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
Sepsis: Year In Transition INTENSIVE MEDICINE CLINICAL PROGRAM FALL CONFERENCE SEPTEMBER 21, 2016 1
RELEVANT FINANCIAL DISCLOSURES 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. 2
OUTLINE 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 3
CURRENT STATE OF SEPSIS AND IMCP Data collection continues at a hospital, regional, and enterprise level Description of our current bundle Collecting both IMCP and SEP 1 bundle elements 4
SEP 1 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 5
SEP 1 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 6
SEP 1 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 7
SEP 1 NUMERATOR AND DENOMINATOR Summary of cohort as of October 1, 2015 Numerator Patients with all bundle/process elements met Denominator Meet inclusion/exclusion criteria above 8
EXTERNAL REPORTING SEP 1 Sampling process 9
SEP 1 SEVERE SEPSIS DEFINITION Documentation of suspected source of infection + 2 or more SIRS criteria + one sign of organ dysfunction OR Provider documents severe sepsis or suspected/possible severe sepsis 10
SEP 1 SEPTIC SHOCK DEFINITION 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/l OR Provider documents septic shock or suspected/possible septic shock within 6 h of presentation of severe sepsis 11
SEP 1 SEVERE SEPSIS CLOCKS 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 12
SEP 1 SEPTIC SHOCK CLOCKS 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) 13
SEP 1 RESPONSE: INTERMOUNTAIN PROS 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) 14
SEP 1 RESPONSE: CMS CONS 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 15
EXTERNAL COMMUNICATIONS Advocating for the reality of clinical work HVHC letter PETAL letter 16
SEP 1 RESPONSE: IMCP STRATEGY 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 17
2016 PROCESS / WORKFLOW
SEP 1 RESPONSE: IMCP STRATEGY 19
OUTLINE 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 20
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 resuscitation Singer 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 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. 23
OUTLINE 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 24
ICENTRA DEVELOPMENT 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) 25
ICENTRA DEVELOPMENT No one promised you would love it, 26
ICENTRA DEVELOPMENT and we ve heard loud and clear that you don t. 27
ICENTRA DEVELOPMENT However, it s here for the foreseeable future 28
ICENTRA DEVELOPMENT so let s make the best of it together and listen to the speaker instead! 29
OUTLINE 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 (?) 30
BUNDLE COMPLIANCE AND MORTALITY You manage what you measure 31
COMPLIANCE AND MORTALITY OVER TIME You manage what you measure 32
THE CURRENT STATE ISN T WELL KNOWN 33
OUTLINE 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 34
FUTURE STATE OF SEPSIS 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 35
BUNDLE COMPLIANCE AND MORTALITY 36
FUTURE STATE OF SEPSIS 37
OUTLINE 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 38
CONCLUSIONS 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 39
QUESTIONS 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 40
SEVERE SEPSIS Abstraction Elements for Identification of Severe Sepsis 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 infection 2. Two or more manifestations of SIRS criteria a. Temperature > 38.3 C/101 F or < 36 C/96.8 F b. Heart rate > 90 c. Respiratory rate > 20 d. 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 pts b. 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 hours d. Bilirubin > 2 mg/dl (34.2mol/L) e. Platelet count < 100 f. INR > 1.5 or PTT > 60 g. Lactate > 2 mmol/l
SEPTIC SHOCK Abstraction Elements for Identification of Septic Shock 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 < 90 b. MAP < 65 c. 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.
SEP 1 TO BE COMPLETED WITHIN 3 HOURS OF TIME OF PRESENTATION 1. Measure lactate level 2. Obtain blood cultures prior to administration of antibiotics 3. Administer broad spectrum antibiotics 4. Administer 30mL/kg crystalloid for hypotension or lactate 4mmol/L TO BE COMPLETED WITHIN 6 HOURS OF TIME OF PRESENTATION 5. 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 ScvO2 7. Re measure lactate* 43
MAJOR DIFFERENCES BETWEEN SEP 1 AND IMCP 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) 44
SEVERE SEPSIS 3 and 6 Hour Requirements 3 Hour Bundle 1. Measure lactate level 2. Broad spectrum or other antibiotics administered 3. Blood cultures drawn prior to antibiotics 6 hour Bundle 1. Remeasure lactate only if initial lactate level is elevated (> 2 mmol/l) within 6 hours of time zero 45
SEPTIC SHOCK 3 and 6 Hour Requirements 3 Hour Bundle 1. Measure lactate level 2. Broad spectrum or other antibiotics administered 3. Blood cultures drawn prior to antibiotics 4. Resuscitation with 30 ml/kg crystalloid fluids ONLY IF hypotension is initially present (SBP < 90 or initial lactate > 4 mmol/l) over 60 minutes 6 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) 46
SEPSIS 3 DEFINITIONS
UPDATE ON IMCP SEPSIS DATA COLLECTION PROCESS (JAN 1 AUG 31)