by Rhee, Chanu; Filbin,
Michael R.; Massaro, Anthony F.; Bulger, Amy L.; McEachern, Donna; Tobin,
Kathleen A.; Kitch, Barrett T.; Thurlo-Walsh, Bert; Kadar, Aran; Koffman,
Alexandra; Pande, Anupam; Hamad, Yasir; Warren, David K.; Jones, Travis M.;
O’Brien, Cara; Anderson, Deverick J.; Wang, Rui; Klompas, Michael; for the
Centers for Disease Control and Prevention (CDC) Prevention Epicenters Program
Objectives: Many
septic patients receive care that fails the Centers for Medicare and Medicaid
Services’ SEP-1 measure, but it is unclear whether this reflects meaningful
lapses in care, differences in clinical characteristics, or excessive rigidity
of the “all-or-nothing” measure. We compared outcomes in cases that passed
versus failed SEP-1 during the first 2 years after the measure was implemented.
Design:
Retrospective cohort study. Setting: Seven U.S. hospitals. Patients: Adult
patients included in SEP-1 reporting between October 2015 and September 2017.
Interventions: None.
Measurements and Main Results: Of 851 sepsis cases in the cohort, 281 (33%)
passed SEP-1 and 570 (67%) failed. SEP-1 failures had higher rates of septic
shock (20% vs 9%; p < 0.001), hospital-onset sepsis (11% vs 4%; p = 0.001),
and vague presenting symptoms (46% vs 30%; p < 0.001). The most common
reasons for failure were omission of 3- and 6-hour lactate measurements
(228/570 failures, 40%). Only 86 of 570 failures (15.1%) had greater than
3-hour delays until broad-spectrum antibiotics. Cases that failed SEP-1 had
higher in-hospital mortality rates (18.4% vs 11.0%; odds ratio, 1.82; 95% CI,
1.19–2.80; p = 0.006), but this association was no longer significant after
adjusting for differences in clinical characteristics and severity of illness
(adjusted odds ratio, 1.36; 95% CI, 0.85–2.18; p = 0.205). Delays of greater
than 3 hours until antibiotics were significantly associated with death
(adjusted odds ratio, 1.94; 95% CI, 1.04–3.62; p = 0.038), whereas failing
SEP-1 for any other reason was not (adjusted odds ratio, 1.10; 95% CI,
0.70–1.72; p = 0.674).
Conclusions: Crude
mortality rates were higher in sepsis cases that failed versus passed SEP-1, but
there was no difference after adjusting for clinical characteristics and
severity of illness. Delays in antibiotic administration were associated with
higher mortality but only accounted for a small fraction of SEP-1 failures.
SEP-1 may not clearly differentiate between high- and low-quality care, and
detailed risk adjustment is necessary to properly interpret associations
between SEP-1 compliance and mortality.
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