Does Inclusion of Viral Prescription Pad Resources Increase Responsiveness to Feedback About Antibiotic Prescribing in Primary Care

January 4, 2023 updated by: Noah Ivers, Women's College Hospital

Do Peer-comparisons, Emphasis on Harms, and/or Inclusion of Viral Prescription Pad Resources Increase Responsiveness to Feedback About Antibiotic Prescribing in Primary Care: Protocol for Two Linked Trials With Embedded Process Evaluations (OH Trial)

Antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. Primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations.

In Ontario, audit and feedback (A&F) is routinely offered to primary care providers from a variety of sources. Ontario Health - an agency created by the Government of Ontario - provides A&F via email to physicians who voluntarily sign up for their "MyPractice" reports. These are multi-topic reports with aggregated (physician-level) data. As of November 2021, the MyPractice reports for family physicians will include data on antibiotic prescribing. To date, less than half of Ontario family physicians have signed up for the MyPractice reports from Ontario Health.

For this study, the investigators will conduct a trial to investigate the effect of adding viral prescription pad resources to family physician A&F received through a MyPractice: Primary Care report. This evaluation provides an opportunity to determine if the addition of this resource to an A&F intervention increases changes to antibiotic prescribing.

Study Overview

Status

Completed

Conditions

Detailed Description

This study will examine ways to optimize the effects of A&F for antibiotic prescribing in primary care. This study will aim to determine if emphasis (or not) on the use of a viral prescription pad developed by Choosing Wisely Canada (CWC) can help physicians act upon the feedback from their MyPractice report to reduce their antibiotic prescribing.

Antibiotic prescribing feedback within the multi-topic MyPractice: Primary Care report will be sent to family physicians who signed up for this program from Ontario Health. This report includes a link to the Choosing Wisely viral prescription pad. Physicians will be randomized to the control group or intervention group. Physicians in the intervention group will receive additional emphasis on the use of the viral prescription pad and will also have a paper copy of the prescription pad mailed to their practice.

One month after the initial intervention, participants will be invited to complete a process evaluation survey to determine why or why not the intervention worked and how individual factors can affect physician motivation, willingness, and ability to engage in new practices. Intervention participants will also be invited to take part in a process evaluation interview.

Study Type

Interventional

Enrollment (Actual)

3379

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 1N8
        • Women's College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Family physicians who sign up for the MyPractice reports by September 2021

Exclusion Criteria:

  • Family physicians who did not sign up for the MyPractice reports by September 2021

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group - Viral prescription pad + emphasis
Physicians in this group will receive their usual MyPractice: Primary Care report from Ontario Health. This report will include antibiotic prescribing indicators as well as a link to the viral prescription pad. As part of the intervention, these physicians will also receive additional emphasis on the viral prescription pad by 1) encouraging it in the dissemination email of the MyPractice feedback report, and (2) mailing a paper version of the viral prescription pad with instructions on embedding the viral prescription pad into the recipient's EMR.
We will investigate the effects of emphasizing the use of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing.
No Intervention: Control group
Physicians in this group will receive their usual MyPractice: Primary Care report from Ontario Health. This report will include antibiotic prescribing indicators as well as a link to the viral prescription pad. This group will not receive any additional emphasis on the viral prescription pad and will not receive a paper copy in the mail.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotic prescribing rate
Time Frame: 6 months
Total number of antibiotic prescriptions per 1000 65+ patient visits
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion Antibiotic Rx with Prolonged Duration
Time Frame: 6 months
Antibiotics prescribed for more than 7 days per episode
6 months
Proportion Antibiotic Rx with Prolonged Duration
Time Frame: 12 months
Antibiotics prescribed for more than 7 days per episode
12 months
Antibiotic drug costs
Time Frame: 6 months
Cost in CDN$
6 months
Antibiotic drug costs
Time Frame: 12 months
Cost in CDN$
12 months
Antibiotics prescribed for viral infections
Time Frame: 6 months
Total number of antibiotic rx per 1000 65+ patient visits for presumed viral condition (and thus likely unnecessary) based on administrative database diagnostic codes
6 months
Antibiotics prescribed for viral infections
Time Frame: 12 months
Total number of antibiotic rx per 1000 65+ patient visits for presumed viral condition (and thus likely unnecessary) based on administrative database diagnostic codes
12 months
Total Antibiotic Days of Therapy
Time Frame: 6 months
Total number DOTs per 1000 65+ patient visits
6 months
Total Antibiotic Days of Therapy
Time Frame: 12 months
Total number DOTs per 1000 65+ patient visits
12 months
Proportion of broad spectrum antibiotic prescriptions
Time Frame: 6 months
antibiotic prescriptions that are broad spectrum
6 months
Proportion of broad spectrum antibiotic prescriptions
Time Frame: 12 months
antibiotic prescriptions that are broad spectrum
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Noah M Ivers, MD, Women's College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Actual)

June 15, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

September 3, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-0024-E (OH Trial)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share this data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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