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

Sore Throat Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03517215
• Other study ID #: 18-0016-E
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: March 2020

Study information

• Verified date: April 2018
• Source: University of Toronto
• Contact: Sophia Virani, MSc
• Phone: 416-586-4800
• Email: sophia.virani[@]sinaihealthsystem.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchitis
• Acute Cystitis
• Acute Rhinosinusitis
• Bronchitis
• Cystitis
• Pharyngitis
• Sore Throat

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	North York General Hospital	North York	Ontario
Canada	Granovsky Gluskin Family Medicine Cwntre	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Sinai Health System

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in antibiotic prescribing	To determine the proportion of antibiotics prescribed for pharyngitis, tonsillitis, acute sinusitis and acute bronchitis	9 months
Secondary	Use of delayed antibiotic prescriptions	Assess the proportion of delayed prescription issued during the post intervention phased compared to the before	9 months
Secondary	Reduction in the duration of prescriptions	Assess where there was a reduction in the duration of prescriptions	9 months
Secondary	Specific antibiotics prescribed	Assess the specific antibiotics prescribed and if there is a reduction in the use of broad spectrum antibiotics.	9 months