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临床试验/NCT07108660
NCT07108660招募中不适用

Prediction and Reduction of Central Line Associated Blood Stream Infections: A Machine Learning Improvement Study

Swedish Medical Center38 个研究点 分布在 1 个国家目标入组 17,800 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
17,800
试验地点
38
主要终点
CLABSI Rate

研究概览

简要总结

Prospective, multi-center, cluster-randomized trial of a hospital Infection Preventionist (IP)-led quality improvement study to provide clinical teams with just-in-time clinical education and reinforcement of existing best practices recommendations based on the output of a possible Central Line Associated Blood Stream Infection (CLABSI) Machine Learning (ML) prediction model.

The objective is to determine whether providing this model to Infection Preventionists will decrease the CLABSI rates versus routine clinical practice.

详细描述

Central Line-Associated Bloodstream Infections (CLABSIs) remain a persistent and costly challenge in U.S. hospitals, contributing to increased mortality, prolonged hospital stays, and elevated healthcare costs. In 2022 alone, Providence St. Joseph Health (PSJH) recorded 275 CLABSIs across 430,000 central line days. Despite the implementation of best-practice prevention bundles, these infections continue to occur, prompting the exploration of machine learning (ML) as a tool to predict and mitigate CLABSI risk. While prior studies have demonstrated the predictive potential of ML models-with area under the curve (AUC) values reaching up to 0.87-no randomized trial has yet evaluated the real-world clinical impact of deploying such a model.

The primary objective of this trial is to determine whether the deployment of a machine learning model that predicts possible CLABSI risk, when provided to hospital Infection Preventionists (IPs) with a standardized workflow, can reduce CLABSI rates compared to routine practice. Secondary objectives include assessing the intervention's impact on central line removal within 48 hours of an alert, the rate of positive blood cultures, and various process metrics such as the frequency of IP interventions. Safety outcomes, including pneumothorax and hemorrhage, are also being monitored.

The study is designed as a prospective, open-label, multi-center, cluster-randomized controlled trial conducted across 20 Providence hospitals with the highest CLABSI burden. These hospitals account for approximately 90% of all CLABSI events within the system during 2023 and 2024. Hospitals were paired using Mahalanobis distance based on the hospital's CLABSI count and NHSN Standardized Infection Ratio (SIR) and then randomized into early and late intervention groups. The early group received access to the ML model for four to five months before the late group. Infection Preventionists at early hospitals used a dashboard to identify high-risk patients and deliver targeted education and interventions focused on central line care.

The machine learning model was developed using data from over 62,000 patients and more than 730,000 line-days collected between January 2015 and September 2024. A positive class was defined as a positive blood culture occurring within 24 to 72 hours in a patient with a central line in place for more than 48 hours. From 87 electronic medical record (EMR) data elements, 207 features were engineered for model development. The modeling process employed XGBoost and addressed class imbalance through oversampling, undersampling, and SMOTE techniques. The final model achieved an AUC of 0.93, with a recall of 0.72, precision of 0.66, and an F1 score of 0.68. To ensure fairness, the model underwent a bias analysis using the EEOC's four-fifths rule, confirming consistent performance across race, sex, and ethnicity subgroups.

Each day, the model scored all adult inpatients with central lines in place for more than 48 hours. Predictions were published to a PowerBI dashboard accessible to IPs at intervention hospitals. These IPs reviewed flagged patients, ensured adherence to the CLABSI prevention bundle, and recommended line removal when appropriate. The IPs actions were documented in the EMR. The intervention was supported by training, scripting for clinical conversations, and access to infectious disease physicians for consultation.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The top twenty Providence St. Joseph Health Hospitals by CLABSI burden.

排除标准

  • Less than 18 years of age

结局指标

主要结局

CLABSI Rate

时间窗: Day 1 of Hospitalization thru Discharge

Rate of CLABSIs (CLABSI Event Per Central Line Days)

次要结局

  • CLABSI Rate expressed as SIR(Day 1 of Hospitalization thru Discharge)
  • Central Line Days(Day 1 of Hospitalization thru Discharge)
  • Possible CLABSI Rate(Day 1 of Hospitalization thru Discharge)
  • Infection preventionist documentation of patient review(Day 1 of Hospitalization thru Discharge)
  • Central line removal within 48 hours of model alert(Day 1 of Hospitalization thru Discharge)
  • Facility Before and After(From trial start until 5 months after trial end.)
  • Safety outcomes after model prediction(Day 1 of Hospitalization thru Discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (38)

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