Reducing Variation in Sepsis Outcomes

Yale University, New Haven CT

Investigators

Linked publications & trials

Abstract

Sepsis affects approximately 1.7 million patients in the US annually, is one of the leading causes of mortality, and is a major driver of US healthcare costs. Some groups experience higher rates of sepsis complications, deviations from standard care, and all-cause and sepsis readmissions compared with others. Despite clear evidence of the ways in which factors at the individual, interpersonal, hospital, and community levels interact to generate poorer sepsis care and outcomes for some groups of patients, there are no evidence-based, prospective interventions to reduce this variability, nor are we aware of studies that report reductions in differences in sepsis care as an outcome. Addressing unwanted variation in sepsis care will require collective action across health systems and community institutions, supported by ways of working (e.g., organizational culture) to collaborate effectively across historical, political, and organizational boundaries. Our prior research has shown that coalition-based leadership development approaches can be effective in cultivating organizational culture that can improve complex health outcomes. We propose to adapt, deliver, and evaluate a coalition-based intervention to equip health systems and their surrounding communities to reduce variability in sepsis care and outcomes. Our specific aims are to: (1) Adapt and deliver a coalition-based leadership intervention in eight U.S. health systems and their surrounding communities to improve domains of organizational culture that are required to reduce unwanted variation; (2) Evaluate the impact of the intervention using a longitudinal, convergent mixed methods approach to quantify change in domains of organizational culture that are required to reduce unwanted variation using a novel survey instrument and describe the experience of culture change within each system, integrating quantitative and qualitative data at the analysis phase in order to develop a comprehensive understanding of the intervention impact and mechanisms by which the impact may have occurred; and (3) Evaluate the impact of the intervention on unwanted variation in three clinical outcomes: a) early identification (time to antibiotic), b) clinical management (in-hospital sepsis mortality) and c) standards-based follow up (same-hospital, all-cause sepsis readmissions) using interrupted time series analysis and comparing clinical outcomes from systems that achieved meaningful change in domains of culture required to reduce variability with those that did not achieve meaningful change. The proposed study is timely, highly relevant, and fully aligned with calls to action by the NIH and the Sepsis Alliance to address unwanted variation in sepsis care and outcomes. It is also highly innovative, as it would be the first to intervene prospectively to mitigate unwanted group-level variation in sepsis care, with implications for improving complex health outcomes beyond sepsis.