A Large Language Model in Outpatient Care
7 juni 2026 uppdaterad av: Tien Yin Wong, Tsinghua University
A Prospective Randomized Controlled Trial of a Large Language Model in Outpatient Care
The goal of this clinical trial is to learn how the use of a large language model (LLM) based tool affects outpatient clinical care in adult patients attending general hospital outpatient clinics. The main questions it aims to answer are:
Does the use of an LLM-based tool affect the efficiency of outpatient visits? Does the use of an LLM-based tool affect the experience of doctors and patients during outpatient care?
Researchers will compare outpatient visits supported by an LLM-based tool to standard outpatient visits without such a tool, to see whether and how the tool influences the care process and the experiences of doctors and patients.
Participants will:
Take part in outpatient visits that may or may not involve an LLM-based tool, depending on their assigned group Complete a short questionnaire about their visit experience after the consultation
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
3500
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
Doctors:
- Licensed physicians providing outpatient consultations at a participating study hospital
- Expected to complete a sufficient number of outpatient clinic sessions during the study period
- Provides written informed consent
Patients:
- Age 18 years or older
- Attending an outpatient consultation with a participating doctor
- Able to interact with the tool using an internet-connected device such as a smartphone
- Provides written informed consent
Exclusion Criteria:
Patients:
- Psychiatric conditions, unstable vital signs, or other medical situations considered unsuitable for AI-based interaction
- Declines to provide informed consent
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Standard Outpatient Care (No AI)
Neither doctors nor patients use a large language model based tool.
Outpatient consultations and documentation are conducted following routine clinical practice.
|
|
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Experimentell: Outpatient Care With a Large Language Model Tool
Before the consultation, patients complete an AI-based pre-consultation interaction.
During the visit, a large language model based tool is available to support the outpatient consultation process.
Doctors may refer to the tool during the visit.
|
A large language model based tool is introduced into the outpatient consultation workflow to support the consultation and documentation process.
|
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Experimentell: Outpatient Care With a Large Language Model Tool and Workflow Support
Before the consultation, patients complete an AI-based pre-consultation interaction.
During the visit, a large language model based tool is used together with additional workflow support to integrate the tool's output into the outpatient consultation process.
|
Additional workflow support is provided to integrate the output of the large language model based tool into the consultation process, approximating a more integrated deployment of the tool.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration of the Outpatient Consultation
Tidsram: During the outpatient visit
|
Time of the outpatient consultation, measured in milliseconds
|
During the outpatient visit
|
|
Doctor-Reported Efficiency of the Consultation
Tidsram: Immediately after the consultation
|
Doctor's self-rated efficiency of the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high), with higher scores indicating higher perceived efficiency.
|
Immediately after the consultation
|
|
Doctor-Reported Satisfaction With the Consultation Process
Tidsram: Immediately after the consultation
|
Doctor's satisfaction with the consultation process, measured on a 5-point Likert scale (1 = very low to 5 = very high), with higher scores indicating higher satisfaction.
|
Immediately after the consultation
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Doctor-Reported Efficiency of Obtaining Patient Information
Tidsram: Immediately after the consultation
|
Doctor's self-rated efficiency in obtaining the patient's clinical information (such as symptoms, history, prior examinations) during the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate higher efficiency.
|
Immediately after the consultation
|
|
Doctor-Reported Cognitive Effort in Clinical Decision-Making
Tidsram: Immediately after the consultation
|
Doctor's self-rated cognitive effort invested in clinical decision-making during the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater effort.
|
Immediately after the consultation
|
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Doctor-Reported Burden of Clinical Documentation
Tidsram: Immediately after the consultation
|
Doctor's self-rated burden of completing the outpatient medical record for the consultation, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater burden.
|
Immediately after the consultation
|
|
Doctor's Intention to Continue Using the Tool
Tidsram: Within 1 week after the participating doctor completes all enrolled consultations
|
Doctor's intention to continue using the large language model based tool in routine practice, measured on a 5-point Likert scale (1 = strongly unwilling to 5 = strongly willing); higher scores indicate stronger intention.
|
Within 1 week after the participating doctor completes all enrolled consultations
|
|
Patient Trust in the Physician
Tidsram: Immediately after the consultation
|
Patient's level of trust in the physician after the visit, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater trust.
|
Immediately after the consultation
|
|
Patient Satisfaction With the Visit
Tidsram: Immediately after the consultation
|
Patient's satisfaction with the visit, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater satisfaction.
|
Immediately after the consultation
|
|
Patient-Perceived Physician Attentiveness
Tidsram: Immediately after the consultation
|
Patient-perceived attentiveness of the physician during the visit, assessed by a multi-item measure and reported as a composite score on a 1-5 scale; higher scores indicate greater perceived attentiveness.
|
Immediately after the consultation
|
|
Patient Satisfaction With the AI Pre-Consultation (Arm 2 and Arm 3 )
Tidsram: Immediately after the consultation
|
Patient's satisfaction with the AI-based pre-consultation interaction, measured on a 5-point Likert scale (1 = very low to 5 = very high); higher scores indicate greater satisfaction.
Assessed only in Arm 2 and Arm 3.
|
Immediately after the consultation
|
|
Patient's Intention to Use AI Pre-Consultation in the Future (Arm 2 and Arm 3)
Tidsram: Immediately after the consultation
|
Patient's intention to use AI-based pre-consultation again in the future, measured on a 5-point Likert scale (1 = strongly unwilling to 5 = strongly willing); higher scores indicate stronger intention.
Assessed only in Arm 2 and Arm 3.
|
Immediately after the consultation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
12 juni 2026
Primärt slutförande (Beräknad)
4 september 2026
Avslutad studie (Beräknad)
4 september 2026
Studieregistreringsdatum
Först inskickad
29 maj 2026
Först inskickad som uppfyllde QC-kriterierna
7 juni 2026
Första postat (Faktisk)
11 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- THU-01-2026-0055
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