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The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program (PC-ASP 2)

Primary Purpose

Acute Rhinosinusitis, Sore Throat, Acute Cystitis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Enhanced CB-ASP
Standard CB-ASP
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Rhinosinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • North York General Hospital
  • Women's College Hospital
  • Granovsky Gluskin Family Medicine Cwntre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Enhanced CB-ASP

Standard CB-ASP

Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Reduction in antibiotic prescribing
To determine the proportion of antibiotics prescribed for pharyngitis, tonsillitis, acute sinusitis and acute bronchitis

Secondary Outcome Measures

Use of delayed antibiotic prescriptions
Assess the proportion of delayed prescription issued during the post intervention phased compared to the before
Reduction in the duration of prescriptions
Assess where there was a reduction in the duration of prescriptions
Specific antibiotics prescribed
Assess the specific antibiotics prescribed and if there is a reduction in the use of broad spectrum antibiotics.

Full Information

First Posted
April 24, 2018
Last Updated
April 24, 2018
Sponsor
University of Toronto
Collaborators
Sinai Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03517215
Brief Title
The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program
Acronym
PC-ASP 2
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
Sinai Health System

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Rhinosinusitis, Sore Throat, Acute Cystitis, Acute Bronchitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced CB-ASP
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard CB-ASP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced CB-ASP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard CB-ASP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in antibiotic prescribing
Description
To determine the proportion of antibiotics prescribed for pharyngitis, tonsillitis, acute sinusitis and acute bronchitis
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Use of delayed antibiotic prescriptions
Description
Assess the proportion of delayed prescription issued during the post intervention phased compared to the before
Time Frame
9 months
Title
Reduction in the duration of prescriptions
Description
Assess where there was a reduction in the duration of prescriptions
Time Frame
9 months
Title
Specific antibiotics prescribed
Description
Assess the specific antibiotics prescribed and if there is a reduction in the use of broad spectrum antibiotics.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia Virani, MSc
Phone
416-586-4800
Ext
6052
Email
sophia.virani@sinaihealthsystem.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren McIsaac, MD
Organizational Affiliation
Sinai Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York General Hospital
City
North York
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Braden O'Neill, MD
Phone
416-756-6980
Email
Braden.O'Neill@nygh.on.ca
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Ivers, PhD
Phone
4163236400
Ext
5210
Email
Noah.Ivers@wchospital.ca
Facility Name
Granovsky Gluskin Family Medicine Cwntre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3L9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34525972
Citation
McIsaac W, Kukan S, Huszti E, Szadkowski L, O'Neill B, Virani S, Ivers N, Lall R, Toor N, Shah M, Alvi R, Bhatt A, Nakamachi Y, Morris AM. A pragmatic randomized trial of a primary care antimicrobial stewardship intervention in Ontario, Canada. BMC Fam Pract. 2021 Sep 15;22(1):185. doi: 10.1186/s12875-021-01536-3.
Results Reference
derived

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The Development and Testing of a Scaling Strategy for a Community-Based Primary Care Antimicrobial Stewardship Program

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