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Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience. (ORL-CareBOT)

4. november 2026 opdateret af: Fondation Hôpital Saint-Joseph

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Determine the effective use of the chatbot
Tidsramme: up to 30days post surgery

Proportion of patients having use the chat bot at least once within the 30Days post surgery

up to 30days post surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Describe how users can interact with the chatbot.
Tidsramme: up to 30days post surgery

number of interaction with the chatbot, topic of the questions

up to 30days post surgery
Assess patient acceptance of the chatbot
Tidsramme: 30days post surgery

System acceptability scale (from 0 to 100)

30days post surgery
Assess patient satisfaction
Tidsramme: 30days post surgery

likert scale (1 to 5)

30days post surgery
Assess the organizational impact
Tidsramme: 30days post surgery

number of phone call made during the 30days follow up period after surgery

30days post surgery
Describe clinical events occurring during the follow-up period
Tidsramme: 30days post surgery

number of out patient visit and hospital stay during the 30days post surgery follow up period

30days post surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

30. oktober 2026

Først indsendt, der opfyldte QC-kriterier

30. oktober 2026

Først opslået (Faktiske)

5. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 853_ORL-CareBOT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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