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- Ensaio Clínico 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.
Visão geral do estudo
Status
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Melanie Morris, MD
- Número de telefone: 2047872682
- E-mail: mmorris@hsc.mb.ca
Estude backup de contato
- Nome: Tibetha Kemble, PhD
- E-mail: kemble@ualberta.ca
Locais de estudo
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Alberta
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Edmonton, Alberta, Canadá, T6G 2C8
- University of Alberta
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Contato:
- Tibetha Kemble, PhD
- E-mail: kemble@ualberta.ca
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Manitoba
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Winnipeg, Manitoba, Canadá, R3E 3P5
- University of Manitoba
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Contato:
- Melanie Morris, MD
- Número de telefone: 2047872682
- E-mail: mmorris@hsc.mb.ca
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Contato:
- Alla Zrazhva
- Número de telefone: 207872682
- E-mail: azrazhva@hsc.mb.ca
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SA
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Saskatoon, SA, Canadá, S7N 0W8
- University of Saskatchewan
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Contato:
- TBD TDB
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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
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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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Comparador Ativo: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Study Feasibility Metrics
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- UM:0278574
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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