Simulated Patient and AI-based Roleplay for History-taking (SPAR-H)

January 11, 2025 updated by: zhen wang

Feasibility Study of Using GPT for History-taking Training in Medical Education

The goal of this clinical trial is to evaluate whether AI-based simulated patient training can improve clinical reasoning and history-taking skills in medical students. The main questions it aims to answer is:

Does GPT-based simulated patient training improve medical students' history-taking skills compared to traditional role-playing methods?

Participants will:

Participants in the intervention group perform medical history-taking conversations with an AI-simulated patient. Receive AI-generated structured feedback on their performance. The control group participated in role-playing exercises with instructors who acted as patients, receiving feedback after each session. Complete standardized assessments to evaluate clinical reasoning and decision-making skills.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Affiliated Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:Medical education enrollment:

Students enrolled in a medical or health-related professional program.

Clinical coursework completion:

Students who have completed basic clinical coursework, including foundational topics in patient communication and clinical reasoning.

Age group:

Participants aged 18-30 years to reflect typical medical student demographics.

Language proficiency:

Adequate proficiency in the language used for the study (e.g., English) to effectively interact with the AI-simulated patient and understand feedback.

Willingness and availability:

Students who provide informed consent and are willing to participate in all required study activities, including training sessions and assessments.

Access to technology:

Ability to access and use the necessary technology, such as a computer and internet connection, to complete the simulated patient interactions.

-

Exclusion Criteria:Non-medical background:

Students not enrolled in medical or related health professions programs. Students in early years of study who have not completed basic clinical coursework.

Technical limitations:

Inability to access or use the required technology (e.g., computer or online platforms).

Time constraints:

Inability to complete all required training and assessments within the study timeline.

Language barriers:

Insufficient proficiency in the language used for the study (e.g., English) to effectively communicate or understand the simulated patient interactions.

Health-related factors:

Conditions that may impair participation, such as significant hearing or vision impairment, or severe psychological conditions.

Prior participation in similar studies:

Students who have already participated in studies involving similar AI-based simulated patient training or feedback.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intervention group
using GPT-simulated patients
Behavioral: GPT-simulated patients
GPT-simulated patients
Active Comparator: control group
using traditional role-playing
Behavioral: traditional role-playing
traditional role-playing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
structured clinical examination to measure students' abilities in history taking
Time Frame: From enrollment to the end of treatment at 4 weeks

Pre and Post Training: This primary endpoint measures improvements in students' clinical skills using a structured clinical examination conducted both before and after the training. The total score is out of 100 points, aggregated from four components:

History Collection (30 points): Assesses the level of detail in the chief complaint and symptoms (10 points), the ability to understand and identify patient information (10 points), and the appropriateness and logic of follow-up questions (10 points).

Clinical Reasoning (30 points): Evaluates the thoroughness of diagnostic thinking (15 points) and efficiency in processing information and forming clinical judgments (15 points).

Communication Skills (20 points): Includes interaction with patients (10 points) and clarity of information delivery (10 points).

Professional Behavior (20 points): Measures adherence to clinical procedural norms (10 points) and professional attitude towards patients (1
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Training Feedback Assessment
Time Frame: From enrollment to the end of treatment at 4 weeks

Training Feedback Assessment Measurement Tool: Structured Questionnaire on a 5-point Likert scale.

Components Assessed:

  • Post-class self-directed learning.
  • Enthusiasm for learning.
  • Communication and feedback skills.
  • Expressiveness.
  • Interview logical reasoning ability.
  • Anxiety levels during the interview process. Description: This secondary endpoint collects feedback on the training methods' effectiveness through a structured questionnaire. Each aspect is rated on a 5-point Likert scale, where 1 indicates 'strongly disagree' and 5 indicates 'strongly agree'.
From enrollment to the end of treatment at 4 weeks
Student Satisfaction Survey
Time Frame: From enrollment to the end of treatment at 4 weeks

Measurement Tool: Satisfaction Questionnaire on a 5-point Likert scale.

Components Assessed:

  • Diversity of diseases encountered during training.
  • Naturalness of patient interaction.
  • Usability of the training methods.
  • Likelihood of recommending the training to peers. Description: This secondary endpoint evaluates student satisfaction concerning various aspects of the training experience. The questionnaire assesses each factor on a 5-point Likert scale, where 1 is 'very dissatisfied' and 5 is 'very satisfied'.
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
zhen wang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GPT for history-taking Trainin
  • 2023jyxm1150 (Other Grant/Funding Number: 2023 Anhui Province Quality Engineering Project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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