The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program (PC-ASP 2)
|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: NCT03517215|
Recruitment Status : Not yet recruiting
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Rhinosinusitis Sore Throat Acute Cystitis Acute Bronchitis||Behavioral: Enhanced CB-ASP Behavioral: Standard CB-ASP||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||March 2020|
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.
Behavioral: Enhanced CB-ASP
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.
Behavioral: Standard CB-ASP
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.
- Reduction in antibiotic prescribing [ Time Frame: 9 months ]To determine the proportion of antibiotics prescribed for pharyngitis, tonsillitis, acute sinusitis and acute bronchitis
- 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
- Reduction in the duration of prescriptions [ Time Frame: 9 months ]Assess where there was a reduction in the duration of prescriptions
- 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.
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): NCT03517215
|Contact: Sophia Virani, MSc||416-586-4800 ext firstname.lastname@example.org|
|North York General Hospital||Not yet recruiting|
|North York, Ontario, Canada, M2K 1E1|
|Contact: Braden O'Neill, MD 416-756-6980 Braden.O'Neill@nygh.on.ca|
|Women's College Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1N8|
|Contact: Noah Ivers, PhD 4163236400 ext 5210 Noah.Ivers@wchospital.ca|
|Granovsky Gluskin Family Medicine Cwntre|
|Toronto, Ontario, Canada, M5T 3L9|
|Principal Investigator:||Warren McIsaac, MD||Sinai Health System|