- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07760675
Evaluating in Person Curriculum for Educating Obstetrical Residents on Better Caring for 2 Spirit Metis Patients Using and AI Assisted OSCE.
Mawiiyahk Nakatikasho: No One Left Behind: Assessing and Improving Competence in Caring for Two-Spirit Metis Patients Through an AI-Assisted Objective Structured Clinical Examination (OSCE): A Multisite Randomized Controlled Feasibility Trial for Ob/Gyn Residents
Two-Spirit (2S) Métis individuals often encounter significant barriers and discrimination in healthcare settings. This multisite randomized controlled feasibility trial evaluates a novel artificial intelligence (AI)-assisted Objective Structured Clinical Examination (OSCE) designed to assess and improve Obstetrics and Gynecology (Ob/Gyn) residents' competencies in delivering culturally safe, trauma-informed, and identity-affirming care to 2S Métis patients.
Up to 90 Ob/Gyn residents across three Canadian academic sites (University of Alberta, University of Manitoba, and University of Saskatchewan) will be randomized 1:1 to complete either a 2S Métis Academic Half Day paired with AI-assisted OSCE evaluation or standard institutional anti-racism training with AI-assisted OSCE evaluation. The primary focus is to evaluate study feasibility (recruitment, retention, and delivery fidelity) and resident performance on clinical communication, trauma-informed care, and cultural humility evaluated using a 2S Métis co-developed scoring rubric.
Study Overview
Status
Conditions
Detailed Description
Two-Spirit (2S) Métis people experience systemic discrimination, exclusion, and culturally unsafe care, particularly in reproductive, perinatal, and gender-affirming healthcare contexts. In response to the Truth and Reconciliation Commission's Call to Action #24, this study introduces an innovative educational model integrating artificial intelligence, Indigenous governance, and culturally specific evaluation frameworks to strengthen resident physician competency.
The AI system serves two primary functions:
- Co-developing culturally grounded assessment rubrics in collaboration with 2S Métis Elders, Knowledge Keepers, and community members.
- Standardizing patient portrayal during OSCE clinical encounters to ensure consistency, eliminate human actor variability, and avoid the emotional burden associated with repeated standardized patient portrayals.
Study Design & Methods: Ob/Gyn residents (PGY1-PGY5) across three participating universities will undergo 1:1 prospective randomization:
- Intervention Arm: 2S Métis Academic Half Day (AHD) + AI-assisted OSCE evaluation.
- Control Arm: Standard institutional anti-racism and Indigenous cultural safety training + AI-assisted OSCE evaluation.
AI Encounter Flow: Participants undergo a 5-minute pre-encounter briefing, a 15-20 minute real-time interaction with the AI-simulated 2S Métis patient, and a 5-minute post-encounter reflection. Recorded encounters will be independently scored by two blinded raters (including at least one 2S Métis community member) using the co-developed structured rubric.
Ethics and Data Sovereignty: All algorithms, datasets, and cultural representations are governed by principles of Indigenous Data Sovereignty (OCAP®) and UNDRIP, ensuring community oversight and authority over cultural content, rubric criteria, and data ownership
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Melanie Morris, MD
- Phone Number: 2047872682
- Email: mmorris@hsc.mb.ca
Study Contact Backup
- Name: Tibetha Kemble, PhD
- Email: kemble@ualberta.ca
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2C8
- University of Alberta
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Contact:
- Tibetha Kemble, PhD
- Email: kemble@ualberta.ca
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P5
- University of Manitoba
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Contact:
- Melanie Morris, MD
- Phone Number: 2047872682
- Email: mmorris@hsc.mb.ca
-
Contact:
- Alla Zrazhva
- Phone Number: 207872682
- Email: azrazhva@hsc.mb.ca
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SA
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Saskatoon, SA, Canada, S7N 0W8
- University of Saskatchewan
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Contact:
- TBD TDB
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Current enrollment in an accredited Obstetrics and Gynecology residency program at one of the participating institutions (University of Alberta, University of Manitoba, or University of Saskatchewan). * Postgraduate Year 1 through 5 (PGY1-PGY5). * Fluency in English to ensure comprehension of AI-based encounters. * Willingness and ability to participate fully in both the Academic Half Day and AI-assisted OSCE assessments. * Provision of informed consent.
Exclusion Criteria:
- Prior participation (within 12 months) in Two-Spirit (2S) Métis-specific or similar cultural safety OSCEs or workshops. * Residents not enrolled in participating Ob/Gyn residency programs.
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: 2S Metis Cultural Safety Training +AI OSCE
Participant complete a 2S Metis Academic Half Day focused on trauma -informed care and cultural humility, followed by AI -assisted OSCE evaluation
|
Ob/GYN residents participate in a dedicated 2S Métis Academic Half Day covering trauma-informed care and cultural humility, followed by a simulated OSCE encounter using an AI-assisted standardized patient and co-developed scoring rubric.
|
|
Active Comparator: Standard Anti-Racism Training+AI OSCE
Participants complete standard institutional Indigenous cultural safety/anti-racism training, followed by AI-assisted OSCE evaluation
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Ob/Gyn residents undergo standard institutional anti-racism/Indigenous cultural safety training, followed by the same AI-assisted 2S Métis OSCE evaluation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study Feasibility Metrics
Time Frame: Up to 12 months
|
Feasibility evaluated by participant recruitment rate (target of 90 Ob/Gyn residents across 3 sites), study retention/completion rate, and intervention delivery fidelity across all participating institutions.
|
Up to 12 months
|
|
Resident Clinical Communication and Cultural Safety Performance Score
Time Frame: Immediately post-intervention
|
Objective Structured Clinical Examination (OSCE) performance score assessing clinical communication, trauma-informed care, and cultural humility evaluated using the co-developed 2S Métis scoring rubric (scored by blinded raters).
|
Immediately post-intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- UM:0278574
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
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