The war on sepsis

Following the widely publicized hospital death in 2012 of a 12-year-old boy from undiagnosed sepsis, New York state has taken the lead in battling the potentially lethal condition, which affects more than 750,000 U.S. patients each year.

Early last year, Gov. Andrew Cuomo announced new regulations, unprecedented nationally, requiring the state's general acute-care hospitals to adopt evidence-based practices to curb sepsis mortality rates among adult and pediatric patients. Cuomo said the regulations would save 5,000 to 8,000 lives a year, and he predicted they would serve as a model for other states.

Some hospital officials and quality experts, however, worry about the time burden the rules will impose on busy emergency department staff, and they caution that getting physicians to change their approach to sepsis is no easy task.

Years before the new regulations, many of the state's hospitals had launched their own ambitious sepsis programs. The STOP Sepsis Collaborative, for instance, an initiative in the greater New York City area now in its fourth year, reported a 23% drop in mortality from severe sepsis—sepsis with associated organ failure—among its 57 member hospitals, as of June 2013.

Sepsis occurs when an infection, such as pneumonia, triggers a cascading, whole-body inflammatory response that, if left untreated, can rapidly lead to progressive organ failure and death. It's the leading cause of hospital death in intensive-care units and the 10th leading cause of death in the U.S overall, according to federal data.

But despite mortality rates as high as 40% and national cost estimates related to sepsis totaling nearly $17 billion annually, hospitals across the country have struggled when it comes to the early detection, monitoring and intensive treatment that experts say are necessary to combat the illness.

Research by Dr. David Gaieski, an associate professor of emergency medicine at the University of Pennsylvania, and his colleagues has shown sepsis “hot spots” across the country where mortality rates are higher than in other regions. The researchers noted high rates of sepsis mortality in the Midwest, mid-Atlantic and Southern states—sometimes as much as four times the national average.

National efforts targeting sepsis are underway, buoyed by the Institute for Healthcare Improvement, Cambridge, Mass., which is working to disseminate sepsis best practices, and by HHS' $1 billion Partnership for Patients quality-improvement initiative.

New York's regulations, however, take improvement efforts even further, experts say.

Sepsis is a tough target. The symptoms—chills, fever, a rapid pulse—can mimic those of other conditions, making it difficult to spot, said Dr. Scott Weingart, director of critical care in the emergency department at 551-bed Elmhurst (N.Y.) Hospital Center, and a co-chair of the STOP Sepsis Collaborative. “There's no single test for sepsis. It requires careful screening of patients who might have it in order to identify the ones who actually do. It's like looking for a needle in a haystack.”

Once it is determined that a patient has sepsis, Weingart said, there isn't one single intervention that targets the illness. Instead, patients require a number of treatments, including antibiotics, lots of intravenous fluids, oxygen and, in some cases, surgery. “There are a set of things that have to be done consistently and that requires real diligence on the part of the care team.”

Improvement efforts also have to overcome deeply ingrained perceptions among physicians about what sepsis is and the dire need for early detection, Gaieski said. “Sometimes it's hard to get seasoned physicians to think about sepsis as time-sensitive disease like a heart attack,” he said. “But with concerted effort and the right resources, we should be able to affect mortality by a huge margin.”

Dr. Mark Rosen, medical director for the American College of Chest Physicians, who co-chairs the collaborative with Weingart, agreed that changing physicians' understanding of sepsis is a major hurdle. In prior years, he said, many physicians thought of sepsis as synonymous with septic shock—the most severe end of the spectrum. “Slowly, awareness is growing that providing prompt and aggressive treatment long before patients get that sick is the best way to improve mortality,” Rosen said.

He credits that increasing awareness, at least in part, to the case of Rory Staunton, a 12-year-old boy from Queens who was brought to the emergency department at NYU Langone Medical Center in 2012, vomiting, with a high fever and leg pain, a day after cutting his arm playing basketball at school. At the ED, despite a rapid pulse, high fever, mottled skin and a blood test showing an elevated white blood cell count—all warning signs of sepsis—Staunton was diagnosed with a probable stomach bug and sent home. By the time his parents brought him back to the hospital, he was gravely ill with septic shock. He died days later.

New York's tough new sepsis rules were named “Rory's Regulations,” after Staunton. “It's unfortunate that it took a tragedy like this, but the Rory Staunton case has created major stimulus for action,” Rosen said.

He said the STOP Sepsis Collaborative, which launched in 2011, was established to correct the systems that allow those kinds of tragic lapses to occur. The initiative has amassed data on more than 17,000 cases of severe sepsis and septic shock and provides evidence-based protocols hospitals can use to improve the diagnosis and care of severe sepsis patients in emergency departments.

Weingart, who chairs the collaborative with Rosen, said a big part of the initiative has been translating guidelines from the well-regarded Surviving Sepsis Campaign—which are designed for use in ICUs—into practices suited for implementation in busy EDs. “We tried to make them as simple as possible,” he said.

During the past year, participating hospitals also began extending their identification and treatment strategies beyond the ED and onto medical-surgical floors, said Zeynep Sumer-King, vice president of regulatory and professional affairs for the Greater New York Hospital Association, which leads the STOP Sepsis Collaborative jointly with the New York-based United Hospital Fund.

In addition to drops in sepsis-related mortality, the collaborative has seen progress on process measures, such as early identification of patients with sepsis and time until patients with sepsis are stabilized, Sumer-King said. She said those successes have helped prepare participating hospitals for the statewide regulations.

Those rules required New York hospitals to submit comprehensive sepsis protocols to the state's department of health by Sept. 3, 2013, and to implement those protocols by no later than Dec. 31. This year, hospitals will begin reporting sepsis-related process and outcomes data to the state.

“The state is requiring an enormous amount of data and that will create a significant burden,” Sumer-King said. “But in terms of processes and outcomes, hospitals that participated in the collaborative are ahead of the game.”

Other New York hospitals are conducting their own sepsis initiatives. In December, physician leaders from North Shore-Long Island Jewish Health System, a 12-hospital system based in Great Neck, N.Y., presented results from their systemwide sepsis initiative at the Institute for Healthcare Improvement's annual National Forum. Since launching the effort in 2009, North Shore-LIJ's hospitals have lowered the mortality among patients diagnosed with sepsis from 31.5% to 15.1%. In 2010, the system partnered with the IHI to create high-reliability care processes around each of the steps of sepsis identification and treatment, said Dr. Martin Doerfler, the system's associate chief medical officer.

He said much of North Shore-LIJ's success has come from taking complex guidelines and metrics—designed for use in intensive care—and modifying them for use in emergency departments. For instance, after seeking input from ED physicians, North Shore-LIJ changed its definition of “time zero”—a data point used to mark the time when sepsis care begins—from the time when a patient arrives at the hospital to the time when an emergency physician notes that a patient meets criteria for sepsis.

“We had to convince ED people that we could make these guidelines relevant to them,” Doerfler said. “We had to redesign processes and metrics to focus on emergency medicine and we needed physician buy-in.”

Like hospitals in the STOP Sepsis Collaborative, Doerfler is confident that North Shore-LIJ's initiative will position the system to be able to meet the requirements of New York's regulations. “Overall, I think we're ready,” he said.

Follow Maureen McKinney on Twitter: @MHMMcKinney