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

23. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

180

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310009
        • Rekruttering
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Traditionel gruppe
Andet: Traditional Workflow

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Normalized Structured Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Active Response Time per Case
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Samarbejdspartnere

Shangrao People's Hospital

Efterforskere

  • Studiestol: Yuan Ding, Second Affiliated Hospital, Zhejiang University, School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. september 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

29. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. august 2026

Først opslået (Faktiske)

12. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2026-0977

Plan for individuelle deltagerdata (IPD)

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