The Impact of EMS Sepsis Care: Data Needs & Evaluation

Jose G. Cabanas, MD, MPH, FACEP, Medical Director Michael Bachman, EMT-P, MHS, Deputy Director of Clinical Affairs Wake County EMS

The Plan • Burden of sepsis• Changes to definitions • Review important literature• Understand data needs and challenges to evaluate impact•Wake County EMS sepsis activation process

Case History• 29 y/o female S/P C-­‐section, C/O -­‐ fever, N/V, low back pain

EMS Findings• Temp 106.9, HR -­‐ 150-­‐160, Resp. Rate 30+, ETCO2 <25 (5 minutes apart)• 1200 cc fluid during transportOutcome• Septic shock from gram negative bacteremia• Dx. pyelonephritis• Did well and was D/H on hospital day 5

The Problem• Approx. 1M cases per/year in the US

o52% are diagnosed in the EDo35% on the hospital wardso13% in the ICU

•Mortality rate between 20-­‐50%• Over $16 Billion spent every year• Clinical performance goals are not met for a high number of patients.

Angus DC. Crit Care Med. 2001;;29(7):1303-­1310.

Today

>1M cases of severe sepsis/year in the US*

Future

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

1,800,000

2001 2025 2050

Year

100,000

200,000

300,000

400,000

500,000

600,000

Severe Sepsis Cases

US Population

Sepsis Cases

Total US Population/1,000

Incidence projected to increase by 1.5% per year

Purpose for Existence?

What is Sepsis?• Traditional definition

oLife threatening infection• 1991 & 2001 consensus conferences:

o Infection with at least 2 SIRS criteria• SIRS reflects ongoing inflammatory process

oRecent efforts to standardize definitionsoDifferentiate between sepsis from uncomplicatedinfection

Sepsis-3 Task Force

February 23, 2016

Sepsis-3 Task Force• New definitions of “sepsis”

oLife-­‐threatening organ dysfunction caused byan aberrant or dysregulated host response toinfection

• Recommendation to transition away from SIRS criteria in definition of sepsisoConcerns SIRS is neither sensitive nor specific

Proposal for New Definition of Septic Shock

Hypotensive (MAP < 65) after fluidsand

Vasopressors required to maintain MAPand

Lactate > 2 after adequate fluid resuscitation

Scoring Systems to predict in-hospital mortality

qSOFAAmong Patients with suspected infection• Respiratory Rate of 22 or more• GCS of 13 or less• Systolic BP of 100 mm or less2 or more of these criteria correlated

with amajor increased risk of in-­‐hospital

mortality

Risk of a Bad Outcome

23% risk of a bad outcome. This is a prompt to consider that sepsis is very likely.

www.qSOFA.org

SIRS vs qSOFA

Ref -­‐ http://emcrit.org/pulmcrit/problems-­‐sepsis-­‐3-­‐definition/

SIRS and qSOFA have a similar overall test performance. qSOFA has a higher specificity than SIRS, at the cost of a lower sensitivity.

Am J Respir Crit Care Med. 2016 Sep 20. [Epubahead of print]

J Emerg Med. 2016 Nov 4

Is Sepsis a Time-Critical Emergency?Does EMS have a role?

• Retrospective analysis of 2,600 patients • Mortality increased progressively with increase in the time to receipt of the first dose of antibiotic from the onset of sepsis-­‐induced hypotension. • 5% to 15% decrease in survival with every hour of delay over the first 6 h.

Critical care 2006

• Community-­‐based cohort of all nonarrest, nontrauma King County EMS

encounters (2000 to 2009)

• Incidence rate of severe sepsis = 3.3 per 100 EMS encounters, greater

than for AMI (2.3) or stroke (2.2) per 100 EMS encounters

• More than 40% of all severe sepsis hospitalizations arrived at the

ED after EMS transport

o 80% of cases were diagnosed on admission.

• Pre-­‐hospital care intervals, on average, exceeded 45 minutes for

those hospitalized with severe sepsis.

• Prospective observational study of ED patients with severe sepsis treated with EGDT. o primary outcome was time to initiation of antibiotics

• 311 patients with 51.4% transported by EMS. o EMS patients had more organ failure (organ failure assessment score 7.0 vs. 6.1, p =0.02)

o shorter time to first antibiotics (111 vs. 146 min p=0.001)

o shorter time from triage to EGDT (119 vs. 160 min p=0.005)

• If EMS provider indicated clinical impression sepsis oshorter time to antibiotics (70 vs. 122 minutes, p=0.003) oshorter time to EGDT initiation (69 vs. 131 minutes, p=0.001)

n Feasibility of sepsis alert protocol using point-­‐of-­‐care lactate– EMS transported 67 severe sepsis patients

n Identified 32 of the 67 severe sepsis patients correctly (47.8%)

n Overall mortality for the sample severe sepsis patients transported by EMS was 26.7%. – Mortality for the sample of severe sepsis patients for whom the Sepsis Alert Protocol was initiated was 13.6%

Role of EMS Sepsis Care

Early recognition

Suspected infection

Sepsis AlertUtilize Screening

criteria

Fluid ResuscitationEarly Intervention

Vasopressors Refractory Hypotension

Appropriate DestinationED/ICU Care

Desired Outcome

Paramedics identify sepsis with high degree of accuracyExpedite process for sepsis patientsMeet clinical performance goalsOngoing performance Improvement

Objectives

-­‐Increase Sepsis recognition-­‐ Decrease morbidity/mortality -­‐Immediate feedback-­‐Assess overall system performance-­‐Assess individual performance

Plan

-­‐Use Actual cases-­‐Real-­‐time data exchange -­‐Automated tracking-­‐Educ./PI review-­‐PDSA per data findings

Sepsis System of Care

EMS Systems Implementation of Sepsis Protocols• Orlando, FL• Greenville, SC• Charleston, SC• Raleigh, NC• Nashville, TN• Anchorage, AL• Columbus, OH• Broward, FL• Memphis, TN

• New York City, NY• OKC/Tulsa, OK• San Francisco, CA• Palm Beach, FL• San Diego, CA• Atlanta, GA• Albuquerque, NM• Seattle, WA• Colorado Springs, CO

How do we Evaluate Impact of EMS Sepsis Care?

Systematic Review (Limited Data)• Methodology variability across studies• The use of screening tools improves prehospital sepsis recognition • Need for validation studies to determine whether prehospital sepsis screening confer clinical benefit

Sepsis Activation Process

EMS ID of Sepsis Activation Criteria

Presence of Sepsis Activation Criteria

EHR

Need for ED Sepsis CareHospital EHR

HDE

This is a measure of EMS performance

This is a measure of criteria performance

Data Needs • Prehospital variables

oClinical assessmentoSepsis screening criteria oClinical interventions

• Receiving facilityoLinkage with prehospital recordoConfirmatory process

• Reliable feedback process for system improvement

Data Challenges• Various definitions

oCMS Sepsis MeasuresoNew Sepsis-­‐3 Task Force

• No accepted US yet…• Clinical pathways across healthcare networks

oVariability across institutions •Multiple repositories of data

oPrehospitaloBillingo In-­‐hospital data sources

Impact Measures• EMS System Performance

o Sensitivity, Specificity o System Process measures

• Time to recognition• Time to antibiotics • Lactate clearance

• Case feedback• Individual provider performance • Quality Reporting Measures

o CMS Sepsis Measures

EMS Sepsis AlertEMS System Activation Sepsis No Sepsis

EMS Activation True Positive (TP) False Positive (FP)

No EMS Activation False Negative (FN) True Negative (TN)

EMS Sepsis AlertEMS System Activation Sepsis No Sepsis

EMS Activation True Positive (TP) False Positive (FP)

No EMS Activation False Negative (FN) True Negative (TN)

Sensitivity Specificity

EMS Sepsis AlertEMS System Activation Sepsis No Sepsis

EMS Activation True Positive (TP) False Positive (FP)

No EMS Activation False Negative (FN) True Negative (TN)

Data integration is critical to understand system performance

CMS Sepsis Within 3 hours:• Lactate• 30mL/kg crystalloid fluids• Blood cultures • Antibiotics•Within 6 hours of presentation:• Repeat serum lactate if initial lactate is >2

• All patients with Septic Shock (as defined by CMS) require a 30 ml/kg IV bolus of crystalloid fluids• CMS allows for the prehospital fluids administered by EMS to be counted toward this total fluid requirement• There are very strict CMS documentation requirements which are currently not allowing hospitals to claim “credit” for EMS fluids

CMS Sepsis

https://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier1&cid=1121785350606

CMS RequirementsFrom: Sep-­‐1 Additional Notes for Abstraction, v5.0b

What are we doing in Wake County?

• Prospective cohort study among sepsis alerts activated by EMSo ≥2 SIRS criteria and ETCO2 ≤25 mmHg in patients with suspected infection

• 330 sepsis alerts, 183 met all protocol criteria. Sepsis alerts more frequently diagnosed with sepsis (78% vs 43%) severe sepsis (47% vs 7%) • Low ETCO2 levels -­‐ strongest predictor and association lactate • Sepsis alerts had a sensitivity of 90% (95% CI 81-­‐95%), a specificity of 58% (95% CI 52-­‐65%)

Wake County EMS System Sepsis Activation Process• Early identification of patients with sepsis

o Clinical presentation + Criteria (etCO2 <26)o Declare Sepsis Alerto Fluid Resuscitation

• Receiving facilities have a clinical pathway for patients with sepsis• First aim to show feasibility of process

o Improve process and impact morbidity/mortalityo Prevent delays in recognition and treatmentoMinimize time to antibiotics

Wake County EMS

Take Away• Sepsis is a time-­‐critical condition• EMS Systems have a role in recognition and early intervention• Need standardized definitions to evaluate impact• Utilize a standardized screening criteria• Build a process for system performance improvement

Thank You…

Questions