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

NCT03517215 | Unknown

• 1 other identifier: 18-0016-E
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Rhinosinusitis; Sore Throat; Acute Cystitis; Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

• Reduction in antibiotic prescribing

  To determine the proportion of antibiotics prescribed for pharyngitis, tonsillitis, acute sinusitis and acute bronchitis

  9 months

Secondary Outcomes (3)

• Use of delayed antibiotic prescriptions

  9 months

• Reduction in the duration of prescriptions

  9 months

• Specific antibiotics prescribed

  9 months

Study Arms (3)

Enhanced CB-ASP

EXPERIMENTAL

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

Standard CB-ASP

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Enhanced CB-ASP BEHAVIORAL

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.

Enhanced CB-ASP

Standard CB-ASP BEHAVIORAL

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.

Standard CB-ASP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnant women or male urinary tract infections

Sponsors & Collaborators

• University of Toronto: lead
• Sinai Health System: collaborator

Study Sites (3)

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

Women's College Hospital

Toronto, Ontario, M5G 1N8, Canada

Location

Granovsky Gluskin Family Medicine Cwntre

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (1)

• 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.

  PMID: 34525972 DERIVED

MeSH Terms

Conditions

Pharyngitis; Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Warren McIsaac, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Virani, MSc

CONTACT

416-586-4800; sophia.virani@sinaihealthsystem.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 7, 2018
• Study Start: September 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: March 1, 2020
• Last Updated: May 7, 2018

Record last verified: 2018-04

Locations

CA (3)