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临床试验/NCT07760675
NCT07760675尚未招募不适用

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

University of Manitoba3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
3
主要终点
Study Feasibility Metrics

研究概览

简要总结

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.

详细描述

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:

  1. Co-developing culturally grounded assessment rubrics in collaboration with 2S Métis Elders, Knowledge Keepers, and community members.
  2. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: 2S Métis Cultural Safety Academic Half Day &AI-OSCE (Behavioral)

Standard Anti-Racism Training+AI OSCE

Active Comparator

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

干预措施: Standard Institutional Cultural Safety Training&AI-OSCE (Behavioral)

结局指标

主要结局

Study Feasibility Metrics

时间窗: 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.

Resident Clinical Communication and Cultural Safety Performance Score

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Morris

Associate Professor of Surgery

University of Manitoba

研究点 (3)

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