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Trial record 37 of 259 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT03862794
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Public Health England

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.

Condition or disease Intervention/treatment Phase
Prescribing, Off-Label Behavioral: new social norm feedback letter with bar chart Behavioral: standard social norm feedback letter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.



Primary Outcome Measures :
  1. total antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU) in November for each GP practice [ Time Frame: 1 month ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  2. total broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice [ Time Frame: 1 month ]
    broad spectrum antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  3. percentage broad spectrum antibiotic prescribing in November for each GP practice [ Time Frame: 1 month ]
    percentage broad spectrum antibiotic prescribing

  4. total non-broad spectrum antibiotic prescribing weighted by STAR-PU in November for each GP practice [ Time Frame: 1 month ]
    total overall antibiotic prescribing minus total broad spectrum antibiotic prescribing

  5. total antibiotic prescribing weighted by STAR-PU in December for each GP practice [ Time Frame: 2 months ]
    antibiotic prescribing weighted by Specific Therapeutic group Age-sex Related Prescribing Unit (STAR-PU)

  6. total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice [ Time Frame: 2 months ]
  7. percentage broad spectrum antibiotic prescribing in December for each GP practice [ Time Frame: 2 months ]
  8. total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice [ Time Frame: 2 months ]
  9. total antibiotic prescribing in January weighted by STAR-PU for each GP practice [ Time Frame: 3 months ]
  10. total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice [ Time Frame: 3 months ]
  11. percentage broad spectrum antibiotic prescribing in January for each GP practice [ Time Frame: 3 months ]
  12. total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice [ Time Frame: 3 months ]
  13. total antibiotic prescribing weighted by STAR-PU in February for each GP practice [ Time Frame: 4 months ]
  14. total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice [ Time Frame: 4 months ]
  15. percentage broad spectrum antibiotic prescribing in February for each GP practice [ Time Frame: 4 months ]
  16. total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice [ Time Frame: 4 months ]
  17. total antibiotic prescribing weighted by STAR-PU in March for each GP practice [ Time Frame: 5 months ]
  18. total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice [ Time Frame: 5 months ]
  19. percentage broad spectrum antibiotic prescribing in March for each GP practice [ Time Frame: 5 months ]
  20. total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice [ Time Frame: 5 months ]
  21. total antibiotic prescribing weighted by STAR-PU in April for each GP practice [ Time Frame: 6 months ]
  22. total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice [ Time Frame: 6 months ]
  23. percentage broad spectrum antibiotic prescribing in April for each GP practice [ Time Frame: 6 months ]
  24. total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice [ Time Frame: 6 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03862794


Locations
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United Kingdom
Public Health England Recruiting
London, United Kingdom, SE1
Contact: Elizabeth Coates    01980612922    elizabeth.coates@phe.gov.uk   
Sponsors and Collaborators
Public Health England

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Responsible Party: Public Health England
ClinicalTrials.gov Identifier: NCT03862794     History of Changes
Other Study ID Numbers: R&D 193
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents