EVALUATION OF THE IMPACT OF SEPSIS BUNDLES ON SEVERE SEPSIS MORTALITY. A Project. Presented. to the Faculty of. California State University, Chico

EVALUATION OF THE IMPACT OF SEPSIS BUNDLES ON SEVERE SEPSIS MORTALITY A Project Presented to the Faculty of California State University, Chico In Partial Fulfillment of the Requirements for the Degree Master of Science in Nursing by Gay Sharon Garton-Lutz Fall 2010

EVALUATION OF THE IMPACT OF SEPSIS BUNDLES ON SEVERE SEPSIS MORTALITY A Project by Gay Sharon Garton-Lutz Fall 2010 APPROVED BY THE DEAN OF GRADUATE STUDIES AND VICE PROVOST FOR RESEARCH: Katie Milo, Ed.D. APPROVED BY THE GRADUATE ADVISORY COMMITTEE: Irene Morgan, Ph.D. Graduate Coordinator Sherry D. Fox, Ph.D., Chair Margaret J. Rowberg, DNP

DEDICATION I wish to dedicate this work to all nurses who so unselfishly give of themselves each and every day in hopes of changing the lives of those they care for. You ask me why I do not write something... I think one's feelings waste themselves in words, they ought all to be distilled into actions and into actions which bring results. Florence Nightingale, 1859... iii

ACKNOWLEDGMENTS The time, energy and effort put into the writing of this project requires acknowledgement to those who supported my endeavors and assisted me from beginning to end, and kept alive the realization of me completing this goal. A special thank you to my daughters, Casey and Cejay, for their undying love and devotion which kept me motivated through times when I could not have walked this path alone. I wish to thank my parents, Robert and Marguerite Garton, who gave me the foundation from which to draw upon and encouraged me with words of wisdom and endless love. To my dear family, who patiently understood each time I mentioned thesis and for all the special events, holidays and times missed throughout the evolution of this project...i love you, and I thank you. Thank you to my dear friend and mentor, Dr. Teri Kozik, who lit that fire beneath me when I felt as though I could not face one more obstacle..., your patience, voice of encouragement, assistance, and vast amounts of time you gave unselfishly...i am forever grateful to you. Lastly, I wish to thank the members of my thesis committee, Prof. Sherry Fox, PhD, Prof. Peggy Rowberg, DNP, and Prof. Irene Morgan, PhD. for guiding me through to completion of this project. I appreciate all of you very much. iv

TABLE OF CONTENTS PAGE Dedication... Acknowledgments... List of Tables... Abstract... iii iv vii viii CHAPTER I. Introduction... 1 Background/Overview of the Problem... 1 Statement of the Problem... 4 Relevance/Importance of the Project for Nursing... 5 Theoretical/Conceptual Framework... 6 Purpose of the Project... 8 Research Question... 8 Definition of Terms/Acronyms... 9 Qualifications of the Researcher... 10 Transitional Statement... 11 II. Literature Review... 13 Identification of Sepsis and Research Critique... 13 Significance of Early Intervention with Sepsis... 15 Evidence-Based Data... 18 Transitional Statement... 21 III. Methodology... 23 Setting... 25 Sample Population... 26 Ethical Considerations: Human Subject s Protection... 26 Design of Data Collection... 27 v

CHAPTER PAGE Data Collection Method... 27 Scope of the Project... 29 Summary... 31 IV. Findings and Results... 32 Baseline Data Analysis... 33 Statistical Analyses of Demographic Variables Related to Mortality... 34 V. Summary, Conclusions and Recommendations... 44 Discussion on the Findings... 44 Reflections on the Findings... 45 Limitations of the Study... 47 Implications of the Study for Nursing Practice... 49 Conclusions and Recommendations for Further Research... 51 Summary... 52 References... 54 Appendices A. IRB Waiver from Target Facility... 60 B. E-mails Confirming Approval from CSU, Chico HSRC... 62 C. Severe Sepsis Bundle... 64 D. Severe Sepsis Order Set... 66 vi

LIST OF TABLES TABLE PAGE 1. Total Sepsis Population... 33 2. Gender and Mortality... 35 3. Gender and Mortality (Chi-Square Test Results)... 35 4. Age of Population... 36 5. Age of Subjects and Mortality Rates... 36 6. Independent Samples T-Test for Age and Mortality... 37 7. Gastrointestinal Disorders... 39 8. Renal Disorders... 40 9. Hyperglycemia Disorders... 40 10. Liver Disorders Related to Alcohol... 41 11. Chi-Square Statistics for Liver Disorders Related to Alcohol... 41 12. Respiratory Disorders... 42 13. Chi-Square Statistics for Respiratory Disorders... 42 vii

ABSTRACT EVALUATION OF THE IMPACT OF SEPSIS BUNDLES ON SEVERE SEPSIS MORTALITY by Gay Sharon Garton-Lutz Master of Science in Nursing California State University, Chico Fall 2010 In the United States, severe sepsis is common and affects over 750,000 people each year and more than 250,000 of those will die. With an alarming mortality rate of between 28% and 50% or higher, the numbers continue to escalate and no one is exempt from this disease process; severe sepsis knows no boundaries and it affects the young as well as the old. One of the most significant interventions regarding severe sepsis is implementing an early goal-directed therapy plan, a sepsis bundle, within six hours of diagnosis. These therapies are evidenced-based treatments and when initiated early on, can reduce progression into multi-system organ failure and mortality. The purpose of this retrospective study was to review whether implementing a sepsis bundle within six hours of diagnosis of severe sepsis would reduce mortality viii

rates. A retrospective review was done using the guidelines established by the Surviving Sepsis Campaign, and included 152 adult subjects admitted via the ED at the Northern Nevada target facility. Seven months of data included 58 pre-bundle patients in 2008 (July 1 thru December 31), and 94 post-bundle patients during the same seven months in 2009. This report summarizes the retrospective review of bundle usage with severe sepsis to determine if mortality rates were reduced at a Northern Nevada community hospital. Deaths due to severe sepsis were overall reduced from 31% (pre-bundles) to 23% after implementing bundles but no statistical significance was noted overall. However, a subset of patients with severe sepsis who had respiratory co-morbidities did have significantly decreased mortality after bundle implementation. Implementation of bundles with patients who have respiratory co-morbidities is strongly recommended, based on these findings. The overall decrease in mortality rates of 8% indicates potential for further research in sepsis bundles. Additional studies might include reviewing sepsis in its earliest stage using the bundles vs. waiting until severe sepsis occurs. ix

CHAPTER I INTRODUCTION Background/Overview of the Problem Severe sepsis is very common in the United States with mortality affecting more than 200,000 people each year. Over 750,000 people across the nation are subject to this type of infectious process with the numbers increasing with each passing year (Institute for Healthcare Improvement, 2007a). Most patients experience involvement of one or more organs (Ahrens & Tuggle, 2004); hence, comes the term multi-system organ failure (MSOF). Mortality rates associated with sepsis have continued to climb at an alarming rate since 1979 (Cheek, McGehee-Smith, Cunneen, & Cartwright, 2005). Ahrens and Tuggle (2004) have identified the rate of mortality to be between 28% and 50% with septic patients, but state that numbers can actually be 60% or greater (p. 2). Identifying patients who are at greatest risk of progressing to severe sepsis is absolutely critical; a delay in identifying and evaluating for a treatment plan can substantially increase the risk of extended hospital stays and even mortality. Sepsis and septic shock account for approximately 10% of the admissions to intensive care units (ICU) across the nation, and account for as many as 2.9% of all hospital admissions (Rivers, McIntyre, Morro & Rivers, 2005, p. 1054). Schorr (2007) explains that early recognition of septic patients, particularly by the triage units of the 1

2 emergency room, will greatly diminish the potential for severe sepsis which ultimately leads to multi-system organ dysfunction, septic shock, and death. The term sepsis is used for the process that occurs to the body s natural immune defenses when compensating for an infectious process (Kleinpell, 2005, p. 1). Coagulation and circulation processes are altered when the body s inflammatory response and cellular function are signaled due to the infection that usually originates from common sites; such as the liver, gallbladder, kidneys, lungs, bowel, and skin (Kleinpell, 2005, p. 48B). With this imbalance, the result is known as systemic inflammatory response syndrome (SIRS). According to Robson and Newell (2005), SIRS is manifested by two or more of the following: High or low temperature > 38 or < 36 degrees Centigrade. Heart rate > 90 beats per minute. Respiratory rate > 20 breaths per minute (or) PaCO2 <4.3kPa. High or low white blood cell count >12,000 or <4,000. (p. 57) Rapid progression to sepsis, severe sepsis, and septic shock can occur within just hours of presentation to a medical facility. It is speculated that if all nurses embrace a program designed to reduce the occurrence of sepsis, the changes can decrease mortality rates by up to 25% over the next few years (Lipley, 2006, p. 2). Awareness of the problem is the first step toward changing the incidence of this high mortality diagnosis. According to Lipley (2006), early goal directed therapy (EGDT) provides a solid evidence-based approach to treating patients with severe sepsis (p. 2). The EGDT would be implemented by way of a bundle approach, which is defined as a group of interventions related to a disease process that, when executed together, result in better

3 outcomes than when implemented individually (Institute for Healthcare Improvement, 2007b). An overview of sepsis is provided by Kortgen, Hofmann, and Bauer (2006) who present some possibilities of why sepsis bundles are not being used: it is an increasingly recognized problem that it takes a too long time period from discovery and evaluation of novel therapies to their implementation in broad daily routine. Some of the factors that may explain this rather incomprehensible situation are: insufficient continuous medical education, lack of awareness, doubts in the generalizability of study results, scientific ignorance, failure of communication, lack of incentives, costs of new therapies but primarily insufficient change management; moreover, physicians often seem to be unwilling to change their routine. (p. 5) Kortgen et al. (2006) clearly explain that sepsis bundles are essential for rapid identification and management of sepsis within the first few hours after presentation; early implementation of bundles will determine the early course of the disease process. Furthermore, the sepsis management bundle more clearly defines modalities of treatment that should be followed during the following 24-hours after initial identification of the disease (p. 8). Silverwood and Francis (2007) identified the fact that sepsis should be addressed by way of a collaborative approach which includes these departments: nursing, respiratory therapy, infectious disease, emergency, pharmacy and critical care. Treating patients within the initial hour of arrival to the facility can greatly increase the quality of outcomes and reduce mortality rates. This time period is known as the golden hour, according to Robson and Newell (2005, p. 57). The financial impact is considerable, according to Ahrens and Tuggle (2004); septic events cost an average patient about $22,000, and hospitals greater than 16.7

4 billion dollars (p. 1). Treating the patient after he or she becomes severe enough for the ICU increases the costs greater than six times that of an ICU patient who does not have sepsis. Robson and Newell (2005) list several factors that should be considered for rapid identification of the onset of sepsis. Patients need to be positive for two or more of the first four criteria which are the key identifying factors for Systemic Inflammatory Response Syndrome (SIRS). They must also be assessed for any or all of the remaining seven criteria which are signs of organ dysfunction: High or low temperature Heart rate > 90 beats per minute Respiratory rate > 20 breaths per minute High or low white blood count (>12,000 or < 4,000), Hypotension, or a reduction of the patient s systolic blood pressure of more than 40mmHg from his/her usual measurement (in the absence of other causes; such as hypovolemia) Altered mental state (Patient s family may provide the most accurate assessment) Hyperglycemia in the absence of diabetes Hypoxemia (oxygen saturation of < 93% ) Acute oliguria Coagulopathy: INR (International Normalized Ratio) >1.5, APPT (activated partial thromboplastin time) >60 seconds, or platelets <100 Serum lactate > 2mmol/L Additional factors may include abnormal liver function tests, and/or ileus. (p. 57) Statement of the Problem Prior to the bundle protocol, patients admitted for sepsis were symptomatically treated. Whatever symptoms happened to be present for the patient, were treated appropriately and independently due to lack of a protocol. However, there

5 are factors that should be noticed on presentation that would allow for immediate implementation of a sepsis bundle, thus, reducing the mortality of this disease cascade. This study will evaluate how the implementation of sepsis protocol bundles will decrease mortality rates associated with severe sepsis at a regional medical center. Wood, Lavieri, and Durkin (2007) described signs and symptoms of sepsis as being very subtle, and that the key factor is to carefully observe and frequently assess for changing signs and symptoms of worsening infection. It is during initial presentation of a patient to any medical facility that these signs should be identified, and ultimately treated if a sepsis bundle were in effect. Relevance/Importance of the Project for Nursing With the implementation of the sepsis bundle the nursing staff will have an established protocol by which they can thoroughly, and appropriately, assess patients at risk for severe sepsis. The expectation will be improved nursing care and prevention of disease progression of severe sepsis to death. Protocols for sepsis management will guide therapy for patients upon entering the emergency department, as well as arrival to the intensive care units. Management will include procedures such as fluid replacement, antibiotic therapy selections, cultures, as well as guiding medical personnel for adherence to a strict timeline for optimal success toward treatment of patients. Shorr, Micek, Jackson, and Kollef (2007) state that the purpose for protocols is to optimize the delivery of care and to create a continuum for sepsis management that runs from the ED to the ICU (p. 1258).

6 The Surviving Sepsis Campaign (SSC) was established for collaborative effort by the Society of Critical Care Medicine, European Society of Intensive Care Medicine, and the International Sepsis Forum; the combined effort of these nationally recognized organizations is to establish a rapid improvement in global standard of care for sepsis patients (Robson & Newell, 2005, p. 60). Nurses play a vital role in identifying potentially septic patients by closely observing for the early signs of sepsis such as changes in their blood pressure, temperature, urine output, respiratory status and the need to transfer to the critical care units. A nurse s prompt recognition of potentially septic patients would ensure that early goal-directed therapy, a sepsis bundle, be implemented; this includes expedient antibiotic and fluid administration, assuring that labs and blood cultures are obtained, and observant monitoring and recording of vital signs and intake and output status. With sepsis bundles available, nurses would have specific guidelines for a globally recognized, optimum standard of care in treating septic patients. Lipley (2006) states, all nurses need to be aware of the signs and symptoms of severe sepsis; and, if nurses embrace the Surviving Sepsis Campaign, they can contribute to the aim of reducing mortality by 25 per cent in the next five years (p. 2). Nurses on the wards, ED, and Critical Care need to collaborate and recognize how early goal-directed therapy can improve outcomes in patients who present with signs and symptoms of sepsis. Theoretical/Conceptual Framework This researcher shall utilize Myra Estrin Levine s Conservation Model (1967) to guide the sepsis project. Levine (1967) writes:

the conservation principles mean keeping it together ; in nursing, to keep together means to maintain a proper balance between active nursing intervention coupled with patient participation on the one hand and the safe limits of the patient s ability on the other. Such a balance is struck only when the patient s present needs, as assessed by the nurse, are measured against the many variables that individualize his predicament of illness. Then, since conservation takes place within a space-time continuum, in planning nursing care the nurse must allow for progress and change and project into the future the patient s response to treatment. (p. 46). The model of conservation utilizes four major concepts as the basis for theory: 1. Personal integrity- sense of self-worth and identity being maintained or restored and uniqueness acknowledged. As registered nurses, we maintain the desire to care for those who are physically, medically, and emotionally in need of our assistance. Not only are we trying to optimize a patient s sense of self worth, but also our own by utilizing our ability to assist with the healing process of our patients. Our own uniqueness allows us to flourish in different areas of patient care, particularly within the ED and the ICUs. Utilizing sepsis bundles will allow us a greater sense of autonomy to participate in expedient nursing procedures for the septic patient, and utilize our uniqueness in these specific areas of nursing. Personal integrity is an important factor with nurses, and is what allows us to care for our patients to the level required for optimum well-being for all involved. 2. Social integrity- patients are social beings & interact with others who are in their social realm, this awareness must be fostered. As nurses, we are also in a position requiring fostered support from our peers, and using Levine s theory for implementation of sepsis protocols will nurture professional strength and support from one another while giving exceptional nursing care to our patients. 7

8 3. Structural integrity prevention of physical breakdown and to promote healing, this must be maintained or restored 4. Energy avoiding excessive fatigue by balancing energy levels whether they are incoming or outgoing. Based on Myra Levine s Conservation Model, nursing interventions and the use of bundles will provide a unified structure toward optimum care for septic patients. Levine (1966) explains, when nursing intervention influences adaptation favorably, or toward renewed social well-being, then the nurse is acting in a therapeutic sense. When nursing intervention cannot alter the course of the adaptation-when her best efforts only maintain the status quo or fail to halt a downhill course-then the nurse is acting in a supportive sense. (p. 2452) Purpose of the Project The purpose of the project is to evaluate a guide to assist in rapid identification of patients who present with the inflammatory response. This protocol, also known as a bundle, will be used as a basis for the treatment of severe sepsis. This bundle shall include identifying features such as the ones listed previously per Robson and Newell (2005). The use of a sepsis bundle would help identify the infectious process and allow for immediate implementation of a defined treatment protocol. Research Question 1. Will implementation of essential therapies, a sepsis bundle, within six hours of a diagnosis of severe sepsis reduce mortality compared to the mortality prior to implementing sepsis bundles?

9 Definition of Terms/Acronyms Bundle A group of interventions related to a disease process that, when executed together, result in better outcomes than when implemented individually (Institute for Healthcare Improvement, 2007d). Early Goal Directed Therapy Evidenced-based best treatments and therapies that are implemented soon after diagnosis of a disease process; in this project, severe sepsis. The terms Early Goal Directed Therapy (EGDT) and Sepsis Bundles have similar meanings and will be used interchangeably throughout this paper. ICU Intensive Care Unit Sepsis Also referred to as systemic inflammatory response syndrome (SIRS). Bacterial infections are the cause of sepsis and can originate anywhere from within the body. Some of the more common sites include liver or gallbladder, kidneys, lungs, bowel, and skin (Medline Plus, 2006). Sepsis Bundle Evidence-based goals must be completed for patients with severe sepsis, septic shock and/or lactate > 4 mmol/l (36 mg/dl) within 6 hours (Society of Critical Care Medicine, 2007).

10 Severe Sepsis Severe sepsis is the presence of defined sepsis, in addition to organ hypoperfusion, organ dysfunction, or hypotension. Organ hypoperfusion is evidenced by an increase in serum lactate level, oliguria, an acute alteration in mentation, and altered circulation to the peripheral extremities. Organ dysfunction is often evidenced by arterial hypoxemia, acute respiratory distress syndrome (ARDS), acute renal failure, thrombocytopenia, and/or disseminated intravascular coagulation (DIC). Qualifications of the Researcher The researcher initially graduated in December 1989 with dual Associate Degrees: one from Palomar College School of Nursing in San Marcos, California and the other a liberal arts degree from MiraCosta Community College, Oceanside, CA. Upon completion of state board exams, the researcher accepted a position as a new graduate into the intensive care unit at one of the most highly regarded Northern Nevada hospital facilities. With a desire for further education, the researcher returned to school at California State University, Chico (CSUC) and completed a Bachelor of Science degree in Nursing in 2005. Currently the researcher has completed the coursework for her Master of Science in Nursing Program at CSUC and is working on her thesis project. After nearly nineteen years of cumulative experience in critical care, Ms. Lutz has held the position of night shift supervisor and staff nurse; both the medical/surgical intensive care unit and the cardiac intensive care units have been her primary settings of focus. The researcher has also been involved in many projects/committees within the ICU that focus on increasing education and decreasing infection. She currently works the day

11 shift and has recently completed an 8-month position on the Ventilator Associated Pneumonia (VAP) task force, and assisted with development of a VAP informational brochure for patient/family use within the critical care departments. In late October of 2007, the researcher initiated study and identification of the in-depth process of sepsis while attending 2007 Quality Summit in Los Angeles, California. The Quality Summit was offered by Catholic Healthcare West, and targeted Sepsis as the focus for a three-year initiative in decreasing incidence and mortality within their healthcare facilities. Lastly, Ms. Lutz attended a Sepsis Symposium where Dr. Daniel Ikeda, Medical Director for Sutter Sacramento Sutter Health, presented a lecture on recognition and management of sepsis. Dr. Ikeda recognizes that Sutter Hospital has saved more than 125 lives from severe sepsis due to early detection and treatment within their facility (Sutter Health, 2006, p. 1). Ms. Garton-Lutz is currently on the Sepsis Team at her Northern Nevada facility. Transitional Statement Reduction of mortality might occur with implementation of a sepsis bundle. More importantly is the fact that organ function will be preserved and overall quality of life can be improved due to positive outcomes from implementing a rapid identification and management of a severe sepsis diagnosis. Chapter II will include a review of the related literature regarding sepsis and the need for rapid identification of the disease. Additionally, the literature review will indicate the importance of implementing bundles for septic patients within the first few

hours of presentation to the emergency department and/or the intensive care unit, as well as management within the first 24 hours for the disease process. 12

CHAPTER II LITERATURE REVIEW Evidenced-based practice suggests that implementation of a sepsis bundle in healthcare facilities providing service to critically ill patients can have a significant impact in reducing the incidence of severe sepsis and septic shock (Institute for Healthcare Improvement, 2005). The following chapter focuses on the review of literature indicating the need to rapidly identify and treat patients admitted with sepsis, thus, reducing length of stay in Critical Care and the facility, as well as reducing the incidence of multi-system organ failure (severe sepsis), and ultimately septic shock and death. Identification of Sepsis and Research Critique A partnership of three leading professional organizations who had an interest in sepsis came together to form The Surviving Sepsis Campaign (SSC); they included the Society of Critical Care Medicine, the European Society of Intensive Care Medicine, and the International Sepsis Forum. This global active partnership with the three organizations was initially established after an international survey in 2002, which polled physicians views on sepsis. The survey inquired about their satisfaction involving identification of sepsis, defining the condition, and current practice regarding diagnosis and treatment modalities. The survey resulted in an action plan involving a multifaceted 13

14 approach to reduce international mortality from severe sepsis by at least 25% by the end of 2009. Final results have not yet been published at this time. The Surviving Sepsis Campaign s main purpose was to establish an international coalition to improve the treatment, management, and diagnosis of sepsis and ultimately reducing the high mortality rate associated with the syndrome (Surviving Sepsis Campaign, 2007). Working with the SSC leadership, the Institute for Healthcare Improvement (IHI) offered their expertise in the field of quality improvement initiatives to reinforce the Surviving Sepsis Campaign s goal to reduce global mortality from sepsis. The multipoint strategy plan included the following: Enhancing awareness of sepsis. Improvement of diagnostic measures for sepsis. Establishing enhanced use of appropriate treatment plans. Increased education to healthcare professionals. Improved care after transfer from ICUs. Establishing guidelines of care for septic patients. Precise data collection for the primary purpose of audits and to provide feedback to medical faculties and healthcare personnel. Websites will remain available throughout the year 2011 to provide resources and information to patients, the general public population, and to healthcare professionals. Support will be available to facilities in the United States who need assistance with implementing bundles via the Society of Critical Care Medicine s (SCCM) Paragon program (SCCM, 2009).

15 As previously identified, sepsis is responsible for over 210,000 fatalities annually, with worldwide deaths exceeding 1,400 per day; mortality rates are between 30 to 50% for sepsis, and can actually account for a 50 to 60% mortality rate when severe sepsis or septic shock is present (Institute for Healthcare Improvement [IHI.], 2007b). Mortality associated with sepsis is responsible for a higher mortality than the combined total of colon cancer, breast cancer, and lung cancer in all of North America in one year s time (IHI, 2007b). Severe sepsis is the presence of defined sepsis, in addition to organ hypoperfusion, organ dysfunction, or hypotension. Organ hypoperfusion is evidenced by an increase in serum lactate level, oliguria, an acute alteration in mentation, and altered circulation to the peripheral extremities. Organ dysfunction is often evidenced by arterial hypoxemia, acute respiratory distress syndrome (ARDS), acute renal failure, thrombocytopenia, and/or disseminated intravascular coagulation (DIC). Septic shock is the presence of sepsis, hypotension (<90 systolic blood pressure-sbp; a mean arterial pressure-map of < 65; or a 40 mm Hg decrease in the SBP from the baseline value); and a negative impact on SBP with a fluid bolus (Rivers et al., 2005, p. 1055). Significance of Early Intervention with Sepsis Lipley (2006) noted that early intervention and implementation of goal directed therapy (a sepsis bundle) is essential in treating sepsis, and that nurses need to be attentive to the signs and symptoms of this diagnosis. The author of this study also stated that if patients are to be given the best chance of survival and reduce the incidence of

16 severe sepsis, more nurses must be committed to raising the awareness of the hazards of sepsis and implement the early goal directed therapy in its earliest stage (p. 2). Early recognition of sepsis, combined with a sepsis bundle, provides the best response to preventing (or) reversing multi- system organ dysfunction, according to Schorr (2007, p. 80). Shorr also emphasizes that if sepsis goes without early detection and if left untreated, patients are almost surely going to be another fatal statistic; early intervention must take place within the emergency departments or in critical care in order for optimum outcome which includes shorter length of stay in the ICU, shorter length of stay within the facility, but most importantly overall survivability of the disease. Ahrens and Tuggle (2004) reported that it is crucial for rapid identification of sepsis in all patients with the potential for, or actual diagnosis of, the severe sepsis or multi system organ dysfunction. These authors stated that with failure of one organ the mortality is approximately 20 percent; mortality increases significantly with each subsequent organ involvement. Ahrens and Tuggle (2004) further indicate that it is not always easy to determine a patient with sepsis because the signs and symptoms are often times ambiguous in the early stages. Recommendations include using physical guidelines to identify patients at risk. Further study is being conducted to see if assessing biomarkers might prove to be beneficial in identifying septic patients; this would be similar to using Troponins to identify myocardial infarction in patients (p. 3). Wood et al. (2007) recognize that during severe sepsis the liver cannot metabolize drugs and waste products due to liver hypoperfusion. A serum lactate level and ammonia will eventually elevate, increasing the risk of mortality. Rapid implementation of sepsis bundles improves the chance of survival with severe sepsis. A

17 rapid downward spiral may occur in a short period of time, and mortality can occur within 24 hours if adequate treatment is not rendered. Sutter Health (2006) describes a case study where sepsis protocols were introduced into their facility at Sutter Sacramento, CA. The sepsis protocols were implemented and Dr. Ikeda acknowledged a reduction of sepsis from 40% mortality rate to less than 15%, in a study involving 125 lives. Additionally, Dr. Ikeda credits their ability to track data with their computerized system for accurate audits and compliance with regard to sepsis. The rapid identification and treatment protocols for sepsis, outlined per IHI s website, was incorporated into Sutter s facility and resulted in a greater than 25% improvement for saving lives. Baptist Memorial Hospital in Memphis, Tennessee, implemented sepsis bundles for Sepsis Resuscitation and Sepsis Management. Their commitment to IHI s evidenced-based practice sepsis protocols, improving patient outcomes, and dedication with regard to providing consistent reliable efforts toward best practice techniques to their patients, resulted in reduction of mortality by 40%, saving over 50 lives, compared to their baseline rates. They state implementing the evidence-based practices, per IHI s bundles, in their Critical Care departments have improved patient safety and their outcomes (IHI, 2007c). A randomized controlled trial was conducted using the six-hour resuscitation bundle for sepsis by the Early Goal-Directed Therapy Collaborative Group from the Department of Emergency Medicine, Henry Ford Health Systems, Case Western Reserve University, Detroit, MI. Adult patients who presented to an urban emergency department of an 850-bed academic tertiary care hospital with severe sepsis, septic shock, or the

18 sepsis syndrome were randomly selected for the study. Early Goal-Directed Therapy (EGDT) was utilized on 130 patients via the bundles by IHI, and resulted in a 16% reduction in mortality. Two hundred sixty-three patients were included in this study, 133 received standard therapy vs. EGDT (Rivers et al., 2001). It was noted that the reduction in mortality was far greater than that produced by thrombolytic therapy in Acute Myocardial Infarctions (Robson & Newell, 2007). Credit was given to the early approach therapy and utilizing the bundles as outlined by IHI. Evidence-Based Data Shorr et al. (2007) suggested that implementation of a sepsis protocol can positively impact the mortality rate by averting the progression into severe sepsis, length of ICU and hospital in-patient status, and costs to the institution (p. 1259). Their retrospective analysis design of a before-and-after study within a United States tertiary teaching hospital included 120 subjects; the average mean age was 64.7 years. All subjects were admitted via the emergency department, had a diagnosis of septic shock and were evenly divided into the before and after subcategories. A multifaceted protocol was established for the interventions on this population and included early administration of antibiotics, fluid resuscitation and other supportive measures as established by the Implementation for Healthcare Improvement: Surviving Sepsis Campaign (2005). Results of the study conducted by Shorr et al. (2007) showed that initiation of a sepsis protocol increased survivability from 51.7% to 70.0%, a 26% reduction in mortality by preventing severe sepsis from occurring with protocols. Costs were reduced from nearly $22,000 to $16,000 per patient, a 27% reduction for each patient. The length

19 of stay was reduced by an average of 5 days per patient for the subjects receiving sepsis protocol intervention (p. 1279). Implementing a sepsis bundle within a 6-hour time frame will significantly improve outcomes according to Rivers et al. (2005). An endogenous anticoagulant called Activated protein C, also known as drotrecogin alfa (activated) or more commonly known as Xigris, could be one chosen modality for therapy. Administration of Xigris, when not contraindicated, can reduce severe sepsis by 6%. A controlled trial, randomized, showed that, compared to a placebo, this medication allowed for the higher percentage of reducing sepsis as studied in the PROWESS study (as cited in Rivers et al., 2005, p. 1062). Rivers et al. also indicated that tight glycemic control, protective lung strategies and optimum antibiotic therapy are also important in treatment of septic patients for positive outcomes which include ultimately survivability; thus, decreasing length of stay in ICU and the facility, and decreasing the progression of the disease to multi-system organ dysfunction. Kortgen et al. (2006) relayed the importance of the Golden Hour and that timely implementation of therapy can prevent the development of multi-system organ failure. Close monitoring of patients, their lab values, vital signs, and overall appearance is critical in allowing for survival from the devastating effects of severe sepsis. These investigators also stated that there are many factors delaying appropriate treatment modalities. Some of these factors include lack of awareness, failure in communicating, lack of incentive, cost of therapies, medical education, doubts in study results, scientific ignorance but primarily the extreme variation in which management of sepsis has been delivered. The authors also highly recognize the fact that physicians are resistant to

20 change, and that they are simply unwilling to change their routines. Lastly, they emphasize that the gap between actual and best patient care is morbidity and mortality in the worst-case scenario (p. 5). The nurse s role in the afore mentioned, Surviving Sepsis Campaign, would be to remain diligent with regard to being a patient advocate and supporting the bundle protocols which are evidence-based best practice. Close nursing observation and monitoring of their patients while in their care is also critical from presentation to the healthcare facility, to discharge. Nurses must immediately report/communicate patient changes to the physician with respect to lab values, signs and symptoms, vital signs and the overall status of the patient. Being an astute observer of even the most subtle of changes is urgent with the septic patient. A multidisciplinary collaboration and team approach is essential for improvement of clinical care patient outcomes. Ahrens and Tuggle (2004) indicate that the nurses role is crucial in preventing the progression in sepsis because their responsibility places them in a position to identify patients at the very first sign of sepsis. Once identified early on, appropriate treatment can be implemented immediately to reduce the progression of sepsis to involve multiple organs. Lipley (2006) stresses the importance of emergency room nurses to introduce early and aggressive therapy for sepsis; also stated was the fact that all nurses need to be aware of the signs and symptoms of severe sepsis and, if nurses embrace the Surviving Sepsis Campaign, we can contribute to the aim of reducing mortality by 25% in the next five years. Raising awareness is the number one defense is treating sepsis at its earliest stage to prevent progression of the process, decreasing costs, and saving lives.

21 Transitional Statement Conclusion The morbidity and mortality associated with sepsis has increased with each passing year since 1979 according to Cheek et al. (2005, p. 38). Septic patients notoriously have very complex hospitalizations and require rapid identification and treatment therapy to allow for optimum outcomes that means decreased length of stay in the ICU and facility, and a decrease in multi-system organ dysfunction which almost certainly leads to death. Kleinpell (2004) states, nurses play an important role in monitoring patients at risk for sepsis, promoting early detection of sepsis and instituting treatment measures, (p. 47). Wood et al. (2007) clearly defined the septic shock downward spiral as being rapid, and in need of early recognition and treatment within the first six hours of presentation. Silverwood and Francis (2007) explained that the key in implementing a sepsis protocol is to have a collaborative approach with all services, such as: pharmacy, infectious diseases, emergency department, nursing, and the entire critical care team. Everyone needs to be onboard with a genuine interest in treating septic patients. These researchers not only implemented an evidence-based practice protocol across the medical disciplines (e.g., physicians, nurses, and technicians), but also across medical departments and hospital services (p. 33). Levy (as cited in IHI, 2009, p. 1) stated, we now have enough data in the literature to inform standard of care for the management of these patients. The sepsis guidelines that were recently published, and that are the basis for the Surviving Sepsis Campaign, are founded on the data that suggest that the era of individual practice variations really needs to come to an

22 end. There is some very good data that point at a survival benefit with specific interventions. Chapter III of this project shall delineate the design of this study. The methods section of this proposal will include such items as the population/sample, ethical considerations, specific methods for data collection, assurance of and reliability and validity of data collection instruments and data analysis methods.

CHAPTER III METHODOLOGY The focus of this project was to evaluate whether mortality outcomes were improved after implementing sepsis bundles on patients that were diagnosed with severe sepsis and admitted via the Emergency Department (ED). A seven month period of time was evaluated both pre-implementation (6/2008 thru 12/2008), and post-implementation (6/2009 thru 12/2009) of sepsis bundles. The Surviving Sepsis Campaign (SSC), formed in 2002, was an international collaborative designed to reduce the mortality rate by 25% within five years (Institute for Healthcare Improvement, 2007b). The guidelines established in the Surviving Sepsis Campaign will be used in this study. Bundling is a concept created by the SSC and IHI. Interventions bundled together and followed per evidence-based strategy allow for safe and effective care of patients to improve clinical outcomes. The severe sepsis bundles include: 1. Blood cultures drawn prior to broad-spectrum antibiotic delivery 2. Antibiotic (broad-spectrum) initiated within 3 hours of ED admission 3. Intravenous fluid resuscitation (Crystalloids or equivalent) of 20 ml/kg-body weight for initial bolus and/or hypotension 4. Serum lactate levels drawn within 6 hours of ED admission Prior to implementing the sepsis bundles, treatment for patients presenting with severe sepsis was inconsistent and left to the discretion of each physician in the 23

24 emergency department. No clear policy or protocol was available to treat the serious condition. With identified evidenced-based protocols, and information from the Institute for Healthcare Improvement and the Surviving Sepsis Campaign, the target facility established a sepsis team and developed a sepsis bundle which was implemented the beginning of 2009 (Appendix C). Sepsis begins with systemic inflammatory response syndrome (SIRS), a cascade of events indicating the body s reaction to infection while trying to maintain homeostasis. Robson and Newell (2005) define SIRS by the presence of two or more of the following signs and symptoms: High or low temperature > 38 or < 36 degrees Centigrade Heart rate > 90 beats per minute Respiratory rate > 20 breaths per minute (or) PaCO2 <4.3kPa High or low white blood cell count >12,000 or <4,000 A patient with an infection, in addition to SIRS, has Sepsis. Severe Sepsis would be the inclusion of an organ dysfunction, systemic hypotension or hypoperfusion. An acute change in mental status, oliguria and metabolic acidosis are indications of organ dysfunction. Initial implementation of sepsis bundles in the emergency department at this Northern Nevada facility was delayed greater than six months due to lack of education and difficulty in physician compliance. At the time of this study, bundle usage was required for data entry into the Midas+ data collection system for severe sepsis. A bundle check-off list was placed into each patient s chart as an indicator for the time treatments and protocols were initiated due to these procedures being time-sensitive, as well as

25 showing confirmation of indicators for compliance and entrance into the Midas+ data system. Prior to bundles, treatment was based on the delayed diagnostics of blood cultures (usually 72 hours), and signs/symptoms the patient eventually developed. Each physician would treat sepsis in a different manner as there were no guidelines to follow. Bundle usage at the facility has acted as a catalyst for rapid implementation of treatment and continuity in care for the severe septic patient. Significance of a decrease in mortality rates with regard to the respiratory system, and an overall 8% decrease in mortality associated with this study, supports the recommendation for future research associated with sepsis. Setting The researcher s Northern Nevada Facility is a 380 bed, JCAHO Accredited, 46-room Emergency Department, and rated in the top one hundred nation-wide. Staff within the ED includes full and part-time employees: Physicians: 12, Physician Assistants: 11, Registered Nurses: 44, Emergency Medical Technicians: 15, Monitor Technicians/Unit Coordinators: 5, Scribes: 9. A person s initial presentation to the ED required an intake representative to enter pertinent patient information into the computer and state why the patient desired medical attention. That individual was then seen by the registered nurse and vital signs were done, and detailed medical information was taken. A computerized screening tool was used by the nurse, and if the patient presented with two or more SIRS criteria, the Severe Sepsis Order Set, (Appendix D) was then initiated. The patient was then seen by

26 the physician and assessed for further intervention, such as central line placement, IV fluids, antibiotics, admission into critical care and additional monitoring and/or treatment procedures. Sample Population The population for this project included all adults, ages 18 to 99, with a diagnosis of severe sepsis admitted via the Emergency Department. All medically coded, severe sepsis patients were entered into an electronic data collection tool, MIDAS+, at the researcher s facility. For a seven month period of time during the calendar year 2009 (June 1 thru December 31) bundle usage on severe septic patients was reviewed with the same 7-month time period for year 2008, where no bundles were utilized for severe septic patients; the retrospective data review was accomplished to ascertain whether bundle usage decreased the mortality rate. Study population included 152 total patients; 58 prebundles, 94 post-bundles. The data collection system automatically excluded patients from the study when compliance was not followed. All patients entered into the Midas+ system was used for review; patients who fell within the exclusion criteria are not a part of this study. Ethical Considerations: Human Subject s Protection Existing data was reviewed for the purpose of this study. No patient identifying criteria was included in this study. No interviews with patients were conducted. All data required for the purpose of this project was extracted from the data

27 base without using patient identifiers. No manipulation of patients, or changes in their care, occurred for the purpose of this study. Approval by the university institutional review board at California State University, Chico was sought once the project received approval for advancement by the Thesis Committee. Approval by the target hospital s institutional review board was also received prior to the beginning of this study. Design of Data Collection Upon diagnosis of severe sepsis in the emergency department (ED) by the physician on duty, and according to the severe sepsis criteria previously stated within this chapter, the bundle was then implemented. Compliance with bundle requirements was reviewed when patients were entered into the data base at the target facility. This process was completed by the Director of Performance Improvement. Four individuals, from a multidisciplinary team, were trained for extracting data from charts of the severe septic patients admitted via the ED; however, there is only one individual that has been responsible for data entry into the MIDAS+ tool. Her position at the facility is Director of Performance Improvement and she holds a Graduate Degree in Hospital Administration. One other individual is responsible for reviewing the statistics related to sepsis. His title is Performance Improvement; Statistical Analyst and he holds a Graduate Degree in Finance. Data Collection Method The device used at the target facility to collect data was an existing system called MIDAS+ Care Management system for quality and case management. It is a data

28 management system that combines information from a live interface data feed that comes directly from the hospital information management system and combines manually entered data such as that used for core measures. The real time interface brings demographic, admission, discharge, transfer and abstracting data elements for inpatient, outpatient, emergency and observation patients into MIDAS+ as soon as it is entered by Access Care Personnel (e.g., the Director of Performance Improvement) for the Severe Sepsis focus study. The data field transactions (information that feeds the MIDAS+ system) were validated at the global level (meaning all 42 CHW facilities). MIDAS+ is a new system at the target facility and the data that is coming from the facility system into MIDAS+ are continually monitored and validated by quality monitoring and improvement activities at the facility. All patients with a diagnosis and medical coding of Severe Sepsis were entered into the MIDAS+ system. After data was entered into MIDAS+ system by the Director of Performance Improvement, one function of the Statistical Analyst was to extract information from the MIDAS+ tool to present data via graphs and charts for the target facility when reviewing compliancy with core measures. MIDAS+ for Severe Sepsis can be accessed by both the Performance Improvement Director and the Statistical Analyst Specialist. This researcher was working with both the Director and the Statistical Analyst to extract the necessary data to be used by the researcher for her project. The instrument used for analyzing this researcher s data was known as SPSS. SPSS is a statistical analysis computer software program available from International Business Machines (IBM). Data were entered by this researcher into the 16 th edition of SPSS Student Version data base (SPSS Inc., Chicago IL.). Data was double-checked for