Impact of New York Sepsis Mandates

The regulation of sepsis care in New York state may have had a more profound impact on in-hospital mortality than most expected.



A recent study found that the implementation of state-mandated sepsis care has led to reductions of in-hospital mortality nearly twice that of states who did not undergo a similar change in regulation.


“Rarely in the U.S. do we force hospitals to implement specific clinical protocols. Typically, quality improvement is achieved through financial incentives and public reporting,” said lead investigator Jeremy Kahn, MD, MS, professor at the University of Pittsburgh School of Medicine. “For the first time, state officials are enshrining in regulations that hospitals must follow certain evidence-based protocols when it comes to sepsis. And our study finds that, at least in New York, it seemed to work.”

After the passage of Rory’s Regulations in 2013, physicians across the nation began to take a noted interest in the effects of these mandated protocols on in-hospitality mortality of sepsis patients. To evaluate the impact, investigators compared data on adult patients hospitalized with sepsis between New York and 4 control states through all-payer hospital discharge data. The control states were Florida, Maryland, Massachusetts, and New Jersey.

The primary outcome measure of the study 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. 



The time period of Jan. 1, 2011 to March 31, 2013 was designated as the before period and after was defined as April 1, 2013 to Sept. 30, 2015. The final analysis included a total of 1,012,410 sepsis admission from 509 hospitals. 



The mean age of the study population was 69.5 years and 47.9% were female. Investigators identified 139,019 patients admitted before the implementation of regulations in New York state and 289,225 patients from the 4 control states during that same time period. Investigators identified 186,767 patients in New York after the initiation of protocols. A group of 397,999 patients from the control states were admitted during that time period.

The unadjusted 30-day in-hospital mortality was 26.3% in New York and 22% in the control states before regulations went onto effect. After adjusting for patient and hospital characteristics, mortality post-implementation of regulations decreased significantly in New York compared to the control states.

Investigators noted that in the 10th quarter following implementation, the adjusted mortality rate was 3.2% lower than expected in New York than in control states. Additionally, the regulations were associated with no significant differences in intensive care unit admission rates, a significant relative decrease in hospital length of stay, a significant relative increase in central venous catheter use, and a significant relative decrease in the C difficile infection rate. 



In an attached editor’s note, Demetrios Kyriacou, MD, PhD, professor at the Northwestern University Feinberg School of Medicine, wrote that results suggesting greater than expected reduction were important in demonstrating the effectiveness of public health interventions, yet cautioned of negative consequences of mandated guidelines. 



“Mandated care regulations usually require increased administrative and clinical resources,” Kyriacou wrote. “Unless additional resources are specifically dedicated to compliance with new regulations, resources could be diverted from other critical care interventions. The approach of the New York State government to improve overall sepsis care and outcomes is an experiment.”

This study, titled “Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis,” is published in JAMA.