NCT07760675

Brief Summary

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.

Trial Health

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Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 23, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

Two-SpiritMétisAIOSCEIndigenous HealthObstetrics and Gynecology

Outcome Measures

Primary Outcomes (2)

  • Study Feasibility Metrics

    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

    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

Study Arms (2)

2S Metis Cultural Safety Training +AI OSCE

EXPERIMENTAL

Participant complete a 2S Metis Academic Half Day focused on trauma -informed care and cultural humility, followed by AI -assisted OSCE evaluation

Behavioral: 2S Métis Cultural Safety Academic Half Day &AI-OSCE

Standard Anti-Racism Training+AI OSCE

ACTIVE COMPARATOR

Participants complete standard institutional Indigenous cultural safety/anti-racism training, followed by AI-assisted OSCE evaluation

Behavioral: Standard Institutional Cultural Safety Training&AI-OSCE

Interventions

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.

2S Metis Cultural Safety Training +AI OSCE

Ob/Gyn residents undergo standard institutional anti-racism/Indigenous cultural safety training, followed by the same AI-assisted 2S Métis OSCE evaluation.

Standard Anti-Racism Training+AI OSCE

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3E 3P5, Canada

Location

University of Saskatchewan

Saskatoon, SA, S7N 0W8, Canada

Location

Central Study Contacts

Melanie Morris, MD

CONTACT

Tibetha Kemble, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Assessors (including 2S Métis raters) scoring the AI-assisted OSCE encounters are blinded to group allocation. Data analysts are also blinded to participant allocation during statistical analysis. Participants cannot be blinded due to the educational nature of the intervention.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 1:1 prospective randomization to either 2S Metis Academic Half Day + AI assigned OSCE or standard institutional training +AI assigned OSCE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start (Estimated)

September 23, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data will not be publicly shared in order to uphold Indigenous Data Sovereignty (OCAP®) governance agreements established with 2S Métis community partners and to protect resident participant confidentiality. Aggregate trial results and summary findings will be made available upon study completion.

Locations