NCT07107880

Brief Summary

This study will evaluate whether a web-based artificial intelligence platform (AI) (Clinical Mind AI \[CMAI\] Stanford, CA), can assess communication skills in anesthesiology trainees, including residents and fellows, in the setting of disclosing medical errors. All participants will participate in an AI-generated simulation by using the platform remotely, and CMAI will assess trainee performance immediately after the simulation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

July 23, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 10, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

July 23, 2025

Last Update Submit

April 21, 2026

Conditions

Keywords

Voice Artificial Intelligence (AI)SimulationClinical Mind Artificial Intelligence (CMAI)Medical Error Disclosure

Outcome Measures

Primary Outcomes (1)

  • Reliability of AI Conversational Performance Assessment

    The primary outcome is to evaluate the reliability of the Clinical Mind AI (CMAI) platform in accurately assessing the communication skills of medical education trainees during a simulated interaction. To measure this outcome, the CMAI will use the Breaking Bad News Assessment Schedule (BBAS), a validated tool assessing participant's communication skills in five domains: 1) Setting the scene, 2) Breaking the news, 3) Eliciting concerns, 4) Informative giving, and 5) Empathy and Support. It includes 17 items, each with sub questions, rated on a 5-point Likert scale from (1-5), where score meanings may vary by each question. The scoring will be guided by Breaking Bad News Rubric, which outlines performance criteria for each item on the BBAS. In addition, two trained human evaluators will independently asses the participant's communication skills using the same BBAS tool and rubric. Lastly, both CMAI and human scores will be compared to determine the reliability of the CMAI platform.

    Immediately after the simulation

Secondary Outcomes (2)

  • Usability of CMAI Simulation Platform

    immediatley after the simulation

  • Satisfaction of CMAI Simulation

    immediately after the simulation

Study Arms (1)

Voice Artificial Intelligence (AI) Group

EXPERIMENTAL

Participants will remotely engage with an AI-simulated parent of a pediatric patient through a voice call, discussing a clinical scenario concerning their child. The participant's communication skills will be assessed using an artificial intelligence (AI) system and two human evaluators using the same rating scales.

Other: Communication Assessment through AI and Human

Interventions

Participants will remotely engage in an AI-generated simulation that presents an voice-based conversation with a simulated parent of a pediatric patient. The scenario involves discussing a clinical scenario concerning their child. Following the simulation, the participant's communication skills will be assessed using an artificial intelligence (AI) system trained to evaluate the key aspects of communication using standardized rating scales. In addition, two human evaluators will assess the participant's communication skills using the same rating scales.

Voice Artificial Intelligence (AI) Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant's must be 18 years of age or older
  • Graduate medical trainess such as residents and fellows at all levels of training excluding PGY1 trainees at Department of Anesthesiology, Perioperative, and Pain Medicine at Stanford University
  • Able to speak and understand English
  • Willing and able to provide consent to participate in research
  • Able to participate in Artificial Intelligence communication simulation

You may not qualify if:

  • Non-English speaker
  • unable to provide consent to participate in research
  • individual with no access to the necessary technology (internet, computer/smart device) required for participating in the digital, voice-based interaction with the AI platform

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

RECRUITING

Study Officials

  • Thomas Caruso, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asheen Rama, MD

CONTACT

Thomas Caruso, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 6, 2025

Study Start

November 10, 2025

Primary Completion (Estimated)

September 14, 2026

Study Completion (Estimated)

November 14, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations