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Improving the Reliability of LLMs as Medical Assistants for the General Public (LAMP-1)

11. Juni 2026 aktualisiert von: Ji Xunming,MD,PhD, Capital Medical University

Improving the Reliability of LLMs as Medical Assistants for the General Public: a Proof of Concept Simulation Trial

This study will evaluate whether three-minute six-dimensions education(3M-6D education) can improve the reliability of large language models as medical assistants for the general public. Participants will be randomly assigned to receive or not receive 3M-6D education and then use ChatGPT, Gemini, or non-AI information resources. The study will assess relevant condition identification, disposition concordance, red-flag identification, and NASA-TLX score.

Studienübersicht

Detaillierte Beschreibung

This randomized, controlled, proof-of-concept simulation trial will evaluate whether three-minute six-dimensions education (3M-6D education) can improve the reliability of large language models as medical assistants for the general public.

Eligible participants will be randomly assigned in a 1:1:1:1:1 ratio to one of five study groups: the 3M-6D education GPT group, the GPT group, the 3M-6D education Gemini group, the Gemini group, or the control group. Participants in the 3M-6D education GPT and 3M-6D education Gemini groups will receive approximately three minutes of education before using ChatGPT or Gemini.Each participant will be randomly assigned one of 10 standardized clinical scenarios and complete a simulated counseling task in unrestricted natural language within approximately 10 minutes. The study will assess relevant condition identification, disposition concordance, red-flag identification, and NASA-TLX score.

Studientyp

Interventionell

Einschreibung (Geschätzt)

525

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Xuanwu Hospital, Capital Medical University
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  1. Age 18 years or greater, male or female;
  2. Completed primary school or higher education;
  3. Able to use a smartphone or computer to complete online interaction;
  4. No history of acute ischemic stroke, systemic lupus erythematosus, gastric ulcer, pneumonia, acute cardiac infarction, urinary tract infection, uterine fibroids, diabetes, osteoarthritis, or migraine.
  5. Able to understand and comply with study procedures and to provide written informed consent.

Exclusion Criteria:

  1. Currently or previously employed as a healthcare worker;
  2. Previously received systematic medical training;
  3. Currently involved in concurrent research that may interfere with the results of the present trial;
  4. The investigator considered that the participant had other conditions that might affect compliance or preclude participation.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 3M-6D education GPT Group
Participants will first be trained in 3M-6D education, then use ChatGPT to complete a consultation task in unrestricted natural language in approximately 10 minutes.

3M-6D education is designed based on Cognitive Load Theory to reduce the cognitive burden on patients during medical interactions with AI and to improve the clarity and completeness of symptom reporting.

Guided by cognitive load theory and the natural process physicians use to take medical histories, we identified candidate information dimensions and developed a structured expression framework with six dimensions for public health queries through a Delphi expert consensus process. Participants were instructed to use the framework to describe their symptoms across these six dimensions; this process can typically be completed within three minutes, so we call this approach three minutes six dimensions education (3M-6D education).

Participants use ChatGPT to complete a standardized simulated clinical scenarios in unrestricted natural language.
Experimental: 3M-6D education Gemini Group
Participants will first be trained in 3M-6D education, then use Gemini to complete a consultation task in unrestricted natural language in approximately 10 minutes.

3M-6D education is designed based on Cognitive Load Theory to reduce the cognitive burden on patients during medical interactions with AI and to improve the clarity and completeness of symptom reporting.

Guided by cognitive load theory and the natural process physicians use to take medical histories, we identified candidate information dimensions and developed a structured expression framework with six dimensions for public health queries through a Delphi expert consensus process. Participants were instructed to use the framework to describe their symptoms across these six dimensions; this process can typically be completed within three minutes, so we call this approach three minutes six dimensions education (3M-6D education).

Participants use Gemini to complete a standardized simulated clinical scenarios in unrestricted natural language.
Aktiver Komparator: GPT Group
Participants will use ChatGPT to complete a consultation task in unrestricted natural language in approximately 10 minutes.
Participants use ChatGPT to complete a standardized simulated clinical scenarios in unrestricted natural language.
Aktiver Komparator: Gemini Group
Participants will use Gemini to complete a consultation task in unrestricted natural language in approximately 10 minutes.
Participants use Gemini to complete a standardized simulated clinical scenarios in unrestricted natural language.
Kein Eingriff: Control group
Participants will use non-AI tools such as internet searches and medical websites to complete a consultation task in unrestricted natural language in approximately 10 minutes.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relevant conditions identification of the 3M-6D education GPT group compared with the GPT group
Zeitfenster: Usually within 1 hour.
Relevant conditions identification is defined as the proportion of participants whose final response includes the expert-defined final diagnosis or a relevant differential diagnosis.
Usually within 1 hour.
Disposition concordance of the 3M-6D education GPT group compared with the GPT group
Zeitfenster: Usually within 1 hour.
Disposition concordance is defined as the proportion of participants whose final care recommendation matches the expert-defined level. The five levels are self-care, routine outpatient care, urgent outpatient care, emergency department visit, and emergency medical services.
Usually within 1 hour.
Relevant conditions identification of the 3M-6D education Gemini group compared with the Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education Gemini group compared with the Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relevant conditions identification of the 3M-6D education GPT group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Relevant conditions identification of the 3M-6D education Gemini group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education GPT group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education Gemini group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education GPT group compared with the GPT group
Zeitfenster: Usually within 1 hour.
Red-flag identification is defined as the proportion of participants whose final response includes the key warning signs that experts defined for the assigned scenario.
Usually within 1 hour.
Red-flag identification in the 3M-6D education GPT group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education Gemini group compared with the Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education Gemini group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education GPT group compared with the GPT group
Zeitfenster: Usually within 1 hour.
NASA-TLX score is a self-reported task-load score measured after the simulated consultation with a physician. It includes six domains: mental demand, physical demand, temporal demand, effort, frustration, and performance. Each domain is scored from 0 to 100. The total score is the mean of the six domains. Higher scores indicate greater perceived task load.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education GPT group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education Gemini group compared with the Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education Gemini group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Relevant conditions identification of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Disposition concordance of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Red-flag identification in the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
NASA Task Load Index score of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Failure to identify red flags in the 3M-6D education GPT group compared with the GPT group
Zeitfenster: Usually within 1 hour.
Failure to identify red flags is defined as the proportion of participants whose final response does not include the expert-defined red-flag symptoms or warning signs for the assigned standardized simulated clinical scenario.
Usually within 1 hour.
Failure to identify red flags in the 3M-6D education GPT group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Failure to identify red flags in the 3M-6D education Gemini group compared with the Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Failure to identify red flags in the 3M-6D education Gemini group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education GPT group compared with the GPT group
Zeitfenster: Usually within 1 hour.
Underestimation of disposition is defined as the proportion of participants whose final care recommendation is lower than the expert-defined disposition level for the assigned standardized simulated clinical scenario.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education GPT group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education Gemini group compared with the Gemini group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.
Underestimation of disposition in the 3M-6D education Gemini group compared with the control group
Zeitfenster: Usually within 1 hour.
Usually within 1 hour.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Juni 2026

Primärer Abschluss (Geschätzt)

20. Juli 2026

Studienabschluss (Geschätzt)

20. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

11. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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