Federal policy intended to improve U.S. sepsis outcomes has been a wash, according to large-scale study by University of Pittsburgh School of Medicine clinician–scientists.

The “all or none” requirements instituted for treatment of suspected sepsis patients neither help nor hurt in their current form, wrote lead author Ian Barbash, M.D., M.S., a UPMC intensivist. But they put a large cost burden on health systems and shouldn’t be left as-is, he added.

The Centers for Medicare & Medicaid Services implemented sweeping policy in October 2015 to combat the outsized numbers of hospital deaths due to sepsis in the United States. According to these SEP-1 guidelines, hospitals are required to provide patients with a list of treatments, including blood cultures, early antibiotics, regular lab tests and IV fluids. They also must report compliance data.

The researchers compared data among 11 UPMC hospitals from two years before and two years after SEP-1 implementation. Overall, the new program wasn’t tied to clinically meaningful patient outcomes, Barbash and team found. Deaths from sepsis already had begun decreasing before the SEP-1 implementation, and the trend would have continued, they said. Meanwhile, the hospitals had made huge investments in versions of the program, they said.

Among 54,225 patient visits, clinicians were found to increase orders of lactate measurement to pinpoint low blood flow or low blood oxygen, for example. But the increased testing did not translate to other changes in care delivery or lower overall mortality, they said.

Image of Jeremy Kahn, M.D., MS
Jeremy Kahn, M.D., MS; Photo credit: UPMC

“We know that early sepsis treatment saves lives,” said senior author Jeremy Kahn, M.D., M.S., professor of critical care medicine and health policy and management. “The issue is whether SEP-1, as it currently exists, was sufficient to move the needle.”

“Sepsis is deadly, but it can be treated,” Barbash concluded. “I suspect that simplifying SEP-1 and focusing on what works, such as early administration of appropriate antibiotics to the patients who need them, will lead to improvements.”

UPMC already had begun improving its sepsis protocol, the authors acknowledged. The program, therefore, may have had a different effect in another hospital system.

“It is possible UPMC already had achieved the improvements that SEP-1 might induce at other hospitals,” they wrote.

Sepsis results from an out-of-control immune system response to infection, and can lead to organ failure. At least 1.7 million adults develop sepsis each year and one in three patients who die in a hospital have sepsis, according to the U.S. Centers for Disease Control and Prevention.

Full findings were published in the Annals of Internal Medicine.