Prospective Evaluation of AI Generated History of Present Illness Drafts in the Emergency Department
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥19 years; presenting to the emergency department; initial encounter documented with EDnote; verbal consent to study participation.
Disqualifiers
Cardiac arrest; limited ability of both patient and guardian to communicate verbally; refusal of participation.
Trial population
Adult patients presenting to the emergency department of a single tertiary teaching hospital in Korea.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
EDnote HPI (AI-generated HPI draft)
Other interventionOn-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 HPI
Other interventionHPI written by the treating emergency physician according to usual practice, blinded to the EDnote-generated HPI draft.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ED patients with EDnote-assisted initial encounter2 interventions
Trial outcomes
Primary outcomes
1
Encounter-level clinical fact capture rate
Time frame
At blinded review, within 6 months after each index ED visitSecondary 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 visit2
AI HPI draft generation time
Time frame
At index ED visit3
Rater identification of document authorship (AI vs. physician-written)
Time frame
At blinded review, within 6 months after each index ED visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov