Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 27, 2019
First Posted Date  ICMJE March 5, 2019
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • 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)
  • 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)
  • percentage broad spectrum antibiotic prescribing in November for each GP practice [ Time Frame: 1 month ]
    percentage broad spectrum antibiotic prescribing
  • 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
  • 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)
  • total broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice [ Time Frame: 2 months ]
  • percentage broad spectrum antibiotic prescribing in December for each GP practice [ Time Frame: 2 months ]
  • total non-broad spectrum antibiotic prescribing weighted by STAR-PU in December for each GP practice [ Time Frame: 2 months ]
  • total antibiotic prescribing in January weighted by STAR-PU for each GP practice [ Time Frame: 3 months ]
  • total broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice [ Time Frame: 3 months ]
  • percentage broad spectrum antibiotic prescribing in January for each GP practice [ Time Frame: 3 months ]
  • total non-broad spectrum antibiotic prescribing weighted by STAR-PU in January for each GP practice [ Time Frame: 3 months ]
  • total antibiotic prescribing weighted by STAR-PU in February for each GP practice [ Time Frame: 4 months ]
  • total broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice [ Time Frame: 4 months ]
  • percentage broad spectrum antibiotic prescribing in February for each GP practice [ Time Frame: 4 months ]
  • total non-broad spectrum antibiotic prescribing weighted by STAR-PU in February for each GP practice [ Time Frame: 4 months ]
  • total antibiotic prescribing weighted by STAR-PU in March for each GP practice [ Time Frame: 5 months ]
  • total broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice [ Time Frame: 5 months ]
  • percentage broad spectrum antibiotic prescribing in March for each GP practice [ Time Frame: 5 months ]
  • total non-broad spectrum antibiotic prescribing weighted by STAR-PU in March for each GP practice [ Time Frame: 5 months ]
  • total antibiotic prescribing weighted by STAR-PU in April for each GP practice [ Time Frame: 6 months ]
  • total broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice [ Time Frame: 6 months ]
  • percentage broad spectrum antibiotic prescribing in April for each GP practice [ Time Frame: 6 months ]
  • total non-broad spectrum antibiotic prescribing weighted by STAR-PU in April for each GP practice [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03862794 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CMO Letter to Reduce Unnecessary Antibiotic Prescribing and Broad Spectrum Prescribing Winter 2018-9
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Prescribing, Off-Label
Intervention  ICMJE
  • 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
  • Behavioral: standard social norm feedback letter
    social norm feedback letter used as standard practice, without specific information about the prescribing percentile
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: new social norm feedback letter with bar chart
  • 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
    Intervention: Behavioral: standard social norm feedback letter
  • 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
    Intervention: Behavioral: new social norm feedback letter with bar chart
  • 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
    Intervention: Behavioral: standard social norm feedback letter
  • 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
    Intervention: Behavioral: new social norm feedback letter with bar chart
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2019)
7000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03862794
Other Study ID Numbers  ICMJE R&D 193
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Public Health England
Study Sponsor  ICMJE Public Health England
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Public Health England
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP