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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Yabes reported receiving grants from the National Institutes of Health. Dr Chong reported receiving grants from the University of Pittsburg. Dr Angus reported receiving grants from the National Institutes of Health; receiving personal fees from Ferring Pharmaceutical Inc, Bristol-Myers Squibb, Bayer AG, GenMark Diagnostics, Sobi Inc, Beckman Coulter Inc, and ALung Technologies Inc; and having patents pending for Selepressin (compounds, compositions, and methods for treating sepsis) and Proteomic biomarkers of sepsis in elderly patients. No other disclosures were reported.

Figures

Figure 1.. Quarter-Specific Estimates of the Primary Outcome

The preregulation period includes hospitalizations from January 1, 2011, through March 31, 2013. The postregulation period includes hospitalizations from April 1, 2013, through September 30, 2015. In A, the circles and squares represent the per-quarter estimates along with fitted ordinary least-squares lines within the preperiod and postperiod. In B, comparative interrupted time series model results are shown. During the preregulation period, the dotted lines represent the risk-adjusted temporal trends in outcome from the fully adjusted model. These lines are extended into the postregulation period, where they represent the counterfactual adjusted outcomes had the preregulation trends continued. The circles and squares represent the adjusted quarter-specific postintervention estimates from the fully adjusted model. Values above the dotted line indicate that adjusted values for that quarter are higher than the counterfactual, and values below the dotted line indicate that adjusted values are lower than the counterfactual. Estimates were adjusted for age, sex, race and ethnicity, admission through the emergency department, transfer from an acute care hospital, number of organ failures present at hospital admission, sepsis infection categories, chronic comorbid conditions, hospital characteristics, season, and preregulation temporal trends.

Figure 2.. Quarter-Specific Estimates of the 4 Secondary Outcomes

In A, C, E, and G, the circles and squares represent the per-quarter estimates along with fitted ordinary least-squares lines within the preperiod and postperiod. In B, D, F, and H, the circles and squares represent quarter-specific postintervention estimates from the fully adjusted model. During the preregulation period, the dotted lines represent the risk-adjusted temporal trends in outcome from the fully adjusted model. These lines are extended into the postregulation period, where they represent the counterfactual adjusted outcomes had the preregulation trends continued.