The Impact of Centers for Medicare & Medicaid Services SEP-1 Core Measure Implementation on Antibacterial Utilization: A Retrospective Multicenter Longitudinal Cohort Study With Interrupted Time-Series Analysis

Abstract

Background The impact of the U.S. Centers for Medicare and Medicaid Services (CMS) Severe Sepsis and Septic Shock: Management Bundle (SEP-1) Core Measure on overall antibacterial utilization is unknown. Methods We performed a retrospective multicenter longitudinal cohort study with interrupted time series analysis to determine the impact of SEP-1 implementation on antibacterial utilization and patient outcomes. All adult patients admitted to 26 hospitals between October 1, 2014, and September 30, 2015 (the “SEP-1 preparation period”) and between November 1, 2015, and October 31, 2016 (the “SEP-1 implementation period”) were evaluated for inclusion.The primary outcome was total antibacterial utilization measured as days of therapy (DOT) per 1,000 patient days. Results The study cohort included 701,055 eligible patient admissions and 4.2 million patient days. Overall antibacterial utilization increased 2% each month during SEP-1 preparation (RR=1.02 per month [95% CI 1.00-1.04]; p=0.02). Cumulatively, the mean monthly DOT/1,000 patient-days increased 24.4% [95% CI 18.0, 38.8] over the entire study period (October 2014-October 2016). The rate of sepsis diagnosis/1,000 patients increased 2% each month during SEP-1 preparation (RR=1.02 per month [95% CI 1.00-1.04]; p=0.04). The rate of all-cause mortality/1,000 patients decreased during the study period (SEP-1 preparation RR=0.95 [0.92-0.98]; p=0.001 and SEP-1 implementation RR=0.98 [95% CI 0.97-1.00]; p=0.01). Cumulatively, the monthly mean all-cause mortality/1,000 patients declined 38.5% [95% CI 25.9, 48.0] over the study period. Conclusions Announcement and implementation of the CMS SEP-1 process measure was associated with increased diagnosis of sepsis and antibacterial utilization and decreased mortality among hospitalized patients.

Temporal Trends in Antimicrobial Prescribing During Hospitalization for Potential Infection and Sepsis

“…In an interrupted time series of hospitalized patients at 111 hospitals, Pakyz et al found that unadjusted days of broad-spectrum antimicrobial therapy per 100 000 patient-days increased immediately after SEP-1 rollout among patients hospitalized for severe sepsis and septic shock, but days of therapy were stable among all-cause hospitalizations. In a study of 26 hospitals, Anderson et al found that, although unadjusted days of antimicrobial therapy per 100 000 patient-days were greater after SEP-1 implementation (vs before), antimicrobial use was increasing before SEP-1 implementation and actually decreased slightly during the year after SEP-1 implementation.…”

The Importance of Shifting Sepsis Quality Measures From Processes to Outcomes

“…University of Pittsburgh Medical Center investigators reported similar trends among 11 affiliated hospitals . The fourth study, including 26 hospitals, reported that (1) antibacterial use increased by 24% between 2014 and 2016 and (2) overall hospital mortality rates were decreasing before SEP-1 but the trend leveled off after SEP-1 went into effect …”

“…Four large, rigorous, multicenter time-series analyses now document the disappointing real-world impact of SEP-1 across hundreds of US hospitals. [1][2][3][4] Broad-spectrum antibiotic use has increased since SEP-1 went into effect, but SEP-1 has not lowered mortality rates.Thefirststudyincluded111hospitalsandreportedthat broad-spectrum antibiotic use increased by 0.4% per month after SEP-1 was implemented. 1 The second study included 114 hospitals and reported a 25% increase in antimethicillin-resistant Staphylococcus aureus antibiotic use in patients with possible sepsis between 2013 and 2017 (from 19.8% to 26.3%) and a 45% increase in antipseudomonal antibiotic use (from 27.7% to 40.5%) but no change in the combined outcome of hospital death or discharge to hospice (from 20.3% to 20.4%; odds ratio, 1.00; 95% CI, 0.97-1.04).…”

“…3 The fourth study, including 26 hospitals, reported that (1) antibacterial use increased by 24% between 2014 and 2016 and (2) overall hospital mortality rates were decreasing before SEP-1 but the trend leveled off after SEP-1 went into effect. 4 The only studies that claim a benefit from SEP-1 are a subset of those comparing outcomes among patients who received SEP-1-compliant vs noncompliant care (ie, all components of the SEP-1 bundle were or were not performed). 5 These studies are unreliable, however, because the patients who receive care that is not com-VIEWPOINT…”

“…Four large, rigorous, multicenter time-series analyses now document the disappointing real-world impact of SEP-1 across hundreds of US hospitals. [1][2][3][4] Broad-spectrum antibiotic use has increased since SEP-1 went into effect, but SEP-1 has not lowered mortality rates.…”