NCT07409233

Brief Summary

This study evaluated an online simulation based educational program designed to improve clinician communication skills. Participants were clinicians and clinical trainees who completed simulated patient interactions and communication assessments as part of an educational evaluation. Participants were randomly assigned to receive either an AI based simulation training program or standard educational materials. Communication performance was assessed using standardized rating methods in simulated scenarios. The study did not involve patients or health related clinical interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 8, 2026

Last Update Submit

February 8, 2026

Conditions

Keywords

Medical educationArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Mean Communication Performance Improvement Score in Simulated Patient Encounters

    Communication performance was assessed during simulated patient encounters using standardized rating instruments completed by trained standardized patients or expert reviewers. The mean communication performance score improvement was calculated for each participant and used to describe communication skills following the assigned educational condition.

    Immediately following completion of the assigned educational condition

Secondary Outcomes (5)

  • Immediately following completion of the assigned educational condition

    Immediately following simulated patient encounter

  • Mean Empathy Rating Score in Simulated Encounters

    Immediately following simulated patient encounter

  • Mean Participant Self Reported Confidence Score

    Immediately following completion of the educational intervention

  • Mean Usability Score of the Educational Intervention

    Immediately following completion of the educational intervention

  • Total Participant Satisfaction Score

    Immediately following completion of the educational intervention

Study Arms (2)

SOPHIE Simulation Training

EXPERIMENTAL

Participants assigned to this arm completed an AI based online simulation training program designed to support the development of clinician communication skills. The training involved interactive virtual patient scenarios focused on communication practice in simulated clinical encounters.

Behavioral: SOPHIE Simulation Training

Control Educational Materials

ACTIVE COMPARATOR

Participants assigned to this arm completed standard educational materials related to clinician communication skills. These materials included instructional content such as videos and readings and did not involve interactive simulation training.

Behavioral: Control Educational Materials

Interventions

An online simulation based educational training program that uses interactive virtual patient scenarios to support the development of clinician communication skills in simulated clinical encounters.

SOPHIE Simulation Training

Standard educational content related to clinician communication skills delivered through instructional materials such as videos and readings without interactive simulation.

Control Educational Materials

Eligibility Criteria

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

You may qualify if:

  • Participants are clinicians or clinical trainees involved in patient communication as part of their professional or educational role
  • Age 18 years or older
  • Ability to participate in online educational activities and simulated patient encounters
  • Ability to provide informed consent

You may not qualify if:

  • Prior participation in this study
  • Inability to complete the required online activities or simulated encounters
  • Any condition that in the opinion of the investigator would interfere with participation or data quality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14620, United States

Location

Study Officials

  • Ehsan Hoque, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors rating simulated patient encounters were blinded to participant group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either an AI based simulation training program or a control educational condition and completed simulated patient encounters for assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Computer Science

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 13, 2026

Study Start

June 1, 2024

Primary Completion

December 31, 2024

Study Completion

January 1, 2025

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Communication skill ratings of individual participants, as measured by expert standardized patients, will be made fully public. All data will be fully anonymized.

Shared Documents
ANALYTIC CODE
Time Frame
03/01/2025 - Indefinitely
Access Criteria
The data is publicly available on an online repository.

Locations