NCT07615621

Brief Summary

This study evaluated whether an emotionally and interactionally adaptive real-time voice virtual patient can improve clinical communication training for resident physicians. Communication with patients in emotionally challenging situations, such as breaking bad news, requires clinicians to deliver information clearly, recognize emotional cues, respond empathically, and maintain a coherent interaction. Standardized patient training can support these skills but is resource intensive and difficult to provide repeatedly. Real-time voice virtual patients may offer scalable practice opportunities, but simple spoken interaction alone may not provide patient responses that change meaningfully according to the learner's communication. The adaptive virtual patient used in this study was designed to update the patient's emotional tone, openness, defensiveness, and interactional style during the conversation based on the learner's communication behavior. The study compared this adaptive virtual patient training with a non-adaptive real-time voice virtual patient and with standardized patient training. Resident physicians were randomly assigned in a 1:1:1 ratio to one of three groups: emotionally and interactionally adaptive virtual patient training, non-adaptive virtual patient training, or standardized patient training. Participants completed two communication training sessions focused on breaking bad news. After training, participants completed learner-reported measures of perceived response contingency and patient realism. Approximately four weeks later, participants completed a mini-objective structured clinical examination using a human standardized patient to assess communication performance in a delayed near-transfer setting. The primary outcome was the total mini-OSCE communication score at four weeks. Secondary outcomes included mini-OSCE domain scores for structured delivery, emotional responsiveness, and interactional process; learner-reported response contingency and patient realism; and expert-rated behavioral consistency and clinical credibility of virtual patient interactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 16, 2026

Last Update Submit

May 28, 2026

Conditions

Keywords

Virtual PatientReal-Time Voice InteractionClinical CommunicationResident PhysiciansMedical EducationGenerative Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Four-Week Mini-OSCE Total Communication Score

    Communication performance was assessed approximately four weeks after training using a mini-objective structured clinical examination with a human standardized patient. The total score was based on a 9-item structured communication rating scale covering structured delivery, emotional responsiveness, and interactional process. Each item was rated from 1 to 5, yielding a total score range of 9 to 45. Higher scores indicate better clinical communication performance. Scores from two blinded expert raters were averaged to generate participant-level total scores.

    4 weeks after completion of training

Secondary Outcomes (3)

  • Four-Week Mini-OSCE Domain Scores

    4 weeks after completion of training

  • Learner-Reported Perceived Response Contingency and Patient Realism

    Immediately after training session 2 (each session was 45 minutes)

  • Expert-Rated Behavioral Consistency and Clinical Credibility of Virtual Patient Interactions

    Training session 2(each session was 45 minutes)

Study Arms (3)

Adaptive Virtual Patient Training

EXPERIMENTAL

Participants assigned to this arm completed two breaking-bad-news communication training sessions with an emotionally and interactionally adaptive real-time voice virtual patient. The virtual patient updated its emotional tone, openness, defensiveness, and interactional style during the conversation based on the participant's communication behavior.

Behavioral: Adaptive Real-Time Voice Virtual Patient Training

Non-Adaptive Virtual Patient Training

ACTIVE COMPARATOR

Participants assigned to this arm completed two breaking-bad-news communication training sessions with a non-adaptive real-time voice virtual patient. The platform, case structure, voice interaction format, and training exposure were matched to the adaptive virtual patient arm, but the patient's emotional and interactional style did not dynamically update based on participant communication behavior.

Behavioral: Non-Adaptive Real-Time Voice Virtual Patient Training

Standardized Patient Training

ACTIVE COMPARATOR

Participants assigned to this arm completed two breaking-bad-news communication training sessions with trained standardized patients. Cases, training objectives, session duration, and communication tasks were structurally matched to the virtual patient arms.

Behavioral: Standardized Patient Training

Interventions

Participants completed two breaking-bad-news communication training sessions with an emotionally and interactionally adaptive real-time voice virtual patient. The virtual patient interacted with participants through continuous spoken dialogue and dynamically updated its emotional tone, openness, defensiveness, and interactional style based on the participant's communication behavior. The adaptive mechanism was designed to provide behavior-contingent patient responses during the encounter.

Adaptive Virtual Patient Training

Participants completed two breaking-bad-news communication training sessions with a non-adaptive real-time voice virtual patient. The platform, case structure, spoken interaction format, training exposure, and communication tasks were matched to the adaptive virtual patient condition. Unlike the adaptive condition, the virtual patient did not dynamically update its emotional or interactional state based on the participant's communication behavior.

Non-Adaptive Virtual Patient Training

Participants completed two breaking-bad-news communication training sessions with trained human standardized patients. The cases, training objectives, session duration, and communication tasks were structurally matched to the virtual patient training conditions. Standardized patients were trained to portray the assigned clinical communication scenarios using standardized case scripts and interactional guidance.

Standardized Patient Training

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Resident physicians in postgraduate years 1-3.
  • Participants who had received basic clinical communication training or related instruction.
  • Participants who had not received systematic, specialized training in breaking bad news communication.
  • Able to complete two training sessions and the four-week follow-up mini-OSCE assessment.
  • Willing to participate and able to provide written informed consent.

You may not qualify if:

  • Prior systematic training in breaking bad news, advanced communication skills, or similar specialized communication training.
  • Prior participation in pilot testing or system testing related to this study.
  • Unable to complete the required training sessions or follow-up assessment.
  • Unwilling to have training or assessment sessions recorded for research scoring and analysis.
  • Concurrent participation in another communication-skills intervention study that could affect communication performance.
  • Any other condition judged by the investigators to make participation inappropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and training facilitators could not be masked because the intervention modalities were visibly different. Outcome assessors who rated the four-week mini-OSCE recordings were masked to group assignment. Expert raters evaluating virtual patient interaction quality were also masked to condition where applicable.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were randomized in a 1:1:1 ratio to one of three parallel groups: emotionally and interactionally adaptive real-time voice virtual patient training, non-adaptive real-time voice virtual patient training, or standardized patient training. All groups completed two structurally matched breaking-bad-news communication training sessions, followed by a four-week delayed mini-OSCE assessment using a human standardized patient.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Chief Physician, Department of General Surgery

Study Record Dates

First Submitted

May 16, 2026

First Posted

May 29, 2026

Study Start

December 1, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared because participant consent and institutional ethics approval do not permit unrestricted public release of human-subject data. Summary data and study materials sufficient to interpret the findings will be provided in the publication and supplementary materials. Additional deidentified data may be made available from the corresponding author upon reasonable request, subject to institutional and ethics approval.

Locations