- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Melanie Morris, MD
- Telefonnummer: 2047872682
- E-mail: mmorris@hsc.mb.ca
Undersøgelse Kontakt Backup
- Navn: Tibetha Kemble, PhD
- E-mail: kemble@ualberta.ca
Studiesteder
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Alberta
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Edmonton, Alberta, Canada, T6G 2C8
- University of Alberta
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Kontakt:
- Tibetha Kemble, PhD
- E-mail: kemble@ualberta.ca
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P5
- University of Manitoba
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Kontakt:
- Melanie Morris, MD
- Telefonnummer: 2047872682
- E-mail: mmorris@hsc.mb.ca
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Kontakt:
- Alla Zrazhva
- Telefonnummer: 207872682
- E-mail: 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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Kontakt:
- TBD TDB
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
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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.
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Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Study Feasibility Metrics
Tidsramme: Up to 12 months
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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.
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Up to 12 months
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Resident Clinical Communication and Cultural Safety Performance Score
Tidsramme: Immediately post-intervention
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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).
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Immediately post-intervention
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UM:0278574
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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