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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Withdrawn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
Saskatchewan Health Authority - Regina Area
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 22, 2022
    Last Updated
    April 11, 2023
    Sponsor
    Saskatchewan Health Authority - Regina Area
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    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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