Sepsis - A Year in Transition Todd L. Allen, MD, FACEP · Sepsis - A Year in Transition Todd L. Allen, MD, FACEP Chair, Emergency Department Development Team; Assistant Quality Officer,

Sepsis - A Year in Transition

Todd L. Allen, MD, FACEP Chair, Emergency Department Development Team; Assistant Quality

Officer, Institute for Healthcare Leadership

Russell R. Miller, III, MD, MPH, FCCM

Medical Director, RICU; Chair, IMCP Critical Care Development Team, Intermountain Healthcare

Objectives:

Describe current concepts in identification and treatment of Severe Sepsis and Septic Shock

Review Intermountain strategy to meet CMS Sepsis Measure and continue to support long standing IMCP Sepsis Bundle quality improvements

Describe and review resources for sepsis management in iCentra

Describe current concepts in identification and treatment of Severe Sepsis and Septic Shock

INTENSIVE MEDICINE CLINICAL PROGRAM FALL CONFERENCE

SEPTEMBER 21, 2016

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Sepsis: Year In Transition

RELEVANT FINANCIAL DISCLOSURES

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RUSS MILLER, MD, MPH, FCCM• Consultant: Enterprise Analysis Corporation• Recipient of Contract Research: ImmunExpress Inc.

TODD ALLEN, MD, FACEP• Consultant: Enterprise Analysis Corporation, ImmunExpress Inc.

OUTLINE

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What in the world is going on?

• Review IMCP sepsis strategy in the SEP‐1 era• New definitions and science in sepsis• Work in iCentra• Current data• Future state

CURRENT STATE OF SEPSIS AND IMCP

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• Data collection continues at a hospital, regional, and enterprise level

• Description of our current bundle• Collecting both IMCP and SEP‐1 bundle elements

SEP‐1

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You have to know the rules

• SEP‐1 becomes law– NQF #0500 submitted in 2007– NQF #0500 approved in 2013

• Methodology for SEP‐1 developed and released for Q4 2015 external, mandatory reporting

• Essentially mirrored resuscitation part of IMCP bundle with a couple of big wrinkles

SEP‐1

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Inclusion criteria

• 18 years or older admitted to the hospital for inpatient acute care

• ICD‐10 principal or other diagnostic code of severe sepsis, septic shock, or sepsis plus additional organ failure code

SEP‐1

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Exclusion criteria

• Age < 18• IV antibiotics > 24 h prior to presentation• Directive for comfort/palliative care within 6 h• Dies/discharged within 3 h of severe sepsis or 6 h of septic shock (soon to be 6 h for all)

• Documented administrative contraindication (refusing care) within 6 h

• Transfer from another acute care facility• Length of stay > 120 d after sepsis admission

SEP‐1 NUMERATOR AND DENOMINATOR

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Summary of cohort as of October 1, 2015

• Numerator– Patients with all bundle/process elements met

• Denominator– Meet inclusion/exclusion criteria above

EXTERNAL REPORTING SEP‐1

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Sampling process

SEP‐1 SEVERE SEPSIS DEFINITION

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• Documentation of suspected source of infection + 2 or more SIRS criteria + one sign of organ dysfunctionOR

• Provider documents severe sepsis or suspected/possible severe sepsis

SEP‐1 SEPTIC SHOCK DEFINITION

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• Severe sepsis PLUS either of the following within 6h of presentation:

1. Hypotension persisting after adequate fluid administration (SBP < 90, MAP < 65, documented decrease in SBP > 40 mm Hg)

2. Lactate ≥ 4 mmol/LOR• Provider documents septic shock or suspected/possible septic shock within 6 h of presentation of severe sepsis

SEP‐1 SEVERE SEPSIS CLOCKS

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• Two clocks– 3 h to complete lactate, cultures, then specified antibiotics, and also fluid if lactate > 2 mmol/L or hypotensive

– 6 h to repeat lactate if initially > 2 mmol/L

SEP‐1 SEPTIC SHOCK CLOCKS

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• Two clocks– 3 h to measure lactate, cultures, then specified antibiotics, and give adequate crystalloid (30mL/kg), unless already completed above

– If hypotension persists, 6 h to give vasopressors and either document focused exam or 2 of 4 (ScvO2, CVP, ECHO, fluid challenge/passive leg raise)

SEP‐1 RESPONSE: INTERMOUNTAIN PROS

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• Long, localized experience• Demonstrable increase in bundle compliance• Decreased mortality (not directly attributable to bundle compliance)

• Established data collection/abstraction• Published implementation results (ongoing work on cost analysis)

SEP‐1 RESPONSE: CMS CONS

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• Not a proven bundle• Cohort identification difficult for all

– time 0 debacle (e.g., septic shock)• Sampling methodology• No maintenance bundle• Would stop data collection as soon as first data element missing

EXTERNAL COMMUNICATIONS

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Advocating for the reality of clinical work

• HVHC letter• PETAL letter

SEP‐1 RESPONSE: IMCP STRATEGY

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• Merge perceived strengths of IMCP and CMS processes

• Continue using IMCP abstractors to review all patients and bundle compliance and have quality abstractors complete all data even if an element is missing

• Encourage hiring of regional sepsis coordinator• Borrow abstractors from the Institute for

Healthcare Delivery and Research

2016 PROCESS / WORKFLOW

SEP‐1 RESPONSE: IMCP STRATEGY

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OUTLINE

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NEW SEPSIS DEFINITION (SEPSIS‐3)AKA “Who moved the cheese?”

• Sepsis = Evidence of infection + life threatening organ dysfunction characterized by a change in the SOFA score ≥ 2

• Septic shock = Sepsis + either hypotension (e.g., MAP < 65 mm Hg) requiring vasopressors to maintain MAP ≥ 65 mm Hg or lactate > 2 mmol/L that persists after adequate fluid resuscitationSinger M et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis‐3). JAMA. 2016; 315(8): 801‐810

NEW SEPSIS DEFINITION (SEPSIS‐3)

• Sepsis = (q)SOFA increase of 2 or more; assume score of 0 at baseline if not known

EVOLVING CLINICAL SCIENCE IN SEPSIS

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ProMISE, ARISE, ProCESS

• Protocolized monitoring of CVP and ScvO2 via a central venous catheter as part of early resuscitation does not confer survival benefit in all patients with septic shock who have received timely antibiotics and fluid resuscitation compared with controls.

• Protocolized measurement of CVP and ScvO2 in all patients with lactate > 4 mmol/L and/or persistent hypotension after initial fluid challenge and timely antibiotics is not supported by available evidence.

OUTLINE

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ICENTRA DEVELOPMENT

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All in continual evolution

• Documentation templates (hard to capture all elements in one note)

• Quick Orders (don’t push toward best practices, documentation)

• PowerPlans (emphasis on aggregating best practices and linking to PowerForm)

• PowerForm (emphasis on documentation for quality reporting, beware the mandatory blue X)

• Sepsis Alert (providing critical alerts with constant revisions to enhance accurate firing)

• Sepsis Advisor (sitting around begging for a good use)

ICENTRA DEVELOPMENT

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No one promised you would love it,…

ICENTRA DEVELOPMENT

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…and we’ve heard loud and clear that you don’t.

ICENTRA DEVELOPMENT

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However, it’s here for the foreseeable future…

ICENTRA DEVELOPMENT

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…so let’s make the best of it together and listen to the speaker instead!

OUTLINE

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• Review IMCP sepsis strategy in the SEP‐1 era• New definitions and science in sepsis• Work in iCentra• Current data• Future state (?)

BUNDLE COMPLIANCE AND MORTALITY

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You manage what you measure

COMPLIANCE AND MORTALITY OVER TIME

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You manage what you measure

THE CURRENT STATE ISN’T WELL KNOWN

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OUTLINE

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FUTURE STATE OF SEPSIS

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Building on our legacy

• MPage to manage sepsis in iCentra• Incorporating new definitions, including matching data

• Research avenues– Cost, resource utilization– Cognitive and behavioral sequelae in and after sepsis– Enhanced diagnostic markers and treatment strategies

• Other

BUNDLE COMPLIANCE AND MORTALITY

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FUTURE STATE OF SEPSIS

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OUTLINE

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CONCLUSIONS

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Gosh, look at the time. Looks like we need to skip questions now!

• The IMCP sepsis strategy has been and will be in transition for now

• New definitions and science should influence our process, and we must remain nimble to manage the changes

• iCentra is a tool to facilitate data to measure, data to manage

• Sepsis simply isn’t going away

QUESTIONS

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Helping Patients Live the Healthiest Lives Possible

Our Vision

Be a model health system by providing

extraordinary care and superior service at an affordable cost

“Severe Sepsis”

Is defined as sepsis associated with hypotension, hypoperfusion, or organ dysfunction as follows:

In order to establish the presence of severe sepsis, either the provider documents the time of severe sepsis, r/o severe sepsis, possible severe sepsis, or all three of the following criteria of which must be met within 6 hours of each other:

1. Documentation of a suspected source of infection2. Two or more manifestations of SIRS criteria

a. Temperature > 38.3 C/101 F or < 36 C/96.8 Fb. Heart rate > 90c. Respiratory rate > 20d. WBC > 12 or < 4 or > 10% bands

3. Organ dysfunction, evidenced by any one of the following: a. SBP < 90 or MAP < 65, or a SBP decrease of more than 40 ptsb. Acute respiratory failure as evidenced by a new need for invasive or non‐invasive

mechanical ventilation. c. Cr > 2.0 or urine output < 0.5 cc/kg/hour for 2 hoursd. Bilirubin > 2 mg/dL (34.2mol/L)e. Platelet count < 100f. INR > 1.5 or PTT > 60g. Lactate > 2 mmol/L

SEVERE SEPSISAbstraction Elements for Identification of Severe Sepsis

“Septic Shock” In order to establish the presence of septic shock, either the provider documents the time of septic shock or the following criteria is met:

1. There must be documentation of severe sepsis present and 2. Tissue hypoperfusion persisting in the hour after crystalloid fluid administration,

evidenced by any of the following: a. SBP < 90b. MAP < 65c. Decrease in SBP by > 40 points from the patient’s baseline d. Lactate ≥ 4

• Everything relating to sepsis care hinges on the time severe sepsis or septic shock is identified through the abstraction process. The measure clock starts when the patient meets last abstraction criteria outlined by CMS.

SEPTIC SHOCKAbstraction Elements for Identification of Septic Shock

SEP‐1

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• TO BE COMPLETED WITHIN 3 HOURS OF TIME OF PRESENTATION1. Measure lactate level2. Obtain blood cultures prior to administration of antibiotics3. Administer broad spectrum antibiotics4. Administer 30mL/kg crystalloid for hypotension or lactate ≥4mmol/L

• TO BE COMPLETED WITHIN 6 HOURS OF TIME OF PRESENTATION5. Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation to maintain a mean arterial pressure (MAP) ≥65mmHg)6. In the event of persistent arterial hypotension despite volume resuscitation (septic shock) or initial lactate ≥4 mmol/L, measure CVP and ScvO27. Re‐measure lactate*

MAJOR DIFFERENCES BETWEEN SEP‐1 AND IMCP

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It Is Hard To Excel At Two Games

• Time of presentation and two clocks• IV fluid administration and documentation• IMCP will still collect data on tight glucose control, use of steroids for

refractory shock and the use of lung protective ventilation (i.e., maintenance bundle elements)

• IMCP will collect data on all eligible patients (versus sampling methodology for SEP‐1)

• We collect all data for IMCP (SEP‐1 quits as soon as there is a failure)

SEVERE SEPSIS

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3 and 6 Hour Requirements

3 Hour Bundle1. Measure lactate level2. Broad spectrum or other antibiotics administered3. Blood cultures drawn prior to antibiotics

6 hour Bundle1. Remeasure lactate only if initial lactate level is elevated (>

2 mmol/L) within 6 hours of time zero

SEPTIC SHOCK

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3 and 6 Hour Requirements

3 Hour Bundle1. Measure lactate level2. Broad spectrum or other antibiotics administered3. Blood cultures drawn prior to antibiotics4. Resuscitation with 30 mL/kg crystalloid fluids ONLY IF hypotension is initially

present (SBP < 90 or initial lactate > 4 mmol/L) over 60 minutes6 hour Bundle

1. Remeasure lactate ONLY IF initial lactate level is elevated (> 2 mmol/L) within 6 hours of time zero

2. Vasopressors ONLY IF hypotension persists after fluids (start with norepinephrine at 0.02 mcg/kg/min)

3. Volume status and tissue perfusion assessment IF EITHER persistent hypotension OR initial lactate > 4 mmol/L by EITHER focused exam or advanced assessment (my words)

SEPSIS‐3 DEFINITIONS

UPDATE ON IMCP SEPSIS DATA COLLECTION PROCESS (JAN 1 – AUG 31)

Documents

Sepsis - A Year in Transition Todd L. Allen, MD, FACEP · Sepsis - A Year in Transition Todd L. Allen, MD, FACEP Chair, Emergency Department Development Team; Assistant Quality Officer,