Managing Clostridium Difficile

Patients with clostridium difficile are at increased risk of mortality and morbidity. Indirect transmission through the interaction with a healthcare provider is thought to be one of the major routes in which this infection is transmitted. Patients who begin exhibiting more than three loose bowel movements within a 24-hour period can potentially have a clostridium difficile infection. Failure to test patients having active diarrhea early during their admission leads to an increased risk of indirect transmission of clostridium difficile spores. To test or not to test is a project to develop an algorithm and evaluate its effectiveness. Data was gathered from selected electronic medical records to compare the average time between the initiation of loose stools and when a stool sample was resulted. Also compared was the average time from the start of loose stools to when a patient was placed into contact precautions. The goal of the project was to develop an algorithm that promoted early recognition and timely treatment for patients at risk for a clostridium difficile infection. The algorithm was designed to be used by nurses working on a local medical-surgical floor. After implementation of the algorithm, data was collected and evaluated for the effectiveness of the algorithm. The project incorporated four objectives; (a) create an algorithm that helps guide nurses to send a stool sample on the third loose bowel movement; (b) implement the algorithm on a medical-surgical unit; (c) evaluate the average time between the initiation of loose stools and obtaining a clostridium difficile stool sample; (d) the findings were disseminated by submitting an abstract to the organizers of the Fifth Annual International Raising Clostridium Difficile Awareness Conference. The retrospective review included analyzing the electronic medical records for the time that the first bowel movement was documented by the nursing staff. The time when the stool sample was received by the laboratory, the time that the clostridium difficile test was resulted, and the time that the patient was placed into contact precautions following a positive clostridium difficile test was also noted. The algorithm was developed through collaboration with the chief of infectious diseases and the infectious disease nurse. Following its development, 28 nurses were educated about the algorithm and how it can be used to identify patients at risk for clostridium difficile. They demonstrated understanding of the education by obtaining an average of 99% on the posttest. The retrospective and prospective studies were performed from May-August 2016 and January-March 15th, 2017 on the charts of patients that had a clostridium difficile stool test. The average time from the initiation of stools to the obtaining of a stool sample was 43.01 hours for the retrospective study and 5.12 hours for the prospective study. A t-test: assuming unequal variances was performed and revealed there was a difference in the retrospective and prospective data obtained for the time required for a patient to have their stool tested following the initiation of stools. An abstract describing the project and the results were sent to the organizers of the 5th International Raising Clostridium Difficile Awareness Conference and the project committee of the 41st Snowbird CME Conference.

Running head: MANAGING CLOSTRIDIUM DIFFICILE 1 Managing Clostridium Difficile Klasina Caballero University of Utah-College of Nursing in partial fulfillment of the requirements for the Doctor of Nursing Practice MANAGING CLOSTRIDIUM DIFFICILE 2 Executive Summary Patients with clostridium difficile are at increased risk of mortality and morbidity. Indirect transmission through the interaction with a healthcare provider is thought to be one of the major routes in which this infection is transmitted. Patients who begin exhibiting more than three loose bowel movements within a 24-hour period can potentially have a clostridium difficile infection. Failure to test patients having active diarrhea early during their admission leads to an increased risk of indirect transmission of clostridium difficile spores. To test or not to test is a project to develop an algorithm and evaluate its effectiveness. Data was gathered from selected electronic medical records to compare the average time between the initiation of loose stools and when a stool sample was resulted. Also compared was the average time from the start of loose stools to when a patient was placed into contact precautions. The goal of the project was to develop an algorithm that promoted early recognition and timely treatment for patients at risk for a clostridium difficile infection. The algorithm was designed to be used by nurses working on a local medical-surgical floor. After implementation of the algorithm, data was collected and evaluated for the effectiveness of the algorithm. The project incorporated four objectives; (a) create an algorithm that helps guide nurses to send a stool sample on the third loose bowel movement; (b) implement the algorithm on a medical-surgical unit; (c) evaluate the average time between the initiation of loose stools and obtaining a clostridium difficile stool sample; (d) the findings were disseminated by submitting an abstract to the organizers of the Fifth Annual International Raising Clostridium Difficile Awareness Conference. The retrospective review included analyzing the electronic medical records for the time that the first bowel movement was documented by the nursing staff. The time when the stool sample was received by the laboratory, the time that the clostridium difficile test was resulted, and the time that the patient was placed into contact precautions following a positive clostridium difficile test was also noted. The algorithm was developed through collaboration with the chief of infectious diseases and the infectious disease nurse. Following its development, 28 nurses were educated about the algorithm and how it can be used to identify patients at risk for clostridium difficile. They demonstrated understanding of the education by obtaining an average of 99% on the posttest. The retrospective and prospective studies were performed from May-August 2016 and JanuaryMarch 15th, 2017 on the charts of patients that had a clostridium difficile stool test. The average time from the initiation of stools to the obtaining of a stool sample was 43.01 hours for the retrospective study and 5.12 hours for the prospective study. A t-test: assuming unequal variances was performed and revealed there was a difference in the retrospective and prospective data obtained for the time required for a patient to have their stool tested following the initiation of stools. An abstract describing the project and the results were sent to the organizers of the 5th International Raising Clostridium Difficile Awareness Conference and the project committee of the 41st Snowbird CME Conference. Linda Johnson, DNP, AGACNP-BC, Project Chair Denise Ward, FNP, ACNP-BC, MS, Acute Care program director Pam Hardin, PhD, RN, Assistant Dean for MS and DNP programs Dr. Kashif Memon, MD, Chief of Medicine, Chief of infectious diseases at Jordan Valley Medical Center and its associated hospitals, Content expert. MANAGING CLOSTRIDIUM DIFFICILE Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Problem Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Clinical Significance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Literature Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Theoretical Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Implementation and Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Project's DNP Essentials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Appendix A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Appendix B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Appendix C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Appendix D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Appendix E. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Appendix F. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48 Appendix G. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Appendix H . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Appendix I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 3 MANAGING CLOSTRIDIUM DIFFICILE 4 Problem Statement Indirect transmission of clostridium difficile spores by healthcare professionals to patients is thought to be a major route of colonization (Dubberke, 2014). Patients who begin exhibiting more than three loose bowel movements within a 24-hour period can potentially have a clostridium difficile infection. Each staff member who unknowingly comes into contact with these patients will increase the spread of the spores as they continue with their daily tasks. Vulnerable patients on the unit will be at increased risk of becoming colonized and possibly developing an active clostridium difficile infection as a result of failing to recognize and further testing of these patients sooner. Clinical Significance Over the last decade, clostridium difficile has increasingly become a public health threat. It contributes to a substantial increase in mortality, morbidity, and medical costs among inpatients, and is the most common cause of healthcare associated infectious diarrhea (Magill et al, 2014). Ghantoji, Sail, Lairson, DuPont and Garey (2010) wrote that clostridium difficile is a public health problem that affects patient safety directly and interrupts the operations of hospitals. This disruption leads to significant economic and health consequences for healthcare organizations and the patients in their care. The Society of Healthcare Epidemiology of America stated that understanding the pathogenesis, epidemiology, treatment, and how to prevent further transmission of clostridium difficile is one of the most important clinical challenges for healthcare epidemiology (Henderson and Palmore, 2010). The burden of healthcare associated infections like clostridium difficile is very costly. The expense of treating two of the most common hospital acquired infections, clostridium difficile and methicillin-resistant staphylococcus aureus, is estimated to be between 28.4-33.8 billion dollars in direct medical care MANAGING CLOSTRIDIUM DIFFICILE 5 costs (Scott, 2009). Each year, there is an estimated 300,000-500,000 new clostridium difficile infections diagnosed in the United States (Gravel et al, 2009; Bouza, 2012; Lessa et al, 2011). Each episode of a clostridium difficile infection is estimated to cost between 3,006 and 15,397 dollars (Dupperke and Olsen, 2012). Worse than the actual cost to treat this infection is the potential for life-long health consequences to the patients suffering from this illness. Patients diagnosed with clostridium difficile are at increased risk for mortality due to toxic megacolon, pseudomembranous colitis, sepsis, or a bowel perforation (Furuya-Kanamori, 2015). Dubberke et al (2012), stated that the deaths attributed to clostridium difficile infections in the United States is around 5-10% or 14,000-20,000 annually. Another factor that increases the burden of clostridium difficile infections is the rate of relapse in people previously diagnosed and treated. Studies show that between 20-25% of people that have been treated for a clostridium difficile infection will have a reoccurrence of diarrhea in their future (Jenkins 2015; Keller and Kuijper, 2015; Gorbach, 2014). Each episode of clostridium difficile costs between 3,006 to 15,397 dollars to treat so the ultimate cost to the patient and the healthcare system is extremely problematic. The stakeholders that can benefit from decreased rates of clostridium difficile infections are numerous. The patients can benefit from improved survival as they avoid some of the complications commonly seen with a clostridium difficile infection. The families of vulnerable patients could benefit by prolonged companionship and financial support. The hospital organization can benefit from improved patient satisfaction and increased patient survival. The decrease in the rates of clostridium difficile could potentially lead to an improvement in healthcare costs by decreasing the prolonged treatment often necessary to eradicate this infection. Clostridium difficile infections are expensive to treat. Therefore, if indirect MANAGING CLOSTRIDIUM DIFFICILE 6 transmission of clostridium difficile spores can be prevented through increased recognition and proper isolation techniques, then all those who enter the hospital can ultimately benefit. Purpose The purpose of this project is to reduce the spread of clostridium difficile among inpatients by using an algorithm that emphasizes timelier testing of stool in patients at risk of having the infection. Increased recognition and rapid testing of patients with symptoms of a clostridium difficile infection can decrease the risk of indirect transmission of spores by the nursing staff. Quick recognition and testing of patient's stool earlier in their admission will allow those found to have a clostridium difficile infection be placed in isolation sooner. Proper recognition, validation of clostridium difficile through testing, and the isolating of those found to have the infection are all key factors in the fight to prevent indirect transmission of spores. Objectives • Create an algorithm that helps guide nurses to send a stool sample on the third loose bowel movement. • Implement the algorithm on the medical-surgical unit. • Evaluate the average time between the initiation of loose stools and obtaining a clostridium difficile stool sample. • Submit an abstract to the organizers of the Fifth Annual International Raising Clostridium Difficile Awareness conference. An literature review was done through the information databases, PubMed and DynaMed, which was located on the University of Utah-Spencer E. Eccles Health Sciences Library. Specific keywords like clostridium difficile, management, algorithm, and contact isolation were used in different combinations in the search bar. The references from the articles MANAGING CLOSTRIDIUM DIFFICILE 7 were reviewed for common articles and authors. The authors and articles frequently cited in the literature were also searched using the information databases mentioned above. Other resources searched for information regarding clostridium difficile management were UpToDate and Krames. Literature Review What is clostridium difficile? Clostridium difficile is a type of bacteria that has become a worldwide health concern. It is described as a gram-positive, anaerobic bacillus that sheds spores in the stools of people who are infected (Dubberke et al, 2014). It is the leading cause of gastroenteritis-associated mortality with over 14,000 deaths in 2007 (Hall, Curns, McDonald, Parashar and Lopman, 2012). In the United States, healthcare associated infections caused by clostridium difficile are now as common as methicillin-resistant staphylococcus aureus (Miller, Chen, Sexton and Anderson, 2011). According to Sarker and Paredes-Sabja (2012), clostridium difficile is spread when an unsuspecting person ingests one of the spores released through the stool of another person. Once ingested, the spores survive in the acidic environment of the stomach and change into a vegetative state as they move into the anaerobic environment of the colon. The vegetative cells of the clostridium difficile bacterium penetrate the lining of the large intestine using their flagella and by secreting enzymes that can degrade the colonic extracellular matrix (Sarker and ParedesSabja, 2012). After penetrating the mucus layer of the large intestine, the clostridium difficile spores adhere to the epithelial cells of the intestine with their bacterial surface layer proteins (Spigaglia et al, 2013). However, there must be a prior disruption of the normal flora that typically provides protection before an invasion of the clostridium difficile spores into the epithelial layer of the large intestine (Buffie et al, 2015). MANAGING CLOSTRIDIUM DIFFICILE 8 To help describe the possible origin of transmission, clostridium difficile infections are classified as community onset or healthcare associated. It is believed that around 50% of newly diagnosed clostridium difficile infections have a community onset or an estimated incidence of 48.2 per 100,000 population (Dubberke et al, 2014; Lessa, 2015). A community onset infection is defined as one that is diagnosed within three days of a hospital admission in a person that has not been exposed to the healthcare system within the past twelve weeks (Lessa et al, 2015). The estimated incidence of healthcare associated clostridium difficile infections is 95.3 cases per 100,000 population (Lessa et al, 2015). Another group of clostridium difficile patients that warrant a thorough discussion are those classified as the asymptomatic carriers. These patients are known to be colonized, generally verified by testing, but are not currently exhibiting any symptoms of a clostridium difficile infection (Furuya-Kanamori, 2015). The number of patients who can be considered asymptomatic carriers is still unclear. Bruminhent et al (2014), estimated the number of admitted patients that are colonized with clostridium difficile, but not actually exhibiting any symptoms, to be around 50%. Bruminhent et al (2014), also projected that the number of asymptomatic carriers of clostridium difficile in acute care facilities to be between 7-26% and 5-7% of elderly residents living in long-term care facilities. Stojanovic et al (2012), estimated the number of adults that are asymptomatic carriers and do not have the risk factors typically seen in patients diagnosed with this infection to be around 0-15%. Furuya-Kanamori et al (2015) also stated that the rate of clostridium difficile among residents living in long-term facilities to be between 051% because it is often endemic within institutions or units. History of clostridium difficile Clostridium difficile was first described by Hall and O'Toole (1935) as a bacterium that is found in the typical flora of the intestinal tracts of infants. MANAGING CLOSTRIDIUM DIFFICILE 9 Recently, the normal progression of clostridium difficile changed with the emergence of a new strain, ribosome 027 or B1/NAP1/O27 (Jenkins, 2015). According to Jenkins (2015), after the emergence of the ribosome 027 strain, the natural course of the infection seemed to become more aggressive. For instance, as the number of clostridium difficile infections classified as ribosome 027 increased, there was also a notable increase in the number of people who had colectomies or were dying as a result of their infection (Jenkins, 2015). Today, the prevalence of this more aggressive strain is estimated to be around 25-35% of those diagnosed with clostridium difficile (Cheknis, Sambol and Davidson, 2009). This estimated number increases dramatically to approximately 28-85% when only adults are considered (Cheknis, Sambol and Davidson, 2009). Susceptible populations All people who are exposed to the healthcare system are at risk of coming into contact with clostridium difficile spores and becoming colonized. Cohen et al (2010), stated that there are three ways in which a patient can become colonized by clostridium difficile. The patient can encounter the spores via a contaminated environment, interaction with a healthcare worker who has been contaminated with the spores, or through direct contact with a person with an active clostridium difficile infection. Dubberke et al (2014), stated that indirect transmission through the interaction with healthcare providers may be the major route in which patients become colonized with clostridium difficile spores. However, even though all people who are exposed to the healthcare system are at risk, certain groups of people have been found to be more vulnerable than others. Lessa et al (2015), reported that females, Caucasians, and adults over the age 65 had a higher incidence of a clostridium difficile infection. The incidence of clostridium difficile infections associated with complications among people 65 years and older is five times that of a younger person due to changes to the intestinal microbiota (Simor, 2010, Claesson et al, 2011; Henrich, Krakower, Bitton and Yokoe, 2009; Garey, Sethi, Yadav and MANAGING CLOSTRIDIUM DIFFICILE 10 Dupont, 2008). For instance, of the 29,000 people who died as a result of a clostridium difficile infection in 2011, around 90% of them were over the age of 65 (Lessa et al, 2015). There are many known risk factors that can put a person in danger for a future clostridium difficile infection. Kong et al (2015), stated that people who have been hospitalized within the last twelve months, have history of a clostridium difficile infection, exhibit the toxin B antibody, or have a history of corticosteroid use are at increased risk of being an asymptomatic carrier. According to Loo et al (2011), a recent hospitalization and the presence of toxin B antibodies increased the risk of asymptomatic colonization of clostridium difficile. The authors also identified other risk factors such as exposure to chemotherapy or chronic use of proton pump inhibitors and histamine H2 antagonists (Loo et al, 2011). Hunter el al (2016), found that 35% of the patients who had not previously been exposed to antibiotics had been exposed to proton pump inhibitors or histamine H2 antagonists within twelve weeks of their diagnosis. Leekha et al (2013), stated that a recent hospitalization, corticosteroid use, and chronic dialysis increases a person's risk of being colonized by asymptomatic toxigenic clostridium difficile spores. Previous antibiotic exposure is another common risk factor for clostridium difficile. Deshpande et al (2013), found that clindamycin followed by the fluoroquinolone drug class, such as levofloxacin, held the greatest risk for a future clostridium difficile infection. Loo et al (2011), stated that previous antibiotic exposure within the past eight weeks is a risk factor for a healthcare associated clostridium difficile infection but does not necessarily put them at increased risk of colonization by these spores. The reason for this discrepancy is that the use of antibiotics that disrupt the intestinal microbiota is not as necessary for clostridium difficile to colonize a person as it is for a colonized person to progress to an active infection (Loo, 2011). MANAGING CLOSTRIDIUM DIFFICILE 11 An example of this discrepancy was described by Chitnis et al (2013), when they found that 36% of their study participants diagnosed with a community acquired clostridium difficile infection had no prior use of antibiotics. Signs and symptoms of clostridium difficile The symptoms of a clostridium difficile infection can vary in severity. Rupnik, Wilcox, and Gerding (2009) described how one person could experience only mild diarrhea while another may suffer one of the major complications of the infection like pseudomembranous colitis, bowel perforation, toxic megacolon, sepsis, or even death. However, according to Dubberke et al (2013), the most notable sign of a clostridium difficile infection is a sustained change in the patient's stool consistency without any other known cause. The range of symptoms caused by clostridium difficile occurs because of the different toxins that can be produced by the bacterium. For example, clostridium difficile can release toxin A, B, or binary toxin into the surrounding environment of the intestines. These toxins, according to Voth and Ballard (2005), are cytotoxic to the cells lining the colon which cause extensive tissue damage and inflammation. For the toxins to exert their effect, they must first bind to receptors of the cells lining the gut and catalyze in the cytosol. The products of the catalyzed toxins inactivate the guanosine triphosphate binding Rho proteins. This sets into motion the depolymerization of the actin cytoskeleton which elicits a cellular response. Neutrophil infiltration and the resulting inflammation leads to the release of interferon gamma and cytokines. Death of the epithelial cell occurs because of the disaggregation of the actin cytoskeleton, Meyer et al (2007). This process, according to Furuya-Kanamori et al (2015), results in extensive inflammation of the colon, epithelial tissue damage, rapid fluid loss into the large intestine, and diarrhea. A clostridium difficile bacterium that does not secrete toxins is MANAGING CLOSTRIDIUM DIFFICILE 12 unable to cause disease and can potentially offer some protection from other potentially toxic strains (Furuya-Kanamori et al, 2015; Tracey, Kirke, Armstrong and Riley, 2015). Isolation precautions Specific infection control methods for clostridium difficile. To effectively control clostridium difficile, there needs to be a plan that consists of appropriate contact isolation, adequate education, hand hygiene, and environmental disinfection (You, Song, Cho and Lee, 2014). There are a number of guidelines that should be followed to control the spread of clostridium difficile (Dubberke et al, 2014). These guidelines, which were developed and sponsored by the Society for Healthcare Epidemiology of America, Infectious diseases Society of America, American Hospital Association, the Joint Commission and the Association for Professionals in Infection Control and Epidemiology, stated patients diagnosed with clostridium difficile should be placed in contact precautions until resolution of their symptoms. Some experts recommend that patients remain in contact isolation for forty-eight hours after their diarrhea resolves, Dubberke et al (2014). However, even after resolution of diarrhea, patients are still capable of contaminating their environment with clostridium difficile spores. In fact, most patients with toxigenic clostridium difficile, who are treated and clinically cured, have been found to continue shedding spores for multiple weeks (Sethi, Al Nassir, Nerandzic, Bobulsky and Donskey, 2010). Patients who are colonized by clostridium difficile, but have never had a clostridium difficile infection, are also capable of shedding spores (Riggs et al, 2007). FuruyaKanamori et al (2015), stated that studies have clearly shown that asymptomatic colonized people shed spores so they may be a potential source of future clostridium difficile infections. For example, Curry et al (2013), discussed how isolates were collected from patients diagnosed with a hospital associated clostridium difficile infection and found that 29% of the samples MANAGING CLOSTRIDIUM DIFFICILE 13 obtained were very similar to isolates found in other patients confirmed to be asymptomatic carriers. However, the degree of contamination of spores into the environment by an asymptomatic carrier, compared to a person with an active infection, is limited due to the reduced quantity released with each bowel movement (Samore, Venkataraman, DeGirolami, Arbeit and Karchmer, 1996). Hard surfaces like counters, bedside tables and medical equipment are another potential reservoir for the transmission of clostridium difficile spores (Dubberke et al, 2013). According to Jenkins (2015), clostridium difficile spores present a huge challenge in the fight to prevent the spread of this infection because of their resilience to chemicals, heat, and dehydration. In fact, Rupnik, Wilcox, and Gerding (2009) stated that the spores produced by clostridium difficile can survive on surfaces for months to even years. To help reduce the risk of indirect transmission of these spores on the hard surfaces in the environment, it is recommended that they undergo disinfection frequently. It has been demonstrated that the spores released by clostridium difficile require ultraviolet radiation devices, peroxide based or chloride sporicidal agents to properly decontaminate the environment (Wilcox et al, 2003; Boyce et al, 2008; Nerandzic, Cadnum, Pultz and Donskey, 2010). Kundrapu, Sunkesula, Jury, Sitzlar, and Donskey (2012) recommend that "high touch" surfaces like tables and hospital countertops undergo daily disinfectant procedures to reduce the accumulation of pathogens in rooms of patients infected with clostridium difficile (2012). Limiting the amount of environmental contamination by these spores is the best way to prevent transmission (Jenkins, 2015). Patient, families and visitors understanding of isolation precautions. In the guidelines written by Dubberke et al (2014), the authors recommended that patients, their families and hospital personnel should be properly educated to help prevent the spread of clostridium difficile MANAGING CLOSTRIDIUM DIFFICILE 14 within the healthcare organizations. The educational material should explain what a clostridium difficile infection entails and why handwashing in conjunction with proper isolation is important to prevent further transmission (Dubberke, 2014). Educating patients frequently during their hospital stay is also important to improve compliance. Gudnadottir et al (2023), reported that eleven percent of the interviewed patients stated that they did not receive information regarding contact isolation, or information telling them their diagnosis of the infection. Yanke et al (2015) identified that visitors were never fully compliant with isolation precautions and therefore may be an important vector that spreads clostridium difficile spores into the hospital common areas. A multidisciplinary approach, including environmental services and visitors, is ideal for compliance for isolation precautions (Yanke et al, 2015). Hospital staff compliance with isolation precautions Despite extensive knowledge of the importance of adherence to contact precautions to prevent the spread of clostridium difficile, the handwashing compliance rates of healthcare workers was far below the expected goal of 100% (Dhar et al, 2014). Yanke et al (2015) attributed the reason for the low rates of compliance with isolation precautions is due to the necessary time required to enter and exit a room compared to one that is not in isolation. The authors also noted that the one component that was missed during proper isolation precautions was handwashing. This was due to an erroneous belief that wearing gloves completely protected them (Yanke et al, 2015). Almaguer-Leyva et al (2013), discussed that compliance with handwashing in the overall population was 60.4% (1,468 out of 2,389 opportunities) and 70.3% among patients in contact precautions (619 out of 881 opportunities). Almaguer-Leyva (2013) also found that the rate of hand hygiene compliance among the staff was 10% lower than the rate of glove and gown use while a patient is in contact precautions. Compliance of isolation precautions of family/ visitors/patients MANAGING CLOSTRIDIUM DIFFICILE 15 Strategies to prevent transmission How does education empower family/patients? Many patients and families are unfamiliar with hospital associated infections and what it could potentially mean for their longterm outcome. Ottum et al (2013), discussed that patients' knowledge of the potential health consequences following a diagnosis with clostridium difficile or a MRSA infection was low. Ottum et al (2013) found that only 44% of the patients surveyed had heard of clostridium difficile. Only six percent of patients with clostridium difficile had previous knowledge that a clostridium difficile infection may result in the need for an extensive surgery and only thirty-two percent knew it could lead to death (Ottum, 2013). Research has shown that handwashing is the most effective strategy for preventing hospital acquired infections (Almaguer-Leyva et al, 2013). Patients and families can be instrumental at increasing compliance rates of handwashing in healthcare workers by just speaking up. McGuckin et al (1999), stated that patients who feel empowered to ask their healthcare providers to wash their hands increased compliance of hand hygiene by 34-94 percent. Improved decision making by educated patients increased compliance for completing their antibiotic regimens, improved hygiene, improved disclosure to other healthcare facilities about past infections, and asking other healthcare providers to wash their hands (Ottum et al, 2013). Most patients want to be involved in their care. Gudnadottir et al (2013), stated that 98% of the patients thought that it was important to have a role in learning about healthcare associated infections. The way patients and their families are educated is vital to help insure that they fully understand their role to prevent the spread of clostridium difficile, Gudnadottir et al (2013). According to Gudnadottir et al (2013), 72% of the patients thought that receiving medical MANAGING CLOSTRIDIUM DIFFICILE 16 education through discussion was helpful while 92% thought that printed material was also helpful. Therefore, it is vital that the patients' preferences must be integrated into the education to help alleviate clostridium difficile. Theoretical Framework The Star Model of Knowledge Transformation is a model that provides the framework for methodically moving evidence based processes into everyday practice (The University of Texas Health Science Center at San Antonio (UTHSC), n.d.). There are five major points of knowledge transformation that make up this model. The point of discovery, is essentially "knowledge generating" in that it involves traditional research methods in the search for new information (UTHSC, n.d.). The evidence summary includes the accumulation of knowledge gained through research to be compiled into a single meaningful statement. This allows large amounts of data to be reduced to a more manageable form where updates can be continuously added (UTHSC, n.d.). The "translation to guidelines" focuses on transforming the evidence summaries found through scientific processes and generating clinical practice guidelines such as an algorithm (UTHSC, n.d.). During this project, an algorithm was developed to help raise awareness among the nursing staff to know when they should consider sending a stool sample to the laboratory. The easy to follow algorithm was developed through practice recommendations that have been proven effective through research. The "practice integration" stage was demonstrated when the algorithm was incorporated into the everyday practice of the nursing staff (UTHSC, n.d.). The nursing staff is now expected to know how to use the algorithm and effectively address any patient suspected of having clostridium difficile in a timelier manner. The "process and outcome evaluation" stage includes an evaluation of how a change ultimately impacted the patients' health outcomes (UTHSC, n.d.). MANAGING CLOSTRIDIUM DIFFICILE 17 Implementation and Evaluation Implementation An algorithm was developed to guide the nursing staff to collect a stool sample as soon as a patient met certain criteria considered significant by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). The initial draft of the algorithm was written using recommendations from current peer-reviewed articles regarding the management of clostridium difficile. The draft was reviewed by the infectious disease nurse and the chief of infectious diseases. Following their review, the formatting changes they recommended were utilized for the final algorithm. The final algorithm was then submitted to the infectious disease nurse, the director of medical-surgical services, and the chief of infectious diseases in December 2016. The director of medical-surgical services and the chief of infectious disease approved the final algorithm (Appendix C). However, the infectious disease nurse expressed that the final algorithm was too complex and would not be beneficial to the nursing staff. She designed a second algorithm from the original algorithm (Appendix D). In December, a meeting was held with the director of medical-surgical services in regards to educating the nursing staff. The original discussion included a PowerPoint presentation with an in-service to the nursing staff. Unfortunately, due to budget shortfalls, the in-service was cancelled and the nursing staff was educated individually or in small groups while on shift. A list of the current employees working on the medical-surgical floor was obtained to keep track of those that had completed the education. The education sessions took place two to three times a week throughout the month of January. A display board detailing the project and the algorithm was placed in the nursing break room to help reinforce the education. The break room was chosen because of its easy access. The display board encompassed the algorithm, the MANAGING CLOSTRIDIUM DIFFICILE 18 educational tool, and a posttest. Following the education, each nurse was asked to complete a posttest (appendix F). The posttest assessed the key points of the algorithm. The average amount of time it took for a stool sample to be sent down to the laboratory following the beginning of a patient's diarrhea was done in two parts. A retrospective review was performed prior to the implementation of the algorithm. The information department was contacted to identify how to obtain a list containing the medical record numbers of all the patients admitted between May and August 2016 who had a clostridium difficile test. The time the laboratory received the sample and the time it was resulted was compiled by the laboratory personal. Patients that were not admitted to the medical-surgical unit at the time of their stool sample were excluded from the retrospective study. All the patients that were on the medicalsurgical unit at the time of the stool sample was further analyzed. Documentation of the average time between the initiation of loose stools and obtaining a clostridium difficile result were recorded. The input/output flow-sheets and specific medical-surgical notes from the electronic medical records were reviewed. The time the specimen was received by the laboratory was recorded. The average time it took for a stool to be resulted by the laboratory was recorded. The average time needed to place a patient into contact precautions following a positive stool sample was found by calculating the difference between the patient's first recorded stool and when contact isolation was documented. Lastly, the inpatient medications list was reviewed to determine if the patient was given anything that could potentially explain why each patient was having loose stools. Once the algorithm was implemented, a perspective analysis was performed on medicalsurgical patients who were documented to have had a stool sample sent to the laboratory. Laboratory process times and a review of medications was performed on the electronic medical MANAGING CLOSTRIDIUM DIFFICILE 19 records identified between January 6th and March 15th, 2017. A t-test, assuming unequal variances, was performed to compare the retrospective and prospective data to see if there was a significant difference. To disseminate the scholarly project, the results were given to the hospital administration. An abstract was submitted to the Fifth Annual Clostridium Difficile Awareness Conference held in November in Las Vegas, Nevada and the 41st Snowbird CME Conference held in August in Salt Lake City, Utah. Evaluation The algorithm that was used in the management of clostridium difficile was developed with collaboration from the Chief of Infectious Disease and the infectious disease nurse. The original algorithm was taken and revised by the infectious disease nurse and submitted to the hospital board for approval without full notice of the collaborating team. The implementation of the algorithm on the medical-surgical floor began in January 2017. Thirty-six staff members were found on the original list compiled by medical-surgical director in December 2016. Five of them were found to be ineligible. Two of them left the hospital prior to the study and the other three transferred to a newly opened unit prior to the release of the algorithm. Of the 31 deemed eligible to complete the education, 28 of them finished it and demonstrated their understanding of the material discussed by obtaining an average of 99% on the posttest. Two members of the staff that were not formally educated and one person received the education but did not turn in the posttest because of time constraints. The education sessions required fifteen minutes to properly educate the staff about the algorithm. Most of the nursing staff had to manage their assigned patient loads during our discussions so they were often pulled away or distracted. MANAGING CLOSTRIDIUM DIFFICILE 20 The opinions of the medical-surgical staff about the algorithm and the education tool varied. Most of the nursing staff thought the algorithm was easy to follow because of its simplicity. However, many people commented that the algorithm may have been too simple and in a way, common sense. In fact, one nurse stated that utilizing the algorithm while performing her patient assessments would be relatively simple because it was something that she did already. On the other hand, the part of the algorithm that stirred up the most questions was the section that stated that stools needed to take on the form of the container to be suitable for testing. The majority of the staff wanted to understand why this was important and it required more in-depth conversation about clostridium difficile. Evaluating the average time between the initiation of loose stools and obtaining a clostridium difficile stool sample also had its challenges. The documentation of stool descriptions and occurrences within the electronic medical system was surprisingly poor, especially during the retrospective analysis. Most of bowel movements documented in the record were not described. It was impossible to know for sure if a documented bowel movement was loose, formed or solid. There was also lack of recorded bowel movements even if the charting by the nursing and medical staff indicated that the patient was having loose stools. Most of the patients' charts did not have more than one stool documented prior to a clostridium difficile test result. Four of the identified patient records analyzed for the retrospective and prospective review did not have documentation indicating that the patient had a bowel movement prior to a stool sample result. Due to the poor documentation of stool descriptions and stool occurrences within the medical record, the time of the first bowel movement was utilized for evaluation. Two of the nine patients found to be positive for clostridium difficile did not have contact isolation documented by the nursing staff in the medical record. MANAGING CLOSTRIDIUM DIFFICILE 21 An abstract summarizing the study and the results was developed. The contact information for the fifth Annual International Raising Clostridium Difficile Awareness Conference was located by searching the website of the clostridium difficile foundation. The abstract was then submitted to the conference organizers. The abstract and final poster was given to the project committee for the 41st Snowbird CME Conference. The results of the study were also disseminated to the hospital administrators through email and one to one conversations. Results The algorithm was developed through the collaboration with the chief of Infectious Disease and the infectious disease nurse. The algorithm was approved by the board in January 2017 to be utilized throughout the hospital. The algorithm was then introduced to some of the local administrators of one other hospital within the organization and is now being considered for potential implementation within that hospital. The nursing staff was educated on the algorithm. Ninety percent of the nursing staff deemed eligible were educated. They demonstrated their understanding of the algorithm and the associated education by obtaining an average of ninety-nine percent on the posttest. The other ten percent of the staff not educated had easy access to the new algorithm and the education material located on the bulletin board displayed in the nursing lounge. Evaluating the average time from the initiation of loose stools and obtaining a clostridium difficile stool sample result was, for the most part, a success. Due to the poor documentation, the time of the first stool had to be used to determine the average time. During the retrospective review, 34 patient charts were analyzed. The average time it took from the first stool being documented to the time the sample was obtained was 43.01 hours. Average laboratory process times was 3.57 hours. Of the 34 different charts analyzed, two had no documentation of a stool MANAGING CLOSTRIDIUM DIFFICILE 22 occurrence prior to the results of a clostridium difficile test. Six of the patients were positive for clostridium difficile. Two of the six had no documentation of contact isolation. One was placed in isolation prior to the obtaining of a stool sample. The average time from the obtaining of a stool sample to the time the patient was placed in isolation was 62.59 hours. During the prospective study, 12 patient charts were analyzed. The average time it took from the first stool being documented to the time the sample was obtained was 5.12 hours. The average laboratory process time was 3.27 hours. Of the 12 charts reviewed, two had no documentation of stool occurrences prior to the results of a clostridium difficile test. Three stool samples tested positive for clostridium difficile. One was placed in isolation prior to obtaining a stool sample. The average time from obtaining a stool sample to the time the patient was placed in isolation was 22.68 hours. A t-test of two-sample assuming unequal variances was performed using the data from the retrospective and prospective studies. The results of the analysis demonstrated that there was not a significant difference in the laboratory process times or the time to contact isolation. However, the comparison did demonstrate that there was a significant difference in the average time between the initiation of stools and obtaining a stool sample. Limitations Limitations of the study include: the poor documentation of stool and the notable improvement in the documentation during the prospective review. The length of time to gather information for the prospective review was limited to two in a half months. The review should have continued for four months. Lastly, the opening of the new unit changed the patient demographics and decreased the number of patients available for the prospective review. Recommendations MANAGING CLOSTRIDIUM DIFFICILE 23 This study should have been expanded to four months of data to evaluate the effectiveness of the algorithm before implementing it throughout the hospital. In the future, a study should be done to evaluate the implementation of the algorithm throughout the hospital system. There were two algorithms developed during this study. In the future, there should be a comparison study done to compare the two algorithms to evaluate which one is more effective at identifying patients at risk of having a clostridium difficile infection and whether testing is clinically warranted. Further research on the laboratory procedures and timing of clostridium difficile results should be done to determine the best way to expedite this process. A future study can also be done to evaluate if the algorithm will have an effect on unnecessary testing by correctly identifying which patients are at higher risk. DNP essentials The American Association of the Colleges of Nursing (2006) wrote that a doctorate of nursing practice prepared nurse should implement and assess practice approaches based on theories from nursing and other disciplines. The theoretical framework used for this project, The Star Model of Knowledge Transformation, helped implement evidence based processes into everyday practice. The developed algorithm educated the nursing staff about evidence based practice to prevent clostridium difficile transmission. The education developed also encouraged the nurses to incorporate patients and their families to help prevent the spread of clostridium difficile spores throughout the unit. The organizational and systems leadership for quality improvement and systems thinking essential was addressed through the development of the algorithm. This algorithm was developed with an interdisciplinary team and approved by leadership of the hospital. The clinical MANAGING CLOSTRIDIUM DIFFICILE 24 scholarship and analytical methods for evidence-based practice essential was also addressed. This essential describes how an advanced practice prepared nurse reviews existing literature to determine what is evidence based practice (AACN, 2006). A literature review of current evidence based practice was utilized to develop the algorithm. Peer reviewed articles, research papers, educational handouts and chapters of published text books discussing the management of clostridium difficile were all reviewed. The health care policy for advocacy in health care was addressed when the corporation implemented the algorithm into policy throughout the hospital. The final essential known as "advanced nursing practice", was demonstrated by the project. The education given during the project helped guide and support the nursing staff as they worked to achieve excellence in nursing practice by preventing the spread of clostridium difficile. Conclusion An algorithm that serves as a guide to manage patients at risk for clostridium difficile was necessary at this local hospital. Before this project, no algorithm existed. Each year, around 300,000-500,000 patients are diagnosed with a clostridium difficile infection in the United States and around 20,000 of them die as a result (Bouza, 2012; Dubberke et al, 2012; Gravel et al, 2009; Lessa et al, 2011). A vast number of these patients were exposed to this potentially devastating illness after they came into contact with contaminated objects or healthcare providers who were unknowingly carrying the spores (Dubberke et al, 2014). Limiting the amount of indirect transmission of clostridium difficile spores is an important step to help prevent future spread to patients and visitors entering the hospital. The staff of the medical-surgical unit did not have a policy or guideline to direct patient care when they suspected a patient might have clostridium difficile. Patients could have MANAGING CLOSTRIDIUM DIFFICILE 25 potentially been exhibiting signs and symptoms of a clostridium difficile infection for a length of time before a member of the medical or nursing staff sent a sample to be tested for clostridium dificile. Many opportunities to intervene and prevent the indirect transmission of clostridium difficile could have been missed. Patients and families entering the hospital could have easily encountered the same spores since there were delays to testing for clostridium difficile. The algorithm developed during this project encompasses the latest evidence based practices in the management of clostridium difficile. It helped guide the nursing staff to identify which patients are more at risk and expedite the process of obtaining a stool sample for clostridium difficile. Identifying these patients and placing them in contact isolation earlier decreases the incidence of indirect transmission of clostridium difficile. 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The University of Texas Health Science Center at San Antonia (n.d.). Star model. Retrieved on October 10th ,2016 from http://nursing.uthscsa.edu/onrs/starmodel/star-model.asp Voth, D.E., & Ballard, J.D. (2005, April). Clostridium difficile toxins: Mechanism of action and role in Disease. Clinical Microbiology Reviews, 18, 247-263. doi:10.1128/CMR.18.2.247-263.2005. Wilcox, M.H., Cunniffe, J.G., Trundle, C., Redpath, C. (1996, September). Financial burden of hospital-acquired clostridium difficile infection. Journal of Hospital Infection, 34 (1), 23-30. Wilcox, M.H., Fawley, W.N., Wigglesworth, N., Parnell, P., Verity, P., & Freeman, J. (2003, June). Comparison of the effect of detergent versus hypochlorite cleaning on environmental contamination and incidence of clostridium difficile infection. Journal of Hospital Medicine, 54, 109-114. Yanke, E., Zellmer, C., Van Hoof, S., Moriarty, H., Carayon, P., & Safdar, N. (2015, March). Understanding the current state of infection prevention to prevent clostridium difficile infection: A human factors and systems engineering approach, American Journal of MANAGING CLOSTRIDIUM DIFFICILE Infection Control, 43 (3), 241-247. doi: 10.1016/j.ajic.2014.11.026. You, E., Song, H., Cho, J., & Lee, J. (2014). Reduction in the incidence of hospital-acquired clostridium difficile infection through infection control interventions other than the restriction of antimicrobial use. International Journal of Infection Diseases, 22, 9-10. doi: 10.1016/j.ijid.2014.01.011. 34 MANAGING CLOSTRIDIUM DIFFICILE 35 Appendix A International Review Board Application and Response 1. Contacts and Title 1. Principal Investigator: Klasina Caballero The Principal Investigator (PI) can create, edit, and submit IRB applications. The PI will also receive all study-related notifications from the ERICA system. Email Training [e-mail] a. CoI Date 11/17/2016 Position of Principal Investigator: Faculty Student Staff Resident/Fellow Other If Other, describe: b. Will the Principal Investigator consent participants? Yes 2. No Contact Person(s) (if different from the PI): Contact persons have access to edit the IRB applications and receive all notifications from the ERICA system. Name Email Training There are no items to display 3. Internal Staff and Sub-Investigator(s) (Within the University of Utah): MANAGING CLOSTRIDIUM DIFFICILE 36 Internal Staff and Sub-Investigators have read-only access to the IRB applications and do not receive notifications from the ERICA system. Add persons here who are responsible for the design, conduct, and reporting of research. Name Email Training Obtaining Consent CoI Date There are no items to display 4. External Sub-Investigator(s) (Investigators outside the University of Utah): External Sub-Investigator cannot view applications in ERICA and will not receive study-related notifications from the ERICA system. Last Name First Name Affiliation There are no items to display 5. Faculty Sponsor (if needed): The Faculty Sponsor has read-only access to applications in ERICA and will receive all study-related notifications from the ERICA system. LINDA JOHNSON 6. Guests: Guests can view applications in ERICA and will not receive study-related notifications from the ERICA system. If you need read Guest Access for an auditor or monitor, please contact the IRB at 801-581-3655. Last Name First Name E-Mail There are no items to display 7. What type of application is being submitted? Request for Non-Human Subject Research Review 8. Title Of Study: Ensure the title matches those listed on the Protocol, Consent, and other appropriate documents. To Test or Not to Test... Know Your Diff MANAGING CLOSTRIDIUM DIFFICILE 9. 37 Study Purposes and Objectives: The objectives should be stated in such a way that the reader can determine the appropriateness of the study design. If appropriate, state the specific hypotheses being tested and/or study aims. Use lay language. 1) create an algorithm that helps guide nurses to send a stool sample on the third loose bowel movement. 2)Implement the algorithm on the medical surgical unit of JVMC-WVC 3)Evaluate the average time between the initiation of loose stools and obtaining a clostridium difficile stool sample. The algorithm that is developed through this study will have its effectiveness tested by monitoring the average time it takes to have a stool sample sent down to the laboratory following the initiation of loose stools. To do this, I will perform a retrospective and prospective study of the electric medical records of patients who had a clostridium difficile stool sample sent down to the laboratory. In each of these charts I will be collecting the time of the patient's stool sample and whether it was positive or negative. I will also look at when the patient's diarrhea was first documented and the time the patient was first placed in isolation precautions (only necessary if the patient was found to have clostridium difficile). I will be monitoring the average time between the initiation of loose stools and the obtaining of a stool sample looking for clostridium difficile as a way to evaluate the effectiveness of the algorithm developed. 10. Background and Introduction: Identify the research area being studied and provide a review of the literature that provides the basis for understanding the objectives of the study. This review should be written such that scientists outside the investigator's area of expertise can understand the issues involved. Any information about previous research related to this study involving animals and/or humans should be summarized. Include studies on pregnant animals if the research is conducted on pregnant women, fetuses, or neonates. In 2011, there was an estimated 453,000 new cases of clostridium difficile infections in the United States (Lessa et al, 2015). It is estimated that between 14,000-20,000 deaths occur each year as a result of a clostridium difficile infection with the New England Journal of Medicine reporting 29,000 people dying in 2011 alone (Dubberke et al, 2014); (Lessa et al, 2015). Clostridium difficile infections are estimated to cost the U.S. healthcare system 28.4-33.8 billion dollars in direct medical care costs (Ottum et al, 2013). MANAGING CLOSTRIDIUM DIFFICILE 38 Indirect transmission through interaction with healthcare providers is thought to be a major route of transmission for clostridium difficile (Dubberke, 2014). The spores produced by clostridium difficile can survive on surfaces for months to years (Tracey, Kirke, Armstrong and Riley, 2015). More than 50% of new clostridium difficile infections have a community onset (Dubberke, 2014) Clostridium difficile infections now contend with MRSA as a leading cause of healthcare care associated infections (Dubberke et al, 2014) Clostridium difficile infections are progressively becoming resistant to treatment (Ottum et al, 2013). Tracey et al wrote, "a multi-pronged approach of prudent prescribing, patient education and adequate testing are effective strategies to control this public health threat" (2015, p. 716) Hard surfaces and equipment that are contaminated by spores are potential reservoirs that can transmit disease (Dubberke et al, 2014). Furuya-Kanamori et al wrote that after resolution of symptoms, patients are still capable of contaminating their surrounding with clostridium difficile spores for up to six weeks. Jenkins wrote, "our best chance of preventing transmission must be based on limiting environmental contamination with C. difficile spores" (2015, p. 1403). Tracey et al found while studying community acquired clostridium difficile infections that around 36% of their study participants were not previously prescribed antibiotics and 41% had only had a low-level exposure to healthcare prior to their diagnosis with clostridium difficile (2013) Tracey et al wrote that, "there is an increasing incidence and severity of community acquired clostridium difficile infections, and evidence of disease in populations not traditionally considered at risk" (2015, p. 716). MANAGING CLOSTRIDIUM DIFFICILE IRB: IRB_00097082 PI: Klasina Caballero Title: To Test or Not to Test... Know Your Diff Date: 1/3/2017 Thank you for submitting your request for approval of this project. The IRB has administratively reviewed your application and has determined on 1/3/2017 that your project does NOT meet the definitions of Human Subjects Research according to Federal regulations. Therefore, IRB oversight is not required or necessary for your project. DETERMINATION JUSTIFICATION: This project appears to be a quality improvement project which does not meet the definition of human subject research. This determination of non-human subjects' research only applies to the project as submitted to the IRB. Since this determination is not an approval, it does not expire or need renewal. Remember that all research involving human subjects must be approved or exempted by the IRB before the research is conducted. If you have questions about this, please contact our office at 581-3655 and we will be happy to assist you. Thank you again for submitting your proposal. SUPPORTING DOCUMENTS Literature Cited/References IRB reference list.docx 39 MANAGING CLOSTRIDIUM DIFFICILE 40 Appendix B Doctor of Nurse Practitioner Proposal Presentation MANAGING CLOSTRIDIUM DIFFICILE 41 MANAGING CLOSTRIDIUM DIFFICILE 42 MANAGING CLOSTRIDIUM DIFFICILE 43 MANAGING CLOSTRIDIUM DIFFICILE 44 MANAGING CLOSTRIDIUM DIFFICILE Appendix C Poster Presentation 45 MANAGING CLOSTRIDIUM DIFFICILE Appendix D Final Version of Algorithm developed through collaboration 46 MANAGING CLOSTRIDIUM DIFFICILE Appendix E Version of algorithm approved by the board on January 5th, 2017 47 MANAGING CLOSTRIDIUM DIFFICILE 48 Appendix F Front and back panel of the nursing staff education pamphlet MANAGING CLOSTRIDIUM DIFFICILE Right and left middle panel of the pamphlet 49 MANAGING CLOSTRIDIUM DIFFICILE Inner panel of pamphlet 50 MANAGING CLOSTRIDIUM DIFFICILE 51 Appendix G Nursing staff post-test following education and algorithm introduction MANAGING CLOSTRIDIUM DIFFICILE 52 Appendix H Retrospective study results N Laboratory process times Sample result Time to contact isolation Other potential causes of diarrhea N=1 Time of first stool to sample sent to the laboratory 57 h 30 m 1h 45m Negative N/A N=2 7 h 26 m 1h 42m Positive N=3 N=4 N=5 N=6 N=7 47h 15m 32h 9m 3m 74h 58m 56h 29m 52m 57m 3h 3m 1h 17m 1h 10m Negative Negative Positive Negative Negative Placed in isolation prior to sample N/A N/A 44h 43m N/A N/A Antibiotics; Stool softeners None N=8 44h 18h 51m Positive N=9 Not documented prior to stool result 154h 154h 67h 25m 20h 50m 135h 26h 31m 2h 10m 21h 35m 1 h 27m Positive No isolation documented 4h 28m 1h 27m 5h 32m 1h 42m 23h 24m 2h 13m 1h 4m 1h 10m 9h 34m Negative Negative Negative Negative Positive Negative Negative Negative N/A N/A N/A N/A 138h 35m N/A N/A N/A 45m 3h 10m 1h 40m Negative Negative Negative N/A N/A N/A N=21 N=22 51h 9m 37h 13m Not documented prior to stool result 35h 45m 64h 1h 26m 44m Negative Negative N/A N/A N=23 N=24 N=25 N=26 N=27 12h 9h 24m 9h 24m 117h 17m 67h 44m 1h 21m 3h 24m 1h 35m 17h 56m 1h 14m Negative Negative Negative Negative Negative N/A N/A N/A N/A N/A N=10 N=11 N=12 N=13 N=14 N=15 N=16 N=17 N=18 N=19 N=20 Antibiotics Antibiotics Antibiotics None Antibiotics; stool softeners Ostomy Antibiotics Antibiotics Antibiotics Antibiotics None Antibiotics Antibiotics Antibiotics Antibiotics; Stool softeners Antibiotics Antibiotics Antibiotics Antibiotics Antibiotics; Stool softeners None Antibiotics None Antibiotics None MANAGING CLOSTRIDIUM DIFFICILE N=28 N=29 N=30 N=31 N=32 N=33 N=34 37h 40m 41h 36m 11m 12h 8m 20h 35m 44h 15m 48m 1h 31m 1h 18m 1h 6m 1h 53m 2h 6m 1h 19m 1h 51m 53 Negative Negative Negative Negative Negative Negative Positive N/A N/A N/A N/A N/A N/A None documented Antibiotics Stool softeners Antibiotics Antibiotics Antibiotics Antibiotics None MANAGING CLOSTRIDIUM DIFFICILE 54 Appendix I Prospective study results N N=1 N=2 N=3 N=4 N=5 N=6 N-7 N=8 N=9 N=10 N=11 N=12 Time of the first stool to sample sent to the laboratory Nothing documented till after sample result 6h 59m Laboratory process times Sample result Time to contact isolation Other potential causes of diarrhea 22h 58m Negative N/A Antibiotics 1h 56m Positive Antibiotics 6h 23 m 0 11 27m 15m 1h 30m Nothing documented till after sample result 4h 39m 0 23h 13m 6h 58m 1h 1m 1 h 3m 1h 1m 1h 11m 1h 5m 2h 26m Negative Negative Positive Negative Negative Negative Before sample was sent down N/A N/A 13h 23m N/A N/A N/A 1h 18m 2h 1m 1h 47m 1h 30m Negative Negative Positive Negative N/A N/A 31h 58m N/A Antibiotics Antibiotics None None Antibiotics Antibiotics None None None Antibiotics MANAGING CLOSTRIDIUM DIFFICILE 55 Abstract To Test or Not to Test… Know Your Diff ABSTRACT: PROJECT PURPOSE: The purpose of this project is to reduce the spread of clostridium difficile among inpatients by using an algorithm that emphasizes timelier testing of stool in patients at risk of having this infection. Increased recognition and rapid testing of patients showing symptoms of a clostridium difficile infection can decrease the risk of indirect transmission of spores by the nursing staff. Quick recognition and testing of patient's stool earlier in their stay will allow those that are found to have a clostridium difficile infection be placed in isolation sooner. Proper recognition, validation of clostridium difficile through testing and the isolating of those found to have the infection are all key factors in the fight to prevent the spread of these spores through indirect transmission. METHODS: An algorithm was developed to help guide the nursing staff to send a clostridium difficile sample to the laboratory by the third loose bowel movement. To evaluate the effectiveness of the developed algorithm, a retrospective and prospective study was done on 46 patient medical records before and after its implementation. Each of the patient charts analyzed for the study was identified through laboratory records. All Medical-Surgical patients who had a clostridium difficile test done between May to August 2016 and January to March 15th 2017 was included. Each of the medical records identified was analyzed for certain key pieces of information. The time that the nursing staff first documented a bowel movement or indicated that the patient was having loose stools was recorded. Other data obtained was the time the laboratory received the stool sample, when it was resulted, the sample result and the time the patient was placed in isolation. Averages in hours was calculated for stool initiation to when a sample was received by the laboratory, sample process times, and the time to contact precautions following a positive result. Lastly, the retrospective and prospective data that was obtained was then compared using the excel, t-test: two sample assuming unequal variances, program to determine if there was a significant difference between the two studies. Results: The t-test: two sample assuming unequal variances showed no significant difference in the data obtained regarding the laboratory process times or the time to contact precautions when comparing the retrospective and prospective data. However, the data analysis did show a significant difference in the average time between the beginning of stools to the obtaining of a stool sample following the implementation of the new algorithm. DISCUSSION: Findings showed a significant difference in the average time calculated from the initiation of stools to the obtaining of a sample looking for clostridium difficile.