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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jonathan D Baghdadi, MD, PhD
- 電話番号：410-706-0066
- メール：jbaghdadi@som.umaryland.edu
研究連絡先のバックアップ
- 名前：Daniel J Morgan, MD, MS
- 電話番号：410-706-0066
- メール：dmorgan@som.umaryland.edu
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time per bacteremia case review
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difficulty of bacteremia case review
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Daniel J Morgan, MD, MS、University of Maryland, Baltimore
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- HP-00120271
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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