Cultural SafetyNCT07760675
Evaluating in Person Curriculum for Educating Obstetrical Residents on Better Caring for 2 Spirit Metis Patients Using and AI Assisted OSCE.
A study testing 2S Métis Cultural Safety Academic Half Day &AI-OSCE and Standard Institutional Cultural Safety Training&AI-OSCE in people with Cultural Safety and Medical Education, run by University of Manitoba at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cultural Safety, Medical Education, Cultural Competency
- What is being tested?
- 2S Métis Cultural Safety Academic Half Day &AI-OSCE and Standard Institutional Cultural Safety Training&AI-OSCE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesCanada
- Study dates
- 23 Sep 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tibetha Kemble, PhD contact
Canada3 sites
University of Alberta
Edmonton, Alberta, T6G 2C8
Tibetha Kemble, PhD, kemble@ualberta.ca
University of Saskatchewan
Saskatoon, SA, S7N 0W8
TBD TDB
University of Manitoba
Winnipeg, Manitoba, R3E 3P5
Melanie Morris, MD, 2047872682, mmorris@hsc.mb.ca
Alla Zrazhva, 207872682, azrazhva@hsc.mb.ca
About this study
Official title: 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.
Read the 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
- Conditions
- Cultural Safety, Medical Education, Cultural Competency
- Being tested
- 2S Métis Cultural Safety Academic Half Day &AI-OSCE, Standard Institutional Cultural Safety Training&AI-OSCE
- Keywords
- Two-Spirit, Métis, AI, OSCE, Indigenous Health, Obstetrics and Gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2S Métis Cultural Safety Academic Half Day &AI-OSCEBehavioural
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.
Standard Institutional Cultural Safety Training&AI-OSCEBehavioural
Ob/Gyn residents undergo standard institutional anti-racism/Indigenous cultural safety training, followed by the same AI-assisted 2S Métis OSCE evaluation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Standard Institutional Cultural Safety Training&AI-OSCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start23 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cultural SafetyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 prospective randomization to either 2S Metis Academic Half Day + AI assigned OSCE or standard institutional training +AI assigned OSCE
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Saskatchewan, University Health Network, Toronto, McMaster University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Melanie Morris, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760675
- Sponsor's protocol ID
- UM:0278574
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07760675
- Acronym / sponsor ID
- UM:0278574
- Conditions
- Cultural Safety, Medical Education, Cultural Competency
- Keywords
- Two-Spirit, Métis, AI, OSCE, Indigenous Health, Obstetrics and Gynecology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Alberta, University of Saskatchewan, University Health Network, Toronto, McMaster University, Canadian Institutes of Health Research (CIHR)
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 prospective randomization to either 2S Metis Academic Half Day + AI assigned OSCE or standard institutional training +AI assigned OSCE
| Arm | Type | Receives |
|---|---|---|
| 2S Metis Cultural Safety Training +AI OSCE | Experimental | Behavioral: 2S Métis Cultural Safety Academic Half Day &AI-OSCEParticipant complete a 2S Metis Academic Half Day focused on trauma -informed care and cultural humility, followed by AI -assisted OSCE evaluation |
| Standard Anti-Racism Training+AI OSCE | Active comparator | Behavioral: Standard Institutional Cultural Safety Training&AI-OSCEParticipants complete standard institutional Indigenous cultural safety/anti-racism training, followed by AI-assisted OSCE evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2S Métis Cultural Safety Academic Half Day &AI-OSCEOb/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. | Behavioural | 2S Metis Cultural Safety Training +AI OSCE |
| Standard Institutional Cultural Safety Training&AI-OSCEOb/Gyn residents undergo standard institutional anti-racism/Indigenous cultural safety training, followed by the same AI-assisted 2S Métis OSCE evaluation. | Behavioural | Standard Anti-Racism Training+AI OSCE |
Primary outcome
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tibetha Kemble, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2S Métis Cultural Safety Academic Half Day &AI-OSCE and Standard Institutional Cultural Safety Training&AI-OSCE in people with Cultural Safety and Medical Education, run by University of Manitoba at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie Morris, MD (2047872682, mmorris@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility Metrics (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.