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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jonathan D Baghdadi, MD, PhD
- Telefonnummer: 410-706-0066
- E-post: jbaghdadi@som.umaryland.edu
Studer Kontakt Backup
- Navn: Daniel J Morgan, MD, MS
- Telefonnummer: 410-706-0066
- E-post: dmorgan@som.umaryland.edu
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Ingen inngripen: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time per bacteremia case review
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difficulty of bacteremia case review
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
|
Infection preventionist-identified safety problems
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Daniel J Morgan, MD, MS, University of Maryland, Baltimore
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HP-00120271
Plan for individuelle deltakerdata (IPD)
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