Recruiting

VTE-AI vs. Manual Method

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06939803

Conditions

Venothromboembolism

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Risk model-driven CDS

Study Details

Brief summary:

Hospital-acquired blood clots (HA-VTE) are the leading cause of death in hospitalized patients in the US. Each year, about 900,000 people get blood clots, costing between $7 and $10 billion in medical expenses. HA-VTE is the second leading cause of long-term disability and causes significant health issues and deaths in both adults and children. About 1 in 3 people who get blood clots experience long-term complications. Reducing HA-VTE is a major challenge.

This study will test a new AI method to predict and prevent HA-VTE. The goal is to see if this AI tool can reduce the number of HA-VTE cases in the Vanderbilt Health System, which includes both urban and rural hospitals.

The AI tool, called VTE-AI, calculates a risk score without needing input from doctors. It will suggest reconsidering blood clot prevention measures for patients who don't have them ordered and have no reasons to avoid them. This suggestion will be made after admission and daily during the hospital stay.

Currently, doctors manually calculate a risk score and choose a prevention option. This study will compare the effectiveness of the AI tool against the current manual method in reducing HA-VTE cases. The study will randomly assign half of the patients to use the AI tool and the other half to the standard manual method.

Conditions

Venothromboembolism

Study ID

NCT06939803

Start date

Dec 17, 2025

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Inpatient admission to Vanderbilt Adult Hospital, Vanderbilt Tullahoma Harton Hospital, Vanderbilt Bedford County Hospital, or Vanderbilt Wilson County Hospital

Exclusion Criteria:

  • None

Study Design

Enrollment

2236 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Interventional

Hospitalizations randomized to receive risk model-driven CDS

no intervention: Standard of Care

Hospitalizations randomized to receive Standard of Care in a given clinical setting

Interventions

Risk model-driven CDS

The CDS intervention will use an automated risk model called "VTE-AI" to add EHR-based prompts in the form of alerts targeting those encounters on which 1) VTE-AI risk is above 5% predicted risk (found to be high risk in prior analyses), 2) no active DVT prophylaxis pharmacologic order is present, 3) no contraindication has been documented in the current admission

Primary outcome measure

  • Incidence of Hospital Acquired VTE [ Time Frame: Baseline to discharge from hospital, approximately 2 to 5 days ]

Central Contacts and Locations

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Colin Walsh

6153225000colin.walsh@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • Clinical decision support
  • Hospital-acquired venous thromboembolism
  • Artificial intelligence
  • Electronic health record
  • Thromboprophylaxis
  • Patient safety
  • Implementation study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-02-13.