NCT07277829

Brief Summary

The goal of this quasi-experimental educational study is to learn whether AI-generated post-consultation feedback in social robotic virtual patient interactions improves medical students' clinical performance in medical history-taking. The main question it aims to answer is: Can AI-generated feedback integrated in an AI-enhanced social robotic virtual patient platform improve medical students' clinical performance in medical history taking? Researchers will compare results from standardised examinations following the structure of an objective structured clinical examination (OSCE), of medical students performing virtual patient interactions with AI-generated post consultation feedback compared to medical students who have not received AI-generated feedback. Participants will perform five virtual patient cases in rheumatology using an established virtual patient platform: the Social AI-enhanced Robotic Interface (SARI). After completion of each case, students participate in follow-up seminars with consultant rheumatologists to discuss the cases. After completion of all nine cases, students take part in a OSCE based examination to evaluate medical-history taking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

January 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 20, 2025

Last Update Submit

November 29, 2025

Conditions

Keywords

AIVirtual PatientMedical History TakingSocial RoboticsFeedbackLarge Language Model

Outcome Measures

Primary Outcomes (1)

  • Total OSCE score

    Immediately after completing the virtual outpatient clinic, participating students underwent an OSCE-like evaluation designed to assess performance in medical history-taking and clinical reasoning. The eight-minute evaluation involved interaction with a standardised patient. Performance was assessed by a consultant rheumatologist using a validated rubric, with the assessor blinded to whether students had received feedback. The assessment used a ten-point scale across five domains: communication at consultation start (0-3 points), generic medical history (0-3.5 points), targeted medical history (0-1.5 points), diagnostics and management reasoning (0-1 point), and communication at consultation end (0-1 point).

    Enrollment and evaluation during the same week during a period of 1.5 working days. Evaluation was done following completion of all virtual patient cases at the end of Day 2 of the Virtual Outpatient Clinic.

Secondary Outcomes (2)

  • Pass rate comparisons

    Enrollment and evaluation during the same week during a period of 1.5 working days. Evaluation was done following completion of all virtual patient cases at the end of Day 2 of the Virtual Outpatient Clinic.

  • Individual OSCE domain comparisons

    Enrollment and evaluation during the same week during a period of 1.5 working days. Evaluation was done following completion of all virtual patient cases at the end of Day 2 of the Virtual Outpatient Clinic.

Study Arms (2)

AI-generated feedback

EXPERIMENTAL

AI-generated post consultation feedback following interaction with the AI-enhanced social robotic virtual patient platform the Social AI-enhanced Robotic Interface (SARI)

Device: AI post consultation feedback

Control

NO INTERVENTION

Interaction with the AI-enhanced social robotic virtual patient platform the Social AI-enhanced Robotic Interface (SARI) with no post consultation feedback.

Interventions

A feedback algorithm which follows a two-stage design was implemented to generate post consultation feedback using large language models (LLMs) from OpenAI. The first stage of the feedback algorithm is an assessment model that evaluates student-VP dialogues using a predefined rubric developed in collaboration with consultant rheumatologists. This assessment model was iteratievly refined and validated prior to the study. The second stage of the feedback algorithm involves generating a feedback output based on the stageone assessment Students received approximately one page of structured written feedback immediately after completing each VP encounter with SARI. This feedback focused on medical history-taking within the context of rheumatology and included constructive comments with examples covering general history-taking, specific symptom enquiries, and systematic assessment of the VPs.

AI-generated feedback

Eligibility Criteria

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

You may qualify if:

  • Sixth-semester medical students at Karolinska Institutet.
  • Assigned to clinical rotations in rheumatology.
  • Participating between January and June 2025.

You may not qualify if:

  • \- None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Solna, SE-171 76, Sweden

Location

Related Publications (2)

  • Borg A, Jobs B, Huss V, Gentline C, Espinosa F, Ruiz M, Edelbring S, Georg C, Skantze G, Parodis I. Enhancing clinical reasoning skills for medical students: a qualitative comparison of LLM-powered social robotic versus computer-based virtual patients within rheumatology. Rheumatol Int. 2024 Dec;44(12):3041-3051. doi: 10.1007/s00296-024-05731-0. Epub 2024 Oct 16.

  • Borg A, Georg C, Jobs B, Huss V, Waldenlind K, Ruiz M, Edelbring S, Skantze G, Parodis I. Virtual Patient Simulations Using Social Robotics Combined With Large Language Models for Clinical Reasoning Training in Medical Education: Mixed Methods Study. J Med Internet Res. 2025 Mar 3;27:e63312. doi: 10.2196/63312.

Study Officials

  • Ioannis Parodis, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Medical students/participants will know if they are part of intervention or control arm. Outcome assessors will be blinded to participant conditions during OSCE based examinations.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 11, 2025

Study Start

January 27, 2025

Primary Completion

June 5, 2025

Study Completion

June 5, 2025

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The datasets generated and analysed during this study are available from the corresponding author upon reasonable request. Access to data will be granted following appropriate ethical review and data sharing agreements and will require completion of a data transfer agreement and approval from the Swedish Ethical Review Authority, as per Swedish data protection regulations and the European General Data Protection Regulation (GDPR).

Shared Documents
STUDY PROTOCOL, SAP

Locations