All Emergency Department Visits Meeting Eligibility CriteriaNCT07804407
Prospective Evaluation of AI Generated History of Present Illness Drafts in the Emergency Department
An observational study of All Emergency Department Visits Meeting Eligibility Criteria, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- All Emergency Department Visits Meeting Eligibility Criteria
- What is being tested?
- EDnote HPI (AI-generated HPI draft) and Conventional physician HPI
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting to the emergency department of a single tertiary teaching hospital in Korea.
Who may be able to join
- Age ≥19 years; presenting to the emergency department; initial encounter documented with EDnote; verbal consent to study participation.
Who cannot join
- Cardiac arrest; limited ability of both patient and guardian to communicate verbally; refusal of participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Severance Hospital
Seoul, Seoul City, 03722
Stephen GW LEE, 82-2-2228-2678, leestephengyungwon@yuhs.ac
About this study
Official title: 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.
- Being tested
- EDnote HPI (AI-generated HPI draft), Conventional physician HPI
- Keywords
- emergency department, ai scribe, ambient scribe, history of present illness
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDnote HPI (AI-generated HPI draft)Other
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.
Conventional physician HPIOther
HPI written by the treating emergency physician according to usual practice, blinded to the EDnote-generated HPI draft.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EDnote HPI (AI-generated HPI draft); Other: Conventional physician HPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Encounter-level clinical fact capture rate
Measured: At blinded review, within 6 months after each index ED visit
Secondary outcomes (3)
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.
Measured: At blinded review, within 6 months after each index ED visit
AI HPI draft generation time
Measured: At index ED visit
Rater identification of document authorship (AI vs. physician-written)
Measured: At blinded review, within 6 months after each index ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Emergency Department Visits Meeting Eligibility CriteriaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE STEPHEN GYUNG WON, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804407
- Sponsor's protocol ID
- 4-2026-0708
- Other IDs
- C-2026-0010
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Artificial Intelligence-generated History of Present Illness Drafts in the Emergency Department
- ClinicalTrials.gov ID
- NCT07804407
- Acronym / sponsor ID
- 4-2026-0708
- Keywords
- emergency department, ai scribe, ambient scribe, history of present illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED patients with EDnote-assisted initial encounter | – | Other: EDnote HPI (AI-generated HPI draft), Other: Conventional physician HPIAdult 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the emergency department of a single tertiary teaching hospital in Korea.
Key inclusion criteria (1 listed)
- Age ≥19 years; presenting to the emergency department; initial encounter documented with EDnote; verbal consent to study participation.
Key exclusion criteria (1 listed)
- Cardiac arrest; limited ability of both patient and guardian to communicate verbally; refusal of 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 |
|---|---|---|
| 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 blinded to the AI HPI draft. | Other | ED patients with EDnote-assisted initial encounter |
| Conventional physician HPIHPI written by the treating emergency physician according to usual practice, blinded to the EDnote-generated HPI draft. | Other | ED patients with EDnote-assisted initial encounter |
Primary outcome
Encounter-level clinical fact capture rate
Time frame: At blinded review, within 6 months after each index ED visit
3 secondary outcomes
Modified PDQI-9 score
Time frame: At blinded review, within 6 months after each index ED visit
AI HPI draft generation time
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to concerns regarding patient privacy and personal information protection.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Emergency Department Visits Meeting Eligibility Criteria, run by Yonsei University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen GW LEE (82-2-2228-2678, leestephengyungwon@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Encounter-level clinical fact capture rate (time frame: At blinded review, within 6 months after each index ED visit). 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 22 Sep 2026.