5/13/19 Background The Effects of the New York State Sepsis: the - PDF document

5/13/19 Background The Effects of the New York State • Sepsis: the dysregulated immune response to infection with life-threatening organ dysfunction Sepsis Regulations on Pediatric Sepsis Outcomes • In children: – 89 cases per 100,000 children – Mortality 5-20% – Costs $52,000 – $65,000 per patient admission Kristin Hittle Gigli, PhD, RN, CPNP-AC • Early recognition and treatment saves lives Post-doctoral scholar Department of Critical Care Medicine University of Pittsburgh BalamuthPed Crit Care Med 2014; Mayer Virulence 2014 ; Evans JAMA 2018 New York state’s 2013 regulations were a landmark policy response • Diagnosing sepsis is difficult • May lead to overuse of antibiotics, invasive “Rory’s Regulations” procedures 1. Early recognition • Prescriptive medical care 2. Protocols for treatment 3. Mandatory reporting of sepsis outcomes Hershey NEJM 2017 Klompas CCM 2019 States are moving towards regulations Objective • To evaluate effects of the New York state sepsis regulations on pediatric sepsis outcomes Massachusetts Sepsis Consortium, 2018 1

5/13/19 Interrupted Time Series Methods • Longitudinal retrospective cohort study • Comparative interrupted time series design – 2011 to 2015 – New York compared to 4 control states • Florida, Massachusetts, Maryland, New Jersey • HCUP State Inpatient Database Comparative Interrupted Time Series Difference-in-Differences Control Group Effects of a policy intervention are Treatment Group estimated in a treatment group compared with a control group not affected by the policy of interest Pre Post Allows different slopes Level change Slope change Patient-level Regression Model Children <18 years old hospitalized with sepsis using Patients validated administrative codes, excluding live births Patient Covariates Hospital Covariates Age, gender, race Patient Volume Seasonality General acute-care hospitals in the five states Organ failure present on admission Teaching Status Matched on: pediatric volume Hospitals Presence of complex chronic conditions Geographic region population Clustered by hospital academic status region size Admission source Primary: In-hospital mortality Secondary: ICU admission rates Outcomes Hospital length of stay Central venous catheter rates C. Difficile infection rates 2

5/13/19 237 hospitals treated children with sepsis All analyses pre-specified and pre-published New York Control States Characteristic P-value (n=83) (n=154) Hospital Type General hospital, small pediatric volume 7 (8.4) 17 (11.0) 0.03 General hospital, medium pediatric volume 49 (59.0) 99 (64.3) General hospital, large pediatric volume 15 (18.1) 10 (6.5) Specialized children’s hospital 12 (14.5) 28 (18.2) Metropolitan statistical area size < 100,000 people 7 (8.4) 5 (3.3) 0.19 100,000 – 1 million people 18 (21.7) 40 (26.0) >1 million people 58 (69.9) 109 (70.8) Teaching Status 0.03 Non-teaching 21 (25.3) 60 (39.0) Teaching 62 (74.7) 94 (61.0) Miguel Science 2014; Thomas JAMA 2012; Kahn osf.io/76u3x 2018 9,436 patients in final analysis Overall pediatric sepsis mortality is decreasing New York Control 2 5 Unadjusted 30-day in-hospital mortality (%) January 2011 Pre Post Pre Post Characteristics NY: 14.1% 2 0 (N = 1,628) (N = 2,336) (N = 2,473) (N = 2,999) Control: 14.6% Age (years) 6.2 (6.3) 6.6 (6.1) 6.4 (6.3) 6.6 (6.2) 1 5 Gender (male) 52.1% 53.3% 55.2% 52.6% Admitted through ED 54.3% 62.2% 56.3% 62.3% 1 0 Complex Chronic Conditions: September 2015 None 23.5% 25.9% 24.1% 23.7% 5 NY: 8.7% One 25.3% 23.8% 23.5% 24.9% Control: 11.5% Two or more 51.3% 50.2% 52.4% 51.4% 0 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 1 0 Organ Failures on Admission Quarter Zero to two 92.4% 93.2% 93.6% 92.2% Two or more 7.6% 6.8% 6.4% 7.8% New Y or k st at e Co nt ro l st at es Pre-specified sensitivity analysis excluding hospitals in 2 5 Greater New York Hospital Association Risk-adjusted in-hospital mortality (%) ∆ ! t Adjusted 2 0 post-implementation trends Difference in pre-post quarterly change: -0.96% 1 5 (95% C.I.: -1.95 - 0.02) Overall test of 1 0 significance: 0.06 Change in Differential Adjusted pre-implementation ∆ ! Study group N quarterly trend change P-value " trends % (95% CI) % (95% CI) 5 No significant impact on - β = ∆ ! t ∆ ! c risk-adjusted mortality. -1.90 New York 1,335 (-3.48 – -0.31) -2.08 0.02 0 (-3.79 - -0.37) -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 1 0 0.18 Control 3,495 Quarter (-0.37 – 0.73) New Yor k stat e Cont rol states 3

5/13/19 No Unintended Consequences Secondary outcomes Change in Differential change Study group Number P-value quarterly trend % (95% CI) % (95% CI) Central line ICU admission rates placement rates No Complex Chronic Conditions No effect (P=0.40) ICU Admissions Central Line Placement No effect (P=0.19) 80 Risk-Adjusted ICU Admission Risk-Adjusted CVL Placement 60 -1.02 78 New York 988 76 55 (-2.01 – -0.04) -1.36 74 50 0.04 Rates, % 72 Rate, % 45 (-2.62 - -0.09) 0.33 70 Control 1,306 40 68 (-0.50 – 1.16) 66 35 64 30 Directly Admitted - 8 - 6 - 4 - 2 0 2 4 6 8 10 - 8 - 6 - 4 - 2 0 2 4 6 8 10 Quarter Quarter -1.83 Con t r ol Ne w Yor k Con t r ol Ne w Yor k New York 1,627 (-3.13 - -0.52) -2.42 Length of Stay C. Difficile Infections 0.01 0.60 (-4.23 - -0.61) 30 8 Risk-Adjusted, No. Days Control 2,211 Risk-Adjusted C. Diff Infection 28 (-0.69 – 1.88) 6 26 Teaching Hospital 4 Rates, % 24 -8.39 22 2 New York 3,934 20 0 (-15.26 - -1.52) -7.10 - 8 - 6 - 4 - 2 0 2 4 6 8 10 - 8 - 6 - 4 - 2 0 2 4 6 8 10 0.05 Length of stay Quarter Quarter -1.30 (-14.04 – 0.15) C. Difficile Controls 5,307 No effect (P=0.18) infection rates Con t r ol Ne w Yor k Con t r ol Ne w Yor k (-3.28 – 0.69) No effect (P=0.15) Limitations Conclusions • Administrative data Implementation of state-wide sepsis regulation • did not improve sepsis mortality trends, • No data on functional outcomes or post-discharge except in subpopulations of pediatric patients survival There was no evidence of adverse consequences • • Results may be sensitive to choice of control states • Pediatric sepsis deaths are rare: live-saving effects may not be measurable at the population level Policy Implications Acknowledgements • Billie Davis, PhD, • Funding from: • Refinement of state-wide sepsis care policies are • Jonathan Yabes, PhD, – Agency for Healthcare needed to positively influence outcomes for all Chung-Chou Chang, PhD, • Research and Quality pediatric patients with sepsis Derek Angus, MD, MPH, (R01HS025146) • – National Institutes of Health Grant Martsolf, PhD, MPH, RN • (T32HL007820) • Need to understand mechanisms that lead to Tina Hershey, JD, MPH, • David Chong, MD • improvements in sepsis outcomes among the Jeremy Kahn, MD MS • subpopulations 4

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