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Completed

NCT Number: NCT07290608

DOACT Algorithm Versus AI-Based Decision Models in Oral Anticoagulant Therapy for Vascular Patients

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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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, 01.223-001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physicians with residency training in Vascular Surgery or official Board Certification in Vascular Surgery.
  • Currently practicing clinical and/or surgical vascular care in Brazil.
  • Completed the informed consent process (TCLE) and voluntarily agreed to participate.

Exclusion criteria

  • Physicians without formal Vascular Surgery residency and without Board Certification.
  • Physicians not performing vascular clinical or surgical care (e.g., exclusively administrative, academic, or non-assistance roles).
  • Less than 1 year of professional experience after medical school graduation.
  • Did not sign or did not fully complete the TCLE.

Large Language Models (LLMs)

  • Inclusion Criteria
  • Free-access LLMs available to the public at the time of data collection.
  • All responses generated using the same standardized prompt.
  • Capable of producing complete, text-based clinical answers relevant to vascular surgery decision-making.

Exclusion criteria

  • Paid or subscription-based LLMs.
  • LLMs requiring institutional licenses, restricted access, or proprietary tokens.
  • Models unable to generate full responses to the standardized prompt.

Treatment and study plan

DOACT algorithm

Other

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).

No algorithm

Other

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).

LLM-based tools

Other

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).

Primary outcomes

  1. Accuracy of the DOACT Algorithm in Guiding Oral Anticoagulant Therapy

    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.

  2. Accuracy of anticoagulation recommendations

    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.

Other outcomes

  1. 1. Identification of key clinical elements 2.Response time

    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.

Sponsors and collaborators

Lead sponsor

ITALO EUGENIO SOUZA GADELHA DE ABREU

Other

Registry information

Official study title

Clinical Performance of the DOACT Algorithm Versus AI-Based Decision Models in Oral Anticoagulant Therapy for Vascular Patients

Acronym: DOACT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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