02 Oct CMS Mandated Sepsis Scoring Resulted in More Testing But No Change in Outcomes
MedicalResearch.com Interview with:
Chanu Rhee, MD, MPH
Harvard Medical School and Harvard Pilgrim Health Institute
MedicalResearch.com: What is the background for this study?
Response: Sepsis is a leading cause of death, disability, and healthcare costs. This has triggered regulators and hospitals to invest heavily in improving sepsis recognition and care. Most notably, the Centers for Medicare & Medicaid Services (CMS) implemented the Severe Sepsis/Septic Shock Early Management Bundle (SEP-1) by the in October 2015. SEP-1 requires hospitals to report compliance with a 3 and 6 hour sepsis care bundle, which includes initial and repeat lactate measurements, blood culture orders, broad-spectrum antibiotic, specific quantities of fluid boluses for hypotension, vasopressors for persistent hypotension, and documentation of a repeat volume and perfusion assessment for patients with septic shock.
While SEP-1 has helped raise awareness of sepsis and catalyzed sepsis quality improvement initiatives around the country, concerns have been raised about its potential unintended consequences — particularly around increasing unnecessary broad spectrum antibiotic use — and the strength of evidence supporting the measure. In this study, we used detailed clinical data from a diverse cohort of hospitals to assess whether SEP-1 implementation was associated with changes in key processes of care and mortality in patients with suspected sepsis.
MedicalResearch.com: What are the main findings?
Response: Our cohort included 117,510 patients with clinical evidence of suspected sepsis on admission to 114 U.S. hospitals between October 2013 and December 2017. These hospitals were diverse with respect to geography, size, and teaching status. Lactate testing rates increased from 55.1% in Q4-2013 to 76.7% in Q4-2017, with a significant immediate increase following SEP-1 implementation in Q4-2015. There were increases in utilization of anti-MRSA antibiotics (19.8% in Q4-2013 to 26.3% in Q4-2017) and anti-Pseudomonal beta-lactam antibiotics (27.7% to 40.5%), but these trends preceded SEP-1 and did not change with SEP-1 implementation. Unadjusted rates of short-term mortality, defined as in-hospital death or discharge to hospice, were similar in the pre-SEP-1 vs post-SEP-1 periods (20.3% vs 20.4%), and there were no changes seen in association with SEP-1 implementation.
MedicalResearch.com: What should readers take away from your report?
Response: In this cohort study, SEP-1 implementation in October 2015 was associated with an immediate increase in lactate testing rates, no significant change in already-rising rates of broad-spectrum antibiotic use, and no change in the combined outcome of in-hospital death or discharge to hospice for patients with clinical evidence of suspected sepsis admitted to 114 U.S. hospitals between 2013-2017. These findings suggest that alternate approaches to improving mortality for patients with sepsis are warranted.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Future research should focus on confirming these findings in an even larger and diverse set of hospitals and assessing whether there were any changes in sepsis outcomes once hospitals’ SEP-1 performance rates became publicly available through the CMS Hospital Compare website in 2018. Future research should also focus on assessing the efficacy of the bundle for specific patient populations (for example, those with septic shock, or certain types of infections) and whether SEP-1 implementation has had a positive impact in specific types of hospitals.
MedicalResearch.com: Is there anything else you would like to add?
Response: I would emphasize that our study did not directly address whether or not adherence to the SEP-1 bundle leads to better sepsis outcomes at an individual patient level. Rather, our analysis was designed to evaluate SEP-1 implementation as a policy by assessing changes in population-level sepsis outcomes.
Disclosures: Funding for this study came from the CDC Prevention Epicenters Program and the Agency for Healthcare Research and Quality.
Citation: Abstract presented at 2021 ID Week
Association Between Implementation of the Centers for Medicare & Medicaid Services Sepsis Performance Measure (SEP-1) and Outcomes in U.S. Hospitals”
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