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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. Read our disclaimer for details. Identifier: NCT03517215
Recruitment Status : Unknown
Verified April 2018 by Warren McIsaac, University of Toronto.
Recruitment status was:  Not yet recruiting
First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Sinai Health System
Information provided by (Responsible Party):
Warren McIsaac, University of Toronto

Brief Summary:
Antibiotic resistant infections are expected to cause 10 million deaths worldwide by 2050, and exceed cancer deaths. Reducing antibiotic use can reduce resistance levels. Hospitals have now developed Antimicrobial Stewardship Programs that promote better use of antibiotics. However, 80% of antibiotics are prescribed in the community where stewardship programs do not exist. Antibiotics are often prescribed for coughs and colds, where it can be difficult to tell if these are cases of pneumonia or strep throat. Doctors may prescribe antibiotics `just in case' and patients may request antibiotics hoping to feel better faster. To help family doctors and patients, a team of infectious disease specialists, researchers and community family physicians have collaboratively developed an Antimicrobial Stewardship Program (ASP) for use in the community. Testing in 3 family medicine clinics is showing reduced antibiotic use. What is needed is a strategy to `scale' up this program province wide to reduce antibiotic use enough to reduce resistance levels, but how to do this is not known. Working with a community clinic network, this project will test two implementation strategies to inform how best to implement a Community-Based ASP.

Condition or disease Intervention/treatment Phase
Acute Rhinosinusitis Sore Throat Acute Cystitis Acute Bronchitis Behavioral: Enhanced CB-ASP Behavioral: Standard CB-ASP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.
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.

Primary Outcome Measures :
  1. Reduction in antibiotic prescribing [ Time Frame: 9 months ]
    To determine the proportion of antibiotics prescribed for pharyngitis, tonsillitis, acute sinusitis and acute bronchitis

Secondary Outcome Measures :
  1. 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

  2. Reduction in the duration of prescriptions [ Time Frame: 9 months ]
    Assess where there was a reduction in the duration of prescriptions

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT03517215

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Contact: Sophia Virani, MSc 416-586-4800 ext 6052

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Canada, Ontario
North York General Hospital
North York, Ontario, Canada, M2K 1E1
Contact: Braden O'Neill, MD    416-756-6980    Braden.O'   
Women's College Hospital
Toronto, Ontario, Canada, M5G 1N8
Contact: Noah Ivers, PhD    4163236400 ext 5210   
Granovsky Gluskin Family Medicine Cwntre
Toronto, Ontario, Canada, M5T 3L9
Sponsors and Collaborators
University of Toronto
Sinai Health System
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Principal Investigator: Warren McIsaac, MD Sinai Health System

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Responsible Party: Warren McIsaac, Associate Professor, University of Toronto Identifier: NCT03517215    
Other Study ID Numbers: 18-0016-E
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Urinary Bladder Diseases
Urologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents