Prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE-like) clinical trial evaluating whether physician-supervised Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support improves diagnostic concordance in emergency department patients presenting with acute cardiopulmonary symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
A Generative Pre-trained Transformer (GPT)-based multimodal visual language model integrates electrocardiograms, chest radiographs, structured clinical information, laboratory findings, vital signs, and relevant clinical history to generate diagnostic suggestions and differential diagnoses for physician-supervised clinical decision support.
Routine emergency department diagnostic evaluation performed according to standard clinical practice without AI-assisted diagnostic support.
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Diagnostic concordance between the final emergency department diagnosis and the blinded adjudicated reference diagnosis established at hospital discharge.
Diagnostic concordance between the treating physician's final emergency department diagnosis and the blinded adjudicated reference diagnosis based on the prespecified principal diagnostic category.
Time frame: During the index hospitalization, up to hospital discharge (average 3 days)
Diagnostic concordance after Generative Pre-trained Transformer (GPT)-assisted diagnostic support
Diagnostic concordance between the physician's final emergency department diagnosis after Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support and the blinded adjudicated reference diagnosis in participants assigned to the intervention group.
Time frame: During the index emergency department visit (average 6 hours)
Time from emergency department presentation to final diagnosis
Time required from emergency department presentation until establishment of the physician's final emergency department diagnosis.
Time frame: During the index emergency department visit (average 6 hours)
Diagnostic reclassification after Generative Pre-trained Transformer (GPT)-assisted evaluation
Frequency of changes between the physician's initial working diagnosis and the final emergency department diagnosis after review of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations.
Time frame: During the index emergency department visit (average 6 hours)
Physician diagnostic confidence
Physician-reported diagnostic confidence recorded before and after Generative Pre-trained Transformer (GPT)-assisted diagnostic support using the prespecified study assessment scale.
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Time frame: During the index emergency department visit (average 6 hours)
Physician acceptance of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations
Frequency of physician acceptance, modification, or rejection of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations in the intervention group.
Time frame: During the index emergency department visit (average 6 hours)
Emergency department disposition accuracy
Accuracy of emergency department disposition decisions, including discharge, hospital admission, or intensive care unit admission, compared with the adjudicated reference diagnosis.
Time frame: Up to hospital discharge (average 3 days)
Emergency department length of stay
Length of stay in the emergency department measured from patient presentation until emergency department discharge or hospital admission.
Time frame: Up to hospital discharge (average 3 days)
Hospital length of stay
Total duration of hospitalization from admission until hospital discharge.
Time frame: Up to hospital discharge (average 3 days)
In-hospital mortality
All-cause mortality occurring during the index hospitalization.
Time frame: Up to hospital discharge (average 3 days)
30-day all-cause mortality
All-cause mortality occurring within 30 days after the index emergency department visit.
Time frame: 30 days
30-day emergency department revisit
Revisit to any emergency department for any cause within 30 days after the index emergency department visit.
Time frame: 30 days
30-day hospital readmission
Hospital readmission for any cause within 30 days after discharge from the index hospitalization.
Time frame: 30 days