- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07917975
Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience. (ORL-CareBOT)
Artificial intelligence (AI), and particularly large language models (LLMs), is playing an increasingly important role in medical practice by facilitating documentation, data analysis, and communication with patients. These tools may improve access to medical information and reduce certain repetitive tasks; however, their use remains limited by risks of errors, hallucinations, variability in responses, and the lack of evaluation in real-world healthcare settings.
In the field of patient-provider communication, several studies have shown that AI-generated responses may be perceived as being as relevant as, or even more empathetic and clearer than, those provided by physicians. However, these findings are based predominantly on simulated scenarios and do not allow conclusions regarding the safety of autonomous use in clinical practice.
Managing patient inquiries outside scheduled consultations represents a substantial workload for healthcare teams. Generative AI could help address this demand, but its implementation requires medical oversight and rigorous safety evaluation.
The postoperative ENT setting provides a relevant area for investigation, as patients frequently experience symptoms that can be difficult to interpret, such as pain, bleeding, or wound-healing complications. A conversational agent could provide consistent responses and continuous accessibility; however, it should never replace on-call medical services. Its primary requirement is the ability to correctly identify situations requiring prompt or urgent medical assessment.
With this objective, a postoperative chatbot was developed using ChatGPT-4 through a secure Retrieval-Augmented Generation (RAG) architecture. Its knowledge base was restricted to recommendations from the French National Authority for Health (HAS), the French Society of Otorhinolaryngology (SFORL), and the PubMed literature in order to improve response reliability. An internal feasibility study yielded encouraging results: 68% of responses were rated as good to excellent by ENT experts, with writing quality and completeness sometimes exceeding those of practicing physicians, although clinicians remained superior in the nuanced assessment of clinical risk.
The objective of the present study is to evaluate the feasibility and acceptability of this ENT postoperative follow-up chatbot among 100 ambulatory surgery patients treated at the Arthur Vernes Institute. The primary aim is to assess the patient experience before evaluating any potential impact on healthcare utilization or medico-economic outcomes.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: juliette courtiade mahler, pHD
- 전화번호: +33144127963
- 이메일: jcourtiade@ghpsj.fr
연구 장소
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Paris, 프랑스
- Institut Arthur Vernes
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연락하다:
- Jean-Baptiste Lecanu, MD
- 전화번호: +33682137107
- 이메일: jblecanu@institut-vernes.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patient aged 18 years or older
- Patient undergoing outpatient ENT surgery at the Arthur Vernes Institute
- Patient covered by a health insurance scheme
- French-speaking patient
- Patient who has provided free, informed, and explicit oral consent
Exclusion Criteria:
- Patient already enrolled in a Category 1 interventional research protocol (RIPH 1)
- Patient without access to equipment enabling use of the chatbot (smartphone or computer)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under judicial protection (safeguard of justice)
- Pregnant or breastfeeding patient
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Post op Care
at D30 post surgery, patients will complete 2 scores : Lickert scale and SUS |
Patient will be given access to a post surgery Chat Bot. All the questions asked to the chat bot will be analyzed. At D30 patients will complete a likert scale (0 to 5) and the System usabilty score (0 to 100) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Determine the effective use of the chatbot
기간: up to 30days post surgery
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Proportion of patients having use the chat bot at least once within the 30Days post surgery |
up to 30days post surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Describe how users can interact with the chatbot.
기간: up to 30days post surgery
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number of interaction with the chatbot, topic of the questions |
up to 30days post surgery
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Assess patient acceptance of the chatbot
기간: 30days post surgery
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System acceptability scale (from 0 to 100) |
30days post surgery
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Assess patient satisfaction
기간: 30days post surgery
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likert scale (1 to 5) |
30days post surgery
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Assess the organizational impact
기간: 30days post surgery
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number of phone call made during the 30days follow up period after surgery |
30days post surgery
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Describe clinical events occurring during the follow-up period
기간: 30days post surgery
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number of out patient visit and hospital stay during the 30days post surgery follow up period |
30days post surgery
|
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
- 853_ORL-CareBOT
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
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