Prescribing, Off-LabelNCT03582072
CMO Letter to Reduce Unnecessary Antibiotic Prescribing March 2018
A study testing letter from the CMO 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 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 from the CMO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,796 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2018to 31 Dec 2018
- 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 increased the number of prescriptions in the financial year 2016/17, compared to the baseline of financial year 2015/16, by 4% or more
Who cannot join
- GP practices are excluded if their current level of prescription (doses per 1000 head of population) is classed as an outlier. The cut off for outliers is made at the 95th percentile of the distribution.
- Practices that have not been open since at least October 2013 will be excluded. This is because they will lack the historical data necessary to apply a control for seasonal effects to the main outcome variable.
- practices whose antibiotic prescribing rate is in the top 20% for their National Health Service (NHS) Local Area, controlling for relevant patient characteristics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contacting GPs to Reduce Unnecessary Prescriptions of Antibiotics
This trial aims to reduce unnecessary prescription of 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, GPs in practices whose prescribing has increase by more than 4% over the past year will receive a letter stating that "The great majority (80%) of practices in England reduced or stabilised their antibiotic prescribing rates in 2016/17. However, your practice is in the minority that have increased their prescribing by more than 4%." The letter will also contain 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.
Read the detailed description
The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group; the statistical analysis will compare prescribing in March, April, and over the summer (treating May-September as a single data point).
- Conditions
- Prescribing, Off-Label
- Being tested
- letter from the CMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letter from the CMOBehavioural
informed GPs that: The great majority (80%) of practices in England reduced or stabilised their antibiotic prescribing rates in 2016/17. However, your practice is in the minority that have increased their prescribing by more than 4%.*
| Study group | Role | What they receive |
|---|---|---|
| letter | Experimental | letter from the CMO: practice outside the top 20% of prescribers whose prescribing increased by > 4%, where GPs in the practice were sent a letter informing them their prescribing had increased Receives: Behavioral: letter from the CMO |
| control | No intervention | practice outside of the top 20% of prescribers whose prescribing increase by >4%, GPs were not sent a letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibiotic prescribing in March
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
Measured: 1 month
antibiotic prescribing in April
antibiotic prescribing weighted by STAR-PU
Measured: 2 months
antibiotic prescribing May-September
antibiotic prescribing weighted by STAR-PU
Measured: 3-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start27 Feb 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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
- Model description
- 930 practices (this will be the number of datapoints), 478 in the intervention, 452 in the control; letter sent to individual GPS (4796 subjects, as below), 2340 in the intervention, 2456 in the control practices
- Masking
- None (open label)
- Enrolment
- 4,796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582072
- Sponsor's protocol ID
- CMO letter March 2018
- Status last verified
- Apr 2018
- First submitted
- 27 Jun 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no individual participant data (IPD). The outcome measure is practice-level prescribing data, which is already publicly available.
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
- Contacting GPs to Reduce Unnecessary Prescriptions of Antibiotics
- ClinicalTrials.gov ID
- NCT03582072
- Acronym / sponsor ID
- CMO letter March 2018
- Conditions
- Prescribing, Off-Label
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,796 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Jul 2018 (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 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, GPs in practices whose prescribing has increase by more than 4% over the past year will receive a letter stating that "The great majority (80%) of practices in England reduced or stabilised their antibiotic prescribing rates in 2016/17. However, your practice is in the minority that have increased their prescribing by more than 4%." The letter will also contain 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.
Detailed description
The investigators hypothesize that the antibiotic prescribing rate in will be lower for the treatment group compared to the control group; the statistical analysis will compare prescribing in March, April, and over the summer (treating May-September as a single data point).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 930 practices (this will be the number of datapoints), 478 in the intervention, 452 in the control; letter sent to individual GPS (4796 subjects, as below), 2340 in the intervention, 2456 in the control practices
| Arm | Type | Receives |
|---|---|---|
| letter | Experimental | Behavioral: letter from the CMOletter from the CMO: practice outside the top 20% of prescribers whose prescribing increased by > 4%, where GPs in the practice were sent a letter informing them their prescribing had increased |
| control | No intervention | –practice outside of the top 20% of prescribers whose prescribing increase by >4%, GPs were not sent a letter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- GP practices that increased the number of prescriptions in the financial year 2016/17, compared to the baseline of financial year 2015/16, by 4% or more
Key exclusion criteria (3 listed)
- GP practices are excluded if their current level of prescription (doses per 1000 head of population) is classed as an outlier. The cut off for outliers is made at the 95th percentile of the distribution.
- Practices that have not been open since at least October 2013 will be excluded. This is because they will lack the historical data necessary to apply a control for seasonal effects to the main outcome variable.
- practices whose antibiotic prescribing rate is in the top 20% for their National Health Service (NHS) Local Area, controlling for relevant patient characteristics.
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 |
|---|---|---|
| letter from the CMOinformed GPs that: The great majority (80%) of practices in England reduced or stabilised their antibiotic prescribing rates in 2016/17. However, your practice is in the minority that have increased their prescribing by more than 4%.* | Behavioural | letter |
Primary outcome
antibiotic prescribing in March
Time frame: 1 month
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
antibiotic prescribing in April
Time frame: 2 months
antibiotic prescribing weighted by STAR-PU
antibiotic prescribing May-September
Time frame: 3-7 months
antibiotic prescribing weighted by 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 3 Mar 2020.
- Individual participant dataSharing planned: No. There is no individual participant data (IPD). The outcome measure is practice-level prescribing data, which is already publicly available.
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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 from the CMO 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 3 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?
antibiotic prescribing in March (time frame: 1 month). The study lists 3 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 3 Mar 2020.