SOPHIE: Standardized Online Patient for Healthcare Interaction Education (SOPHIE)

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.

Study Overview

• Status: Completed
• Conditions: Clinician Communication Skills Training
• Intervention / Treatment: Behavioral: SOPHIE Simulation Training; Behavioral: Control Educational Materials

Detailed Description

This study was a randomized educational evaluation of an AI based online simulation training program designed to support the development of clinician communication skills. Participants included clinicians and clinical trainees who routinely engage in patient communication as part of their professional roles.

Participants were randomly assigned to either the SOPHIE simulation training program or a control educational condition consisting of standard instructional materials. All participants completed simulated patient encounters that were evaluated by trained standardized patients and expert raters using structured communication assessment tools.

The primary outcomes of interest focused on communication skill performance in simulated scenarios as well as participant feedback on the educational experience. The study did not involve real patients clinical care or health related interventions and was conducted as an educational research project.

The study was approved by the institutional review board prior to participant enrollment. It was registered retrospectively in ClinicalTrials.gov at the request of a journal during manuscript preparation.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOPHIE Simulation Training; 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; 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.
Active Comparator: Control Educational Materials; 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; Standard educational content related to clinician communication skills delivered through instructional materials such as videos and readings without interactive simulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediately following completion of the assigned educational condition	A structured communication skills rating tool was used to evaluate specific communication behaviors demonstrated during simulated patient encounters. The total communication skill rating score was calculated for each participant.	Immediately following simulated patient encounter
Mean Empathy Rating Score in Simulated Encounters	Empathy was assessed during simulated patient encounters using standardized empathy rating scales completed by trained evaluators. The mean empathy rating score was calculated for each participant.	Immediately following simulated patient encounter
Mean Participant Self Reported Confidence Score	Participant confidence in communication skills was assessed using a self reported questionnaire administered after completion of the educational intervention. Mean confidence scores were calculated across questionnaire items.	Immediately following completion of the educational intervention
Mean Usability Score of the Educational Intervention	Usability of the assigned educational intervention was assessed using a standardized usability questionnaire. Mean usability scores were calculated to describe participant experience with the intervention.	Immediately following completion of the educational intervention
Total Participant Satisfaction Score	Participant satisfaction with the educational experience was assessed using a structured questionnaire. The total satisfaction score was calculated for each participant.	Immediately following completion of the educational intervention

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: James P. Wilmot Cancer Center
• Investigators: Principal Investigator: Ehsan Hoque, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Medical education; Artificial intelligence
• Other Study ID Numbers: STUDY00006689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Communication skill ratings of individual participants, as measured by expert standardized patients, will be made fully public. All data will be fully anonymized.
• IPD Sharing Time Frame: 03/01/2025 - Indefinitely
• IPD Sharing Access Criteria: The data is publicly available on an online repository.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No