- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03517215
The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program (PC-ASP 2)
The Development and Testing of a Scaling Strategy for a Community-based Primary Care Antimicrobial Stewardship Program Utilizing an Innovative University of Toronto Primary Care Testing Platform: the UTOPIAN Practice Based Research Network
Study Overview
Status
Intervention / Treatment
Detailed Description
Antimicrobial resistance is evolving globally. The latest 'superbug', plasmid mediated colistin resistant E.coli (MDR-1), identified in North America highlights this. Previously, colistin was the drug of last resort that could be used for organisms resistant to all other antibiotics. Current projections are that by 2050, there will be 10 million deaths annually from antimicrobial resistant infections, and this will exceed deaths from cancer.
Antibiotic overuse is considered a main factor in promoting antimicrobial resistance. Countries with high volumes of antibiotic use have higher levels of resistant organisms. After a single antibiotic course, a person's risk of acquiring an antimicrobial resistant infection is increased. Recognizing the need for action to address this crisis, governments in the United States and Canada have issued recent policy statements calling for, among other actions, reductions in antibiotic overuse. Over 80% of antibiotics in Canada are prescribed in the community for common respiratory and other infections. Currently, this amounts to one antibiotic prescription issued for every 6 Canadians each year.
In an ongoing 2014-15 Innovation Fund grant (Community ASP-Phase 1), a team of infectious disease experts and pharmacists with hospital ASP experience, community family physicians working in primary care clinics, and researchers with expertise in community infections collaboratively developed a Community-Based Primary Care Antimicrobial Stewardship Program(CB-ASP). Preliminary results (presented below) show positive effects on key antibiotic utilization parameters. What is needed now is a strategy to 'scale' this program up to similar clinics province wide. This will be necessary to achieve the reduction in the volumes of antibiotic use needed to reduce resistance. Exactly the optimal way to do this and what resources will be needed is not known. Providing the answers to these questions are the objectives of this proposal (CB-ASP -Phase 2).
Objectives - This study will seek to determine the best way for the developed CB-ASP to be successfully scaled up to other family medicine clinics, by testing strategies that are resourced with different intensities, utilizing an innovative primary care research platform.
Study Design - This study will be a 9-month cluster randomized trial over one winter of a less resource intensive and more resource intensive scaling strategy for disseminating a Community-Based Antimicrobial Stewardship Program (CB-ASP) in 6 clinics within a network (UTOPIAN) of linked primary care practices, stratified by small verses large urban center.
This study will test different levels of support (resources provided) in delivering a clinic-based, educational, community-focused ASP intervention directed at family physicians and nurse practitioners. These health professionals are licensed to prescribe antibiotics in these settings.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophia Virani, MSc
- Phone Number: 6052 416-586-4800
- Email: sophia.virani@sinaihealthsystem.ca
Study Locations
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-
Ontario
-
North York, Ontario, Canada, M2K 1E1
- North York General Hospital
-
Contact:
- Braden O'Neill, MD
- Phone Number: 416-756-6980
- Email: Braden.O'Neill@nygh.on.ca
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Toronto, Ontario, Canada, M5T 3L9
- Granovsky Gluskin Family Medicine Cwntre
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Toronto, Ontario, Canada, M5G 1N8
- Women's College Hospital
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Contact:
- Noah Ivers, PhD
- Phone Number: 5210 4163236400
- Email: Noah.Ivers@wchospital.ca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults who present with an illness consistent with one of the following conditions, as judged by the prescriber: a sore throat presentation (either pharyngitis, tonsillitis), an uncomplicated upper respiratory infection (URI; ie- the common cold), acute sinusitis, acute bronchitis, or non-pregnant women who present with acute uncomplicated cystitis.
Exclusion Criteria:
- pregnant women or male urinary tract infections
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced CB-ASP
If a site is randomized to the enhanced CB-ASP, prescribers at that site will be required to attend an education session.
In the four months following the initial session, prescribers will be asked to complete one on-line eModule for each target condition (acute sinusitis, sore throat, acute bronchitis and acute uncomplicated cystitis) each month.
Each module will take approximately 15 minutes to complete.
Two audit and feedback reports (every 3 months) of their clinic's prescriptions for these conditions will be provided where they will be asked to review and discuss with their colleagues and study staff.
|
The education session will be a 1-hour on site presentation that will cover antimicrobial resistance, antimicrobial stewardship, an introduction to effective primary care interventions for reducing antibiotic prescribing, and a review of the clinic's baseline audit of antimicrobial prescribing for the prior year.
E-Modules will be completed online and audit and feedback sessions will be held in person to give an overview of each clinic's prescribing numbers.
|
Active Comparator: Standard CB-ASP
If a site is randomized to the standard CB-ASP strategy arm, prescribers will be offered the opportunity to attend the 1 hour introductory seminar by a web-link, provided with access to the short e-learning modules each month by email, and sent their clinic's audit and feedback reports by email for review two times during the study.
|
A one hour introductory educational seminar will be offered to prescribers via a web-link.
They will be provided with access to e-modules each month by email and sent their audit and feedback reports by email.
|
No Intervention: Control
If a site is randomized to the control arm, the site will not receive any active interventions.
Prescribers at the site will be offered access to the eModules at the completion of the study and provided with one audit and feedback report of their clinic's antibiotic prescribing patterns for local quality improvement needs as desired.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in antibiotic prescribing
Time Frame: 9 months
|
To determine the proportion of antibiotics prescribed for pharyngitis, tonsillitis, acute sinusitis and acute bronchitis
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of delayed antibiotic prescriptions
Time Frame: 9 months
|
Assess the proportion of delayed prescription issued during the post intervention phased compared to the before
|
9 months
|
Reduction in the duration of prescriptions
Time Frame: 9 months
|
Assess where there was a reduction in the duration of prescriptions
|
9 months
|
Specific antibiotics prescribed
Time Frame: 9 months
|
Assess the specific antibiotics prescribed and if there is a reduction in the use of broad spectrum antibiotics.
|
9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Warren McIsaac, MD, Sinai Health System
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-0016-E
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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