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

NCT07290608 | Completed

• 1 other identifier: DOACT-AI-VASC Study
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Vein Thrombosis; Superficial Thrombophlebitis; Pulmonary Thromboembolisms; Clinical Decision Support Systems; Artificial Intelligence

Keywords

anticoagulant; algorithm; thrombosis

Outcome Measures

Primary Outcomes (2)

• Accuracy of the DOACT Algorithm in Guiding Oral Anticoagulant Therapy

  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.

  Day 1

• Accuracy of anticoagulation recommendations

  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.

  Day 1

Other Outcomes (1)

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

  Day 1

Study Arms (3)

DOACT algorithm

EXPERIMENTAL

Use of DOACT algorithm (Dose-Oriented Anticoagulant Calculator for Evidence-Based Decision Tool) to recommend appropriate oral anticoagulant regimens.

Other: DOACT algorithm

No algorithm

PLACEBO COMPARATOR

Standard clinical decision-making to recommend appropriate oral anticoagulant regimens.

Other: No algorithm

LLM-based tools

ACTIVE COMPARATOR

Use of large language model (LLM)-based tools to recommend appropriate oral anticoagulant regimens.

Other: LLM-based tools

Interventions

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).

DOACT algorithm

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).

No algorithm

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).

LLM-based tools

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ITALO EUGENIO SOUZA GADELHA DE ABREU: lead

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01.223-001, Brazil

Location

Related Publications (4)

• Gee E. The National VTE Exemplar Centres Network response to implementation of updated NICE guidance: venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism (NG89). Br J Haematol. 2019 Sep;186(5):792-793. doi: 10.1111/bjh.16010. Epub 2019 Jun 5. No abstract available.

  PMID: 31168834 BACKGROUND

• Vinogradova Y, Coupland C, Hill T, Hippisley-Cox J. Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting: cohort study in primary care. BMJ. 2018 Jul 4;362:k2505. doi: 10.1136/bmj.k2505.

  PMID: 29973392 BACKGROUND

• Nielsen PB, Lundbye-Christensen S, Rasmussen LH, Larsen TB. Improvement of anticoagulant treatment using a dynamic decision support algorithm: a Danish Cohort study. Thromb Res. 2014 Mar;133(3):375-9. doi: 10.1016/j.thromres.2013.12.042. Epub 2014 Jan 7.

  PMID: 24444650 BACKGROUND

• Kakkos SK, Gohel M, Baekgaard N, Bauersachs R, Bellmunt-Montoya S, Black SA, Ten Cate-Hoek AJ, Elalamy I, Enzmann FK, Geroulakos G, Gottsater A, Hunt BJ, Mansilha A, Nicolaides AN, Sandset PM, Stansby G, Esvs Guidelines Committee, de Borst GJ, Bastos Goncalves F, Chakfe N, Hinchliffe R, Kolh P, Koncar I, Lindholt JS, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, De Maeseneer MG, Comerota AJ, Gloviczki P, Kruip MJHA, Monreal M, Prandoni P, Vega de Ceniga M. Editor's Choice - European Society for Vascular Surgery (ESVS) 2021 Clinical Practice Guidelines on the Management of Venous Thrombosis. Eur J Vasc Endovasc Surg. 2021 Jan;61(1):9-82. doi: 10.1016/j.ejvs.2020.09.023. Epub 2020 Dec 15. No abstract available.

  PMID: 33334670 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single-blind. Investigator was blinded to the intervention assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: January 20, 2025
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)