Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers (VA-AI-CLABSI)
VA National AI Initiative (NAII) Evaluation of an AI-Assisted CLABSI Surveillance Tool: A Prospective Cluster-Randomized Trial
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jonathan D Baghdadi, MD, PhD
- Telefonní číslo: 410-706-0066
- E-mail: jbaghdadi@som.umaryland.edu
Studijní záloha kontaktů
- Jméno: Daniel J Morgan, MD, MS
- Telefonní číslo: 410-706-0066
- E-mail: dmorgan@som.umaryland.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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:
- VA medical center that provides short- or long-term acute care
- CLABSI surveillance is performed by a local infection prevention team who agree to complete all study assessments
Exclusion Criteria:
1. VA medical center planned for conversion to the Cerner electronic health record within the anticipated study period
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Post-implementation of an AI for CLABSI surveillance
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. |
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. |
|
Žádný zásah: Standard 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time per bacteremia case review
Časové okno: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
|
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. |
At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Difficulty of bacteremia case review
Časové okno: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
|
Measured using the Single Ease Question, a validated single-item 7-level scale. |
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
Časové okno: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
|
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)"). |
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
Časové okno: At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
|
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)"). |
At completion of each bacteremia case review performed during the study period beginning 1 month prior to implementation until 6 months post-implementation.
|
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Infection preventionist-identified safety problems
Časové okno: Assessed monthly during each facility's 6-month post-implementation period
|
Reported using a binary question (yes/no) on the monthly survey administered to all sites during the post-implementation period. |
Assessed monthly during each facility's 6-month post-implementation period
|
|
Infection preventionist-identified direct patient harm
Časové okno: Assessed monthly during each facility's 6-month post-implementation period
|
Reported using a binary question (yes/no) on the monthly survey administered to all sites during the post-implementation period. |
Assessed monthly during each facility's 6-month post-implementation period
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Daniel J Morgan, MD, MS, University of Maryland, Baltimore
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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