NCT07189364

Brief Summary

The purpose of this study is to evaluate the effect of a peer comparison feedback report, combined with a best practices toolkit, on the volume of antimicrobial use by general medicine physicians. The study also aims to understand the qualitative and quantitative impact of peer comparison feedback on antimicrobial prescribing in hospital. This study will leverage data from GEMINI, a hospital research collaborative that collects administrative and clinical data from 30+ Ontario hospitals, to create these peer comparison feedback reports.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Sep 2025Apr 2027

First Submitted

Initial submission to the registry

August 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

August 26, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

Antimicrobial StewardshipAntimicrobial ResistanceAudit and feedback

Outcome Measures

Primary Outcomes (1)

  • Antimicrobial Days of Therapy (DOT)/100 days present

    The primary trial outcome will be aggregate DOT (Days of Therapy)/100 days present, at the physician level. DOT are defined by the sum of days treated with each antimicrobial agent (e.g., 2 agents each day over 2 days is 4 DOT/days present). Days present are defined by the number of days between hospital admission and discharge attributed to each physician. Partial days are considered days present based upon the percentage of the day in hospital calculated by hour of admission and discharge. This highly relevant outcome captures many axes of use including initiation and discontinuation decisions.

    The primary outcome will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).

Secondary Outcomes (11)

  • Initiation of antimicrobial therapy

    All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).

  • Discontinuation of antimicrobial therapy within 72 hours

    All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).

  • Antimicrobial-free days

    All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).

  • Antimicrobial choice

    All secondary outcomes will be measured for 24 month prior to intervention delivery (i.e., the baseline period) and for 12 months after intervention delivery (i.e., the follow-up period).

  • Mechanism of action (interview)

    This process evaluation outcome will be measured within 12 months of the intervention delivery (i.e., during the follow-up period).

  • +6 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive an electronic peer-comparison feedback report on their antimicrobial prescribing practices and a knowledge toolkit about antimicrobial use, bundled as a single intervention.

Behavioral: Peer Comparison Feedback Report

Control Group

NO INTERVENTION

The control group will not receive a peer-comparison feedback report on their antimicrobial prescribing practices, or a knowledge toolkit on antimicrobial use.

Interventions

The intervention will be an electronic, individualized, peer-comparison feedback report on the participant's antimicrobial prescribing practices, combined with a knowledge toolkit focused on optimizing antimicrobial use.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient-level: All adult inpatients (\>=18 years of age) discharged within the baseline evaluation period and follow up period will be included in a physician report if they match the following criteria: a) Total in-hospital length of stay (LOS) is less than or equal to 14 days; b) and admitted to or discharged from a general medicine or hospitalist ward; c) admitted via the emergency department.
  • Physician-level: Physicians will be included if they have at least 50 hospitalizations attributed to them during the baseline period. Physicians who practice at multiple sites will only be included at the hospital with more encounters.
  • Hospital-level: In total, 29 teaching and community hospitals that provide data to GEMINI, with comprehensive geographic coverage of Ontario, will be included in this trial.

You may not qualify if:

  • Patient-level: All data from ICU dates of care will be excluded from the trial (defined by ICU admission start and stop dates). All antimicrobial use data from ICU dates will be censored and excluded from attribution to GM physicians. Additionally, all patients with ICD-10-CA code Z51.5 for palliative care will be excluded owing to expected differences in antimicrobial management strategies.
  • Hospital-level: Two hospitals in the GEMINI network will be excluded from this trial due to their lack of GM wards (a cancer hospital and a COVID-19 reactivation hospital). Additionally, any hospitals in the GEMINI network that do not meet annual data quality standards for antimicrobial use or other data fields will not be included in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GEMINI Research Program

Toronto, Ontario, M5B 1T8, Canada

Location

Study Officials

  • Fahad Razak, MD

    St. Michael's Hospital - Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, St. Michael's Hospital - Unity Health Toronto

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 23, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data for this trial will be collected passively through GEMINI's existing data collection procedures. Therefore, the data being leveraged for this trial (i.e., a research-ready dataset of all inpatient antimicrobial prescribing across 60% of Ontario's medical hospital beds) will be available for other researchers to use as soon as data validation is complete. GEMINI's data dictionary, which will contain further information about the data used for this trial, is available here: https://geminimedicine.ca/the-gemini-database/. To use GEMINI data, researchers must follow GEMINI's data access process, which can be found here: https://geminimedicine.ca/access-gemini-data/.

Time Frame
Beginning in September 2025, with no end date.
Access Criteria
GEMINI data can be accessed through GEMINI's secure research environment, once approved by GEMINI's Projects \& Publications Committee and the appropriate REB Office. To access data, researchers must submit a project proposal to GEMINI.Research@unityhealth.to, using the standardized template available here: https://geminimedicine.ca/access-gemini-data/
More information

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