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Clinical Trials/NCT07108660
NCT07108660RecruitingNot Applicable

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

Swedish Medical Center19 sites in 1 country17,800 target enrollmentStarted: July 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
17,800
Locations
19
Primary Endpoint
CLABSI Rate

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •Less than 18 years of age

Arms & Interventions

Hospitals receiving "EARLY" access to the prediction model.

Experimental

During the study period, the "EARLY" hospitals receive access to the Possible CLABSI ML model.

Intervention: Infection Preventionist Led Best Practices Reminders (Behavioral)

Hospitals receiving "LATE" access to the prediction model.

No Intervention

During the comparison period, the "LATE" hospitals do not receive access to the Possible CLABSI ML model.

Outcomes

Primary Outcomes

CLABSI Rate

Time Frame: Day 1 of Hospitalization thru Discharge

Rate of CLABSIs (CLABSI Event Per Central Line Days)

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (19)

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