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Providing Antibiotic Prescribing Feedback to Primary Care Physicians: The Ontario Program To Improve AntiMicrobial USE (OPTIMISE)

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ClinicalTrials.gov Identifier: NCT03776383
Recruitment Status : Active, not recruiting
First Posted : December 14, 2018
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Health Quality Ontario
Information provided by (Responsible Party):
Kevin Schwartz, Ontario Agency for Health Protection and Promotion

Brief Summary:
Antibiotic overuse occurs in multiple jurisdictions and is associated with rising rates of antimicrobial resistance. Mailing letters to the highest antibiotic prescribing physicians is a potentially effective method to optimize antibiotic use. The objectives of this study are to improve enrollment to Health Quality Ontario's Primary Care Practice report and reduce unnecessary antibiotic use. The investigators are conducting a randomized controlled trial recruiting the 3500 highest antibiotic prescribing primary care physicians in Ontario. The investigators have incorporated behavioural science theory into designing letters to modify prescribing behaviour. Letter 1 is testing change ideas related to antibiotic initiation and letter 2 is testing change ideas related to antibiotic duration. There will be 1500 physicians receiving letter 1, 1500 receiving letter 2, and 500 will serve as controls. Twelve months later all 3500 physicians will receive a letter.

Condition or disease Intervention/treatment Phase
Antibiotic Prescribing Audit and Feedback Other: Antibiotic use feedback letter Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3:3:1 for intervention 1: intervention 2: control
Masking: Single (Outcomes Assessor)
Masking Description: The data for the outcome are being provided from a third party with no involvement in the study
Primary Purpose: Health Services Research
Official Title: Ontario Healthcare Implementation Laboratory: A Learning Health System Approach That Leverages Data to Improve Quality in Primary Care: Stage 1
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Antibiotic use feedback letter 1
Antibiotic use feedback letter 1 provides physicians with information on their antibiotic use plus change ideas on appropriate antibiotic prescribing for acute respiratory conditions
Other: Antibiotic use feedback letter
Mailed letters indicating that the physician prescribes more antibiotics than 75% of their peers

Active Comparator: Antibiotic use feedback letter 2
Antibiotic use feedback letter 2 provides physicians with information on their antibiotic use plus change ideas on appropriate antibiotic durations for common infections
Other: Antibiotic use feedback letter
Mailed letters indicating that the physician prescribes more antibiotics than 75% of their peers

No Intervention: Control
Controls will not receive a letter



Primary Outcome Measures :
  1. Antibiotic prescribing rate [ Time Frame: 12 months ]
    Number of antibiotics prescribed per 100 total prescriptions

  2. Prolonged duration prescribing rate [ Time Frame: 12 months ]
    Proportion of antibiotic prescriptions that are >7 days per 100 total prescriptions


Secondary Outcome Measures :
  1. New enrollment for Health Quality Ontario primary care practice reports [ Time Frame: 24 months ]
    Proportion of new sign ups for Health Quality Ontario primary care practice reports


Other Outcome Measures:
  1. New enrollment for Health Quality Ontario primary care practice reports [ Time Frame: 6 months ]
    Proportion of new sign ups for Health Quality Ontario primary care practice reports

  2. New enrollment for Health Quality Ontario primary care practice reports [ Time Frame: 12 months ]
    Proportion of new sign ups for Health Quality Ontario primary care practice reports

  3. Antibiotic prescribing rate [ Time Frame: 3 months ]
    Number of antibiotics prescribed per 100 total prescriptions

  4. Antibiotic prescribing rate [ Time Frame: 6 months ]
    Number of antibiotics prescribed per 100 total prescriptions

  5. Antibiotic prescribing rate [ Time Frame: 9 months ]
    Number of antibiotics prescribed per 100 total prescriptions

  6. Antibiotic prescribing rate [ Time Frame: 24 months ]
    Number of antibiotics prescribed per 100 total prescriptions

  7. Prolonged duration prescribing [ Time Frame: 3 months ]
    Proportion of antibiotic prescriptions that are >7 days per 100 total prescriptions

  8. Prolonged duration prescribing [ Time Frame: 6 months ]
    Proportion of antibiotic prescriptions that are >7 days per 100 total prescriptions

  9. Prolonged duration prescribing [ Time Frame: 9 months ]
    Proportion of antibiotic prescriptions that are >7 days per 100 total prescriptions

  10. Prolonged duration prescribing [ Time Frame: 24 months ]
    Proportion of antibiotic prescriptions that are >7 days per 100 total prescriptions



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Ontario primary care physicians
  • Prescribe more antibiotics by volume than 75% of Ontario primary care physicians
  • A College of Physicians and Surgeons of Ontario number in 2017-2018

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): NCT03776383


Locations
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Canada, Ontario
Public Health Ontario
Toronto, Ontario, Canada, M5G 1V2
Sponsors and Collaborators
Ontario Agency for Health Protection and Promotion
Canadian Institutes of Health Research (CIHR)
Health Quality Ontario
Investigators
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Principal Investigator: Kevin Schwartz, MD MSc Ontario Agency for Health Protection and Promotion

Publications:
Nudge vs Superbugs: A behavioural economics trial to reduce the overprescribing of antibiotics, Available online at: http://behaviouraleconomics.pmc.gov.au/sites/default/files/projects/report-nudge-vs-superbugs.pdf (accessed June 27, 2018).

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Responsible Party: Kevin Schwartz, PI, Ontario Agency for Health Protection and Promotion
ClinicalTrials.gov Identifier: NCT03776383     History of Changes
Other Study ID Numbers: 2018-046.01
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data are proprietary and private and cannot be shared with external parties. Study results will be aggregated for publication

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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 Kevin Schwartz, Ontario Agency for Health Protection and Promotion:
Antibiotic use
Audit and feedback
implementation science
Antimicrobial stewardship

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents