Fewer Deaths After Sepsis Protocol Mandate

Veronica Hackethal, MD

September 07, 2018

Deaths from sepsis declined during the 2 years following implementation of a state mandate requiring hospitals to follow sepsis care bundles and report on patient outcomes, according to a study published online September 7 in the American Journal of Respiratory and Critical Care Medicine.

The study results demonstrate "improved care for patients with sepsis as evidenced by increased compliance with performance metrics and decreased risk-adjusted mortality over the first 2 years of the ongoing initiative. A state-wide initiative using regulations and non-financial incentives appears to have substantially changed care," Mitchell M. Levy, MD, from the Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Alpert Medical School at Brown University, Providence, Rhode Island, and colleagues write.

The mandate required hospitals to develop and submit for approval evidence-based sepsis care bundles, as well as report on sepsis care and patient mortality. Hospitals were allowed to tailor bundles for their specific hospitals, but were required to include the following:

  • 3-hour bundle (all severe sepsis patients): administration of antibiotics and measurement of lactate levels within 3 hours of sepsis diagnosis, with collection of blood cultures before giving antibiotics

  • 6-hour bundle (for septic shock: systolic blood pressure <90 mm Hg, or lactate ≥4 mmol/L): intravenous fluid bolus (30 cc/kg), vasopressors for refractory hypotension, remeasurement of lactate levels within 6 hours of triggering the bundle

To investigate the impact of the sepsis initiative, the researchers analyzed data on 91,357 adult patients with sepsis and septic shock (median age, 71 years) seen at 183 hospitals from April 2014 to June 2016.

Results showed that for 81.3% of these patients (n = 74,293), a sepsis bundle was triggered. Use of the 3-hour bundle increased from 53.4% to 64.7% (P < .001), and use of the 6-hour bundle among eligible patients increased from 23.9% to 30.8% (P < .001).

Among patients who received the sepsis bundle, risk-adjusted mortality decreased from 28.8% before the initiative to 24.4% after it (P < .001).

That translates to a 4.4% absolute decrease and a 15% relative decrease in risk-adjusted mortality during the study period.

Hospitals with greater compliance with the sepsis bundles had lower mortality than those with less compliance. Risk-adjusted mortality for the least compliant hospitals was 29.8% vs 23.5% for the most compliant. Also, for hospitals with greater compliance, lengths of stays were shorter.

Although the study cannot prove that the sepsis bundles directly improved mortality, the authors write, "there is reason to believe that this may be the case," particularly because bundle initiation and completion correlated with improved patient outcomes.

History of the Sepsis Mandate

In 2013, New York state introduced the nation's first mandated public reporting initiative for sepsis. The New York state initiative was motivated by the death of 12-year old Rory Staunton, who died from undiagnosed sepsis after developing an infection from a scrape. The issue gained widespread attention from the media, as well as from advocacy groups, the Centers for Medicare & Medicaid Services, and from the governor of New York.

"Governor Andrew Cuomo and then Commissioner of Health Nirav Shah responded to Rory's preventable death by mandating public reporting of sepsis process and outcomes, with the goal of improving earlier diagnosis and management of sepsis," Levy said in a news release.

"The reason the state adopted these particular bundles is that our group had published evidence that there was a strong association between compliance with these interventions and improved survival in sepsis," he added.

"The New York State sepsis initiative provides strong evidence that compliance with sepsis performance measures is associated with improved survival in these critically ill patients," Levy explained. "At least in sepsis, our study strongly supports the value of public reporting of outcomes."

The study was funded by the New York Department of Health. One or more authors report having received grants from one or more of the following organizations: the National Institutes of Health, the Veterans Affairs Health Services Research and Development Investigator-Initiated Research program, and IPRO.

Am J Respir Crit Care Med. Published online September 7, 2018. Abstract

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