter sent * Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1) * Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2) |
| Over target letter | Experimental | Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target (Letter B1)
Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter Receives: Behavioral: Letter |
| Over target letter with bar chart | Experimental | Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target, including a bar chart showing their prescribing compared to the target (Letter B1)
Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter Receives: Behavioral: Letter |
| Top 20% feedback letter control | Active comparator | Targeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on--standard practice--(Letter C1)
Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter Receives: Behavioral: Letter |
| Top 20% above target letter | Experimental | Targeting practices that are currently in the top 20% of prescribers; letters informing them that their prescribing exceeds the new target (Letter C2)
Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter. Receives: Behavioral: Letter |
| Top 20% feedback letter with specific example of patient harm | Experimental | Targeting practices that are currently in the top 20% of prescribers
• Control: Current standard practice, a social norms message, that their practice is in the top 20% of prescribers (Letter C1) Targeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on with a specific example of a case of patient harm caused by antimicrobial resistance (Letter C3)
Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter. Receives: Behavioral: Letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total antibiotic prescribing in September
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 1 month
Total antibiotic prescribing in October
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 2 months
Total antibiotic prescribing in November
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 3 months
Total antibiotic prescribing in December
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 4 months
Total antibiotic prescribing in January
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 5 months
Total antibiotic prescribing in February
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 6 months
Total antibiotic prescribing in from September-February
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 6 months
Proportion of practices in each group whose prescribing was under the target
Whether antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) for April 2019-March 2020 is under the NHS target of 0.965 items per STAR-PU
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start31 Aug 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051281
- Sponsor's protocol ID
- CMO Letter 2019/20
- Status last verified
- Sep 2020
- First submitted
- 7 Aug 2019
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Note that the trial will use publicly available prescribing data, so any researcher should be able to access it.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Letter From the CMO in England to Reduce Antibiotic Prescribing in General Practice: A Randomized Controlled Trial Comparing Monitoring and Feedback (With and Without Graphs), and Social Norms Feedback (Without and Without a Specific Case Study of Patient Harm)
- ClinicalTrials.gov ID
- NCT04051281
- Acronym / sponsor ID
- CMO Letter 2019/20
- Conditions
- Prescribing, Off-Label
- Keywords
- antimicrobial resistance, social norms feedback, behavioural science, feedback and monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,963 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 9 Aug 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 inappropriate 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.
There will be three intervention samples:
- practices whose prescribing in the past year was under the new target of 0.965 items per STAR-PU but who would exceed the target if they had a 5% increase in prescribing; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing is just under the new target to that of practices that are not sent a letter
- Practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing exceeds the new target to practices who get a letter that includes a graph showing their prescribing relative to the target and to practices that are not sent a letter
- Practices that are currently in the top 20% of prescribers; trial compares effect on prescribing of a feedback letter with a social norms message (current standard practice for this group) to a letter informing GPs that their practice's prescribing exceeds the new target and to a letter with a social norms message, that includes a specific example of a case of patient harm caused by antimicrobial resistance.
Detailed description
The study will involve three trials, each conducted as non-blinded randomised controlled trial, with GP practices as the unit of randomisation.
Trial 1 Targeting practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing
- Control: No letter
- Intervention: Letter informing them that their practice's prescribing is just under the new target (Letter A) Trial hypothesis: Sending a letter to GPs whose practices are just under the new prescribing target will reduce antibiotic prescribing
Trial 2 Targeting practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers
- Control: No letter
- Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1)
- Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2) Hypotheses: (i) Sending a letter to GPs whose practices missed the new prescribing target will reduce their prescribing; (ii) A letter with a graph will be more effective than a letter without a graph.
Trial 3 Targeting practices that are currently in the top 20% of prescribers
- Control: Current standard practice, a social norms message, that their practice is in the top 20% of prescribers (Letter C1)
- Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter C2)
- Intervention 2: Social norms message, that they are in the top 20%, with a specific example of a case of patient harm caused by antimicrobial resistance (Letter C3)
Hypotheses: (i) A letter with a social norms message and a specific example of a case where a patient came to harm will be more effective than a feedback letter without a specific example; (ii) A letter telling GPs that they missed the prescribing target will be no less effective than a letter with social norms feedback
For each letter, there will be two versions, one for practices whose prescribing has increased by > 5% in the previous year, informing them of that their prescribing has increased since the previous year, and one for practices whose prescribing has not been increasing.
The letters will signpost GPs to resources to help address patient demand for inappropriate antibiotic prescribing, recognising that many GPs feel that patients expect antibiotics and that GPs may find it difficult to have the necessary patient conversations, especially within a short consultation. As with previous letters, these letters will advise GPs of actions that they can take to reduce inappropriate prescribing, supporting them to have conversations with patients, and there will be TARGET leaflets enclosed.
Power calculation All trials are powered to detect a 2% reduction in prescribing at a significance level of 0.05 with a power of 80%.
Statistical analysis plan In order to test our hypotheses, the investigators will use a fixed effects panel regression model, with time trends accounting for seasonal effects, to estimate the effect of treatment status on prescribing. The investigators will also run ANCOVAs for each month separately and one covering the whole six months of the trial. Analysis will control for baseline prescribing rates and for whether practices got the version of the letter saying that their prescribing has been increasing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Just under target control | No intervention | –Practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing; no letter sent. |
| Just under target letter | Experimental | Behavioral: LetterPractices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing: receive a letter informing of this. Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter |
| Over target control | No intervention | –Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; no letter sent * Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1) * Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2) |
| Over target letter | Experimental | Behavioral: LetterPractices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target (Letter B1) Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter |
| Over target letter with bar chart | Experimental | Behavioral: LetterPractices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target, including a bar chart showing their prescribing compared to the target (Letter B1) Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter |
| Top 20% feedback letter control | Active comparator | Behavioral: LetterTargeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on--standard practice--(Letter C1) Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter |
| Top 20% above target letter | Experimental | Behavioral: LetterTargeting practices that are currently in the top 20% of prescribers; letters informing them that their prescribing exceeds the new target (Letter C2) Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter. |
| Top 20% feedback letter with specific example of patient harm | Experimental | Behavioral: LetterTargeting practices that are currently in the top 20% of prescribers • Control: Current standard practice, a social norms message, that their practice is in the top 20% of prescribers (Letter C1) Targeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on with a specific example of a case of patient harm caused by antimicrobial resistance (Letter C3) Randomization is stratified according to whether their prescribing had increased by > 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GP practices that prescribed more than 0.919 Antibacterial Items/STAR- PU (5% under the target of 0.965) for the twelve months April 2018 - March 2019
Key exclusion criteria (1 listed)
- Practices in the 99th percentile of prescribers
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 |
|---|---|---|
| LetterLetters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization) | Behavioural | Just under target letter, Over target letter, Over target letter with bar chart, Top 20% above target letter, Top 20% feedback letter control, Top 20% feedback letter with specific example of patient harm |
Primary outcome
Total antibiotic prescribing in September
Time frame: 1 month
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Total antibiotic prescribing in October
Time frame: 2 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Total antibiotic prescribing in November
Time frame: 3 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Total antibiotic prescribing in December
Time frame: 4 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Total antibiotic prescribing in January
Time frame: 5 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Total antibiotic prescribing in February
Time frame: 6 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Total antibiotic prescribing in from September-February
Time frame: 6 months
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Proportion of practices in each group whose prescribing was under the target
Time frame: 8 months
Whether antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) for April 2019-March 2020 is under the NHS target of 0.965 items per STAR-PU
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 29 Sep 2020.
- Individual participant dataSharing planned: No. Note that the trial will use publicly available prescribing data, so any researcher should be able to access it.
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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 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 1 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 29 Sep 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 in September (time frame: 1 month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2020.