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New York’s Sepsis Protocols Lower Death Rates, New Study Shows

A new study led by researchers at the University of Pittsburgh and published today in the Journal of the American Medical Association (JAMA), shows for the first time that New York’s sepsis protocols are directly responsible for the significant reduction in sepsis deaths in the state. Sepsis is the body’s extreme response to infection. It kills more than 275,000 Americans each year and leaves hundreds of thousands more with life-changing disabilities.

New York’s sepsis protocols–known as Rory’s Regulations–were signed into law by Governor Andrew Cuomo in 2013, following the death of 12-year-old Rory Staunton from undiagnosed, untreated sepsis. They require all hospitals to adopt evidence-based protocols for the rapid identification and treatment of sepsis.

While previous studies of New York’s sepsis data have shown that the interventions mandated by the protocols–including the timely administration of antibiotics and IV fluids–lead to a reduction in sepsis mortality, this is the first study to conclusively tie improvements in sepsis outcomes with the implementation of holistic, evidence-based regulations.

"For the first time, we have rigorous evidence showing that New York's sepsis protocols are associated with significant decline in sepsis deaths in that state. Our findings suggest the value of a holistic approach to regulatory practice, which includes education and training within hospitals, as well as public reporting of sepsis data,” said lead author Jeremy Kahn, M.D., M.S., professor in the Department of Critical Care Medicine at Pitt’s School of Medicine and the Department of Health Policy and Management at Pitt’s Graduate School of Public Health

Kahn and his team analyzed more than a million sepsis admission records from New York and four control states in the years before and after the implementation of Rory’s Regulations. They found that sepsis mortality rates dropped further and faster in New York than in the control states following the adoption of the regulations: In New York, the sepsis death rate in the state dropped 4.3% while in control states, it dropped 2.9%.

By comparing New York’s sepsis data with that of the control states–Florida, Maryland, Massachusetts, and New Jersey– and taking into account patient and hospital characteristics and pre-existing sepsis trends in the states, the study showed that New York’s sepsis death rate was 3.2% lower following the regulations than would have been expected, relative to the control states–proving that the protocols themselves are the source of the improvement.

"One thing that likely impacted the success of the New York regulations was the state’s collaborative approach to policy making,” said Dr. Kahn. “These weren’t just top-down regulations. All relevant stakeholders including the state department of health, hospitals, and the Rory Staunton Foundation–a grassroots patient advocacy organization–came together to develop sepsis policy. This collaborative approach is substantially likely to increase the chance of success as other states move to adopt similar regulations.”

Ciaran and Orlaith Staunton–the parents of Rory Staunton and the founders of the Rory Staunton Foundation for Sepsis Prevention, the leading sepsis advocacy organization in the country–were instrumental in the passage of Rory’s Regulations. In a joint statement, they said: “The research conducted by Dr. Kahn and his colleagues shows conclusively that a policy approach to combating sepsis works. Protocols are the most effective tool we have in the fight against this condition. We urge healthcare policymakers not to ignore the evidence. Protocols save lives and we will continue to advocate for their adoption in every hospital in the country.”

About the Rory Staunton Foundation
The Rory Staunton Foundation for Sepsis Prevention is the nation’s leading sepsis advocacy organization. It was established in 2013, following the preventable death of 12-year-old Rory Staunton from sepsis. The Foundation works to end preventable deaths from sepsis through the establishment of mandatory sepsis protocols in hospitals, the development and dissemination of quality education materials for K-12 students and families, and the creation of national public awareness campaigns to ensure that all Americans understand the signs of sepsis and the importance of seeking immediate medical assistance.

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