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

September 1, 2026 updated by: LEE STEPHEN GYUNG WON, Yonsei University

Prospective Evaluation of Artificial Intelligence-generated History of Present Illness Drafts in the Emergency Department

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Seoul City
      • Seoul, Seoul City, South Korea, 03722
        • Recruiting
        • Yonsei University Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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 blindedto the AI HPI draft.
Other: Conventional physician HPI
HPI written by the treating emergency physician according to usual practice, blinded to the EDnote-generated HPI draft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Encounter-level clinical fact capture rate
Time Frame: At blinded review, within 6 months after each index ED visit
At blinded review, within 6 months after each index ED visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified PDQI-9 score
Time Frame: At blinded review, within 6 months after each index ED visit
At blinded review, within 6 months after each index ED visit
AI HPI draft generation time
Time Frame: At index ED visit
At index ED visit
Rater identification of document authorship (AI vs. physician-written)
Time Frame: At blinded review, within 6 months after each index ED visit
At blinded review, within 6 months after each index ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 1, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 4, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2026-0708
  • C-2026-0010 (Other Grant/Funding Number: Severance Hospital Research fund for Clinical excellence(SHRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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