CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9 (CMO2018-9)

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

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.

Study Overview

• Status: Completed
• Conditions: Prescribing, Off-Label
• Intervention / Treatment: Behavioral: new social norm feedback letter with bar chart; Behavioral: standard social norm feedback letter

• Study Type: Interventional
• Enrollment (Actual): 7000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1
    • Public Health England

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high total and high broad spectrum prescribing letter; social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average	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
Active Comparator: high total and high broad spectrum prescribing control; standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive the standard practice overall prescribing letter as a control	Behavioral: standard social norm feedback letter; social norm feedback letter used as standard practice, without specific information about the prescribing percentile
Experimental: high total prescribing only intervention letter; social norm feedback letter with bar chart GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive a letter that has specific information about the percentile they are on for overall prescribing and a bar chart representing their overall prescribing compared to the average	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
Active Comparator: high total prescribing control letter; standard social norm feedback letter GPs who prescribe more than 1.161 Antibacterial Items/ STAR-PU and less than 10% broad spectrum receive the standard practice overall prescribing letter as a control	Behavioral: standard social norm feedback letter; social norm feedback letter used as standard practice, without specific information about the prescribing percentile
Experimental: moderate total prescribing and high broad spectrum letter; social norm feedback letter with bar chart GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum will receive a letter that has specific information about the percentile they are on for broad spectrum prescribing and a bar chart representing their broad spectrum prescribing compared to the average	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
No Intervention: moderate total prescribing and high broad spectrum control; GPs who prescribe more than 0.965 but less than 1.161 Antibacterial Items/ STAR-PU and more than 10% broad spectrum receive no letter, which is standard practice, as a control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
percentage broad spectrum antibiotic prescribing in November for each GP practice	percentage broad spectrum antibiotic prescribing	1 month
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
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
total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice		2 months
percentage broad spectrum antibiotic prescribing in December for each GP practice		2 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice		2 months
total antibiotic prescribing in January weighted by STAR-PU for each GP practice		3 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice		3 months
percentage broad spectrum antibiotic prescribing in January for each GP practice		3 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice		3 months
total antibiotic prescribing weighted by STAR-PU in February for each GP practice		4 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice		4 months
percentage broad spectrum antibiotic prescribing in February for each GP practice		4 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice		4 months
total antibiotic prescribing weighted by STAR-PU in March for each GP practice		5 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice		5 months
percentage broad spectrum antibiotic prescribing in March for each GP practice		5 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice		5 months
total antibiotic prescribing weighted by STAR-PU in April for each GP practice		6 months
total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice		6 months
percentage broad spectrum antibiotic prescribing in April for each GP practice		6 months
total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice		6 months

Collaborators and Investigators

• Sponsor: Public Health England

Publications and helpful links

General Publications

• Gold N, Sallis A, Saei A, Arambepola R, Watson R, Bowen S, Franklin M, Chadborn T. Using text and charts to provide social norm feedback to general practices with high overall and high broad-spectrum antibiotic prescribing: a series of national randomised controlled trials. Trials. 2022 Jun 18;23(1):511. doi: 10.1186/s13063-022-06373-y.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: R&D 193

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No