NCT04051281

Brief Summary

This trial aims to reduce inappropriate 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. There will be three intervention samples:

  1. 1.practices whose prescribing in the past year was under the new target of 0.965 items per STAR-PU but who would exceed the target if they had a 5% increase in prescribing; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing is just under the new target to that of practices that are not sent a letter
  2. 2.Practices whose prescribing in the past year was above the new target but who not in the top 20% of prescribers; trial compares prescribing of practices whose GPs receive a letter informing them that their practice's prescribing exceeds the new target to practices who get a letter that includes a graph showing their prescribing relative to the target and to practices that are not sent a letter
  3. 3.Practices that are currently in the top 20% of prescribers; trial compares effect on prescribing of a feedback letter with a social norms message (current standard practice for this group) to a letter informing GPs that their practice's prescribing exceeds the new target and to a letter with a social norms message, that includes a specific example of a case of patient harm caused by antimicrobial resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,963

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

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

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

August 31, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

August 7, 2019

Last Update Submit

September 28, 2020

Conditions

Prescribing, Off-Label

Keywords

antimicrobial resistancesocial norms feedbackbehavioural sciencefeedback and monitoring

Outcome Measures

Primary Outcomes (8)

  • Total antibiotic prescribing in September

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

    1 month

  • Total antibiotic prescribing in October

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

    2 months

  • Total antibiotic prescribing in November

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

    3 months

  • Total antibiotic prescribing in December

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

    4 months

  • Total antibiotic prescribing in January

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

    5 months

  • Total antibiotic prescribing in February

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

    6 months

  • Total antibiotic prescribing in from September-February

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

    6 months

  • Proportion of practices in each group whose prescribing was under the target

    Whether antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) for April 2019-March 2020 is under the NHS target of 0.965 items per STAR-PU

    8 months

Study Arms (8)

Just under target control

NO INTERVENTION

Practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing; no letter sent.

Just under target letter

EXPERIMENTAL

Practices whose prescribing in the past year was under the new target but who would exceed the target if they had a 5% increase in prescribing: receive a letter informing of this. Randomization is stratified according to whether their prescribing had increased by \> 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Behavioral: Letter

Over target control

NO INTERVENTION

Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; no letter sent * Intervention 1: Letter informing them that their practice's prescribing exceeds the new target (Letter B1) * Intervention 2: Letter informing them that their practice's prescribing exceeds the new target with a graph representing prescribing relative to the target (Letter B2)

Over target letter

EXPERIMENTAL

Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target (Letter B1) Randomization is stratified according to whether their prescribing had increased by \> 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Behavioral: Letter

Over target letter with bar chart

EXPERIMENTAL

Practices whose prescribing in the past year was above the new target but who were not in the top 20% of prescribers; receive a letter informing them that their practice's prescribing exceeds the new target, including a bar chart showing their prescribing compared to the target (Letter B1) Randomization is stratified according to whether their prescribing had increased by \> 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Behavioral: Letter

Top 20% feedback letter control

ACTIVE COMPARATOR

Targeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on--standard practice--(Letter C1) Randomization is stratified according to whether their prescribing had increased by \> 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter

Behavioral: Letter

Top 20% above target letter

EXPERIMENTAL

Targeting practices that are currently in the top 20% of prescribers; letters informing them that their prescribing exceeds the new target (Letter C2) Randomization is stratified according to whether their prescribing had increased by \> 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter.

Behavioral: Letter

Top 20% feedback letter with specific example of patient harm

EXPERIMENTAL

Targeting practices that are currently in the top 20% of prescribers • Control: Current standard practice, a social norms message, that their practice is in the top 20% of prescribers (Letter C1) Targeting practices that are currently in the top 20% of prescribers; letters informing them of the percentile they are on with a specific example of a case of patient harm caused by antimicrobial resistance (Letter C3) Randomization is stratified according to whether their prescribing had increased by \> 5% compared to the previous year; those whose prescribing had increased had it mentioned in the letter.

Behavioral: Letter

Interventions

LetterBEHAVIORAL

Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)

Just under target letterOver target letterOver target letter with bar chartTop 20% above target letterTop 20% feedback letter controlTop 20% feedback letter with specific example of patient harm

Eligibility Criteria

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

You may qualify if:

  • GP practices that prescribed more than 0.919 Antibacterial Items/STAR- PU (5% under the target of 0.965) for the twelve months April 2018 - March 2019

You may not qualify if:

  • Practices in the 99th percentile of prescribers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health England

London, SE1, United Kingdom

Location

MeSH Terms

Interventions

College Fraternities and Sororities

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

August 31, 2019

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Note that the trial will use publicly available prescribing data, so any researcher should be able to access it.

Locations

GB(1)