The Power of the Pyramid:

The Power of the Pyramid: A Proven Sepsis Implementation Program for Saving Lives SepsisSolutionsInternational 2011 Kathleen Vollman MSN, RN, CCNS, FCCM, FAAN Clinical Nurse Specialist, Educator, Consultant Sepsis Solutions International LLC/ ADVANCING NURISNG LLC Northville MI kvollman@comcast.net Severe Sepsis: A Significant Healthcare Challenge Major cause of morbidity and mortality worldwide Leading cause of death in non-coronary ICU (US) 1 10th leading cause of death overall (US) 2 * More than 750,000 cases of severe sepsis in the US annually 3 In the US, more than 500 patients die of severe sepsis daily 3 * Based on data for septicemia Reflects hospital-wide cases of severe sepsis as defined by infection in the presence of organ dysfunction 1.Sands KE, Bates DW, Lanken PN, et al. Epidemiology of sepsis syndrome in 8 academic medical centers. JAMA 1997;278:234-40. 2.National Vital Statistics Reports. 2005. 3.Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome and associated costs of care. Crit Care Med 2001;29:1303-10. 1

Sepsis: Defining a Disease Continuum Severe Sepsis Infection SIRS Adult criteria Temp.: >38 C or <36 C HR: >90 beats/min Respirations: >20/min WBC count: >12,000/mm 3 or <4,000/mm 3 or >10% Immature neutrophils (bands) Sepsis SIRS with a presumed or confirmed infectious process Sepsis with 1 signof organ dysfunction, hypoperfusion or hypotension. Examples: Cardiovascular (refractory hypotension) Renal Respiratory Hepatic Shock Hematologic CNS Unexplained metabolic acidosis SIRS = Systemic Inflammatory Response Syndrome Bone R, Balk R, Cerra F, et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest. 1992;101:1644-1655. How Does Severe Sepsis Compare to Your Current Care Priorities? Quality US # of Mortality Projects Incidence Deaths Rate AMI 1 895,000 171,000 19% Stroke 1 700,000 157,800 23% Pneumonia 2 1,300,000 61,800 4.8% Severe Sepsis 3 751,000 215,000 29% Why do you think that severe sepsis has not received the same focus as these other common disease states? 1. American Heart Association. Heart Disease and Stroke Statistics 2006 Update. 2. National Center for Health Statistics. Available at: www.cdc.gov/nchs/fastats/pneumonia.htm. Accessed February 4, 2005. 3. Angus DC, et al. Crit Care Med 2001;29(7):1303-1310. 2

4-Tier Process for Severe Sepsis Program Implementation Measuring Success Implementation of the Sepsis Bundle Early Screening with Tools and Triggers Organizational Consensus that Severe Sepsis Must be Managed Early and Aggressively Organization Support Executive management at hospital actively supports the Target Severe Sepsis Program Improving care of severe sepsis is aligned with hospital s current year goals Willingness to align resources with program Minimum.5 FTE for project management, data collection & teachable moments Understanding that this is a 2 to 3+ year program to make this the standard of practice for this patient population Existing culture that supports change Successfully implemented other major change programs e.g., vent bundle, tight glucose control, CR-BSI Established team in place with ICU physician and nurse champion, ED physician and nurse champion that are recognized leaders in the hospital 3

The Team Is KEY! Can Be Major Barrier If Not Functioning Well Must have nurse and physician champions from ED and ICU (need at least one physician at all meetings) Must be linked in the organization s quality or operational structure Must meet at least 2 times per month Team members must be well educated on the evidence and armed with tools and knowledge to change behavior at the bedside MUST have bedside nurses on team provide reality check and best knowledge of barriers Economic Implications of an Evidence-based Sepsis Protocol Objective To determine financial impact of a sepsis protocol designed for use in the ED Design Analysis of results from recent prospective study comparing outcomes in patients with septic shock before and after initiation of sepsis protocol Setting Academic, tertiary care hospital in US Subjects: Adults (n=120) who sequentially presented to ED with septic shock, specifically: ED = Emergency Department Shorr AF et al. Crit Care Med. 2007;35:1257 1262. 4

Summary of Results Post-protocol, savings of ~$6,000/patient observed Translated into total cost difference of $573,000 between the two groups Post-protocol, ICU costs reduced by ~35% (p=0.026) and ward costs fell by 30% (p=0.033) Protocol resulted in a reduction in overall hospital LOS of 5 days (p=0.023) Pre-protocol, 28-day mortality rate was 48.3% vs. 30.0% following protocol initiation (p=0.040) ICU, intensive care unit; LOS, length of stay Shorr AF et al. Crit Care Med. 2007;35:1257 1262. Tier I: Organizational Consensus Milestones and Checklist Define Sepsis Program Goal Collect Baseline Data essential ti step Sepsis Goals aligned with organizational goals Develop sepsis team(do we have all the right people here?) and schedule monthly(minimum) meeting for at least 6 months Identify nursing and physician champions in ED and dicu and ensure champions attend dteam meeting Begin to define action plan and timeline for program development and implementation 5

Baseline Data Collection Process Pick time period for medical record query Sample size: minimum of 20 pts per ICU Query strategies: ICD 9 codes: 785.52 and 995.92 Patients in ICU on 1-2 antibiotics, ventilator, vasopressor (review charts to see if meet criteria for severe sepsis or septic shock before include in outcome data or process data Select Data Collection Elements Outcome Process Second Tier: Implementation of Early Screening Tools and Triggers Early Screening with Tools and Triggers Organizational Consensus that Severe Sepsis Must be Managed Early and Aggressively 6

Severe Sepsis: Defining a Disease Continuum Infection SIRS Sepsis Severe Sepsis Adult Criteria A clinical response arising from a nonspecific insult, including 2 of the following: Temperature:> 38 C or < 36 C Heart Rate: > 90 beats/min Respiration:> 20/min WBC count: > 12,000/mm 3, or < 4,000/mm 3, or > 10% immature neutrophils SIRS = Systemic Inflammatory Response Syndrome Bone et al. Chest.1992;101:1644-1654. SIRS with a presumed or confirmed infectious process Sepsis with 1 sign of organ dysfunction, hypoperfusion or hypotension. Examples: Cardiovascular (refractory hypotension) Renal Respiratory Hepatic Hematologic CNS Unexplained metabolic acidosis Shock Why Do You Need to Have a Screening Process? TIME IS TISSUE!! Similar to polytrauma, AMI, or stroke, the speed and appropriateness of therapy administered in the initial hours after severe sepsis develops are likely to influence outcomes. 1 To screen effectively, it must be part of the nurses daily routines i.e., part of admission and shift assessment Must define a process for what to do with the results of the screen If you don t screen you will miss patients that may have benefited from the interventions. 1. Dellinger RP, Levy MM, Carlet JM, et al. Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008;36:296-327. 7

Tier II: Screening for Severe Sepsis Milestones and Checklist Develop screening process for ED, rapid response team and ICU (eventually housewide) Develop audit process to evaluate compliance and effectiveness Ensure screening process has clear next steps defined for nursing staff ICU SEVERE SEPSIS SCREENING TOOL 8

PATIENT CARE UNIT SEVERE SEPSIS SCREENING TOOL 9

Screening: Barriers/Strategies Barriers Time for nurses to do it (perception vs. reality) Screening is not sensitive only for severe sepsis Positive screen is not a diagnosis of severe sepsis Strategies Must assign responsibility and enforce accountability Perform audits to measure compliance and identify problems Round on unit and ask nurses how it is going and discuss issues Screening: Barriers/Strategies Lesson learned: Bedside nurse must do daily screening. Education/Simulation/Education Every 6 months Build into orientation Must be part of your documentation structure Practice-Practice-Practice www.icu-usa/pro 10

Third Tier: Implementation of Evidence-Based Sepsis Bundles Implementation of the Sepsis Bundle Early Screening with Tools and Triggers Organizational Consensus that Severe Sepsis Must be Managed Early and Aggressively The Severe Sepsis Bundles: Surviving Sepsis Campaign/IHI* Resuscitation Bundle (To be accomplished as soon as possible and scored over first 6 hours): Serum lactate measured Management Bundle (To be accomplished as soon as possible and scored over first 24 hours): Low-dose steroids administered for Blood cultures obtained prior to antibiotics septic shock in accordance with a standardized ICU policy. (Given to patients who respond poorly to fluids or vasopressors) (2C) administered (1C) Perform imaging studies promptly to find source (1C) Administration of broad- spectrum antibiotics within 1 hour of diagnosis of septic shock (1B) and severe sepsis without septic shock (1D) For hypotension and/or lactate > 4 mmol/l: Deliver an initial minimum of 20 ml/kg of crystalloid (or colloid equivalent) (1C) Apply vasopressors for hypotension not responding to initial fluid resuscitation to maintain MAP > 65 mmhg. (1C) For persistent hypotension despite initial fluid resuscitation (septic shock) and/or lactate > 4 mmol/l (1C) Achieve CVP of 8-12 mmhg & MAP > 65 mmhg & UO >0.5mL/kg/hr Achieve ScvO 2 of > 70% or SvO 2 > 65%. if ScvO 2 not > 70% blood or dobutamine (2C) Drotrecogin alfa (activated) administered in patients with severe sepsis and clinical assessment of high risk of death (2B, except 2C for postoperative patients) Glucose control maintained to < 150 mg/dl (8.3 mmol/l). (2C) Tidal volume 6 ml/kg (1B) Inspiratory plateau pressures < 30 cmh 2 O for mechanically ventilated patients. (1C) *Adapted from Dellinger PR, et al. SSC: International guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008;36(1):296-327. 11

Tier III: Implementation of Sepsis Bundles Milestones and Checklist Develop easy to use order sets (ED and ICU should be the same), organized by bundle Order sets approved by appropriate medical and nursing leadership/committees Assess physician/provider skill level with CVP insertion. Create strategy to deal with gap in skill if present Define who will put in the CVP line for patients when the come from the floor, especially on off shifts and weekends Ability to get lactate results in one hour or less Ability to get antibiotics administered within one hour of diagnosis or first hypotensive episode Identify equipment needs and make capital requests Tier III: Sepsis Bundle Implementation Milestones and Checklist ED is actively participating and have completed the following: Defined who will place central line when pt has lactate>4 or still hypotensive after initial fluid bolus Nurses in ED are competent in monitoring CVP and ScvO2 There is sufficient nursing staff to handle the acuity and intensity of these patients in the ED Define process for ED to ICU handoff If ED LOS is longer than 6 hrs, need to be able to implement the management bundle 12

Tier III: Sepsis Bundle Implementation Milestones and Checklist Identify tools to assist bedside staff to implement Identify tools to assist bedside staff to implement bundles (algorithm, pathway, checklist, pocket cards ect) Identify resistance and barriers to bundle implementation and develop solutions Develop triggers/processes to alert staff when time to move from resuscitation to management bundle Define educational plan for all staff: Develop implementation plan 13

Implementation Hospital resources often focus on planning phase and then back off after implementation. The implementation phase is the most critical. Frequent rounds by project champion recommended on unit to support staff and answer questions. Defined resources for bedside nurse: Project champion has pager to be available 24/7 initiallyiti Clinical nurse champions identified on each ICU unit and ED to be resources to bedside staff (these staff should be members of the sepsis team/committee from the beginning) 14

Tier III: Develop and Implement the Education Plan Content: (present to physicians, nurses and RTs) Significance of problem Sepsis continuum Pathophysiology of severe sepsis Prevention and management (share the evidence) Case studies for staff to practice with bedside tools Methods: Self learning modules Classroom and/or small groups of staff on unit Web-based: IE:ICU-USAPRO Ongoing: build into orientation, monthly for residents, every 6 months for all staff, one-on one during rounds TIER III: Develop Implementation Plan Identify who will oversee the implementation and the expectations of that person(sepsis nurse or program coordinator) Define ICU/ED resources for staff that they can call at any time for questions and assistance Create rounding schedule and process Should begin as daily in the ICU and ED Keep master list of all patients who go on the bundles (and those who should have but didn t if possible) Do real time interventions to ensure patients get the evidence based practices Define follow up process for review and evaluate missed opportunities 15

Fourth Tier: Measuring Process & Outcome Changes Use of evidence-based Measuring approach Success Implementation of the Sepsis Bundle Early Screening with Tools and Triggers Organizational Consensus that Severe Sepsis Must be Managed Early and Aggressively Tier IV: Measurement Milestones and Checklist Define outcome and process data elements that will be collected Develop and implement a data collection process Revise and update goals and action plan as needed Execute implementation plan 16

Data Collection Patient Log Define how will find all patients that receive the bundles Real time data collection is optimal then used as checklist to ensure patient receives all appropriate interventions Outcome Mortality (ICU and Hosp) Hosp LOS Cost per case (total t and direct) Process SSC database Data elements that measure implementation of resuscitation and management bundle Septic Shock Clinical Pathway 17

Three Biggest Challenges Challenge #1: Finding the Patients Redefining what a septic shock patient looks like Before NOW Supine in bed Sitting up in bed Ventilator Nasal canula Fluids wide open IV boluses Increasing vasopressors Weaning vasopressors Minimally responsive Awake Don t look sick enough to be in ICU or to have a central line Must correct this misperception 18

Additional Strategies: Finding the Patient Unit sepsis champions Sepsis coordinator ED and ICU rounding RRT screen on every call Prospective patient log Discuss sepsis screen as part of Multidisciplinary Rounds Reports Patients who screened positive Lactate Finding the Patients: Prospective Patient Log Unit Pt # Point of Entry Date of Septic Shock Dx Time of Septic Shock Dx Data Data Comments / Obtained Complete Follow-up 19

Sepsis Management: Challenges #2 Strategies: Physician Buy-in Redefining what a septic shock patient looks like Physician Champions-ED and ICU Part of sepsis team Follow up with physician when bundles not followed ED and ICU rounding Unit sepsis champions Sepsis coordinator Data--- Often and detailed Physician specific Administrative support Communication Policy Environment **Poor between RN & MD re:diagnosis. (2) **RN not comfortable discussing w/ MD Poor between ER-ICU & OR-ICU (2) Lack of guidance on MN & Weekends (5) No IV line holders at head of bed Materials Nurse does not know where to look for information re:bundles Delay in antibiotic verification in pharmacy. (4) Unclear process (4) Order sets not being used. (3) Process No ICU beds to transfer patient to. (4) **Nurse/Patient ratio 1:2 with high acuity (10) Staff overwhelmed with other initiatives. **Signs go unrecognized (8) **Unsure how to follow bundle (8) -RN forgot to screen (2) -Unsure how to measure CVP from PICC (4) **-No sense of urgency (6) **-MD buy in (3) -RN: lack of knowledge -Reoccurance goes unrecognized -Lack of critical thinking/cant put it all together (3) Resuscitation goals not achieved in 6 hours -RN/MD refuses to follow bundles People 20

Challenges #3: Not Meeting Resuscitation Goals in 6 hrs Focused Incremental Goals First hour of care Lactate, blood cultures, antibiotics and 20ml/kg fluid bolus Resuscitation goals within 6 hours CVP greater than or equal to 8mmHg MAP greater than or equal to 65mmHg ScvO2 greater than or equal to 70 % Work on resuscitation bundle then focus on management bundle First Hour Hours 2-6 21

Sustaining and Improving: Strategies Independent checks Checklists, pathway Multidisciplinary rounds Real time feedback and on-going education Unit rounds Unit champions Staff meetings Orientation---RN and residents Quarterly with current staff Sustaining and Improving: Strategies Creating sense of urgency Code Sepsis or Sepsis Alert Staffing ratio for initial 6 hours of ICU or ED care Clock on the door Protocol Watch 22

A Prospective Multi-Center Collaborative Study Before and After Implementation ti of an Early Sepsis Initiative The Multi-Center Severe Sepsis & Septic Shock Collaborative Group Presented by Emanuel Rivers at the World Federation of Critical care Medicine, Florence Italy 08/09 23

Results There were 5467 total patients enrolled, 1446 preand 4021 post-implementation. The post-implementation group had higher baseline APACHE II scores with a 8.45% higher predicted mortality. In-hospital mortality was 39.12% before implementation and 28.97% after implementation (P < 0.001) for an absolute risk reduction of 10.15% and a relative risk reduction of 26.0%. Post-implementation secondary outcomes included improved organ dysfunction and lactate clearance; less vasopressor use and mechanical ventilation; shorter hospital length of stay Seize the Opportunity The Power of The Pyramid Can The Power of The Pyramid Can Make a Difference in Your Hospital s Severe Sepsis Outcomes 24