NCT03582072

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,796

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 3, 2020

Status Verified

April 1, 2018

Enrollment Period

10 months

First QC Date

June 27, 2018

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • antibiotic prescribing in March

    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

    1 month

  • antibiotic prescribing in April

    antibiotic prescribing weighted by STAR-PU

    2 months

  • antibiotic prescribing May-September

    antibiotic prescribing weighted by STAR-PU

    3-7 months

Study Arms (2)

letter

EXPERIMENTAL

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

Behavioral: letter from the CMO

control

NO INTERVENTION

practice outside of the top 20% of prescribers whose prescribing increase by \>4%, GPs were not sent a letter

Interventions

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%.\*

letter

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health England

London, SE1, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 930 practices (this will be the number of datapoints), 478 in the intervention, 452 in the control; letter sent to individual GPS (4796 subjects, as below), 2340 in the intervention, 2456 in the control practices
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 10, 2018

Study Start

February 27, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 3, 2020

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

There is no individual participant data (IPD). The outcome measure is practice-level prescribing data, which is already publicly available.

Locations