SEPSIS MANAGEMENT - PROTOCOL VARIATION “SO WHAT DO I DO NOW?”

Using Simulation as a Tool to Improve Performance and Outcomes

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DISCLOSURE

Tara Crockett BN, RN, CHSE Director Clinical Delivery

Medical Simulation Corporation

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OUTLINE

• Compare and Contrast Sepsis Trials Trials Non-Invasive Strategies Commonalities

• Recognition is Key • Time Zero • Antibiotics

• Keys to a Successful Initiative • Accelerating the Process - Using Simulation

as Part of the Solution • HASC Sepsis Training Results • MSC Sepsis Quality Solution

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THE TRIALS

EGDT Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock.”1 Rivers, et al. published NEJM 2001. (building block of SSC Guidelines2)

Challengers

• ProCESS – published March 18, 2014 in NEJM

• ARISE - Estimated Study Completion Date: April 2015 Estimated Primary Completion Date: July 2014

• PRoMISe – Estimated Completion Date – November 2014

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SURVIVING SEPSIS CAMPAIGN GUIDELINES 3 HOUR BUNDLE

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 30 mL/kg crystalloid for hypotension or lactate ≥4 mmol/L

† “time of presentation” is defined as the time of triage in the Emergency Department or, if presenting from another care venue, from the earliest chart annotation consistent with all elements severe sepsis or septic shock ascertained through chart review.

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SURVIVING SEPSIS CAMPAIGN GUIDELINES 6 HOUR BUNDLE

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 (36mg/dl): - Measure central venous pressure (CVP) - Measure central venous oxygen saturation (ScvO2)

7. Remeasure lactate 8. Targets for quantitative resuscitation included in the guidelines are

CVP of ≥8 mm Hg, ScvO2 of ≥70% and lactate normalization

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PROCESS3

Three Arms

• EGDT – 439 patients

• Protocolized Standard Therapy – 446 patients

• “Usual" care - 456 patients 31 hospitals participated

Study sites had to use the measurement of serum lactate

levels and had to adhere to the Surviving Sepsis Campaign guidelines for nonresuscitation aspects of care

1. >75% received antibiotics prior to randomization 2. All arms received > 2L NS prior to randomization

• Could not routinely use resuscitation protocols for septic

shock

• Could not routinely use continuous Scvo2 catheters Results: the 60 day all cause mortality was no different among the groups and ranged from 18% to 20%.

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PROCESS

EGDT

• Dobutamine/PRBCs • 93% central line placement • Mortality 21%

Protocol-Based

• No dobutamine/PRBCs only if HGB < 7.5 • Fluids until MD thought patient was replete • 57% central line placement • Mortality rate 18.2%

“Usual Care”

• Bedside provider decided all aspects of care • 58% central line placement • Mortality rate 18.9%

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PROCESS

Considerations: • Patients were documented to have lower baseline lactate,

were younger and less comorbidities, than in the Rivers trial.

• Usual care most likely heavily influenced by familiarity

with EGDT

70% of the hospitals in ProCESS had some form of

“sepsis protocol”

The 18% mortality rate in the “usual care” arm of

illustrates a dramatic change in the management

and outcomes of patients with septic shock.

• Enrolled patients were recognized to be in septic shock

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SURVIVING SEPSIS CAMPAIGN RESPONDS TO PROCESS TRIAL 28 MARCH 20144

• ProCESS does not address the protocolized management

of patients who are in severe sepsis without septic shock,

a group of patients for whom early detection and

treatment remain critical.

• Aggressive protocolized management of these patients

has likely lowered severe sepsis and septic shock mortality

since the inception of the SSC.

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NQF DECISION5

A National Quality Forum (NQF) patient-safety committee removed

its earlier recommendation to use central-line catheterization in some

sepsis patients on the heels due to the ProCESS findings that central

lines did not improve patient outcomes.

10:44 AM - April 24, 2014

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NON-INVASIVE STRATEGIES

• Mortality was 23% in the ScvO2 group vs. 17% in the Lactate Clearance group (non significant difference)

Results • EGDT protocol using serial measurement of serum lactate levels was

not inferior to an EGDT protocol that used Scvo2 monitoring.

• In-hospital mortality and the use of intravenous fluids, blood transfusions, and dobutamine were similar to those seen in the ProCESS trial.

• Rivers’ study did appear to have sicker patients on average than Jones’ patients

Jones 2010 – Lactate Clearance vs. ScvO2 Measurement6

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ARISE

• The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicenter, randomized, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis.

Estimated Study Completion Date: April 2015 Estimated Primary

Completion Date: July 2014 Final data collection date for primary outcome measure

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PROMISE

• Protocolised Management In Sepsis - study to investigate whether early, goal-directed, protocolised resuscitation (targeting specific, measured hemodynamic goals) improve outcomes in emerging septic shock relative to usual resuscitation Duration: April 2010 - November 2014

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NON-INVASIVE STRATEGIES IVC Ultrasound to assess fluid responsiveness

• Studies have correlated increased IVC collapse with low central venous pressures in septic patients7-9

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• Patients who were predicted to be fluid responsive (measured IVC collapse >50%) demonstrated statistically significant improvements in catheter-measured cardiac index, cardiac output and mean arterial pressure after fluid resuscitation. 10-11

NON-INVASIVE STRATEGIES IVC Ultrasound to assess fluid responsiveness

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INVASIVE VERSUS NON-INVASIVE PROTOCOLS

The GNYHA/UHF STOP Sepsis Collaborative12

• Alternative protocol of non-invasive options that uses ultrasonography to

assess volume administration

• Measures serum lactate as a surrogate marker of tissue oxygenation

Findings: • Hospitals that chose the non-invasive protocol over the invasive

approach still achieved a comparable mortality benefit

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STOP SEPSIS COLLABORATIVE’S SIMILARITIES TO PROCESS TRIAL

• Non-invasive and invasive severe sepsis protocols were applied only in patients with severe sepsis who came into the hospital through the ED and whose goals of care were curative

• All had severe sepsis or septic shock with hypotension despite being given 2L of fluids, or their serum lactate level was elevated at >4 mmol/L

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SSC ON NON-INVASIVE MEASUREMENTS13

The Surviving Sepsis Campaign leadership still recommends targeting

• CVP of 8-12 mm Hg, • SCVO2 of 70% or SVO2 of 65% • Lactate normalization

The Campaign recognizes some limitations with CVP and ScvO2 BUT maintain

• Low CVP and low ScvO2 are useful measurements to guide resuscitation

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CAN WE REACH A CONSENSUS?

All studies agree: • Early recognition is key

• Early treatment

Time to antibiotics Time to tissue – (optimize tissue oxygenation) – fluids – lactate

clearance 1. ProCESS – lactate clearance emphasized 2. Jones – lactate as efficient as ScvO2 3. SSC Guidelines – 3 hr bundle – measure

lactate/antibiotics/fluids

No CVP or ScvO2 monitoring in 3 hr. bundle

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THE MAIN PROBLEM - RECOGNITION

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EARLY RECOGNITION

Time Zero

Needs to offer the best balance of : • Reliability and reproducibility

• Optimizing the overall performance improvement effort as to: Early diagnosis Appropriate treatment of severe sepsis

Will lead to earlier and more frequent recognition Increased total number patients with improved outcomes

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EARLY RECOGNITION

Should time zero be onset of hypotension? Such a time would:

• Falsely decrease the number of observed cases meeting severe sepsis criteria

• Diminish awareness of organ dysfunction other than hypotension

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Efforts to just treat recognized sepsis alone are incomplete

• A critical aspect of mortality reduction is pushing practitioners to identify sepsis earlier14

• Earlier recognition accounts most likely accounts for much of the reduction in mortality and sharply increasing incidence15

EARLY RECOGNITION

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TIMELY ANTIBIOTICS

Delayed recognition of sepsis and septic shock

• Infection

• Hypotension

• Lack of protocol

• Logistical delays

Barriers to timely antibiotics:

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TIMELY ANTIBIOTICS

Education of healthcare professionals

• Multidisciplinary approach • Medical Emergency Teams

Update policies to minimize delays

• Administer antibiotics prior to transfer • Order all initial IV antibiotics as stat • Standardized treatment approach

Symptom-based treatment pathway Sepsis protocols and order sets

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TIMELY ANTIBIOTICS16

• Each hour of delay in administration of antibiotics is associated with an average decrease in survival of 7.6%.

• By getting shock-to-antibiotic times of < 2h for ALL septic shock patients, we would save 32,360 lives per year (89 people a day) (3.7 people an hour)

Adapted from Kumar et Care Med 2006; 34: 1589-96.

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PERFORMANCE IMPROVEMENT17 - JAMA STUDY MAY 18, 2014

Hospital Deaths in Patients With Sepsis From 2 Independent Cohorts Vincent Liu, MD, MS1; Gabriel J. Escobar, MD1; John D. Greene, MA1; Jay Soule2; Alan Whippy, MD2; Derek C. Angus, MD, MPH3,4; Theodore J. Iwashyna, MD, PhD5 Kaiser Permanente Northern California (KPNC) and the Healthcare Cost and Utilization Project Nationwide Inpatient Sample (NIS).

• Sepsis contributed to 1 in every 2 to 3 deaths

• Most of these patients had sepsis at admission

• Patients with initially less severe sepsis made up the majority of sepsis deaths.

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PERFORMANCE IMPROVEMENT - JAMA STUDY MAY 18, 2014

• Performance improvement efforts in the treatment of sepsis have primarily focused on standardizing care for the most severely ill patients

• Improvements in standardized care for patients with less severe

sepsis could drive future reductions in hospital mortality.

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REQUIREMENTS FOR A SUCCESSFUL INITIATIVE18

1. Formalize Identification – Develop screening tools/alerts • Defined sepsis processes that coordinate the roles of the care

team to deliver timely treatment for every patient, every time

2. Accelerate Treatment – Train and empower nurses to start bundles after identification in order to meet time goals

3. Globalize Prevention – Expand care efforts across health systems • Engage frontline clinicians to identify and address

process breakdowns • Foster a culture of accountability for sepsis protocol adherence

Advisory Board Company – Crimson Continuum of Care and Physician Executive Council

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REQUIREMENTS FOR A SUCCESSFUL INITIATIVE

Requires a System Approach Optimal Sepsis Care Requires a Defined, Team Approach

• Sepsis failures rarely can be traced back to a single provider. The culprit is typically a system breakdown

Sepsis Program Rollout Should Start in the ED

• 83% of sepsis patients present to the ED

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Requires a Continuous Learning Environment & Outcome Measurement

A Sepsis Initiative Should Ingrain Sustainable Behaviors

Accountability

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REQUIREMENTS FOR A SUCCESSFUL INITIATIVE Traditional Form of Staff Education

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REQUIREMENTS FOR A SUCCESSFUL INITIATIVE

• Involves participants in clinically challenging situations • Accelerates knowledge transfer19-21

• Develops muscle memory • No risk to a patient • Improves functioning as a team • Allows concentration on specific skills and knowledge

Benefits of Simulation

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PRINCIPLES OF EFFECTIVE SIMULATION

• Assess needs first • Must be carefully integrated with

other educational events22

• “Authenticity should have a high priority when programs for the assessment of professional competence are being designed.”

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AGGREGATE HASC SEPSIS TRAINING SPRING 2014 KNOWLEDGE GAIN

0 20 40 60 80 100

0

0.01

0.02

0.03

0.04

0.05

0

5

10

15

20

25

30

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100

Part

icip

ants

Knowledge Check 0 20 40 60 80 100

0

0.01

0.02

0.03

0.04

0.05

0

5

10

15

20

25

30

0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100

Part

icip

ants

Simulation Post-Test

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12 2

26

73

46

2

7

4 5

11 3 6

Clinical Roles

MD NP ED RN Med-Surg RN ICU Sepsis Coordinator

Educator Nurse Manager Directors Charge Nurse Lab Tech Pharm D

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HASC SEPSIS TRAINING RESULTS

• 197 healthcare professionals from 23 Southern California hospitals participated in the Sepsis Quality Initiative Program, May 5-9, 12 – May 16, and 19-23, 2014.

• 144 participants completed both of these assessments and are

therefore included in the following aggregates. Individual assessment scores are available to each participant by logging onto the MSC website.

• Participants demonstrated a 31% increase in knowledge from the knowledge check to the simulation post-test. Additionally, the standard deviation decreased by 29%.

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COMMENTS

• “We are in the process of developing our sepsis protocols. This training has been very helpful and giving an understanding of the treatment, causes of dealing with sepsis.” Hospital Director

• “This course will help us initiate the Code Sepsis protocol throughout the hospital. My recommendation will be mandatory 2 hour class on Sepsis and Septic Shock.” ICU RN

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COMMENTS

• “Course is extremely well done. Simulation enforced the online learning. Everyone from critical care, Hospitalists and ED should take this program.” ED MD

• “The simulation provided more give and take information than just the online course. It also provided me with insight into the medical decision making that practitioners may use. In collecting data for our Sepsis sheet this has been very valuable.” Educator

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1. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N

Engl J Med 2001; 345:1368-1377

2. Dellinger RP, Levy MM, Rhodes A, et al: Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med 2013; 41:580–637

3. Yealy DM, Kellum JA, Juang DT, et al: A randomized trial of protocol-based care for early septic shock. N Engl J Med 2014; DOI: 10.1056/NEJMoa1401602

4. Surviving Sepsis Campaign Responds to ProCESS Trial Updated 19 May 2014 http://www.survivingsepsis.org/SiteCollectionDocuments/SSC-Responds-Process-Trial.pdf

5. www.Qualityforum.org

6. Jones AE, Shapiro NI, Trzeciak S, et al. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA 2010: 303:739-746

7. Brennan JM, Blair JE, et al. A comparison by medicine residents of physical examination versus handcarried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun;99(11):1614-6.],[2.

8. The role of echocardiography in hemodynamic monitoring John H. Boyd and Keith R. Walley

9. Barbier C, Loubieres Y, Schmit C, et al. Respiratory changes in inferior vena cava diameter are helpful in predicting fluid responsiveness in ventilated septic patients. Intensive Care Med 2004; 30:1740–1746.

10. Emergency Department Bedside Ultrasonographic Measurement of the Caval Index for Noninvasive Determination of Low Central Venous Pressure Arun D. Nagdev, MD

REFERENCES

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11. Roland C. Merchant, MD, MPH, ScD Alfredo Tirado-Gonzalez, MD Craig A. Sisson, MD Michael C. Murphy, MD 2010 [Ann Emerg Med. 2010;55:290-295.] 12. http://www.gnyha.org/whatwedo/quality-patient-safety/ 13. Osborn TM, Levy MM, Dellinger RP, Annane D: [Response to letter to the editor]: Surviving Sepsis. Crit Care Med

2013; in press

14. Levy MM, Dellinger RP, Townsend SR ,et al. The Surviving Sepsis Campaign: Results Of An International Guideline-Based Performance Improvement Program Targeting Severe Sepsis. Crit Care Med. 2010 Feb;38(2):367-74.

15. Gaieski DF, Edwards JM, Kallan MJ, et al. Benchmarking the Incidence and Mortality of Severe Sepsis in the United States. Crit Care Med. 2013 Feb 25. [Epub ahead of print]

16. Kumar A1, et al , Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96.

17. Vincent Liu, MD, MS1; Gabriel J. Escobar, MD1; John D. Greene, MA1; Jay Soule2; Alan Whippy, MD2; Derek C. Angus, MD, MPH3,4; Theodore J. Iwashyna, MD, PhD5 Hospital Deaths in Patients With Sepsis From 2 Independent Cohorts JAMA. Published online May 18, 2014. doi:10.1001/jama.2014.5804

18. Playbook for Elevating Septicemia Care Advisory Board Company – Crimson Continuum of Care and Physician Executive Council

19. Wayne DB, Didwania A, Feinglass J, Fudala MJ, Barsuk JH, McGaghie WC. Simulation-based education improves the quality of care during cardiac arrest team responses at an academic teaching hospital: a case control study. Chest 2008;133:56–61

REFERENCES

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REFERENCES

20. Barsuk JH, McGaghie WC, Cohen ER, O’Leary KS, Wayne DB. Simulation-based mastery learning reduces complications during central venous catheter insertion in a medical intensive care unit. Crit Care Med2009;37:2697–2701. 21. Barsuk JH, Cohen ER, Feinglass J, McGaghie WC, Wayne DB. Use of simulation-based education to reduce catheter-related bloodstream infections. Arch Intern Med 2009;169:1420–3. 22. A critical review of simulation-based medical education research: 2003–2009 William C McGaghie, S Barry Issenberg, Emil R Petrusa & Ross J S calese Blackwell Publishing Ltd 2009. MEDICAL EDUCATION 2010; 44: 50–63