NCT03862794

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

March 3, 2020

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

February 27, 2019

Last Update Submit

March 2, 2020

Conditions

Prescribing, Off-Label

Outcome Measures

Primary Outcomes (24)

  • 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

Study Arms (6)

high total and high broad spectrum prescribing letter

EXPERIMENTAL

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

high total and high broad spectrum prescribing control

ACTIVE COMPARATOR

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

high total prescribing only intervention letter

EXPERIMENTAL

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

high total prescribing control letter

ACTIVE COMPARATOR

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

moderate total prescribing and high broad spectrum letter

EXPERIMENTAL

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

moderate total prescribing and high broad spectrum control

NO INTERVENTION

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.

Interventions

new social norm feedback letter with bar chartBEHAVIORAL

letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average

high total and high broad spectrum prescribing letterhigh total prescribing only intervention lettermoderate total prescribing and high broad spectrum letter
standard social norm feedback letterBEHAVIORAL

social norm feedback letter used as standard practice, without specific information about the prescribing percentile

high total and high broad spectrum prescribing controlhigh total prescribing control letter

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health England

London, SE1, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35717262DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2019

First Posted

March 5, 2019

Study Start

November 1, 2018

Primary Completion

April 30, 2019

Study Completion

May 30, 2019

Last Updated

March 3, 2020

Record last verified: 2018-12

Locations

GB(1)