4. Clostridioides difficilea Infection Authors: Elizabeth Schoyer, M.P.H., Kendall K. Hall, M.D., M.S., and Eleanor Fitall, M.P.H. Introduction Preventing Clostridioides difficile infection (CDI) in healthcare settings is an important U.S. public health priority and has led to new research, guidelines, and reporting requirements that have emerged since the last version of this report, Making Health Care Safer II (MCHS II). While many of the patient safety practices (PSPs) that help prevent a range of healthcare-associated infections (HAIs) also help to prevent the transmission of CDI (e.g., contact precautions), several CDI-specific practices address the unique risk factors, pathology, and transmission of CDI. After discussions with the Agency for Healthcare Research and Quality (AHRQ) and the Technical Expert Panel, as well as an indepth review of published guidelines and PSP research, the following CDI-specific PSPs were selected for review in the CDI chapter of this report: • Antimicrobial Stewardship • Hand Hygiene • Environmental Cleaning • Surveillance • Testing We retrieved and screened studies that evaluated these PSPs and were published in English from 2008 onward. Many studies were quasi-experimental with a pre-post design, and most were in hospital settings (although some research was in long-term care facilities [LTCFs]). The search revealed multiple studies that evaluated outcomes following combined implementation of more than one enhanced prevention strategy. After reviewing the results of our search for the five above PSPs, we decided to include a section on: • Multicomponent CDI prevention Interventions. Multicomponent studies show outcomes associated with different combinations of CDI PSPs. They also offer insight into implementation methods, as well as challenges and facilitators of CDI prevention interventions. Other CDI PSPs such as contact precautions and patient isolation continue to be recommended by experts1 and were addressed briefly in the last MHCS report. Communication and staff education were also identified in the CDI PSP guidelines and are often important components of the reviewed PSPs (e.g., clinician education about revised antimicrobial prescribing guidelines and communication of CDI status aDuring the writing of this report, the Clinical and Laboratory Standards Institute (CLSI) and the CDC transitioned from use of the name Clostridium difficile to Clostridioides difficile. For the purposes of this report, the names are synonymous. Clostridioides difficile Infection 4-1 after testing). Since these are cross-cutting practices and little research focused on these practices and this harm area specifically, they are discussed separately in the cross-cutting chapter of the report. Background C. difficile is a contagious bacterium that can cause diarrhea, fever, colitis (an inflammation of the colon), toxic megacolon (a dilated colon that may be accompanied by septic shock), and, in some cases, death. The C. difficile bacterium colonizes in the large intestine. In infected patients, toxins produced by the organism cause CDI symptoms, primarily diarrhea and colitis. The most common risk factors for CDI are antimicrobial use, advanced age, hospitalization, and a weakened immune system. C. difficile is transmitted through the fecal-oral route and acquisition is most frequently attributed to the healthcare setting.2,3 Complications are common in patients age 65 and older and an estimated 1 in 11 patients 65 and older with healthcare-associated CDI dies within 30 days of CDI diagnosis.4 Patients with a healthy immune response to the organism can be carriers of C. difficile (and contagious) but asymptomatic. These patients are considered “colonized” and are at higher risk of developing CDI.5 Research on CDI prevention practices has evolved and expanded over the last decade. Therefore, to address C. difficile prevention, this report dedicates an entire chapter to CDI PSPs; in the last report, much of the information on HAI PSPs was grouped together, in a more “horizontal” approach to prevention. In addition, the previous report noted the emergence of hypervirulent C. difficile strains and briefly discussed research on CDI risk prediction tools. That report noted that CDI PSPs with good supporting evidence were wearing gloves and antimicrobial stewardship. Alternatively, the current review found strong evidence that supports not just contact precautions and antimicrobial stewardship, but also environmental cleaning practices, surveillance, and testing as effective PSPs for preventing CDI. The research reviewed in this report reflects not only new knowledge, but also new technologies and policies now in widespread use. For example, electronic health records (EHRs) are now commonly used and are valuable for antimicrobial stewardship efforts and CDI surveillance. Research on no-touch decontamination technology has grown in the last 10 years, as has understanding of CDI transmission pathways. Testing methods have also evolved, with Food and Drug Administration (FDA) approval of nucleic acid amplification tests (NAATs) in 2009. There are increased mandates for surveillance of CDI and the standard interim CDI case definitions that the CDC published in 2007 have been revised in recent years.1,6 Facilities have implemented new automated surveillance systems, and CDI data collection at the national level is now standardized, with the advent of the National Healthcare Safety Network’s (NHSN’s) LabID Event reporting in 2013. Importance of Harm Area CDI is among the most common HAIs, representing roughly 12 percent of all HAIs.7 According to a recent estimate, approximately half a million incident clinical infections occur (with more than 100,000 in U.S. nursing homes) per year in the United States, with around 30,000 deaths per year as a result of the pathogen.3,4 The financial cost of CDI is also high; in recent years, CDI has resulted in about $5 billion a year in healthcare costs.8,9 Costs attributable to primary and recurrent CDI are $24,205 and $10,580 per case, respectively.10 CDI colonization is also a concern, and two U.S. studies found that around 10 percent of admitted hospital patients were colonized with C. difficile.11,12 Clostridioides difficile Infection 4-2 CDI incidence nearly tripled in the first decade of the 21st century,13 and data from 2010 to 2016 showed CDI rates plateauing. However, after falling short of 2013 reduction goals, the Department of Health and Human Services set a target reduction of 30 percent in hospital-onset CDI from 2015 to 2020.14 Healthcare-associated CDI has been decreasing slightly, while community-associated (CA) CDI is stable or increasing slightly; according to CDC estimates, in 2015, almost half of CDI cases were CA.15 The clinical severity of the infection has also evolved since the last report. Increasingly virulent strains were a concern roughly 10 years ago.1 However, a 10-year study of a sample of inpatient data found CDI-related mortality rates declined from 2005 to 2014.16 Other CDI incidence outcomes, including rates of recurrent CDI, have increased.17 It is notable that healthcare-associated CDI incidence trends differ based on setting, with a greater decline seen in nursing homes versus hospitals and other healthcare facilities.18 Reimbursement policies have increasingly mandated and reinforced the reduction of CDI. CDI LabID Event reporting began in January 2013 for all acute care hospitals facilitywide using the NHSN. The Centers for Medicare & Medicaid Services (CMS) Inpatient Quality Reporting program’s CDI reporting requirements became mandatory as of January 1, 2013. Since 2017, CDI rates are among the hospital- acquired complications CMS uses to penalize the lowest performing hospitals. Many States also now mandate CDI data submission by hospitals to NHSN as part of State HAI public reporting programs.19 In the future, participation in surveillance reporting will increase and include a broader spectrum of settings. For example, data from a larger group of LTCFs will be used to establish national benchmarks and track achievement of prevention goals.20 PSP Selection To identify the PSPs for inclusion in this report, we started by reviewing the consensus guidelines for CDI prevention published by government agencies and reputable organizations. From this review, we developed an initial list that was reviewed by AHRQ and the Technical Expert Panel. The focus of this review was to identify practices that combat a prevalent harm in the U.S. healthcare system or a harm that has a high impact (e.g., high mortality). After this review and a narrowing of practices, we conducted a literature search in two databases (CINAHL and MEDLINE) and reviewed resulting abstracts for relevance. As noted, some CDI PSPs (e.g., staff training) spanned multiple harm areas, so they were moved to cross-cutting chapters (and some CDI PSP searches yielded too few articles to warrant a review [e.g., communication, contact precautions]). Five PSPs had sufficient research in the last 10 years to conduct a review. While screening articles, we found several studies of interventions that included more than one CDI PSP (i.e., multicomponent prevention interventions). Due to the number of studies on multicomponent interventions that included patient outcomes, we decided to include an addendum on this topic. Clostridioides difficile Infection 4-3 References for Introduction 1. McDonald LC, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):e1-e48. doi: 10.1093/cid/cix1085. 2. Mada PK, Alam MU. Clostridium difficile. Statpearls [internet]: StatPearls Publishing; 2019. 3. Lessa FC, Winston LG, McDonald LC. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015;372(24):2369-70. doi: 10.1056/NEJMc1505190. 4. Centers for Disease Control and Prevention. Nearly half a million Americans suffered from Clostridium difficile infections in a single year. https://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html.