Medical EducationNCT07714655
Intelligent Simulated Patient System for Gastroenterology Education
A study testing Intelligent Simulated Patient System (ISPS) and Conventional Clinical Teaching in people with Medical Education and Clinical Competence, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
This randomized controlled trial evaluated a large language model-based Intelligent Simulated Patient System (ISPS) for gastroenterology history-taking education. Ninety medical students were randomly assigned in a 1:1 ratio to 4 weeks of conventional clinical learning or ISPS-assisted training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Clinical Competence, History Taking
- What is being tested?
- Intelligent Simulated Patient System (ISPS) and Conventional Clinical Teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergraduate medical students at Zhejiang Chinese Medical University who had completed their clinical clerkship and the required coursework in Diagnostics and Internal Medicine (Gastroenterology).
- Postgraduate students in Clinical Medicine at the First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine).
- Able and willing to provide written informed consent.
- Willing to complete the entire 4-week study protocol and all outcome assessments.
Who cannot join
- Individuals with extensive prior clinical experience in gastroenterology that could substantially influence baseline performance.
- Individuals with severe visual, hearing, or other impairments that would prevent effective participation in the Intelligent Simulated Patient System training.
- Individuals unable to complete the required training sessions or the final Objective Structured Clinical Examination (OSCE).
- Individuals who withdrew informed consent or had incomplete outcome assessment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang
About this study
Official title: Development and Evaluation of an Intelligent Simulated Patient System Based on Large Language Models for Gastroenterology History-Taking Education: A Prospective Randomized Controlled Trial
This randomized controlled trial evaluated a large language model-based Intelligent Simulated Patient System (ISPS) for gastroenterology history-taking education. Ninety medical students were randomly assigned in a 1:1 ratio to 4 weeks of conventional clinical learning or ISPS-assisted training.
The ISPS used teacher-defined structured case information to support simulated patient interactions and generated item-level formative feedback using predefined scoring rubrics. The implemented system did not use external electronic health record retrieval, retrieval-augmented generation, a vector database, or semantic-similarity threshold scoring.
The primary outcomes were post-intervention medical history-taking performance and clinical diagnostic accuracy. History-taking performance was assessed in a standardized Objective Structured Clinical Examination by two senior physicians who were blinded to group allocation. Secondary outcomes included patient-centered communication competence and participants' acceptance of the ISPS.
Read the detailed description
Background and Objective
The Intelligent Simulated Patient System (ISPS) was developed to provide repeatable history-taking practice, automated formative assessment, and structured feedback for medical students learning gastroenterology. The study evaluated the reliability of the automated history-taking scoring system and the educational effectiveness of ISPS-assisted training.
ISPS Intervention
Teachers configured structured disease templates, patient-specific case information, examination tasks, scoring items, and reference diagnoses within the system. Students conducted multiround history-taking interviews with large language model-driven simulated patients. The simulated patients were instructed to respond only according to the teacher-defined patient information.
After each training encounter, the ISPS evaluated history-taking completeness item by item against a predefined 100-point Medical History-Taking Assessment (MHTA) rubric and generated formative feedback. Patient-centered communication was assessed separately in four domains: exploring the patient's ideas, exploring the patient's concerns, exploring the impact of illness, and expressing understanding and support.
All case information and scoring criteria used in the evaluated version were configured by teachers and provided directly to the model as structured prompt context. The system did not use external electronic health record retrieval, retrieval-augmented generation, a separate vector database, knowledge-graph retrieval, instruction fine-tuning, SBERT-based semantic-similarity threshold scoring, or rule-tree coverage scoring.
Automated Scoring Validation
Before evaluation of the educational intervention, the automated history-taking scoring system was assessed using 50 complete interview records. The ISPS scored each record using the predefined MHTA rubric. Two senior clinical educators independently scored the same records using the identical rubric and were blinded to the ISPS-generated scores and to each other's ratings. Agreement between ISPS-generated scores and the mean expert scores was evaluated using Pearson correlation, the intra-class correlation coefficient, and Bland-Altman analysis.
Randomized Controlled Trial
Ninety eligible medical students who had completed the relevant theoretical and clinical instruction provided written informed consent and were randomly assigned in a 1:1 ratio to the intervention or control group.
Participants in the control group received 4 weeks of conventional clinical learning, including teaching rounds, case-based discussions, paper medical records, bedside interviews, and verbal feedback from senior physicians. Participants in the intervention group independently practiced gastroenterology history taking using the ISPS. After each training encounter, the system provided a formative MHTA score and item-level feedback. These training scores were used for formative learning and were not used as the primary post-intervention outcome.
Outcome Assessment
The primary outcomes were post-intervention MHTA score and clinical diagnostic accuracy. History-taking performance was evaluated independently of the ISPS training platform in a standardized Objective Structured Clinical Examination. Each participant interviewed a trained human standardized patient, and two senior physicians who were blinded to group allocation independently rated the participant using the 100-point MHTA rubric. The mean of the two physician ratings was used as the final MHTA score. Clinical diagnostic accuracy was determined by whether the participant's first diagnosis matched the predefined reference diagnosis for the examination case.
Secondary outcomes included patient-centered communication competence and satisfaction with and acceptance of the ISPS. Communication competence was assessed using a four-domain scale based on the Understanding the Patient's Perspective domain of the SEGUE framework. Each domain was scored from 1 to 5, producing a total score ranging from 4 to 20. Participants in the intervention group completed a Technology Acceptance Model questionnaire after the intervention.
Registration Information
Participant enrollment and follow-up had been completed before this study record was first submitted to ClinicalTrials.gov. The record was subsequently revised to ensure that the intervention description and outcome measures accurately reflected the study as conducted. Previous versions remain available in the ClinicalTrials.gov Record History.
- Conditions
- Medical Education, Clinical Competence, History Taking
- Being tested
- Intelligent Simulated Patient System (ISPS), Conventional Clinical Teaching
- Keywords
- Large Language Model, Artificial Intelligence, Virtual Patient, Gastroenterology, Medical Education, History Taking, Simulation Training, Clinical Skills, Automated Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Simulated Patient System (ISPS)Other
Participants received 4 weeks of self-directed gastroenterology history-taking training using the Intelligent Simulated Patient System (ISPS). Participants selected teacher-configured clinical cases and conducted multiround history-taking interviews with large language model-driven simulated patients. Simulated-patient responses were constrained by teacher-defined structured patient information.
After each training encounter, the ISPS evaluated history-taking completeness item by item using a predefined 100-point Medical History-Taking Assessment rubric and provided individualized formative feedback. Patient-centered communication competence was assessed separately from the complete interview transcript using a four-domain scale. These automated scores and feedback were used solely for formative training and were not used as the primary post-intervention outcome of the randomized trial.
In the system version evaluated in this study, case information and scoring criteria were configure
Conventional Clinical TeachingOther
Participants received conventional clinical education for four weeks, including bedside teaching, case-based learning, paper-based medical record review, and faculty-guided clinical discussions according to the standard curriculum.
| Study group | Role | What they receive |
|---|---|---|
| ISPS Group | Experimental | Participants received four weeks of training using the Intelligent Simulated Patient System (ISPS), a large language model-based virtual patient platform for gastroenterology education. The system provides repeated history-taking practice, automated assessment, and individualized feedback. Receives: Other: Intelligent Simulated Patient System (ISPS) |
| Control Group | Active comparator | Participants received four weeks of conventional clinical education, including bedside teaching, case-based learning, paper-based medical record review, and faculty-guided clinical discussions according to the standard curriculum. Receives: Other: Conventional Clinical Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Diagnostic accuracy was defined as the proportion of participants who correctly identified the primary diagnosis during the standardized OSCE.
Measured: Immediately after the 4-week intervention
History-taking completeness score
History-taking completeness was evaluated during a standardized Objective Structured Clinical Examination (OSCE) using a validated rubric with a total score ranging from 0 to 100. Higher scores indicate more complete history-taking performance.
Measured: Immediately after the 4-week intervention
Secondary outcomes (2)
Communication Competence
Communication competence was assessed from the complete standardized history-taking interview transcript using a four-domain scale based on the Understanding the Patient's Perspective domain of the SEGUE framework. The four domains were exploring the patient's ideas, exploring the patient's concerns, exploring the impact of illness, and expressing understanding and support. Each domain was scored from 1 to 5, producing a total score ranging from 4 to 20. Higher scores indicated better patient-centered communication competence.
Measured: Immediately after the 4-week intervention
Acceptance of the Intelligent Simulated Patient System
Participants in the intervention group completed a 19-item questionnaire based on the Technology Acceptance Model. Items were rated using a 5-point Likert scale and assessed perceived usefulness, perceived ease of use, perceived enjoyment, attitude toward use and behavioral intention, and perceived risks and limitations. Item scores were transformed to a scale ranging from 20 to 100. Higher scores indicated more favorable evaluations, except in the Risks and Limitations domain, in which higher scores indicated greater perceived concerns.
Measured: Immediately after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start10 Aug 2026
- Primary completion25 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the Intelligent Simulated Patient System (ISPS) group or the conventional teaching group for four weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714655
- Sponsor's protocol ID
- ISPS-2026-001
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Intelligent Simulated Patient System Based on Large Language Models for Gastroenterology History-Taking Education: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07714655
- Acronym / sponsor ID
- ISPS-2026-001
- Conditions
- Medical Education, Clinical Competence, History Taking
- Keywords
- Large Language Model, Artificial Intelligence, Virtual Patient, Gastroenterology, Medical Education, History Taking, Simulation Training, Clinical Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial evaluated a large language model-based Intelligent Simulated Patient System (ISPS) for gastroenterology history-taking education. Ninety medical students were randomly assigned in a 1:1 ratio to 4 weeks of conventional clinical learning or ISPS-assisted training.
The ISPS used teacher-defined structured case information to support simulated patient interactions and generated item-level formative feedback using predefined scoring rubrics. The implemented system did not use external electronic health record retrieval, retrieval-augmented generation, a vector database, or semantic-similarity threshold scoring.
The primary outcomes were post-intervention medical history-taking performance and clinical diagnostic accuracy. History-taking performance was assessed in a standardized Objective Structured Clinical Examination by two senior physicians who were blinded to group allocation. Secondary outcomes included patient-centered communication competence and participants' acceptance of the ISPS.
Detailed description
Background and Objective
The Intelligent Simulated Patient System (ISPS) was developed to provide repeatable history-taking practice, automated formative assessment, and structured feedback for medical students learning gastroenterology. The study evaluated the reliability of the automated history-taking scoring system and the educational effectiveness of ISPS-assisted training.
ISPS Intervention
Teachers configured structured disease templates, patient-specific case information, examination tasks, scoring items, and reference diagnoses within the system. Students conducted multiround history-taking interviews with large language model-driven simulated patients. The simulated patients were instructed to respond only according to the teacher-defined patient information.
After each training encounter, the ISPS evaluated history-taking completeness item by item against a predefined 100-point Medical History-Taking Assessment (MHTA) rubric and generated formative feedback. Patient-centered communication was assessed separately in four domains: exploring the patient's ideas, exploring the patient's concerns, exploring the impact of illness, and expressing understanding and support.
All case information and scoring criteria used in the evaluated version were configured by teachers and provided directly to the model as structured prompt context. The system did not use external electronic health record retrieval, retrieval-augmented generation, a separate vector database, knowledge-graph retrieval, instruction fine-tuning, SBERT-based semantic-similarity threshold scoring, or rule-tree coverage scoring.
Automated Scoring Validation
Before evaluation of the educational intervention, the automated history-taking scoring system was assessed using 50 complete interview records. The ISPS scored each record using the predefined MHTA rubric. Two senior clinical educators independently scored the same records using the identical rubric and were blinded to the ISPS-generated scores and to each other's ratings. Agreement between ISPS-generated scores and the mean expert scores was evaluated using Pearson correlation, the intra-class correlation coefficient, and Bland-Altman analysis.
Randomized Controlled Trial
Ninety eligible medical students who had completed the relevant theoretical and clinical instruction provided written informed consent and were randomly assigned in a 1:1 ratio to the intervention or control group.
Participants in the control group received 4 weeks of conventional clinical learning, including teaching rounds, case-based discussions, paper medical records, bedside interviews, and verbal feedback from senior physicians. Participants in the intervention group independently practiced gastroenterology history taking using the ISPS. After each training encounter, the system provided a formative MHTA score and item-level feedback. These training scores were used for formative learning and were not used as the primary post-intervention outcome.
Outcome Assessment
The primary outcomes were post-intervention MHTA score and clinical diagnostic accuracy. History-taking performance was evaluated independently of the ISPS training platform in a standardized Objective Structured Clinical Examination. Each participant interviewed a trained human standardized patient, and two senior physicians who were blinded to group allocation independently rated the participant using the 100-point MHTA rubric. The mean of the two physician ratings was used as the final MHTA score. Clinical diagnostic accuracy was determined by whether the participant's first diagnosis matched the predefined reference diagnosis for the examination case.
Secondary outcomes included patient-centered communication competence and satisfaction with and acceptance of the ISPS. Communication competence was assessed using a four-domain scale based on the Understanding the Patient's Perspective domain of the SEGUE framework. Each domain was scored from 1 to 5, producing a total score ranging from 4 to 20. Participants in the intervention group completed a Technology Acceptance Model questionnaire after the intervention.
Registration Information
Participant enrollment and follow-up had been completed before this study record was first submitted to ClinicalTrials.gov. The record was subsequently revised to ensure that the intervention description and outcome measures accurately reflected the study as conducted. Previous versions remain available in the ClinicalTrials.gov Record History.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either the Intelligent Simulated Patient System (ISPS) group or the conventional teaching group for four weeks.
| Arm | Type | Receives |
|---|---|---|
| ISPS Group | Experimental | Other: Intelligent Simulated Patient System (ISPS)Participants received four weeks of training using the Intelligent Simulated Patient System (ISPS), a large language model-based virtual patient platform for gastroenterology education. The system provides repeated history-taking practice, automated assessment, and individualized feedback. |
| Control Group | Active comparator | Other: Conventional Clinical TeachingParticipants received four weeks of conventional clinical education, including bedside teaching, case-based learning, paper-based medical record review, and faculty-guided clinical discussions according to the standard curriculum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergraduate medical students at Zhejiang Chinese Medical University who had completed their clinical clerkship and the required coursework in Diagnostics and Internal Medicine (Gastroenterology).
- Postgraduate students in Clinical Medicine at the First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine).
- Able and willing to provide written informed consent.
- Willing to complete the entire 4-week study protocol and all outcome assessments.
Key exclusion criteria (4 listed)
- Individuals with extensive prior clinical experience in gastroenterology that could substantially influence baseline performance.
- Individuals with severe visual, hearing, or other impairments that would prevent effective participation in the Intelligent Simulated Patient System training.
- Individuals unable to complete the required training sessions or the final Objective Structured Clinical Examination (OSCE).
- Individuals who withdrew informed consent or had incomplete outcome assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intelligent Simulated Patient System (ISPS)Participants received 4 weeks of self-directed gastroenterology history-taking training using the Intelligent Simulated Patient System (ISPS). Participants selected teacher-configured clinical cases and conducted multiround history-taking interviews with large language model-driven simulated patients. Simulated-patient responses were constrained by teacher-defined structured patient information. After each training encounter, the ISPS evaluated history-taking completeness item by item using a predefined 100-point Medical History-Taking Assessment rubric and provided individualized formative feedback. Patient-centered communication competence was assessed separately from the complete interview transcript using a four-domain scale. These automated scores and feedback were used solely for formative training and were not used as the primary post-intervention outcome of the randomized trial. In the system version evaluated in this study, case information and scoring criteria were configure | Other | ISPS Group |
| Conventional Clinical TeachingParticipants received conventional clinical education for four weeks, including bedside teaching, case-based learning, paper-based medical record review, and faculty-guided clinical discussions according to the standard curriculum. | Other | Control Group |
Primary outcome
Diagnostic accuracy
Time frame: Immediately after the 4-week intervention
Diagnostic accuracy was defined as the proportion of participants who correctly identified the primary diagnosis during the standardized OSCE.
History-taking completeness score
Time frame: Immediately after the 4-week intervention
History-taking completeness was evaluated during a standardized Objective Structured Clinical Examination (OSCE) using a validated rubric with a total score ranging from 0 to 100. Higher scores indicate more complete history-taking performance.
2 secondary outcomes
Communication Competence
Time frame: Immediately after the 4-week intervention
Acceptance of the Intelligent Simulated Patient System
Time frame: Immediately after completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Simulated Patient System (ISPS) and Conventional Clinical Teaching in people with Medical Education and Clinical Competence, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: Immediately after the 4-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.