- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xunming Ji
- 전화번호: 01083198962
- 이메일: jixm@ccmu.edu.cn
연구 연락처 백업
- 이름: Chuanjie Wu
- 전화번호: 01083199439
- 이메일: wuchuanjie@ccmu.edu.cn
연구 장소
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100053
- Xuanwu Hospital, Capital Medical University
-
연락하다:
- Chuanjie Wu
- 전화번호: 010-83199439
- 이메일: wuchuanjie@ccmu.edu.cn
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
실험적: 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.
|
|
활성 비교기: 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.
|
|
활성 비교기: 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.
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Relevant conditions identification of the 3M-6D education GPT group compared with the GPT group
기간: 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
기간: 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
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Disposition concordance of the 3M-6D education Gemini group compared with the Gemini group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Relevant conditions identification of the 3M-6D education GPT group compared with the control group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Relevant conditions identification of the 3M-6D education Gemini group compared with the control group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Disposition concordance of the 3M-6D education GPT group compared with the control group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Disposition concordance of the 3M-6D education Gemini group compared with the control group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Red-flag identification in the 3M-6D education GPT group compared with the GPT group
기간: 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
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Red-flag identification in the 3M-6D education Gemini group compared with the Gemini group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Red-flag identification in the 3M-6D education Gemini group compared with the control group
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Failure to identify red flags in the 3M-6D education GPT group compared with the GPT group
기간: 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
기간: 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
기간: 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
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Underestimation of disposition in the 3M-6D education GPT group compared with the GPT group
기간: 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
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Underestimation of disposition in the 3M-6D education Gemini group compared with the Gemini group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
|
|
Underestimation of disposition in the 3M-6D education Gemini group compared with the control group
기간: Usually within 1 hour.
|
Usually within 1 hour.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LAMP-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .