- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: juliette courtiade mahler, pHD
- Numéro de téléphone: +33144127963
- E-mail: jcourtiade@ghpsj.fr
Lieux d'étude
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Paris, France
- Institut Arthur Vernes
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Contact:
- Jean-Baptiste Lecanu, MD
- Numéro de téléphone: +33682137107
- E-mail: jblecanu@institut-vernes.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Determine the effective use of the chatbot
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Describe how users can interact with the chatbot.
Délai: 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
Délai: 30days post surgery
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System acceptability scale (from 0 to 100) |
30days post surgery
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Assess patient satisfaction
Délai: 30days post surgery
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likert scale (1 to 5) |
30days post surgery
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Assess the organizational impact
Délai: 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
Délai: 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
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 853_ORL-CareBOT
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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