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First-Ever State Regulation on Sepsis Tied to Lower Death Rates

NY Hospitals Required to Implement Protocols in Suspected Cases

Sepsis death rates declined faster in New York than expected, after the introduction of the first state-mandated sepsis regulation in the U.S., according to an analysis by University of Pittsburgh researchers. The policy requires all New York hospitals to quickly implement certain protocols whenever sepsis is suspected. 

The finding, published today in JAMA, is welcome news for the other states at varying stages of adopting similar policies to reduce deaths from the life-threatening condition. Sepsis is the main cause of death in hospitalized patients.

The researchers say that it is very rare that U.S. hospitals are compelled to implement specific clinical protocols. Usually, quality improvement would be achieved by means of financial incentives and public reporting. However, state officials are requiring hospitals to follow certain evidence-based protocols when it comes to sepsis and the study shows that in New York at least, the protocols are having an effect.

In 2013, the New York State Department of Health issued Rory’s Regulations, named after 12-year-old Rory Staunton, who died of undiagnosed sepsis. The regulations require New York hospitals to follow sepsis protocols that include administering antibiotics within three hours and intravenous fluids within six hours of hospitalization. The hospitals also must regularly train staff in the protocols and report adherence and clinical outcomes to the state. 

The researchers analyzed the records of over one million sepsis admissions in 509 hospitals in New York and four control states with no sepsis regulation: Florida, Maryland, Massachusetts, and New Jersey. The team looked at dates from two years before the adoption of Rory’s Regulations, and two years after.

Prior to the regulations being put in place, 26.3% of people diagnosed with sepsis in New York died while hospitalized, compared to 22% in the control states. Following the regulations, the state’s sepsis mortality rate dropped 4.3% to 22%, whereas the death rate fell by only 2.9% to 19.1% in the control states. 

After taking into consideration patient and hospital characteristics, and pre-existing sepsis trends in the states, New York’s sepsis death rate was 3.2% lower following the regulation than would have been expected, relative to the control states.

This comparison was vital for estimating the improvement, and separates the study from previous ones. As sepsis outcomes are known to improve with time, a study that examined New York alone could not differentiate the effects of the regulations from underlying trends. But as these improvements occurred more quickly in New York than in other states, the researchers are confident that the regulations are the source of the improvement.

Source: EurekAlert!, July 16, 2019

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