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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2018
Source Public Health England
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
new social norm feedback letter with bar chart
letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
standard social norm feedback letter
social norm feedback letter used as standard practice, without specific information about the prescribing percentile

Locations

Country Name City State
United Kingdom Public Health England London

Sponsors (1)

Lead Sponsor Collaborator
Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT03582072 - CMO Letter to Reduce Unnecessary Antibiotic Prescribing March 2018 N/A
Completed NCT04051281 - CMO Letter to Reduce Inappropriate Antibiotic Prescribing Winter 2019/2020 N/A
Completed NCT05172687 - The Effect of De-Prescribing Antipsychotics on Health and Quality of Life for People With Dementia