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

September 23, 2026 updated by: Second Affiliated Hospital, Zhejiang University, School of Medicine

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

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.

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 diagnosis and management planning scores than the LLM-assisted workflow?
  • Does the Agent-assisted workflow yield better diagnosis and management planning scores than the conventional workflow without AI assistance? Researchers will compare three parallel groups (traditional workflow group, LLM-assisted group, Agent-assisted group) to determine whether the agent tool can improve diagnostic and management planning performance 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
  • Work through 6 anonymized simulated HIS admission cases and complete as many as they can.
  • 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.
  • Complete a post-session questionnaire after submitting all cases.

Study Overview

Status

Status

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

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 (Estimated)

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.
180

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Health Services Research
  • 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.
Active Comparator: Traditional group
Other: Traditional Workflow

Conventional resources only: the pre-admission clinical record, conventional search engines, permitted conventional non-generative clinical information resources. No AI assistance.
Experimental: Agent-assisted group
Other: Agent-assisted workflow

Conventional resources (the pre-admission clinical record, conventional search engines, permitted conventional non-generative clinical information resources) 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.
Experimental: LLM-assisted group
Other: LLM-assisted workflow

Conventional resources (the pre-admission clinical record, conventional search engines, permitted conventional non-generative clinical information 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.

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
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.
Within one-hour study

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
Active Response Time per Case
Time Frame: Within one-hour study

Active response time in seconds for each case, recorded automatically by the platform.
Within one-hour study
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-assisted group and LLM-assisted group only.
Within one-hour study

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.
Second Affiliated Hospital, Zhejiang University, School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shangrao People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yuan Ding, Second Affiliated Hospital, Zhejiang University, School of Medicine

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.
September 6, 2026

Primary Completion (Estimated)

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 1, 2026

Study Completion (Estimated)

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 1, 2026

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).
July 29, 2026

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.
August 9, 2026

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.
August 12, 2026

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.
September 28, 2026

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.
September 23, 2026

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.
September 1, 2026

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.
  • 2026-0977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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