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CompletedNCT07867782PED-AIUpdated Oct 9, 2026

Effect of an AI Agent on Caregiver Communication Experience in the Pediatric Emergency Department

An interventional study of AI Agent (conversational LLM pre-consultation history-taking tool) in Communication, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2026, registered Sep 2026).
Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

This single-center, single-blind, randomized controlled trial evaluates whether the use of a conversational large language model (LLM)-based AI agent, used by caregivers during the waiting period before physician consultation in a pediatric emergency department (ED), affects the caregiver-perceived effectiveness of clinical information delivery compared with standard care. The AI agent collects and summarizes the child's symptoms via voice before the consultation and does not participate in any diagnostic, prescribing, or treatment decisions. A total of 34 caregivers were enrolled at Samsung Medical Center.

Read the detailed description

Caregivers (aged 19 years or older) of children (younger than 18 years) presenting to the Samsung Medical Center pediatric emergency department (ED) were randomized 1:1 (computerized block randomization, block size 4) to an intervention or control group after providing written informed consent. The intervention group used the AI agent on a study tablet for approximately 5 to 10 minutes during the pre-consultation waiting period; the control group received standard care. All outcomes were assessed once by electronic questionnaire after the ED visit. The primary outcome was the caregiver-perceived effectiveness of clinical information delivery (a 5-item, 5-point Likert instrument). Secondary outcomes included ED physician consultation experience and communication/service experience, AI agent evaluation (intervention group only), ED length of stay, and AI agent usage logs. The outcome assessor (data analyst) was blinded to group allocation; participants could not be blinded due to the nature of the intervention. The AI agent was developed as part of the Ministry of Health and Welfare "Life Careverse" project and functions solely as a pre-consultation history-taking support tool; all clinical decisions were made by the treating physicians.

02

Conditions studied

  • Communication

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Keywords

  • pediatric emergency department
  • AI agent
03

In context

Communication

200 studies on the registry are indexed under Communication; 85 are open to participants now.

This study's enrollment of 34 is below the median of 161 across 170 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Caregiver aged 19 years or older of a child younger than 18 years presenting to the Samsung Medical Center pediatric emergency department
  • Able to self-report and complete the questionnaire
  • Provides written informed consent

Exclusion criteria

Exclusion Criteria:

  • Critical or emergent status (e.g., Korean Triage and Acuity Scale level 1)
  • Caregiver unable to self-report
  • Visual or hearing impairment precluding participation
  • Refusal to participate
  • Duplicate participation
  • Otherwise unsuitable for the study objectives per investigator judgment
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    AI Agent (Intervention)

    Caregivers used the LLM-based AI agent on a study tablet for approximately 5 to 10 minutes during the pre-consultation waiting period, before the physician consultation.

    Other: AI Agent (conversational LLM pre-consultation history-taking tool)

  • No intervention
    Standard Care (Control)

    Caregivers received usual pediatric emergency department care without using the AI agent.

Interventions

  • OtherAI Agent (conversational LLM pre-consultation history-taking tool)

    A conversational large language model (LLM)-based AI agent used by caregivers on a study tablet before the physician consultation to collect and summarize the child's symptoms. It functions as a pre-consultation history-taking support tool and does not make diagnostic, prescribing, or treatment decisions.

06

What researchers measure

Primary outcomes

  1. Caregiver-perceived effectiveness of clinical information delivery (PART 2-1)

    Caregiver-perceived effectiveness of clinical information delivery, measured with an investigator-developed exploratory instrument (PART 2-1). Five items on a 5-point Likert scale (total score range 5 to 25); higher scores indicate better perceived information delivery.

    Time frame: Once, after completion of the index emergency department visit (assessed within approximately 1 hour after ED discharge)

Secondary outcomes

  1. ED communication and service experience (PART 1 and PART 2-2 to 2-9)

    Caregiver-reported emergency department physician consultation experience and communication/service experience, assessed in both groups using an 11-item questionnaire (PART 1 plus PART 2-2 to 2-9) rated on a 5-point scale; higher scores indicate a better experience.

    Time frame: Within 1 hour after emergency department discharge

  2. Emergency department length of stay

    Total emergency department length of stay (in minutes), calculated from the arrival time to the discharge time extracted from the electronic medical record.

    Time frame: From emergency department arrival to discharge, assessed up to 24 hours

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06351, South Korea
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07867782
Collaborators
Haheho Co., Ltd.
Responsible party
Meong Hi Son (Principal Investigator, Samsung Medical Center) — Principal investigator
First posted
Oct 9, 2026
Start date
Jun 18, 2026
Primary completion
Aug 12, 2026
Completion
Aug 12, 2026
Last update
Oct 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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