Little Benefit Seen From Federal Sepsis Tx Bundle

Sepsis outcomes remained largely unchanged after the federal government began requiring hospitals to report adherence to a so-called SEP-1 treatment protocol for sepsis -- at least, that was the case for one large, urban health system, researchers said.

At the University of Pittsburgh Medical Center (UPMC), risk-adjusted mortality, successful discharge, and ICU admission after SEP-1 implementation differed only slightly from what would have been expected without the requirement, reported Ian Barbash, MD, MS, and colleagues at UPMC in Annals of Internal Medicine.

Rates of specific outcomes for all 22,759 sepsis patients in UPMC's 11-hospital system treated under SEP-1 were as follows:

• In-hospital mortality: 3.9% expected, 4.0% observed; difference 0.1% (95% CI -0.9% to 1.1%, P=0.87)

• Discharge to home: 69.8% expected, 68.0% observed; difference -1.8% (95% CI -4.1% to 0.6%, P=0.15)

• ICU admission: 20.4% expected, 22.4% observed; difference 2.0% (95% CI 0%-4.0%, P=0.06)

"Expected" rates were derived from adjustments for patients' risk as well as extrapolating trends seen prior to SEP-1.

Few changes were seen in adherence to the particular treatment processes specified in SEP-1, the researchers also found. The main exceptions involved lactate measurement. Testing for lactate levels within 3 hours of diagnosis reached 70.2% following SEP-1 (95% CI 69.1%-71.2%) compared with an expected rate of 46.5% (95% CI 43.6%-49.3%) in the absence of SEP-1.

The protocol also requires a repeat measurement at 6 hours, and compliance with this step improved by an absolute 17.4% (95% CI 14.4%-20.4%), from the expectation of 9.6% to 27.0%.

Initiation of antibiotics within 3 hours and 30 mL/kg IV fluid administration, on the other hand, improved only a few percentage points; providing vasopressors within 6 hours decreased slightly.

Barbash and colleagues concluded that SEP-1 had, at best, "variable effects" on treatment processes and no clear positive impact for patients.

"[E]ither there was no associated change in outcomes or that any benefits to patients may be counterbalanced by harm in other patients from the fixed application of a sepsis treatment bundle," the team wrote.

The findings contrast with those reported previously from New York state's widely applauded sepsis-bundle program, which also requires the hospital to collect and report data on specific treatment processes and outcomes. Barbash and colleagues noted that the federal program differs in key respects: for one thing, CMS considers a patient's treatment to be adherent only if every process element is followed. New York, on the other hand, determines adherence separately for different types of processes.

Also, New York includes an education component lacking in CMS's rules, which give hospitals no guidance on implementing the required tests and treatments.

In an accompanying editorial, two specialists at Harvard Medical School and the Harvard Pilgrim Health Care Institute in Boston identified a number of other possible reasons for SEP-1's apparent failure at UPMC.

Michael Klompas, MD, MPH, and Chanu Rhee, MD, MPH, said the protocol's elements may not be appropriate for all patients. The insistence on lactate measurement "may in fact lead to over-resuscitation, particularly for patients who are less sick," they wrote.

Similarly, the mandatory IV fluid infusion can be harmful, "and the data on time to antibiotic administration and outcomes are nuanced." Sepsis is not homogeneous, and one-size-fits-all approaches may be as likely to harm as help, the editorialists suggested.

They subtly questioned the original impetus for mandatory protocols. New York's rules are known as "Rory's Regulations," named after a 12-year-old boy named Rory Staunton, whose sepsis death in 2012 was tied to slow recognition and undertreatment.

Klompas and Rhee contended that such cases aren't typical: "sepsis preferentially affects patients with severe comorbidities whose deaths are difficult to prevent once they become septic, even with optimal hospital-based care," they wrote. "Devastating deaths in young and healthy persons have helped catalyze sepsis measures and mandates, but patients hospitalized for sepsis are rarely perfectly healthy."

The editorialists also pointed to the study's most obvious limitation: that UMPC may not be representative of all hospitals. In a UPMC press release, Barbash acknowledged this, suggesting immodestly that it's "possible UPMC already had achieved the improvements that SEP-1 might induce at other hospitals."

Be that as it may, CMS's reporting on UPMC facilities shows their adherence to SEP-1 is not an outlier in either direction. Its biggest hospital in the city of Pittsburgh, for example, shows 59% adherence, compared with national and state averages of 60% and 57%, respectively.

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