- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05044052
Does Inclusion of Viral Prescription Pad Resources Increase Responsiveness to Feedback About Antibiotic Prescribing in Primary Care
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1N8
- Women's College Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Noah M Ivers, MD, Women's College Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-0024-E (OH Trial)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Infection
-
West Virginia UniversityEnrolling by invitationSkin and Soft Tissue Infection | Gastrointestinal Infection | Pulmonary Infection | Bone and Joint Infection | Endovascular Infection | Genitourinary InfectionUnited States
-
Ondine Biomedical Inc.CompletedSurgical Site Infection | Nosocomial Infection | Healthcare Associated InfectionUnited States
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site Infection | Superficial Surgical Site Infection | Deep Surgical Site Infection | Organ/Space Surgical Site InfectionUnited States
-
Croydon Health Services NHS TrustCompletedSurgical Site Infection | Wound Infection | Cesarean Section; Infection | Perineal InfectionUnited Kingdom
-
Cairo UniversityRecruitingPostoperative Infection | Cesarean Section Complications | Vaginal InfectionEgypt
-
Vastra Gotaland RegionGöteborg UniversityRecruitingProsthetic Joint Infection | Hip Prosthesis Infection | Prosthetic Infection | Knee Prosthesis InfectionSweden
-
Duke UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedSurgical Site Infection | Infection ControlUnited States
-
Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... and other collaboratorsRecruitingProsthetic-joint Infection | Infection Hip | Infection; Knee, JointNetherlands
-
University of ZurichRecruitingProsthetic Joint Infection | Surgical Site Infection | Prosthesis and Implants | Postoperative Wound Infection Deep Incisional Surgical SiteSwitzerland
-
Ondine Biomedical Inc.CompletedNosocomial Infection | Surgical Site Infections | Healthcare Associated InfectionsUnited States