- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582072
CMO Letter to Reduce Unnecessary Antibiotic Prescribing March 2018
March 2, 2020 updated by: Public Health England
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
4796
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, SE1
- Public Health England
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: letter
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
|
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%.*
|
|
No Intervention: control
practice outside of the top 20% of prescribers whose prescribing increase by >4%, GPs were not sent a letter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
antibiotic prescribing in March
Time Frame: 1 month
|
antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)
|
1 month
|
|
antibiotic prescribing in April
Time Frame: 2 months
|
antibiotic prescribing weighted by STAR-PU
|
2 months
|
|
antibiotic prescribing May-September
Time Frame: 3-7 months
|
antibiotic prescribing weighted by STAR-PU
|
3-7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2018
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
June 27, 2018
First Submitted That Met QC Criteria
June 27, 2018
First Posted (Actual)
July 10, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- CMO letter March 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no individual participant data (IPD).
The outcome measure is practice-level prescribing data, which is already publicly available.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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