Improving the Reliability of LLMs as Medical Assistants for the General Public (LAMP-1)
11 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
525
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Xunming Ji
- Numéro de téléphone: 01083198962
- E-mail: jixm@ccmu.edu.cn
Sauvegarde des contacts de l'étude
- Nom: Chuanjie Wu
- Numéro de téléphone: 01083199439
- E-mail: wuchuanjie@ccmu.edu.cn
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100053
- Xuanwu Hospital, Capital Medical University
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Contact:
- Chuanjie Wu
- Numéro de téléphone: 010-83199439
- E-mail: wuchuanjie@ccmu.edu.cn
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Expérimental: 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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Comparateur actif: 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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Comparateur actif: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Relevant conditions identification of the 3M-6D education GPT group compared with the GPT group
Délai: 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
Délai: 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
Délai: 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
Délai: Usually within 1 hour.
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Usually within 1 hour.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Relevant conditions identification of the 3M-6D education GPT group compared with the control group
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Usually within 1 hour.
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Usually within 1 hour.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Failure to identify red flags in the 3M-6D education GPT group compared with the GPT group
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Usually within 1 hour.
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Usually within 1 hour.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
20 juin 2026
Achèvement primaire (Estimé)
20 juillet 2026
Achèvement de l'étude (Estimé)
20 juillet 2026
Dates d'inscription aux études
Première soumission
11 juin 2026
Première soumission répondant aux critères de contrôle qualité
11 juin 2026
Première publication (Réel)
16 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- LAMP-1
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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