Diagnostic safety and quality optimization in sepsis study protocol.

Shrestha, Sachita; Kowalkowski, Marc; Birken, Sarah; Palakshappa, Jessica; King, Jessie; Miller, Chadwick; Pogue, Jason; Taylor, Stephanie · J Hosp Med · 2025

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Abstract

Sepsis ranks among the "Big Three" conditions most prone to harmful diagnostic errors. Despite its high prevalence and severity, health systems lack effective and contextually tailored strategies to optimize diagnostic accuracy for sepsis. The purpose of this study is to understand factors related to high sepsis diagnostic accuracy using principles and tools of safety and implementation science. This is a multi-site study involving 20 hospitals across four states in the United States. The primary objectives are to (1) describe hospital-level variability and understand barriers and facilitators to sepsis diagnostic accuracy and (2) apply cross-case and coincidence analysis to determine minimally sufficient and necessary conditions for optimal sepsis diagnosis that minimizes under- and overtreatment. To identify barriers and facilitators of acute sepsis diagnosis, we will conduct electronic surveys and in-depth interviews with key informants from each hospital. We will use data from electronic health records (EHR) and data warehouses to operationalize sepsis diagnostic accuracy. We have enrolled 20 hospitals and begum data collection. The findings of this study will be used to develop a context-specific toolkit that guides the selection of feasible and important strategies to promote optimal sepsis diagnosis in diverse hospitals settings. The study uses tools and principles from safety and implementation science to generate first-of-its-kind evidence to improve diagnostic excellence in sepsis.

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