CommunicationPED-AINCT07867782
Effect of an AI Agent on Caregiver Communication Experience in the Pediatric Emergency Department
A study testing AI Agent (conversational LLM pre-consultation history-taking tool) in people with Communication, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- AI Agent (conversational LLM pre-consultation history-taking tool)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2026to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an AI Agent on Caregiver Communication Experience in the Pediatric Emergency Department: A Randomized Controlled Trial
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.
- Conditions
- Communication
- Being tested
- AI Agent (conversational LLM pre-consultation history-taking tool)
- Keywords
- pediatric emergency department, AI agent
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Agent (conversational LLM pre-consultation history-taking tool)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| AI Agent (Intervention) | Experimental | 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. Receives: Other: AI Agent (conversational LLM pre-consultation history-taking tool) |
| Standard Care (Control) | No intervention | Caregivers received usual pediatric emergency department care without using the AI agent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once, after completion of the index emergency department visit (assessed within approximately 1 hour after ED discharge)
Secondary outcomes (2)
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.
Measured: Within 1 hour after emergency department discharge
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.
Measured: From emergency department arrival to discharge, assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start18 Jun 2026
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Haheho Co., Ltd.
- Responsible party
- Principal investigator, Meong Hi Son, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867782
- Sponsor's protocol ID
- 2026-05-085-001
- Other IDs
- RS-2023-KH135171
- Acronym
- PED-AI
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an AI Agent on Caregiver Communication Experience in the Pediatric Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867782
- Acronym / sponsor ID
- PED-AI / 2026-05-085-001
- Conditions
- Communication
- Keywords
- pediatric emergency department, AI agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Haheho Co., Ltd.
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Agent (Intervention) | Experimental | Other: AI Agent (conversational LLM pre-consultation history-taking tool)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. |
| Standard Care (Control) | No intervention | –Caregivers received usual pediatric emergency department care without using the AI agent. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI 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. | Other | AI Agent (Intervention) |
Primary outcome
Caregiver-perceived effectiveness of clinical information delivery (PART 2-1)
Time frame: Once, after completion of the index emergency department visit (assessed within approximately 1 hour after ED discharge)
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.
2 secondary outcomes
ED communication and service experience (PART 1 and PART 2-2 to 2-9)
Time frame: Within 1 hour after emergency department discharge
Emergency department length of stay
Time frame: From emergency department arrival to discharge, assessed up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Agent (conversational LLM pre-consultation history-taking tool) in people with Communication, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver-perceived effectiveness of clinical information delivery (PART 2-1) (time frame: Once, after completion of the index emergency department visit (assessed within approximately 1 hour after ED discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.