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

Conditions

• Venothromboembolism

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Dec 17, 2025

Status verified

Feb 2026

Primary completion

Dec 16, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

2,236 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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

Primary Outcome Measure

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

Locations (1)

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