AI-driven Clinical Decision Support to Reduce Hospital-Acquired Venous Thromboembolism: Study Protocol for the VTE-AI Randomized Trial.

NCT06939803 | Recruiting DMC

• 1 other identifier: 241978
• Study Type: interventional
• Target: 2,236
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Hospital Acquired VTE

  Percentage of admissions in which patients were diagnosed with VTE more than 48 hours after admission, defined as "Hospital Acquired" in prior literature

  Baseline to discharge from hospital, approximately 2 to 5 days

Secondary Outcomes (3)

• Thirty-day hospital readmissions

  Day 30 following hospital discharge

• Bleeding events

  Baseline to discharge from hospital, approximately 2 to 5 days

• Length of Stay

  Date of admission to date of discharge from hospital, approximately 2 to 5 days

Study Arms (2)

Interventional

EXPERIMENTAL

Hospitalizations randomized to receive risk model-driven CDS

Other: Risk model-driven CDS

Standard of Care

NO INTERVENTION

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

Interventions

Risk model-driven CDS OTHER

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

Interventional

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Related Publications (2)

• Tillman BF, Domenico HJ, Moore RP, Byrne DW, Morton CT, Mixon AS, French B. A real-time prognostic model for venous thromboembolic events among hospitalized adults. Res Pract Thromb Haemost. 2024 May 6;8(4):102433. doi: 10.1016/j.rpth.2024.102433. eCollection 2024 May.

  PMID: 38882464 BACKGROUND

• Walsh CG, Long Y, Novak LL, Salwei ME, Tillman B, French B, Mixon AS, Law ME, Franklin J, Embi PJ. AI-Driven Clinical Decision Support to Reduce Hospital-Acquired Venous Thromboembolism: A Trial Protocol. JAMA Netw Open. 2025 Oct 1;8(10):e2535137. doi: 10.1001/jamanetworkopen.2025.35137.

  PMID: 41042513 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Clinical Trial

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)