ClinicalTrials.gg
RecruitingNCT07804407Updated Sep 22, 2026

Prospective Evaluation of AI Generated History of Present Illness Drafts in the Emergency Department

An observational study in All Emergency Department Visits Meeting Eligibility Criteria, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Primary conditionnone(registry's first term: Emergencies)No conditionIs this wrong?Emergencies describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
19 Years and older
Sex
All
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Study summary

This single-center prospective observational study evaluates whether an on-premise, large language model-based tool (EDnote) that generates a draft history of present illness (HPI) from real-time transcription of the patient-physician encounter produces documentation of higher quality than conventional physician-written HPI in the emergency department. The treating physician writes the conventional HPI blinded to the AI draft. Unedited AI-generated HPI drafts and conventional HPI are compared through blinded review by independent emergency physicians.

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Conditions studied

  • All Emergency Department Visits Meeting Eligibility Criteria

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Keywords

  • emergency department
  • ai scribe
  • ambient scribe
  • history of present illness
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.

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

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients presenting to the emergency department of a single tertiary teaching hospital in Korea.

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

  • Age ≥19 years; presenting to the emergency department; initial encounter documented with EDnote; verbal consent to study participation.

Exclusion criteria

Exclusion Criteria:

  • Cardiac arrest; limited ability of both patient and guardian to communicate verbally; refusal of participation.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • ED patients with EDnote-assisted initial encounter

    Adult emergency department patients whose initial encounter was recorded by EDnote. While the treating physician conducts usual care and writes the conventional HPI, EDnote generates an AI HPI draft in the background; the physician remains blinded to the draft. Both HPIs are evaluated by independent raters blinded to document source.

    Other: EDnote HPI (AI-generated HPI draft) · Other: Conventional physician HPI

Interventions

  • OtherEDnote HPI (AI-generated HPI draft)

    On-premise large language model-based tool that transcribes the patient-physician encounter in real time and generates an unedited HPI draft. The treating physician is blinded to the AI HPI draft.

  • OtherConventional physician HPI

    HPI written by the treating emergency physician according to usual practice, blinded to the EDnote-generated HPI draft.

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What researchers measure

Primary outcomes

  1. Encounter-level clinical fact capture rate

    Time frame: At blinded review, within 6 months after each index ED visit

Secondary outcomes

  1. Modified PDQI-9 score

    Modified Physician Documentation Quality Instrument-9 (Modified PDQI-9) score. The modified instrument consists of 10 items, each rated from 1 to 5, yielding a total score ranging from 10 to 50. Higher scores indicate better documentation quality.

    Time frame: At blinded review, within 6 months after each index ED visit

  2. AI HPI draft generation time

    Time frame: At index ED visit

  3. Rater identification of document authorship (AI vs. physician-written)

    Time frame: At blinded review, within 6 months after each index ED visit

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 4, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07804407
Lead sponsor
Yonsei University
Responsible party
LEE STEPHEN GYUNG WON (Clinical assistant professor, Yonsei University) — Principal investigator
First posted
Sep 4, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 22, 2026

Study contacts

Stephen GW LEE
Contact
leestephengyungwon@yuhs.ac
82-2-2228-2678

Oversight

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

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