Prescribing, Off-Label Clinical Trial
— CMO2018-9Official 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
NCT number | NCT03862794 |
Other study ID # | R&D 193 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | May 30, 2019 |
Verified date | December 2018 |
Source | Public Health England |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7000 |
Est. completion date | May 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Public Health England | London |
Lead Sponsor | Collaborator |
---|---|
Public Health England |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 1 month | |
Primary | 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) | 1 month | |
Primary | percentage broad spectrum antibiotic prescribing in November for each GP practice | percentage broad spectrum antibiotic prescribing | 1 month | |
Primary | 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 | 1 month | |
Primary | 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) | 2 months | |
Primary | total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice | 2 months | ||
Primary | percentage broad spectrum antibiotic prescribing in December for each GP practice | 2 months | ||
Primary | total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice | 2 months | ||
Primary | total antibiotic prescribing in January weighted by STAR-PU for each GP practice | 3 months | ||
Primary | total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice | 3 months | ||
Primary | percentage broad spectrum antibiotic prescribing in January for each GP practice | 3 months | ||
Primary | total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice | 3 months | ||
Primary | total antibiotic prescribing weighted by STAR-PU in February for each GP practice | 4 months | ||
Primary | total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice | 4 months | ||
Primary | percentage broad spectrum antibiotic prescribing in February for each GP practice | 4 months | ||
Primary | total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice | 4 months | ||
Primary | total antibiotic prescribing weighted by STAR-PU in March for each GP practice | 5 months | ||
Primary | total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice | 5 months | ||
Primary | percentage broad spectrum antibiotic prescribing in March for each GP practice | 5 months | ||
Primary | total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice | 5 months | ||
Primary | total antibiotic prescribing weighted by STAR-PU in April for each GP practice | 6 months | ||
Primary | total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice | 6 months | ||
Primary | percentage broad spectrum antibiotic prescribing in April for each GP practice | 6 months | ||
Primary | total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice | 6 months |
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Completed |
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