An interventional study of Generative AI tool for CLABSI surveillance in Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia and Bloodstream Infections, sponsored by University of Maryland, Baltimore. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Health services research
Infection prevention and control programs at US hospitals perform surveillance to detect and publicly report hospital-onset central line-associated bloodstream infections (CLABSI) using standards set by CDC's National Healthcare Safety Network (NHSN). Because this process requires time-consuming review of the medical record by dedicated infection preventionists, VA has developed a generative artificial intelligence (AI) tool that applies the NHSN CLABSI standard to clinical data from the medical record. In this quality improvement initiative, we will evaluate the tool as it is implemented operationally across a cohort of VA medical centers in 3 randomized waves. The purpose of this evaluation is (1) to determine whether the tool reduces the time required for CLABSI surveillance, (2) to assess the objectivity and trustworthiness of the tool from the perspective of infection preventionists, and (3) to detect patient safety events.
This study is being conducted from a VA operational perspective as quality improvement. This will proceed regardless of research approvals. This was submitted to the University of Maryland / Baltimore VA joint IRB/VA Research \& Development committees and determined to be non-human subjects research.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 30 is below the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
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Infection preventionists will participate in this study if their VA medical center is eligible based on the inclusion and exclusion criteria below. At participating sites, all positive blood culture events reviewed as potential central line-associated bloodstream infections (CLABSI) during the study period will be included in the analysis.
Inclusion Criteria:
Exclusion Criteria:
1. VA medical center planned for conversion to the Cerner electronic health record within the anticipated study period
Infection preventionists (reviewers) at participating VA medical centers will use the generative artificial intelligence (AI) tool while reviewing cases of bacteremia to adjudicate the presence of a central line-associated bloodstream infection (CLABSI). The tool operationalizes the CDC's National Healthcare Safety Network definition of CLABSI as discrete steps. Reviewers will be allowed to flexibly implement the tool within their workflow, will not be restricted from performing independent review of the medical record to clarify tool output when necessary, and will retain final authority regarding all CLABSI determinations for event reporting.
Other: Generative AI tool for CLABSI surveillance
Infection preventionists at participating VA medical centers will use their pre-intervention approach to surveillance for central line-associated bloodstream infections (CLABSI), which involves manual review of the medical record and reporting per the CDC National Healthcare Safety Network CLABSI definition.
The intervention involves implementation of a generative artificial intelligence (AI) tool that operationalizes the CDC National Healthcare Safety Network definition for central line-associated bloodstream infections (CLABSI) to support CLABSI surveillance. The tool reviews the medical record to confirm the presence and duration of a central line, identify competing or secondary sources of infection, exclude commensal organisms and bloodstream infections due to mucosal barrier injury, and provide supporting quotations from the medical record.
Time per bacteremia case review
Time in elapsed minutes captured automatically by start and end time of the per-case review form. Assessed at time of completion of the bacteremia case review.
Time frame: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
Difficulty of bacteremia case review
Measured using the Single Ease Question, a validated single-item 7-level scale.
Time frame: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
Objectivity of case review
Measured using a question on the case review form ("How objective is the case to review? (1=not at all objective to 7=very objective)").
Time frame: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
Reviewer confidence in case review
Measured using a question on the case review form ("How confident are you with your review of this case? (1=not confident to 7=very confident)").
Time frame: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
Infection preventionist-identified safety problems
Reported using a binary question (yes/no) on the monthly survey administered to all sites during the post-implementation period.
Time frame: Assessed monthly during each facility's 6-month post-implementation period
Infection preventionist-identified direct patient harm
Reported using a binary question (yes/no) on the monthly survey administered to all sites during the post-implementation period.
Time frame: Assessed monthly during each facility's 6-month post-implementation period
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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