跳至主要内容
临床试验/NCT06939803
NCT06939803招募中不适用

AI-driven Clinical Decision Support to Reduce Hospital-Acquired Venous Thromboembolism

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 2,236 人开始时间: 2025年12月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
2,236
试验地点
1
主要终点
Incidence of Hospital Acquired VTE

研究概览

简要总结

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.

详细描述

Background Hospital Acquired Venous Thromboembolism (HA-VTE) remains the leading cause of death in hospitalized patients in the US. Approximately 900,000 people experience VTE each year, with incidence-based medical costs estimated between $7 and $10 billion per year. The second leading cause of disability-adjusted life-years, HA-VTE causes significant morbidity and mortality in adult and pediatric patients. Roughly 1 in 3 people experience long-term complications (i.e., post-thrombotic syndrome) following VTE. Reducing HA-VTE presents a major diagnostic challenge.

Despite numerous published prognostic models of HA-VTE, no single model outperforms the rest. And HA-VTE affects groups inequitably, which means models might reflect or worsen healthcare disparities if they are not deployed in the context of responsible, algorithmovigilant systems. Integrating scalable AI for HA-VTE prevention into effective clinical decision support (CDS) might effectively reduce HA-VTE incidence while aiding the realization of the potential for AI in high-value clinical practice. Recently, a Vanderbilt team of clinicians and biostatisticians validated a regression risk score called "VTE-AI" to prognosticate risk of HA-VTE on admission.

The urban-rural divide has long caused healthcare disparities in morbidity and mortality. These differences might not result from rurality itself, but from "the effects of socio-economic disadvantage, ethnicity, poorer service availability, higher levels of personal risk and more hazardous environmental, occupational and transportation conditions." AI implementation will be no different without close attention to differences in both deployment settings. Studying multiple simultaneous implementations of AI in both urban and rural setting with adult and pediatric patients will yield unprecedented insights for AI-driven CDS.

Rationale and Specific Aims This study will rigorously study a novel AI approach to predicting risk of HA-VTE and guiding prevention. This trial will produce strong evidence for the pragmatic use of novel AI-CDS to prevent HA-VTE across diverse sites and populations.

The goal of this study is to evaluate the effectiveness of AI-driven CDS to reduce the incidence of HA-VTE across the Vanderbilt Health System including urban and rural sites: Vanderbilt Adult Hospital (VUH) and the Vanderbilt Regional Health System (VRHS) including Vanderbilt Tullahoma Harton Hospital (VTHH), Vanderbilt Bedford County Hospital (VBCH), and Vanderbilt Wilson County Hospital (VWCH).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Standard of Care

No Intervention

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

Interventional

Experimental

Hospitalizations randomized to receive risk model-driven CDS

干预措施: Risk model-driven CDS (Other)

结局指标

主要结局

Incidence of Hospital Acquired VTE

时间窗: Baseline to discharge from hospital, approximately 2 to 5 days

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

次要结局

  • Bleeding events(Baseline to discharge from hospital, approximately 2 to 5 days)
  • Thirty-day hospital readmissions(Day 30 following hospital discharge)
  • Length of Stay(Date of admission to date of discharge from hospital, approximately 2 to 5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Colin G. Walsh

Associate Professor

Vanderbilt University Medical Center

研究点 (1)

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