Federal policy to reduce deaths from sepsis was mostly ineffective

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The first large-scale, cross-hospital evaluation of an “all or nothing” federal policy to improve outcomes in sepsis patients found the guidelines to be a wash – on average, despite significant investment in their implementation, they have neither helped nor harmed an analysis by clinicians and University of Pittsburgh School of Medicine scholars from nearly a dozen hospitals in an academic health system.

The results, published today in the Annals of Internal Medicine, show how the guidelines known as Severe Sepsis and Septic Shock: Management Bundle or “SEP-1” could be built and possibly improved.

“We cannot just stop with SEP-1 as it currently exists. Our data suggest that ongoing efforts must be made to refine and update SEP-1 to benefit more patients,” said senior author Ian Barbash, MD, MS, a UPMC Intensivist and Assistant Professor in Pitt’s Department of Pulmonary, Allergy and Critical Care Medicine. “Getting a health system in place to put the infrastructure in place to respond to this type of action is a big thing. If you do, you want to be fairly confident that it will improve patient outcomes.”

Sepsis occurs when a person’s organs stop working properly due to an out-of-control immune response to an infection. It is responsible for 1 in 5 deaths worldwide. In the US, at least 1.7 million adults develop sepsis each year, and one in three patients who died in a hospital had sepsis, according to the US Centers for Disease Control and Prevention.

In response to these astonishing numbers, the Centers for Medicare & Medicaid Services (CMS) implemented SEP-1 in October 2015. For hospitals to be considered compliant, patients need to receive a bundle of treatments, including blood cultures, early antibiotics, and regular lab tests and IV fluids, and hospitals need to collect and report data on their compliance.

Barbash and his team examined electronic health record data from 54,225 adult patient visits to 11 hospitals of various sizes in the UPMC system serving urban, suburban or rural populations. UPMC responded to SEP-1 with several strategies that are common to hospitals across the United States, including sepsis alerts, electronic order sets, and clinical documentation reminders.

The researchers compared data from two years before and two years after the implementation of SEP-1.

The most significant change during the study period was that doctors increased the order in which they measured lactate. This is a test that measures the amount of lactic acid in a patient’s blood to see if they have low blood flow or low blood oxygen levels. However, the increased testing did not result in other changes in service delivery or overall fewer deaths.

“It’s not that the bundle elements aren’t good for patients – we know early sepsis treatment saves lives,” said senior author Jeremy Kahn, MD, MS, professor of intensive care medicine and health policy and management at Pitt. “The question is whether SEP-1, as it currently exists, was enough to move the needle.

“Tests like lactate are useful when they give you information that can help improve patient outcomes,” Kahn continued. “But testing to report that you took the test is only useful if you are doing other things as well.”

Overall, SEP-1 was not associated with clinically meaningful patient outcomes. Sepsis deaths fell before the policy was implemented and the trend continued as later expected. Additionally, another study found that an academic hospital was investing more than $ 150,000 per month in responding to SEP-1.

“Sepsis is fatal, but it can be treated,” said Barbash. “I suspect that simplifying SEP-1 and focusing on what works – like giving appropriate antibiotics to patients who need them early – will lead to improvements.

“One limitation of our study, however, was that hospitals were included in an academic health system – UPMC – that has long been working to improve sepsis outcomes in its patients and is currently working with CMS to improve it,” continued Barbash. “It is possible that UPMC has already made the improvements that SEP-1 could bring to other hospitals.”

How the sepsis care program saves lives and cuts costs

More information:
Internal Medicine Annals (2021). https://www.acpjournals.org/doi/10.7326/M20-5043 Provided by the University of Pittsburgh

Quote: Federal policy to reduce sepsis deaths has been largely ineffective (2021, April 19) and was released on April 19, 2021 from https://medicalxpress.com/news/2021-04-federal-policy-deaths-sepsis -ineffective.html

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