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OpenTrials
Completed

NCT Number: NCT07409233

SOPHIE: Standardized Online Patient for Healthcare Interaction Education

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.

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Key information

Conditions

Clinician Communication Skills Training

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14620, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOPHIE Simulation Training

Behavioral

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.

Control Educational Materials

Behavioral

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

Primary outcomes

  1. Mean Communication Performance Improvement Score in Simulated Patient Encounters

    Time frame: Immediately following completion of the assigned educational condition

    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.

Secondary outcomes

  1. Immediately following completion of the assigned educational condition

    Time frame: Immediately following simulated patient encounter

    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.

  2. Mean Empathy Rating Score in Simulated Encounters

    Time frame: Immediately following simulated patient encounter

    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.

  3. Mean Participant Self Reported Confidence Score

    Time frame: Immediately following completion of the educational intervention

    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.

  4. Mean Usability Score of the Educational Intervention

    Time frame: Immediately following completion 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.

  5. Total Participant Satisfaction Score

    Time frame: Immediately following completion of the educational intervention

    Participant satisfaction with the educational experience was assessed using a structured questionnaire. The total satisfaction score was calculated for each participant.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • James P. Wilmot Cancer Center

Registry information

Acronym: SOPHIE

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.