Abstract
In October 2015, the Centers for Medicare & Medicaid Services began requiring US hospitals to report adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). To evaluate the association of SEP-1 implementation with sepsis treatment patterns and outcomes in diverse hospitals. This retrospective cohort study with interrupted time-series analysis and logistic regression models was conducted among adults admitted to 114 hospitals from October 2013 to December 2017 with suspected sepsis (blood culture orders, ≥2 systemic inflammatory response syndrome criteria, and acute organ dysfunction) within 24 hours of hospital arrival. Data analysis was conducted from September 2020 to September 2021. SEP-1 implementation in the fourth quarter (Q4) of 2015. The primary outcome was quarterly rates of risk-adjusted short-term mortality (in-hospital death or discharge to hospice). Secondary outcomes included lactate testing and administration of anti-methicillin-resistant Staphylococcus aureus (MRSA) or antipseudomonal β-lactam antibiotics within 24 hours of hospital arrival. Generalized estimating equations with robust sandwich variances were used to fit logistic regression models to assess for changes in level or trends in these outcomes, adjusting for baseline characteristics and severity of illness. The cohort included 117 510 patients (median [IQR] age, 67 years [55-78] years; 60 530 [51.5%] men and 56 980 [48.5%] women) with suspected sepsis. Lactate testing rates increased from 55.1% (95% CI, 53.9%-56.2%) in Q4 of 2013 to 76.7% (95% CI, 75.4%-78.0%) in Q4 of 2017, with a significant level change following SEP-1 implementation (odds ratio [OR], 1.34; 95% CI, 1.04-1.74). There were increases in use of anti-MRSA antibiotics (19.8% [95% CI, 18.9%-20.7%] in Q4 of 2013 to 26.3% [95% CI, 24.9%-27.7%] in Q4 of 2017) and antipseudomonal antibiotics (27.7% [95% CI, 26.7%-28.8%] in Q4 of 2013 to 40.5% [95% CI, 38.9%-42.0%] in Q4 of 2017), but these trends preceded SEP-1 and did not change with SEP-1 implementation. Unadjusted short-term mortality rates were similar in the pre-SEP-1 period (Q4 of 2013 through Q3 of 2015) vs the post-SEP-1 period (Q1 of 2016 through Q4 of 2017) (20.3% [95% CI, 20.0%-20.6%] vs 20.4% [95% CI, 20.1%-20.7%]), and SEP-1 implementation was not associated with changes in level (OR, 0.94; 95% CI, 0.68-1.29) or trend (OR, 1.00; 95% CI, 0.97-1.04) for risk-adjusted short-term mortality rates. In this cohort study, SEP-1 implementation was associated with an immediate increase in lactate testing rates, no change in already-increasing rates of broad-spectrum antibiotic use, and no change in short-term mortality rates for patients with suspected sepsis. Other approaches to decrease sepsis mortality may be warranted.
Highlights
Sepsis is a leading cause of death, disability, and health care costs.[1,2] This has triggered regulators and hospitals to invest heavily in improving sepsis recognition and care
Key Points Question Was implementation of the Centers for Medicare & Medicaid Services (CMS) Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) in October 2015 associated with improvements in sepsis-associated mortality?. In this cohort study of 117 510 adult patients admitted to 114 US hospitals with clinical evidence of suspected sepsis between October 2013 and December 2017, SEP-1 implementation was associated with an immediate increase in lactate testing rates, no change in already-increasing rates of broad-spectrum antibiotic use, and no change in the combined outcome of in-hospital death or discharge to hospice
SEP-1 Implementation and Outcomes in Patients With Sepsis in US Hospitals. In this cohort study, SEP-1 implementation was associated with an immediate increase in lactate testing rates, no change in already-increasing rates of broadspectrum antibiotic use, and no change in short-term mortality rates for patients with suspected sepsis
Summary
Sepsis is a leading cause of death, disability, and health care costs.[1,2] This has triggered regulators and hospitals to invest heavily in improving sepsis recognition and care. SEP-1 has catalyzed widespread sepsis quality improvement efforts, but concerns have been raised about its potential unintended consequences, including increasing inappropriate use of broadspectrum antibiotics, overresuscitation with intravenous fluids, and diagnostic misdirection by overemphasizing sepsis to the exclusion of other serious diagnoses.[5,6,7,8,9,10,11,12,13] Concerns have been raised about the strength of evidence supporting the measure.[14] SEP-1 is predominantly supported by observational studies reporting population-level decreases in sepsis-associated mortality after implementing sepsis bundles.[15,16,17,18,19,20] bundle implementations are almost always accompanied by efforts to increase early sepsis recognition. This leads to the detection of milder cases of sepsis, making it difficult to determine whether improved mortality rates are owing to bundle implementations or because patients who are less severely ill are being included in sepsis case counts.[21,22]
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