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Original Investigation
July 16, 2019

Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis

Author Affiliations
  • 1CRISMA Center, Department of Critical Care Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 2Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 3Division of General Internal Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 4Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 5Division of Pulmonary, Allergy and Critical Care Medicine, Columbia University Medical Center, New York, New York
  • 6Department of Acute and Tertiary Care, School of Nursing, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 7RAND Corporation, Pittsburgh, Pennsylvania
JAMA. 2019;322(3):240-250. doi:10.1001/jama.2019.9021
Key Points

Question  Were the 2013 New York State regulations mandating the use of protocols for sepsis recognition and treatment associated with in-hospital mortality differences compared with states that did not implement sepsis regulations?

Findings  In this retrospective cohort study of 1 012 410 hospitalized adults with sepsis, mandated protocolized sepsis care in New York State was associated with a significantly greater decline in risk-adjusted mortality in New York compared with a group of control states that did not implement mandated protocolized sepsis care. By the 10th quarter after implementation of the regulations, the adjusted absolute mortality was 3.2% lower than expected in New York State relative to the control states.

Meaning  The New York State sepsis regulations were associated with significantly reduced sepsis mortality, but whether broader adoption of state-level sepsis mandates in other states would lead to further reductions in sepsis-related mortality is unknown.

Abstract

Importance  Beginning in 2013, New York State implemented regulations mandating that hospitals implement evidence-based protocols for sepsis management, as well as report data on protocol adherence and clinical outcomes to the state government. The association between these mandates and sepsis outcomes is unknown.

Objective  To evaluate the association between New York State sepsis regulations and the outcomes of patients hospitalized with sepsis.

Design, Setting, and Participants  Retrospective cohort study of adult patients hospitalized with sepsis in New York State and in 4 control states (Florida, Maryland, Massachusetts, and New Jersey) using all-payer hospital discharge data (January 1, 2011-September 30, 2015) and a comparative interrupted time series analytic approach.

Exposures  Hospitalization for sepsis before (January 1, 2011-March 31, 2013) vs after (April 1, 2013-September 30, 2015) implementation of the 2013 New York State sepsis regulations.

Main Outcomes and Measures  The primary outcome was 30-day in-hospital mortality. Secondary outcomes were intensive care unit admission rates, central venous catheter use, Clostridium difficile infection rates, and hospital length of stay.

Results  The final analysis included 1 012 410 sepsis admissions to 509 hospitals. The mean age was 69.5 years (SD, 16.4 years) and 47.9% were female. In New York State and in the control states, 139 019 and 289 225 patients, respectively, were admitted before implementation of the sepsis regulations and 186 767 and 397 399 patients, respectively, were admitted after implementation of the sepsis regulations. Unadjusted 30-day in-hospital mortality was 26.3% in New York State and 22.0% in the control states before the regulations, and was 22.0% in New York State and 19.1% in the control states after the regulations. Adjusting for patient and hospital characteristics as well as preregulation temporal trends and season, mortality after implementation of the regulations decreased significantly in New York State relative to the control states (P = .02 for the joint test of the comparative interrupted time series estimates). For example, by the 10th quarter after implementation of the regulations, adjusted absolute mortality was 3.2% (95% CI, 1.0% to 5.4%) lower than expected in New York State relative to the control states (P = .004). The regulations were associated with no significant differences in intensive care unit admission rates (P = .09) (10th quarter adjusted difference, 2.8% [95% CI, −1.7% to 7.2%], P = .22), a significant relative decrease in hospital length of stay (P = .04) (10th quarter adjusted difference, 0.50 days [95% CI, −0.47 to 1.47 days], P = .31), a significant relative decrease in the C difficile infection rate (P < .001) (10th quarter adjusted difference, −1.8% [95% CI, −2.6% to −1.0%], P < .001), and a significant relative increase in central venous catheter use (P = .02) (10th quarter adjusted difference, 4.8% [95% CI, 2.3% to 7.4%], P < .001).

Conclusions and Relevance  In New York State, mandated protocolized sepsis care was associated with a greater decrease in sepsis mortality compared with sepsis mortality in control states that did not implement sepsis regulations. Because baseline mortality rates differed between New York and comparison states, it is uncertain whether these findings are generalizable to other states.

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