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

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The Effects of the New York State Sepsis Regulations on Pediatric Sepsis Outcomes

Kristin Hittle Gigli, PhD, RN, CPNP-AC Post-doctoral scholar Department of Critical Care Medicine University of Pittsburgh

Background

• Sepsis: the dysregulated immune response to infection with

life-threatening organ dysfunction

• In children:

– 89 cases per 100,000 children – Mortality 5-20% – Costs $52,000 – $65,000 per patient admission

• Early recognition and treatment saves lives

BalamuthPed Crit Care Med 2014; Mayer Virulence 2014 ; Evans JAMA 2018

“Rory’s Regulations”

• 1. Early recognition
• 2. Protocols for treatment
• 3. Mandatory reporting of sepsis outcomes

Hershey NEJM 2017

New York state’s 2013 regulations were a landmark policy response

• Diagnosing sepsis is difficult
• May lead to overuse of antibiotics, invasive

procedures

• Prescriptive medical care

Klompas CCM 2019

States are moving towards regulations

Massachusetts Sepsis Consortium, 2018

Objective

• To evaluate effects of the New York state sepsis

regulations on pediatric sepsis outcomes

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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

Interrupted Time Series Difference-in-Differences Comparative Interrupted Time Series

Effects of a policy intervention are estimated in a treatment group compared with a control group not affected by the policy of interest Pre

Allows different slopes

Post

Level change Slope change Control Group Treatment Group

Primary: In-hospital mortality Secondary: ICU admission rates Hospital length of stay Central venous catheter rates

• C. Difficile infection rates

Outcomes

Children <18 years old hospitalized with sepsis using validated administrative codes, excluding live births

Patients

General acute-care hospitals in the five states Matched on: pediatric volume academic status region size

Hospitals

Patient-level Regression Model

Patient Covariates Hospital Covariates

Age, gender, race Patient Volume Seasonality Organ failure present on admission Teaching Status Presence of complex chronic conditions Geographic region population Clustered by hospital Admission source

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All analyses pre-specified and pre-published

Miguel Science 2014; Thomas JAMA 2012; Kahn osf.io/76u3x 2018

237 hospitals treated children with sepsis

Characteristic New York (n=83) Control States (n=154) P-value Hospital Type General hospital, small pediatric volume General hospital, medium pediatric volume General hospital, large pediatric volume Specialized children’s hospital 7 (8.4) 49 (59.0) 15 (18.1) 12 (14.5) 17 (11.0) 99 (64.3) 10 (6.5) 28 (18.2) 0.03 Metropolitan statistical area size < 100,000 people 100,000 – 1 million people >1 million people 7 (8.4) 18 (21.7) 58 (69.9) 5 (3.3) 40 (26.0) 109 (70.8) 0.19 Teaching Status Non-teaching Teaching 21 (25.3) 62 (74.7) 60 (39.0) 94 (61.0) 0.03

9,436 patients in final analysis

New York Control Characteristics Pre (N = 1,628) Post (N = 2,336) Pre (N = 2,473) Post (N = 2,999) Age (years) 6.2 (6.3) 6.6 (6.1) 6.4 (6.3) 6.6 (6.2) Gender (male) 52.1% 53.3% 55.2% 52.6% Admitted through ED 54.3% 62.2% 56.3% 62.3% Complex Chronic Conditions: None One Two or more 23.5% 25.3% 51.3% 25.9% 23.8% 50.2% 24.1% 23.5% 52.4% 23.7% 24.9% 51.4% Organ Failures on Admission Zero to two Two or more 92.4% 7.6% 93.2% 6.8% 93.6% 6.4% 92.2% 7.8%

Overall pediatric sepsis mortality is decreasing

5 1 0 1 5 2 0 2 5

• 8
• 7
• 6
• 5
• 4
• 3
• 2
• 1

1 2 3 4 5 6 7 8 9 1 0

Quarter

New Y or k st at e Co nt ro l st at es Unadjusted 30-day in-hospital mortality (%) January 2011 NY: 14.1% Control: 14.6% September 2015 NY: 8.7% Control: 11.5% Risk-adjusted in-hospital mortality (%) Overall test of significance: 0.06

5 1 0 1 5 2 0 2 5

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1 2 3 4 5 6 7 8 9 1 0

Quarter New Yor k stat e Cont rol states

Adjusted pre-implementation trends Adjusted post-implementation trends

!t

∆ ∆!

" !t

∆ !c ∆ β =

• Difference in pre-post

quarterly change: -0.96% (95% C.I.: -1.95 - 0.02) No significant impact on risk-adjusted mortality.

Pre-specified sensitivity analysis excluding hospitals in Greater New York Hospital Association

Study group N Change in quarterly trend % (95% CI) Differential change % (95% CI) P-value New York 1,335

• 1.90

(-3.48 – -0.31)

• 2.08

(-3.79 - -0.37) 0.02 Control 3,495 0.18 (-0.37 – 0.73)

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Study group Number Change in quarterly trend % (95% CI) Differential change % (95% CI) P-value No Complex Chronic Conditions New York 988

• 1.02

(-2.01 – -0.04)

• 1.36

(-2.62 - -0.09) 0.04 Control 1,306 0.33 (-0.50 – 1.16) Directly Admitted New York 1,627

• 1.83

(-3.13 - -0.52)

• 2.42

(-4.23 - -0.61) 0.01 Control 2,211 0.60 (-0.69 – 1.88) Teaching Hospital New York 3,934

• 8.39

(-15.26 - -1.52)

• 7.10

(-14.04 – 0.15) 0.05 Controls 5,307

• 1.30

(-3.28 – 0.69)

No Unintended Consequences

64 66 68 70 72 74 76 78 80

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2 4 6 8 10

Risk-Adjusted ICU Admission Rates, % Quarter

ICU Admissions

Con t r ol Ne w Yor k

ICU admission rates No effect (P=0.40)

2 4 6 8

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• 6
• 4
• 2

2 4 6 8 10

Risk-Adjusted C. Diff Infection Rates, % Quarter

• C. Difficile Infections

Con t r ol Ne w Yor k

• C. Difficile

infection rates No effect (P=0.15)

20 22 24 26 28 30

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• 6
• 4
• 2

2 4 6 8 10

Risk-Adjusted, No. Days Quarter

Length of Stay

Con t r ol Ne w Yor k

Length of stay No effect (P=0.18)

30 35 40 45 50 55 60

• 8
• 6
• 4
• 2

2 4 6 8 10

Risk-Adjusted CVL Placement Rate, % Quarter

Central Line Placement

Con t r ol Ne w Yor k

Central line placement rates No effect (P=0.19)

Secondary outcomes Limitations

• Administrative data
• No data on functional outcomes or post-discharge

survival

• 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

Conclusions

• Implementation of state-wide sepsis regulation

did not improve sepsis mortality trends, except in subpopulations of pediatric patients

• There was no evidence of adverse consequences

Policy Implications

• Refinement of state-wide sepsis care policies are

needed to positively influence outcomes for all pediatric patients with sepsis

• Need to understand mechanisms that lead to

improvements in sepsis outcomes among the subpopulations

Acknowledgements

• Billie Davis, PhD,
• Jonathan Yabes, PhD,
• Chung-Chou Chang, PhD,
• Derek Angus, MD, MPH,
• Grant Martsolf, PhD, MPH, RN
• Tina Hershey, JD, MPH,
• David Chong, MD
• Jeremy Kahn, MD MS
• Funding from:

– Agency for Healthcare Research and Quality (R01HS025146) – National Institutes of Health (T32HL007820)

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