Pediatric Outcomes After Regulatory Mandates for Sepsis Care

Abstract

Background: In 2013, New York introduced regulations mandating that hospitals develop pediatric-specific protocols for sepsis recognition and treatment.

Methods: We used hospital discharge data from 2011 to 2015 to compare changes in pediatric sepsis outcomes in New York and 4 control states: Florida, Massachusetts, Maryland, and New Jersey. We examined the effect of the New York regulations on 30-day in-hospital mortality using a comparative interrupted time-series approach, controlling for patient and hospital characteristics and preregulation temporal trends.

Results: We studied 9436 children admitted to 237 hospitals. Unadjusted pediatric sepsis mortality decreased in both New York (14.0% to 11.5%) and control states (14.4% to 11.2%). In the primary analysis, there was no significant effect of the regulations on mortality trends (differential quarterly change in mortality in New York compared with control states: -0.96%; 95% confidence interval [CI]: -1.95% to 0.02%; P = .06). However, in a prespecified sensitivity analysis excluding metropolitan New York hospitals that participated in earlier sepsis quality improvement, the regulations were associated with improved mortality trends (differential change: -2.08%; 95% CI: -3.79% to -0.37%; P = .02). The regulations were also associated with improved mortality trends in several prespecified subgroups, including previously healthy children (differential change: -1.36%; 95% CI: -2.62% to -0.09%; P = .04) and children not admitted through the emergency department (differential change: -2.42%; 95% CI: -4.24% to -0.61%; P = .01).

Conclusions: Implementation of statewide sepsis regulations was generally associated with improved mortality trends in New York State, particularly in prespecified subpopulations of patients, suggesting that the regulations were successful in affecting sepsis outcomes.

FIGURE 1

Quarter-specific 30-day in-hospital sepsis mortality over time in New York and control states. A, Unadjusted: quarter-specific unadjusted mortality, with the regulation implementation noted as a vertical dotted line. B, Adjusted: quarter-specific adjusted mortality, with the regulation implementation noted as a vertical dotted line. In the prespecified model, linear mortality trends were estimated separately for both the pre- and postregulation periods, allowing for a discrete change in mortality just after the regulations (as indicated by the gray shaded bar).