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

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

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

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

180

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310009
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Tradisjonell gruppe
Conventional resources only: the pre-admission clinical record, standard search engines. No AI assistance.
Eksperimentell: Agent-assisted group
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.
Eksperimentell: LLM-assisted group
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
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 and LLM arms only.
Within one-hour study
Active Response Time per Case
Tidsramme: 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.
Within one-hour study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

29. juli 2026

Først innsendt som oppfylte QC-kriteriene

9. august 2026

Først lagt ut (Faktiske)

12. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere