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NCT Number: NCT07760051

Effects of Agent-assisted, LLM-assisted and Traditional Workflows on Diagnosis and Management Planning at Admission

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

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Key information

Conditions

Clinical Decision Support Systems Artificial Intelligence (AI) Diagnostic Reasoning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location contact

Human Subject Research Ethics Committee

CONTACT

[email protected]

+86 0571 87783759

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Agent-assisted workflow

Other

Conventional resources (pre-admission clinical record, search engines) plus an in-system Agent entry that automatically reads the full record and report images, produces a structured summary with source-text tracing, and supports multi-turn Q&A and one-click editable drafts.

LLM-assisted workflow

Other

Conventional resources plus an in-system multi-turn AI dialogue entry. The AI does not automatically read the record; participants paste text or send partial screenshots.

traditional workflow

Other

Conventional resources only: the pre-admission clinical record, standard search engines. No AI assistance.

Primary outcomes

  1. Mean Normalized Structured Score

    Time frame: Within one-hour study

    Mean of the rescaled case scores (each case rescaled to 100), divided by the number of cases completed; range 0 to 100.

Secondary outcomes

  1. Active Response Time per Case

    Time frame: Within one-hour study

    Active response time in seconds for each case, recorded automatically by the platform.Time is counted per case while that case's response page is active.

  2. Degree of Adherence to AI-Generated Recommendations

    Time frame: Within one-hour study

    Degree to which the submitted answer incorporates AI output. Assessed in the Agent and LLM arms only.

Study contacts

Contact information is provided by the study sponsor or research team.

Yixin Zhang

CONTACT

[email protected]

+86 19157950225

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Collaborators

  • Shangrao People's Hospital

Registry information

Official study title

Effects of Agent-assisted, LLM-assisted and Traditional Workflows on Diagnosis and Management Planning at Admission: A Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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