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NCT07760051
Effects of Agent-assisted, LLM-assisted and Traditional Workflows on Diagnosis and Management Planning at Admission
Conditions: Clinical Decision Support Systems, Diagnostic Reasoning, Artificial Intelligence (AI)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 180
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Location: 2nd Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang
Summary
The goal of this clinical trial is to evaluate whether AI-assisted workflows improve physicians' admission diagnosis and management planning performance on standardized simulated inpatient cases, among practicing internal medicine and surgery physicians across all seniority levels and across three tiers of the Chinese healthcare system.
The main questions it aims to answer are:
* Does the Agent-assisted workflow yield better structured admission diagnosis and management planning scores than standalone LLM assistance?
* Does the Agent-assisted workflow outperform the traditional workflow without AI tools? Researchers will compare three parallel groups (traditional workflow group, LLM-assisted group, Agent-assisted group) to determine whether the Agent tool can improve diagnostic accuracy and efficiency.
Participants will:
* Be recruited from 15 hospitals in China and participate remotely under video proctoring
* Be randomly assigned to one of the three fixed workflows, with randomization stratified by hospital tier, specialty and seniority
* Complete 6 anonymized simulated HIS admission cases within one hour
* Submit structured answers for each case covering principal diagnosis, secondary diagnoses, differential diagnoses, diagnostic justification, next diagnostic or therapeutic steps, consultation and referral decisions, and diagnostic confidence
* Have their operation logs and time consumption recorded automatically by the study platform
Eligibility Criteria
Inclusion Criteria
* Hold a Medical Practitioner Qualification Certificate and/or Medical License, or be a recognized standardized resident physician; able to independently read electronic medical records, laboratory and imaging reports on an HIS.
* Currently engaged in clinical work in internal medicine or surgery at one of the 15 participating hospitals.
* Able to complete the case assessment in one continuous hour without breaks.
* Able to participate remotely under video proctoring, with a stable internet connection and a working camera.
* Voluntarily agree to participate and sign the informed consent form, including the declaration not to use unauthorized AI tools during the assessment.
* Have not participated in case drafting, review, rubric development, or any activity that may leak the reference standard.
Exclusion Criteria
* Have previously accessed the official test cases or reference standard of this study.
* Unable to complete the training module, qualification test, or all experimental tasks.
* Have conflicts of interest, e.g. participation in developing core algorithms of the tested system.
* Unwilling to comply with remote proctoring, including keeping the camera on throughout.
* Judged unsuitable by the investigators.
Source: ClinicalTrials.gov (NCT07760051). StuddyBuddy aggregates publicly available trial information.