RSMI HEALS (Health Equity Advances Through Language Solutions) (AI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 700
- Locations
- 16
- Primary Endpoint
- Number of interpretation errors
Study Overview
Brief Summary
The study will be conducted in 2 overlapping phases. In Phase 1, there will be a 3-arm randomized controlled trial of Remote Simultaneous Medical Interpreting/RSMI (Arm 1), versus Remote Consecutive Medical Interpreting/RCMI (Arm 2) and versus Remote Consecutive Video Medical Interpreting/RCVI (Arm 3) in breast cancer outpatient clinical encounters with Spanish- and Mandarin-speaking patients with Limited English Proficiency/LEP (Stages II and III disease) and English- speaking providers (who do not speak Spanish/Mandarin). In Phase 2, there will be a sequential mixed-methods explanatory, multi-stakeholder process evaluation to gather implementation potential data.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Phase I Patients
- •Age >=18 years (per EMR)
- •Preferred language for healthcare is Spanish or Mandarin (per self-report)
- •Limited English Proficient; cannot speak English "very well" (per self-report)
- •Diagnosis of breast cancer or gastrointestinal (per EMR)
- •Will be visiting MSK oncology teams for the first or second appointment (per EMR)
- •Agrees to be audio-recorded (per self-report)
- •Phase 1 Providers
- •Breast or gastrointestinal cancer provider who sees patients (e.g., breast or gastrointestinal oncologists, advanced practice providers, and/or nurses)
- •Does not speak Spanish and/or Mandarin; providers who speak one language and not the other may participate (e.g., speaks Spanish but not Mandarin) (per self-report)
- •Agrees to be audio-record (per self-report) Phase 2 (clinic staff only; patient participants will be drawn from Phase 1)
- •Is a staff member who works/worked in one of the study clinic sites during the period of Phase 1 RCT study activities
- •Agrees to be audio-recorded (per self-report)
Exclusion Criteria
- •Phase 1 Patients
- •Has significant psychiatric disturbance (i.e., acute psychiatric symptoms) sufficient to preclude completion of the assessments, interviews, or informed consent (per EMR, patient's care team, or study team)
- •Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patients, care team, or study team)
- •Phase I Providers
- •Phase 2 (clinic staff only; Phase 1 patient participants follow above criteria)
Arms & Interventions
Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
Intervention: Remote Simultaneous Medical Interpreting/RSMI (Other)
Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
Intervention: Remote Consecutive Medical Interpreting/RCMI (Other)
Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers
Intervention: Remote Consecutive Video Medical Interpreting/RCVI (Other)
Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluation
Will examine RSMI utilization (Arm 1 participants only and clinic staff), intervention barriers and facilitators, and implementation potential
Intervention: Remote Simultaneous Medical Interpreting/RSMI (Other)
Outcomes
Primary Outcomes
Number of interpretation errors
Time Frame: up to 30 days
Via translation and transcription of audio recordings, errors will be determined in the interpretation of medical facts made in each of the RCT arms during Study Visit 1 (post- diagnosis)
Secondary Outcomes
No secondary outcomes reported