Pluses and minuses of New York state’s sepsis care mandate
• by Salynn Boyles
Contributing Writer May 21, 2017
• This article is a collaboration between MedPage Today® and:
WASHINGTON — Earlier administration of antibiotics, but not intravenous fluids, was associated with lower in-hospital death rates among patients with suspected sepsis treated in New York state emergency departments following the adoption of statewide hospital mandates known as “Rory’s Regulations.”
The first-in-the-nation regulations requiring the early assessment and treatment of sepsis in the hospital emergency department setting were implemented in 2013, following the death of 12-year-old Rory Staunton from sepsis undiagnosed in a hospital ED until it was too late to save him.
The study findings support the association between time to treatment and outcome among patients with sepsis or septic shock treated in emergency departments under the statewide initiative, said researcher Christopher W. Seymour, MD, of the University of Pittsburgh School of Medicine.
Each 1-hour delay in completing the mandated protocol or administering antibiotics was associated with a 4% increase in the odds of in-hospital death, Seymour said.
Seymour presented the findings May 21 at ATS 2017 International Conference, the annual meeting of the American Thoracic Society. They were published simultaneously in the New England Journal of Medicine.
Seymour told MedPage Today that the move toward requiring protocolized early treatment of suspected sepsis or septic shock has been controversial within emergency medicine. Studies examining the impact of early treatment have been mixed, with a 2015 meta-analysis of 11 observational studies showing no mortality benefit with early antibiotic administration (within three hours of ED triage).
He said the New York mandate presented a unique opportunity to study the impact of early treatment of suspected sepsis in very different hospital ED settings.
In addition to legally requiring guideline-based clinical protocols for timely fluid resuscitation, antibiotic administration and frequent assessment of hemodynamic response to treatment, the mandate requires that the state’s department of health perform audits to determine if the treated patients actually had sepsis.
The study included data from patients with sepsis and septic shock reported to the New York State Department of Health between April 1, 2014, and June 30, 2016.
The primary outcome was in-hospital mortality, and the primary exposure was the time to completion of the 3-hour bundle, which includes measurement of lactate levels, prompt blood culture followed by administration of broad spectrum antibiotics and administration of intravenous fluids.
Among 49,331 patients treated at 149 hospitals, 40,696 (82.5%) were treated according to protocol within three hours. The median time to completion of the 3-hour bundle was 1.30 hours (IQR 0.65-2.35) and the median time to administration of antibiotics was 0.95 hours (IQR 0.35-1.95). The median time to completion of the fluid bolus was 2.56 hours (IQR 1.33-4.20).
Among patients who had the 3-hour bundle completed within 12 hours:
• Longer time to bundle completion was associated with higher risk-adjusted in-hospital mortality (OR 1.04 per hour, 95% CI 1.02-1.05; P<0.001)
• Longer time to antibiotic administration was also associated with higher adjusted in-hospital mortality (OR 1.04 per hour, 95% CI 1.03-1.06; P<0.001)
• Longer time to bolus fluid was not associated with a statistically significant increase in mortality (OR 1.01; 95% CI 0.99-1.02; P=0.21)
The analysis also showed large variations in protocol completion times from hospital to hospital, despite the fact that all hospitals in the state were legally required to follow the mandate, Seymour said.
“This is a really important finding and we need to understand more about why some hospitals are much better at providing this emergency department care,” Seymour said, adding that smaller hospitals in more rural areas tended to provide faster bundled care than larger, urban hospitals.
And an editorial published with the study in NEJM, expressed caution about broadly adopting Rory’s Regulations nationwide.
“Recent clinical trials suggest that protocolized resuscitation strategies, which are also mandated by Rory’s Regulations, may paradoxically lead to increased lengths of stay in the ICU and in the hospital and higher costs,” wrote Tina B. Hershey, MD, MPH and Jeremy M. Kahn, MD, of the University of Pittsburgh. “The regulations may also lead to antibiotic overuse, if hospitals, in an attempt to increase their adherence to guidelines, give antibiotics to patients who are not infected.”
They added that, “more broadly, there are insidious risks to turning clinical practice guidelines into policy mandates.”
“Clinical practice guidelines may make strong recommendations based on rigorous scientific evidence, but they are also inherently flexible, allowing physicians to exercise considerable professional judgment,” they wrote. “Legislation and regulation, however, are inherently inflexible, forcing clinicians to adopt certain care practices independent of clinical judgment.”
The research was funded by the National Institutes of Health, Veteran’s Affairs Services, and others.