Dataset Information

Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis.

ABSTRACT:

Importance

Beginning in 2013, New York State implemented regulations mandating that hospitals implement evidence-based protocols for sepsis management, as well as report data on protocol adherence and clinical outcomes to the state government. The association between these mandates and sepsis outcomes is unknown.

Objective

To evaluate the association between New York State sepsis regulations and the outcomes of patients hospitalized with sepsis.

Design, setting, and participants

Retrospective cohort study of adult patients hospitalized with sepsis in New York State and in 4 control states (Florida, Maryland, Massachusetts, and New Jersey) using all-payer hospital discharge data (January 1, 2011-September 30, 2015) and a comparative interrupted time series analytic approach.

Exposures

Hospitalization for sepsis before (January 1, 2011-March 31, 2013) vs after (April 1, 2013-September 30, 2015) implementation of the 2013 New York State sepsis regulations.

Main outcomes and measures

The primary outcome was 30-day in-hospital mortality. Secondary outcomes were intensive care unit admission rates, central venous catheter use, Clostridium difficile infection rates, and hospital length of stay.

Results

The final analysis included 1 012 410 sepsis admissions to 509 hospitals. The mean age was 69.5 years (SD, 16.4 years) and 47.9% were female. In New York State and in the control states, 139 019 and 289 225 patients, respectively, were admitted before implementation of the sepsis regulations and 186 767 and 397 399 patients, respectively, were admitted after implementation of the sepsis regulations. Unadjusted 30-day in-hospital mortality was 26.3% in New York State and 22.0% in the control states before the regulations, and was 22.0% in New York State and 19.1% in the control states after the regulations. Adjusting for patient and hospital characteristics as well as preregulation temporal trends and season, mortality after implementation of the regulations decreased significantly in New York State relative to the control states (P = .02 for the joint test of the comparative interrupted time series estimates). For example, by the 10th quarter after implementation of the regulations, adjusted absolute mortality was 3.2% (95% CI, 1.0% to 5.4%) lower than expected in New York State relative to the control states (P = .004). The regulations were associated with no significant differences in intensive care unit admission rates (P = .09) (10th quarter adjusted difference, 2.8% [95% CI, -1.7% to 7.2%], P = .22), a significant relative decrease in hospital length of stay (P = .04) (10th quarter adjusted difference, 0.50 days [95% CI, -0.47 to 1.47 days], P = .31), a significant relative decrease in the C difficile infection rate (P < .001) (10th quarter adjusted difference, -1.8% [95% CI, -2.6% to -1.0%], P < .001), and a significant relative increase in central venous catheter use (P = .02) (10th quarter adjusted difference, 4.8% [95% CI, 2.3% to 7.4%], P < .001).

Conclusions and relevance

In New York State, mandated protocolized sepsis care was associated with a greater decrease in sepsis mortality compared with sepsis mortality in control states that did not implement sepsis regulations. Because baseline mortality rates differed between New York and comparison states, it is uncertain whether these findings are generalizable to other states.

SUBMITTER: Kahn JM

PROVIDER: S-EPMC6635905 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesInitial evidence suggests that state-level regulatory mandates for sepsis quality improvement are associated with decreased sepsis mortality. However, sepsis mandates require financial investments on the part of hospitals and may lead to increased spending. We evaluated the effects of the 2013 New York State sepsis regulations on the costs of care for patients hospitalized with sepsis.DesignRetrospective cohort study using state discharge data from the U.S. Healthcare Costs and Utilization Project and a comparative interrupted time series analytic approach. Costs were calculated from admission-level charge data using hospital-specific cost-to-charge ratios.SettingGeneral, short stay, acute care hospitals in New York, and four control states: Florida, Massachusetts, Maryland, and New Jersey.PatientsAll patients hospitalized with sepsis between January 1, 2011, and September 30, 2015.InterventionsThe 2013 New York mandate that all hospitals develop and implement protocols for sepsis identification and treatment, educate staff, and report performance data to the state.Measurements and main resultsThe analysis included 1,026,664 admissions in 520 hospitals. Mean unadjusted costs per hospitalization in New York State were $42,036 ± $60,940 in the pre-regulation period and $39,719 ± $59,063 in the post-regulation period, compared with $34,642 ± $52,403 pre-regulation and $31,414 ± $48,155 post-regulation in control states. In the comparative interrupted time series analysis, the regulations were not associated with a significant difference in risk-adjusted mean cost per hospitalization (p = 0.12) or risk-adjusted mean cost per hospital day (p = 0.44). For example, in the 10th quarter after implementation of the regulations, risk-adjusted mean cost per hospitalization was $3,627 (95% CI, -$681 to $7,934) more than expected in New York State relative to control states.ConclusionsMandated protocolized sepsis care was not associated with significant changes in hospital costs in patients hospitalized with sepsis in New York State.

Project description:ImportanceThe death of a pediatric patient with sepsis motivated New York to mandate statewide sepsis treatment in 2013. The mandate included a 1-hour bundle of blood cultures, broad-spectrum antibiotics, and a 20-mL/kg intravenous fluid bolus. Whether completing the bundle elements within 1 hour improves outcomes is unclear.ObjectiveTo determine the risk-adjusted association between completing the 1-hour pediatric sepsis bundle and individual bundle elements with in-hospital mortality.Design, settings, and participantsStatewide cohort study conducted from April 1, 2014, to December 31, 2016, in emergency departments, inpatient units, and intensive care units across New York State. A total of 1179 patients aged 18 years and younger with sepsis and septic shock reported to the New York State Department of Health who had a sepsis protocol initiated were included.ExposuresCompletion of a 1-hour sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour.Main outcomes and measuresRisk-adjusted in-hospital mortality.ResultsOf 1179 patients with sepsis reported at 54 hospitals (mean [SD] age, 7.2 [6.2] years; male, 54.2%; previously healthy, 44.5%; diagnosed as having shock, 68.8%), 139 (11.8%) died. The entire sepsis bundle was completed in 1 hour in 294 patients (24.9%). Antibiotics were administered to 798 patients (67.7%), blood cultures were obtained in 740 patients (62.8%), and the fluid bolus was completed in 548 patients (46.5%) within 1 hour. Completion of the entire bundle within 1 hour was associated with lower risk-adjusted odds of in-hospital mortality (odds ratio [OR], 0.59 [95% CI, 0.38 to 0.93], P = .02; predicted risk difference [RD], 4.0% [95% CI, 0.9% to 7.0%]). However, completion of each individual bundle element within 1 hour was not significantly associated with lower risk-adjusted mortality (blood culture: OR, 0.73 [95% CI, 0.51 to 1.06], P = .10; RD, 2.6% [95% CI, -0.5% to 5.7%]; antibiotics: OR, 0.78 [95% CI, 0.55 to 1.12], P = .18; RD, 2.1% [95% CI, -1.1% to 5.2%], and fluid bolus: OR, 0.88 [95% CI, 0.56 to 1.37], P = .56; RD, 1.1% [95% CI, -2.6% to 4.8%]).Conclusions and relevanceIn New York State following a mandate for sepsis care, completion of a sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour was associated with lower risk-adjusted in-hospital mortality among patients with pediatric sepsis and septic shock.

Project description:BACKGROUND:In 2013, New York began requiring hospitals to follow protocols for the early identification and treatment of sepsis. However, there is controversy about whether more rapid treatment of sepsis improves outcomes in patients. METHODS:We studied data from patients with sepsis and septic shock that were reported to the New York State Department of Health from April 1, 2014, to June 30, 2016. Patients had a sepsis protocol initiated within 6 hours after arrival in the emergency department and had all items in a 3-hour bundle of care for patients with sepsis (i.e., blood cultures, broad-spectrum antibiotic agents, and lactate measurement) completed within 12 hours. Multilevel models were used to assess the associations between the time until completion of the 3-hour bundle and risk-adjusted mortality. We also examined the times to the administration of antibiotics and to the completion of an initial bolus of intravenous fluid. RESULTS:Among 49,331 patients at 149 hospitals, 40,696 (82.5%) had the 3-hour bundle completed within 3 hours. The median time to completion of the 3-hour bundle was 1.30 hours (interquartile range, 0.65 to 2.35), the median time to the administration of antibiotics was 0.95 hours (interquartile range, 0.35 to 1.95), and the median time to completion of the fluid bolus was 2.56 hours (interquartile range, 1.33 to 4.20). Among patients who had the 3-hour bundle completed within 12 hours, a longer time to the completion of the bundle was associated with higher risk-adjusted in-hospital mortality (odds ratio, 1.04 per hour; 95% confidence interval [CI], 1.02 to 1.05; P<0.001), as was a longer time to the administration of antibiotics (odds ratio, 1.04 per hour; 95% CI, 1.03 to 1.06; P<0.001) but not a longer time to the completion of a bolus of intravenous fluids (odds ratio, 1.01 per hour; 95% CI, 0.99 to 1.02; P=0.21). CONCLUSIONS:More rapid completion of a 3-hour bundle of sepsis care and rapid administration of antibiotics, but not rapid completion of an initial bolus of intravenous fluids, were associated with lower risk-adjusted in-hospital mortality. (Funded by the National Institutes of Health and others.).

Project description:ImportanceSepsis is associated with a high burden of inpatient mortality. Treatment in intensive care units (ICUs) that have more experience treating patients with sepsis may be associated with lower mortality.ObjectiveTo assess the association between the volume of patients with sepsis receiving care in an ICU and hospital mortality from sepsis in the UK.Design, setting, and participantsThis retrospective cohort study used data from adult patients with sepsis from 231 UK ICUs between 2010 and 2016. Demographic and clinical data were extracted from the Intensive Care National Audit & Research Centre (ICNARC) Case Mix Programme database. Data were analyzed from January 1, 2010, to December 31, 2016.ExposuresAnnual sepsis case volume in an ICU in the year of a patient's admission.Main outcomes and measuresHospital mortality after ICU admission for sepsis assessed using a mixed-effects logistic model in a 3-level hierarchical structure based on the number of individual patients nested in years nested within ICUs.ResultsAmong 273 001 patients included in the analysis, the median age was 66 years (interquartile range, 53-76 years), 148 149 (54.3%) were male, and 248 275 (91.0%) were White. The mean ICNARC-2018 illness severity score was 21.0 (95% CI, 20.9-21.0). Septic shock accounted for 19.3% of patient admissions, and 54.3% of patients required mechanical ventilation. The median annual sepsis volume per ICU was 242 cases (interquartile range, 177-334 cases). The study identified a significant association between the volume of sepsis cases in the ICU and mortality from sepsis; in the logistic regression model, hospital mortality was significantly lower among patients admitted to ICUs in the highest quartile of sepsis volume compared with the lowest quartile (odds ratio [OR], 0.89; 95% CI, 0.82-0.96; P = .002). With volume modeled as a restricted cubic spline, treatment in a larger ICU was associated with lower hospital mortality. A lower annual volume threshold of 215 patients above which hospital mortality decreased significantly was found; 38.8% of patients were treated in ICUs below this threshold volume. There was no significant interaction between ICU volume and severity of illness as described by the ICNARC-2018 score (β [SE], -0.00014 [0.00024]; P = .57).Conclusions and relevanceThe findings suggest that patients with sepsis in the UK have higher odds of survival if they are treated in an ICU with a larger sepsis case volume. The benefit of a high sepsis case volume was not associated with the severity of the sepsis episode.

Project description:ImportanceThe Early Management Bundle for Severe Sepsis/Septic Shock (SEP-1) is a quality metric based on a care bundle for early sepsis management. Published evidence on the association of SEP-1 with mortality is mixed and largely excludes cases of hospital-onset sepsis.ObjectiveTo assess the association of the SEP-1 bundle with mortality and organ dysfunction in cohorts with hospital-onset or community-onset sepsis.Design, setting, and participantsThis retrospective cohort study used data from 4 University of California hospitals from October 1, 2014, to October 1, 2017. Adult inpatients with a diagnosis consistent with sepsis or disseminated infection and laboratory or vital signs meeting the Sepsis-3 (Third International Consensus Definitions for Sepsis and Septic Shock) criteria were divided into community-onset sepsis and hospital-onset sepsis cohorts based on whether time 0 of sepsis occurred after arrival in the emergency department or an inpatient area. Data were analyzed from April to October 2019. Additional analyses were performed from December 2019 to January 2020.ExposuresAdministration of SEP-1 and 4 individual bundle components (serum lactate level testing, blood culture, broad-spectrum intravenous antibiotic treatment, and intravenous fluid treatment).Main outcomes and measuresThe primary outcome was in-hospital mortality. The secondary outcome was days requiring vasopressor support, measured as vasopressor days.ResultsAmong the 6404 patient encounters identified (3535 men [55.2%]; mean [SD] age, 64.0 [18.2] years), 2296 patients (35.9%) had hospital-onset sepsis. Among 4108 patients (64.1%) with community-onset sepsis, serum lactate level testing within 3 hours of time 0 was associated with reduced mortality (absolute difference, -7.61%; 95% CI, -14.70% to -0.54%). Blood culture (absolute difference, -1.10 days; 95% CI, -1.85 to -0.34 days) and broad-spectrum intravenous antibiotic treatment (absolute difference, -0.62 days; 95% CI, -1.02 to -0.22 days) were associated with fewer vasopressor days. Among patients with hospital-onset sepsis, broad-spectrum intravenous antibiotic treatment was the only bundle component significantly associated with any improved outcome (mortality difference, -5.20%; 95% CI, -9.84% to -0.56%). Care that was adherent to the complete SEP-1 bundle was associated with increased vasopressor days in patients with community-onset sepsis (absolute difference, 0.31 days; 95% CI, 0.11-0.51 days) but was not significantly associated with reduced mortality in either cohort (absolute difference, -0.07%; 95% CI, -3.02% to 2.88% in community-onset; absolute difference, -0.42%; 95% CI, -6.77% to 5.93% in hospital-onset).Conclusions and relevanceSEP-1-adherent care was not associated with improved outcomes of sepsis. Although multiple components of SEP-1 were associated with reduced mortality or decreased days of vasopressor therapy for patients who presented with sepsis in the emergency department, only broad-spectrum intravenous antibiotic treatment was associated with reduced mortality when time 0 occurred in an inpatient unit. Current sepsis quality metrics may need refinement.

Project description:OBJECTIVES:A growing number of patients survive sepsis hospitalizations each year and are at high risk for readmission. However, little is known about temporal trends in hospital-based acute care (emergency department treat-and-release visits and hospital readmission) after sepsis. Our primary objective was to measure temporal trends in sepsis survivorship and hospital-based acute care use in sepsis survivors. In addition, because readmissions after pneumonia are subject to penalty under the national readmission reduction program, we examined whether readmission rates declined after sepsis hospitalizations related to pneumonia. DESIGN AND SETTING:Retrospective, observational cohort study conducted within an academic healthcare system from 2010 to 2015. PATIENTS:We used three validated, claims-based approaches to identify 17,256 sepsis or severe sepsis hospitalizations to examine trends in hospital-based acute care after sepsis. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:From 2010 to 2015, sepsis as a proportion of medical and surgical admissions increased from 3.9% to 9.4%, whereas in-hospital mortality rate for sepsis hospitalizations declined from 24.1% to 14.8%. As a result, the proportion of medical and surgical discharges at-risk for hospital readmission after sepsis increased from 2.7% to 7.8%. Over 6 years, 30-day hospital readmission rates declined modestly, from 26.4% in 2010 to 23.1% in 2015, driven largely by a decline in readmission rates among survivors of nonsevere sepsis, and nonpneumonia sepsis specifically, as the readmission rate of severe sepsis survivors was stable. The modest decline in 30-day readmission rates was offset by an increase in emergency department treat-and-release visits, from 2.8% in 2010 to a peak of 5.4% in 2014. CONCLUSIONS:Owing to increasing incidence and declining mortality, the number of sepsis survivors at risk for hospital readmission rose significantly between 2010 and 2015. The 30-day hospital readmission rates for sepsis declined modestly but were offset by a rise in emergency department treat-and-release visits.

Project description:ImportanceEarly administration of intravenous fluids is recommended for all patients with sepsis, but the association of this treatment with mortality may depend on the patient's initial blood pressure.ObjectiveTo test the association between early administration of intravenous fluids by paramedics and in-hospital mortality among patients with sepsis, accounting for patients' initial blood pressure.Design, setting, and participantsCohort study in which multiple analyses were conducted using a 1-year (from April 1, 2015, to March 31, 2016) cohort of 1871 patients with sepsis who were transported to the hospital by paramedics from a large emergency medical services system in Alberta, Canada. Multivariable logistic regression and a propensity-matched analysis adjusting for baseline patient characteristics were used to minimize confounding by indication and test the association between early administration of intravenous fluids by paramedics and in-hospital mortality. Nonparametric additive regression was used to assess the association of early administration of intravenous fluids with prehospital and in-hospital treatment times.ExposuresIntravenous fluids administered by paramedics at the point of first contact and during transportation to the hospital.Main outcomes and measuresThe primary outcome was in-hospital mortality. Secondary outcomes included prehospital and emergency department treatment times.ResultsA total of 1871 patients with sepsis were identified (955 women and 916 men; median age, 77 years [interquartile range, 64-85 years]), with an overall in-hospital mortality of 28.2% (n = 528). More than half of patients (1015 [54.2%]) received intravenous fluids from paramedics; the median volume provided was 400 mL (interquartile range, 250-500 mL). The association of intravenous fluids with mortality depended on the patient's initial systolic blood pressure (range, 42-222 mm Hg; P < .001 for interaction). For example, in a typical patient with an initial systolic blood pressure of 100 mm Hg, intravenous fluids were associated with decreased mortality (odds ratio, 0.73; 95% CI, 0.56-0.95), but for a typical patient with the median initial systolic blood pressure of 125 mm Hg, intravenous fluids were not associated with in-hospital mortality (odds ratio, 1.41; 95% CI, 0.81-2.44). Similar results were obtained in the propensity-matched analysis. The administration of intravenous fluids was associated with increased prehospital time compared with patients who did not receive intravenous fluids (median difference, 3.2 minutes; 95% CI, 1.7-4.7 minutes) but was not associated with time to assessment in the emergency department (median difference, 2.4 minutes; 95% CI, -2.4 to 7.3 minutes).Conclusions and relevanceIntravenous fluids provided by paramedics were associated with reduced in-hospital mortality for patients with sepsis and hypotension but not for those with a higher initial systolic blood pressure.