Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, 01.223-001, Brazil
NCT Number: NCT07290608
Study using a decision algorithm for the application of an oral anticoagulant calculator in vascular diseases, aimed at validating a clinical decision-support tool for conditions such as deep vein thrombosis, superficial thrombophlebitis, and pulmonary thromboembolism.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
São Paulo, 01.223-001, Brazil
Cross-sectional, three-arm comparative validation study evaluating the accuracy and clinical utility of the DOACT algorithm versus standard clinical decision-making and large language model (LLM)-based decision tools.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Large Language Models (LLMs)
Exclusion criteria
Vascular and non-vascular physicians using DOACT (Dose-Oriented Anticoagulant Calculator for Evidence-Based Decision Tool) to recommend appropriate oral anticoagulant regimens-dose selection and duration responding 15 standardized clinical case vignettes representing patients with vascular diseases such as deep vein thrombosis (DVT), superficial thrombophlebitis, and pulmonary thromboembolism (PTE).
Vascular and non-vascular physicians using standard clinical decision-making (no use of algorithm) to recommend appropriate oral anticoagulant regimens-dose selection and duration responding 15 standardized clinical case vignettes representing patients with vascular diseases such as deep vein thrombosis (DVT), superficial thrombophlebitis, and pulmonary thromboembolism (PTE).
Vascular and non-vascular physicians using large language model (LLM)-based tools to recommend appropriate oral anticoagulant regimens-dose selection and duration responding 15 standardized clinical case vignettes representing patients with vascular diseases such as deep vein thrombosis (DVT), superficial thrombophlebitis, and pulmonary thromboembolism (PTE).
Time frame: Day 1
Accuracy of anticoagulation recommendations
Description: Proportion of correct responses generated by the four evaluated LLMs, vascular surgeons, and non-vascular physicians, with and without access to the DOACT algorithm, using standardized clinical vignettes.
Time frame: Day 1
Proportion of correct responses generated by LLMs, vascular surgeons, and non-vascular physicians with and without access to the DOACT algorithm. All LLM outputs will be generated using the same standardized prompt, following methodological guidance recommended by IBM for evaluating large language models.
Time frame: Day 1
Correct reporting of dosing adjustments, renal criteria, bleeding risks, reversal agents, and contraindications.
Description: Time (seconds) from prompt submission to full answer generation for LLMs, and time to completion for physicians.
ITALO EUGENIO SOUZA GADELHA DE ABREU
Other
Clinical Performance of the DOACT Algorithm Versus AI-Based Decision Models in Oral Anticoagulant Therapy for Vascular Patients
Acronym: DOACT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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