- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Xunming Ji
- Numer telefonu: 01083198962
- E-mail: jixm@ccmu.edu.cn
Kopia zapasowa kontaktu do badania
- Nazwa: Chuanjie Wu
- Numer telefonu: 01083199439
- E-mail: wuchuanjie@ccmu.edu.cn
Lokalizacje studiów
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Beijing Municipality
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Beijing, Beijing Municipality, Chiny, 100053
- Xuanwu Hospital, Capital Medical University
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Kontakt:
- Chuanjie Wu
- Numer telefonu: 010-83199439
- E-mail: wuchuanjie@ccmu.edu.cn
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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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.
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Eksperymentalny: 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.
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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.
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Aktywny komparator: GPT Group
Participants will use ChatGPT to complete a consultation task in unrestricted natural language in approximately 10 minutes.
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Participants use ChatGPT to complete a standardized simulated clinical scenarios in unrestricted natural language.
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Aktywny komparator: Gemini Group
Participants will use Gemini to complete a consultation task in unrestricted natural language in approximately 10 minutes.
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Participants use Gemini to complete a standardized simulated clinical scenarios in unrestricted natural language.
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Brak interwencji: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Relevant conditions identification of the 3M-6D education GPT group compared with the GPT group
Ramy czasowe: Usually within 1 hour.
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Relevant conditions identification is defined as the proportion of participants whose final response includes the expert-defined final diagnosis or a relevant differential diagnosis.
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Usually within 1 hour.
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Disposition concordance of the 3M-6D education GPT group compared with the GPT group
Ramy czasowe: Usually within 1 hour.
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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.
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Usually within 1 hour.
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Relevant conditions identification of the 3M-6D education Gemini group compared with the Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Disposition concordance of the 3M-6D education Gemini group compared with the Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Relevant conditions identification of the 3M-6D education GPT group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Relevant conditions identification of the 3M-6D education Gemini group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Disposition concordance of the 3M-6D education GPT group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Disposition concordance of the 3M-6D education Gemini group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Red-flag identification in the 3M-6D education GPT group compared with the GPT group
Ramy czasowe: Usually within 1 hour.
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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.
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Usually within 1 hour.
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Red-flag identification in the 3M-6D education GPT group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Red-flag identification in the 3M-6D education Gemini group compared with the Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Red-flag identification in the 3M-6D education Gemini group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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NASA Task Load Index score of the 3M-6D education GPT group compared with the GPT group
Ramy czasowe: Usually within 1 hour.
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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.
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Usually within 1 hour.
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NASA Task Load Index score of the 3M-6D education GPT group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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NASA Task Load Index score of the 3M-6D education Gemini group compared with the Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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NASA Task Load Index score of the 3M-6D education Gemini group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Relevant conditions identification of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Disposition concordance of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Red-flag identification in the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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NASA Task Load Index score of the 3M-6D education GPT group compared with the 3M-6D education Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Failure to identify red flags in the 3M-6D education GPT group compared with the GPT group
Ramy czasowe: Usually within 1 hour.
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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.
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Usually within 1 hour.
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Failure to identify red flags in the 3M-6D education GPT group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Failure to identify red flags in the 3M-6D education Gemini group compared with the Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Failure to identify red flags in the 3M-6D education Gemini group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Underestimation of disposition in the 3M-6D education GPT group compared with the GPT group
Ramy czasowe: Usually within 1 hour.
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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.
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Usually within 1 hour.
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Underestimation of disposition in the 3M-6D education GPT group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Underestimation of disposition in the 3M-6D education Gemini group compared with the Gemini group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Underestimation of disposition in the 3M-6D education Gemini group compared with the control group
Ramy czasowe: Usually within 1 hour.
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Usually within 1 hour.
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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- LAMP-1
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Relevant Conditions Identification
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Psychedelic Data SocietyMaastricht University; Quantified Citizen Technologies Inc.Jeszcze nie rekrutacjaBadanie No Conditions koncentruje się na używaniu substancji i osobowości