Treatment Patterns and Clinical Outcomes After the Introduction of the Medicare Sepsis Performance Measure (SEP-1)

Abstract

Background: Medicare requires that hospitals report on their adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1).

Objective: To evaluate the effect of SEP-1 on treatment patterns and patient outcomes.

Design: Longitudinal study of hospitals using repeated cross-sectional cohorts of patients.

Setting: 11 hospitals within an integrated health system.

Patients: 54 225 encounters between January 2013 and December 2017 for adults with sepsis who were hospitalized through the emergency department.

Intervention: Onset of the SEP-1 reporting requirement in October 2015.

Measurements: Changes in SEP-1-targeted processes, including antibiotic administration, lactate measurement, and fluid administration at 3 hours from sepsis onset; repeated lactate and vasopressor administration for hypotension within 6 hours of sepsis onset; and sepsis outcomes, including risk-adjusted intensive care unit (ICU) admission, in-hospital mortality, and home discharge among survivors.

Results: Two years after its implementation, SEP-1 was associated with variable changes in process measures, with the greatest effect being an increase in lactate measurement within 3 hours of sepsis onset (absolute increase, 23.7 percentage points [95% CI, 20.7 to 26.7 percentage points]; P < 0.001). There were small increases in antibiotic administration (absolute increase, 4.7 percentage points [CI, 1.9 to 7.6 percentage points]; P = 0.001) and fluid administration of 30 mL/kg of body weight within 3 hours of sepsis onset (absolute increase, 3.4 percentage points [CI, 1.5 to 5.2 percentage points]; P < 0.001). There was no change in vasopressor administration. There was a small increase in ICU admissions (absolute increase, 2.0 percentage points [CI, 0 to 4.0 percentage points]; P = 0.055) and no changes in mortality (absolute change, 0.1 percentage points [CI, -0.9 to 1.1 percentage points]; P = 0.87) or discharge to home.

Limitation: Data are from a single health system.

Conclusion: Implementation of the SEP-1 mandatory reporting program was associated with variable changes in process measures, without improvements in clinical outcomes. Revising the measure may optimize its future effect.

Primary funding source: Agency for Healthcare Research and Quality.

Figure 1.

Patient selection flow diagram. ED = emergency department; LOS = length of stay; SEP-1 = Severe Sepsis and Septic Shock Early Management Bundle; SOFA = Sequential Organ Failure Assessment.

Figure 2.

Changes in unadjusted process measures in overall cohort. The solid black circles represent unadjusted quarterly rates of 3 process measures: antibiotics (top), lactate (middle), and IV fluids (bottom). The hollow circle is the washout quarter. The vertical dashed line is the time of SEP-1 implementation in Q4 2015. The solid gray line is baseline trend without SEP-1, fitted in the baseline period and projected into the post-SEP-1 period. The solid black line is the fitted line for the trend in the post-SEP-1 period. The black vertical error bars in Q4 2017 represent 95% CIs surrounding the point estimate for the expected value of the process measure from the fitted line in the presence of SEP-1. The gray vertical error bars in Q4 2017 represent 95% CIs surrounding the point estimate for the expected value of the process measure from the fitted line in the pre-SEP-1 baseline, projected into the post–SEP-1 period. The difference between these expected values is the effect estimate for SEP-1 in Q4 2017. IV = intravenous; Q = quarter; SEP-1 = Severe Sepsis and Septic Shock Early Management Bundle.

Figure 3.

Changes in risk-adjusted outcome measures in overall cohort. The solid black circles represent risk-adjusted quarterly rates of 3 outcome measures: ICU admission (top), in-hospital mortality (middle), and discharge home among survivors (bottom). The hollow circle is the washout quarter. The vertical dashed line is the time of SEP-1 implementation in Q4 2015. The solid gray line is baseline trend without SEP-1, fitted in the baseline period and projected into the post–SEP-1 period. The solid black line is the fitted line for the trend in the post–SEP-1 period. The black vertical error bars in Q4 2017 represent 95% CIs surrounding the point estimate for the expected value of the outcome measure from the fitted line in the presence of SEP-1. The gray vertical error bars in Q4 2017 represent 95% CIs surrounding the point estimate for the expected value of the outcome measure from the fitted line in the pre-SEP-1 baseline, projected into the post–SEP-1 period. The difference between these expected values is the effect estimate for SEP-1 in Q4 2017. ICU = intensive care unit; Q = quarter; SEP-1 = Severe Sepsis and Septic Shock Early Management Bundle.