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Trial record 42 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

CMO Letter to Reduce Inappropriate Antibiotic Prescribing Winter 2019/2020

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ClinicalTrials.gov Identifier: NCT04051281
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Public Health England

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. 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. 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. 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.

Condition or disease Intervention/treatment Phase
Prescribing, Off-Label Behavioral: Letter Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2963 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Letter From the CMO in England to Reduce Antibiotic Prescribing in General Practice: A Randomized Controlled Trial Comparing Monitoring and Feedback (With and Without Graphs), and Social Norms Feedback (Without and Without a Specific Case Study of Patient Harm)
Estimated Study Start Date : August 31, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Just under target control
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.
Experimental: Just under target letter

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

No Intervention: Over target control

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)
Experimental: Over target letter

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

Experimental: Over target letter with bar chart

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

Active Comparator: Top 20% feedback letter control

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

Experimental: Top 20% above target letter

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

Experimental: Top 20% feedback letter with specific example of patient harm

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




Primary Outcome Measures :
  1. Total antibiotic prescribing in September [ Time Frame: 1 month ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  2. Total antibiotic prescribing in October [ Time Frame: 2 months ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  3. Total antibiotic prescribing in November [ Time Frame: 3 months ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  4. Total antibiotic prescribing in December [ Time Frame: 4 months ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  5. Total antibiotic prescribing in January [ Time Frame: 5 months ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  6. Total antibiotic prescribing in February [ Time Frame: 6 months ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  7. Total antibiotic prescribing in from September-February [ Time Frame: 6 months ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  8. Proportion of practices in each group whose prescribing was under the target [ Time Frame: 8 months ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Practices in the 99th percentile of prescribers


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051281


Locations
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United Kingdom
Public Health England
London, United Kingdom, SE1
Sponsors and Collaborators
Public Health England

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Responsible Party: Public Health England
ClinicalTrials.gov Identifier: NCT04051281     History of Changes
Other Study ID Numbers: CMO Letter 2019/20
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Note that the trial will use publicly available prescribing data, so any researcher should be able to access it.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Public Health England:
antimicrobial resistance
social norms feedback
behavioural science
feedback and monitoring
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents