Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
Primary Purpose
Upper Respiratory Tract Infections
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audit and Feedback Letter
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infections focused on measuring audit and feedback, antimicrobials, primary healthcare
Eligibility Criteria
Inclusion Criteria:
- must be a practicing family physician in Saskatchewan
- top 25th percentile of antimicrobial prescribers
Exclusion Criteria:
- fewer than 12 months of historical prescribing data available
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Audit and Feedback Letter
No Audit and Feedback Letter
Arm Description
This group will receive 2 audit and feedback letters and a study closure letter.
This group will only receive a study closure letter.
Outcomes
Primary Outcome Measures
Total Antibiotic Prescriptions
Total number of antibiotic prescriptions compared to covariate-adjusted baseline number of prescriptions prior to the intervention.
Secondary Outcome Measures
Total Prolonged-Duration Prescription
Number of prescriptions longer than 7 days.
Total Days of Therapy
Number of days of therapy of antimicrobials for each provider.
Antibiotic Cost
Total cost of prescribed antibiotics.
Total Specific Antibiotic Prescriptions
Number of prescriptions for specific antibiotics.
Full Information
NCT ID
NCT05557214
First Posted
September 22, 2022
Last Updated
April 11, 2023
Sponsor
Saskatchewan Health Authority - Regina Area
1. Study Identification
Unique Protocol Identification Number
NCT05557214
Brief Title
Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
Official Title
Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to execute data sharing agreement with Ministry of Health.
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saskatchewan Health Authority - Regina Area
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Approximately 90% of antibiotics are prescribed in primary healthcare (PHC) in Canada (Public Health Agency of Canada, 2020), making this an important sector for antimicrobial stewardship. Upper respiratory tract infections (URTIs) represent a common indication in PHC for which antibiotics are often prescribed unnecessarily (Leis et al, 2020; Schwartz et al., 2020). Reducing unnecessary antibiotic treatment in this sector is a vital part of contributing to minimizing the global burden of antibiotic resistance.
The goal of this research project is to reduce the number of antibiotic prescriptions among family physicians identified as high prescribers in Saskatchewan. To achieve this, the investigators will send letters to the top 25th percentile of high prescribers in PHC. The letters will contain data indicating the prescribers high antimicrobial usage as well as guidance for reducing unnecessary prescriptions and promoting appropriate lengths of prescriptions for upper respiratory tract infections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
audit and feedback, antimicrobials, primary healthcare
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Audit and Feedback Letter
Arm Type
Experimental
Arm Description
This group will receive 2 audit and feedback letters and a study closure letter.
Arm Title
No Audit and Feedback Letter
Arm Type
No Intervention
Arm Description
This group will only receive a study closure letter.
Intervention Type
Behavioral
Intervention Name(s)
Audit and Feedback Letter
Intervention Description
Physicians in the Audit and Feedback Letter Arm will receive an initial letter indicating their high prescriber status with guidance on reducing unnecessary antimicrobial use. They will also receive a follow-up letter at the 6 month mark indicating any change in prescribing habits. There will be a study closure letter mailed at the 12 month mark.
Primary Outcome Measure Information:
Title
Total Antibiotic Prescriptions
Description
Total number of antibiotic prescriptions compared to covariate-adjusted baseline number of prescriptions prior to the intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total Prolonged-Duration Prescription
Description
Number of prescriptions longer than 7 days.
Time Frame
12 months
Title
Total Days of Therapy
Description
Number of days of therapy of antimicrobials for each provider.
Time Frame
12 months
Title
Antibiotic Cost
Description
Total cost of prescribed antibiotics.
Time Frame
12 months
Title
Total Specific Antibiotic Prescriptions
Description
Number of prescriptions for specific antibiotics.
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
must be a practicing family physician in Saskatchewan
top 25th percentile of antimicrobial prescribers
Exclusion Criteria:
fewer than 12 months of historical prescribing data available
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified aggregate data will be shared via a published manuscript at the conclusion of the study.
Citations:
PubMed Identifier
31930218
Citation
Leis JA, Born KB, Ostrow O, Moser A, Grill A. Prescriber-led practice changes that can bolster antimicrobial stewardship in community health care settings. Can Commun Dis Rep. 2020 Jan 2;46(1):1-5. doi: 10.14745/ccdr.v46i01a01. eCollection 2020 Jan 2.
Results Reference
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PubMed Identifier
32381687
Citation
Schwartz KL, Langford BJ, Daneman N, Chen B, Brown KA, McIsaac W, Tu K, Candido E, Johnstone J, Leung V, Hwee J, Silverman M, Wu JHC, Garber G. Unnecessary antibiotic prescribing in a Canadian primary care setting: a descriptive analysis using routinely collected electronic medical record data. CMAJ Open. 2020 May 7;8(2):E360-E369. doi: 10.9778/cmajo.20190175. Print 2020 Apr-Jun.
Results Reference
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Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
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