- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07651280
Improving the Reliability of LLMs as Medical Assistants for the General Public (LAMP-1)
Improving the Reliability of LLMs as Medical Assistants for the General Public: a Proof of Concept Simulation Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
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
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Xunming Ji
- Telefonnummer: 01083198962
- E-Mail: jixm@ccmu.edu.cn
Studieren Sie die Kontaktsicherung
- Name: Chuanjie Wu
- Telefonnummer: 01083199439
- E-Mail: wuchuanjie@ccmu.edu.cn
Studienorte
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100053
- Xuanwu Hospital, Capital Medical University
-
Kontakt:
- Chuanjie Wu
- Telefonnummer: 010-83199439
- E-Mail: wuchuanjie@ccmu.edu.cn
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Age 18 years or greater, male or female;
- Completed primary school or higher education;
- Able to use a smartphone or computer to complete online interaction;
- No history of acute ischemic stroke, systemic lupus erythematosus, gastric ulcer, pneumonia, acute cardiac infarction, urinary tract infection, uterine fibroids, diabetes, osteoarthritis, or migraine.
- Able to understand and comply with study procedures and to provide written informed consent.
Exclusion Criteria:
- Currently or previously employed as a healthcare worker;
- Previously received systematic medical training;
- Currently involved in concurrent research that may interfere with the results of the present trial;
- The investigator considered that the participant had other conditions that might affect compliance or preclude participation.
Studienplan
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
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- LAMP-1
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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 .
Klinische Studien zur Relevant Conditions Identification
-
McMaster UniversityNational Health and Medical Research Council, Australia; Canadian Institutes... und andere MitarbeiterAbgeschlossenGastrointestinale Blutung (klinisch relevant, oben)Kanada, Australien, Vereinigte Staaten, Brasilien, Kuwait, Pakistan, Saudi-Arabien, Vereinigtes Königreich
-
Ewha Womans University Mokdong HospitalNoch keine RekrutierungArzneimittelbedingte Nebenwirkungen und Nebenwirkungen | Vorhofflimmern (AF) | Gastrointestinale Blutung (klinisch relevant, oben) | Obere gastrointestinale Blutung (UGIB)Südkorea