Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:37 PM
Study NCT ID:
NCT07409233
Status:
COMPLETED
Last Update Posted:
2026-02-13
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOPHIE: Standardized Online Patient for Healthcare Interaction Education
Sponsor:
University of Rochester
Organization:
Study Overview
Official Title:
SOPHIE: Standardized Online Patient for Healthcare Interaction Education
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOPHIE
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: