SEP-1 Bundle Compliance Associated with Reduced Hospital Readmissions

As the leading cause of unplanned 30-day hospital readmissions,¹ sepsis affects more than 1.5 million individuals in the United States each year.² Although numerous studies have been conducted to address improving sepsis mortality, studies on methods to reduce readmissions are lacking. To this end, investigators from the Cleveland Clinic Health System in Cleveland, Ohio, sought to determine whether there was an association between Early Management Bundle, Severe Sepsis/Septic Shock (SEP-1) performance measure compliance, and hospital readmission. The results of the study were presented at the 47th Critical Care Congress, which took place February 25 to 28, 2018, in San Antonio, Texas.

For the study, patients who were admitted to 1 of 12 hospitals in a single health system between October 2015 and May 2017 “with administrative coding for sepsis during their index hospital admission, were evaluated for SEP-1 eligibility,” the study authors wrote. Those patients identified for the measure population were designated as either passing or failing SEP-1. The specific element of the bundle that led to the failure was also identified and recorded, with the most frequent element that led to failure as initial lactate collection. Status of 30-day readmission was evaluated for those patients who survived the index hospitalization.

A total of 1986 patients were coded for sepsis during the study period, of which 87.1% (1729) were eligible for the SEP-1 measure. Thirty-four percent (596) of those patients passed SEP-1, and 90.3% (1561) survived index hospitalization. The investigators found that survival was higher in those patients who passed SEP-1 than in those who failed SEP-1 (94.8% vs 87.9%, P<.01). Furthermore, according to the investigators, “readmission for index admission survivors was common (23.4% overall) and differed by facility (range 4.5% to 33.3%, P<.01).” Those patients who survived index hospitalization and passed SEP-1 bundle were readmitted less frequently than those who survived but failed SEP-1 (20.4% vs 25.1%, P = .03).

The investigators did not find an association between readmission and compliance with individual elements of the SEP-1 bundle (all P>.45); however, SEP-1 compliance was found to be independently associated with lower odds of readmission (OR, 0.73; 95% CI, 0.56-0.94; P = .02), after adjusting for facility with multivariable logistic regression.

The authors acknowledged that the main limitation of the study is that the data are from 1 health-system. Although it is a large health-system with hospitals that represent several types seen across the United States, it is unclear if these data are similar at other health-systems. “Additionally, we were only able to account for hospital re-admissions within our health-system,” commented co-author Seth R. Bauer, PharmD, FCCM, FCCP, BCPS, BCCCP, Critical Care Clinical Coordinator and Medical Intensive Care Clinical Pharmacist at Cleveland Clinic in Cleveland, Ohio, to Contagion®. “Most frequently patients return to our health-system, but not always. Thus, the number of re-admissions in each group may be under-represented.”

Based on those results, the investigators concluded that SEP-1 bundle compliance was associated with lower odds of hospital readmission and, as such, may be an appropriately targeted intervention to reduce readmissions. According to Dr. Bauer, in the future, the team “plans to evaluate data in a larger sample in order to try to evaluate the contribution of individual SEP-1 bundle failure elements.”

Interestingly, a systematic review published in the Annals of Internal Medicine this year reported that there is no high- or moderate-level evidence indicating that SEP-1 bundle compliance is associated with improved survival of adults with sepsis.³

For the study, investigators searched bibliographic databases such as PubMed and clinicaltrials.gov for “randomized and observational studies of death among adults with sepsis who received versus those who did not receive either the entire SEP-1 bundle or 1 or more SEP-1 hemodynamic interventions, including serial lactate measurements; a fluid infusion of 30 mL/kg of body weight; and assessment of volume status and tissue perfusion with a focused examination, bedside cardiovascular ultrasonography, or fluid responsiveness testing [that were published] from inception to November 28, 2017,” according to the study authors. “High- or moderate-level evidence required studies to have no confounders and low risk of bias.”

Of 56,563 references, only 20 studies met the inclusion criteria. Furthermore, only 1 single-center observational study found that lower in-hospital mortality was seen after implementing the SEP-1 bundle. A total of 16 studies (2 randomized, 14 observational) “reported increased survival with serial lactate measurements or 30-mL/kg fluid infusions,” according to the study authors. “None of the 17 studies were free of confounders or at low risk of bias. In 3 randomized trials, fluid responsiveness testing did not alter survival.”

The study is not without limitations, including the fact that the 2015 version of the SEP-1 was used in addition to the 2013 version of Centers for Medicare & Medicaid Services evidence criteria. Both of these were updated in 2017.

References

1. Mayr FB, Talisa VB, Balakumar V, Chang CH, Fine M, Yende S. Proportion and cost of unplanned 30-day readmissions after sepsis compared with other medical conditions. JAMA. 2017;317(5):530-531. doi:10.1001/jama.2016.20468.
2. Sepsis. Centers for Disease Control and Prevention website. cdc.gov/sepsis/datareports/index.html. Updated August 25, 2017. Accessed March 26, 2018.
3. Pepper DJ, Jaswal D, Sun J, Welsh J, Natanson C, Eichacker PQ. Evidence underpinning the Centers for Medicare & Medicaid services’ Severe Sepsis and Septic Shock Management Bundle (SEP-1): a systematic review Ann Intern Med. doi: 10.7326/M17-2947.