The regulations require that hospitals in New York follow protocols for sepsis that include early detection and treatment, staff training, and reporting of adherence and clinical outcomes to the state.
In January 2013, Gov. Andrew Cuomo announced new required evidence-based protocols for the early detection and treatment of sepsis, making New York the first to issue state-wide regulations for the condition. The protocols, known as Rory’s Regulations, were implemented in memory of a 12-year-old boy who died from undiagnosed sepsis.
Under the regulations, all New York state (NYS) hospitals are required to employ protocols that address: screening and recognition of sepsis, severe sepsis, and septic shock; identification and documentation of appropriate treatment for patients with sepsis; and use of guidelines for treatment including early delivery of antibiotics. In addition, hospitals are required to report adherence and clinical outcomes to the state government.
In order to evaluate the effectiveness of the NYS sepsis regulations, a team of investigators conducted a retrospective cohort study of adult patients in the hospital with sepsis in NYS and 4 control states. The results of the study were published today in JAMA.
“The regulations require that hospitals in New York follow protocols for sepsis that include giving antibiotics within 3 hours and intravenous fluids within 6 hours of hospitalization,” Jeremy M. Kahn, MD, MS, professor in the Department of Critical Care Medicine at University of Pittsburgh School of Medicine and the Department of Health Policy and Management at the Graduate School of Public Health, and study lead author, explained to Contagion®.
For the study, Kahn and his team studied 1,012,410 sepsis admissions to 509 hospitals across the 5 states. In NYS and the control states, 139,019 and 289,225 patients, respectively, were admitted before the new regulations took effect, and 186,767 and 397,399 patients, respectively, were admitted after the implementation. The primary object of the study was to determine if the regulations had an effect on 30-day in-hospital mortality.
The investigators found that unadjusted 30-day in-hospital mortality was 26.3% in NYS and 22.0% in the control states before the regulations, and 22.0% in NYS and 19.1% in the control states after the regulations. After adjusting for patient and hospital characteristics, mortality after implementation decreased “significantly” in NYS relative to control states (P = 0.2 for the joint test of the comparative series estimates).
Furthermore, the study team reports that by the 10th quarter after implementation, adjusted absolute mortality was 3.2% (95% confidence interval [CI], 1.0 to 5.4%), lower than expected in NYS compared with the control states (P = .004).
“We found that after the regulations were implemented, sepsis outcomes improved much more rapidly in New York than would have been expected. More importantly, similar changes were not observed in other states,” Kahn continued. “Following the regulations, New York’s sepsis mortality rate dropped 4.3% to 22%, but the death rate only fell 2.9% to 19.1% in the control states. These data strongly suggest that the regulations had their intended effect of reducing sepsis death rates.”
Based on the findings, the authors write that mandated protocolized sepsis care was associated with greater decrease in sepsis morality compared with sepsis mortality in states that did not implement regulations. However, due to the fact that baseline mortality rates differed between NYS and the control states, it is unclear whether the findings are generalizable to other states.
“Right now, about 12 states are actively considering these regulations, and many others are considering them,” Kahn told Contagion®. “Our data clearly show that these regulations work in New York and they are likely to work elsewhere”
However, Kahn says, other states should be cognizant of their unique sepsis outcomes before adopting sepsis mandates.
“It’s conceivable that if their sepsis outcomes are already good, perhaps due to regional quality improvement efforts, they may not see a strong as an effect as we saw in New York. Policy makers should also be sure to engage hospitals, physicians, and advocacy groups from the beginning—it’s likely that what makes New York special is that the policy was a result of the hard work of a lot of engaged stakeholders, not just a ‘top down’ policy designed by regulators and handed to hospitals,” Kahn concluded.