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Cheri Lattimer RN, BSN Executive Director National Transitions of Care Coalition Washington, DC Sahil Khanna, MBBS Associate Professor of Medicine Gastroenterology and Hepatology Mayo Clinic Rochester, MN Nancy C Caralla Founder and Executive Director C Diff Foundation New Port Richey, FL James E Lett, II, MD, CMD Family Medicine Physician Medical Director Avar Consulting Rockville, MD Director of the National Board National Transitions of Care Coalition Washington, DC Kevin W Garey, PharmD Professor and Chair Department of Pharmacy Practice and Translational Research University of Houston Houston, TX This activity is provided by PRIME Education. There is no fee to participate. This activity is supported by an educational grant from Merck & Co. Inc. Interprofessional Steering Committee

PRIME Education - Interprofessional Steering Committee CDiff Pathways... · 2019-11-20 · Avar Consulting Rockville, MD Director of the National Board National Transitions of Care

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Cheri Lattimer RN, BSNExecutive DirectorNational Transitions of Care CoalitionWashington, DC

Sahil Khanna, MBBSAssociate Professor of MedicineGastroenterology and HepatologyMayo ClinicRochester, MN

Nancy C CarallaFounder and Executive DirectorC Diff FoundationNew Port Richey, FL

James E Lett, II, MD, CMDFamily Medicine PhysicianMedical DirectorAvar ConsultingRockville, MDDirector of the National BoardNational Transitions of Care CoalitionWashington, DC

Kevin W Garey, PharmDProfessor and Chair Department of Pharmacy Practice and Translational ResearchUniversity of HoustonHouston, TX

This activity is provided by PRIME Education. There is no fee to participate. This activity is supported by an educational grant from Merck & Co. Inc.

Interprofessional Steering Committee

© 2019 PRIME Education, LLC. All Rights Reserved. www.primeinc.org

Table of Contents

INTRODUCTION....................................................................................................................................................................................

PURPOSE AND SCOPE........................................................................................................................................................

GUIDING PRINCIPLES IN TRANSITIONS OF CARE.........................................................................................................................

THE BURDEN OF CDI ON PATIENTS, HEALTH CARE PROFESSIONALS, AND HEALTHCARE FACILITIES...................................

What is Clostridioides difficile?................................................................................................................................................

How Does CDI Impact Patients’ Lives?.............................................................................................................. ........

What CDI Epidemiology Trends Should Health care Professionals Be Aware Of?...............................................................

What is the Impact of CDI on Healthcare Facilities?..............................................................................................................

GUIDELINE-RECOMMENDED CDI DIAGNOSIS, TREATMENT, AND MANAGEMENT...................................................................

What are the Risk Factors for CDI?.........................................................................................................................................

How can we Prevent CDI in Healthcare and Community Settings?......................................................................................

How is CDI Diagnosed?...........................................................................................................................................................

Point-of-Care Algorithm for CDI Testing.............................................................................................................

How Would You Manage Primary CDI?..................................................................................................................................

How Would You Manage Recurrent CDI?...............................................................................................................................

Point-of-Care Algorithm for CDI Treatment........................................................................................................

CONSIDERATIONS IN TRANSITIONS OF CARE...............................................................................................................................

BARRIERS TO EFFECTIVE CARE TRANSITIONS IN CDI.................................................................................................................

System-Level Barriers..............................................................................................................................................................

Clinician-Level Barriers............................................................................................................................................................

Patient-Level Barriers...............................................................................................................................................................

STRATEGIES FOR OPTIMIZING CDI CARE TRANSITION PATHWAYS...........................................................................................

Identify the Transition Team.....................................................................................................................................................

Empower Patients....................................................................................................................................................................

Point-of-Care Resource for Patient Education..................................................................................................

Create Discharge Management and Protocols......................................................................................................................

Point-of-Care Checklist for Transitions of Care Assessment and Coordination..........................................

REFERENCES........................................................................................................................................................................................

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INTRODUCTIONPURPOSE AND SCOPE

The purpose of this transitions of care (TOC) guide is to describe pathways that enable patients with Clostridioides difficile infection (CDI) and health care professionals managing such patients to coordinate care across multidisciplinary health care settings. The guide—developed by an expert interprofessional steering committee that includes a primary care provider, a gastroenterologist, a pharmacist, a case manager/nurse navigator, and a CDI patient representative—provides strategies, tools, and resources to support the implementation of collaborative team-based approaches for CDI management.

Health care providers, patients, and caregivers can use this guide to learn about strategies that can be applied by the interprofessional team to prevent primary CDI, reduce of the risk of recurrences, and mitigate hospital readmissions following CDI treatment.

GUIDING PRINCIPLES IN TRANSITIONS OF CAREThe National Transitions of Care Coalition (NTOCC) developed Seven Essential Intervention Categories (Figure 1) that align with key transitions of care policies crafted by national health care organizations, including the American College of Physicians, the Society of General Internal Medicine, the Society of Hospital Medicine, the American Geriatrics Society, the American College of Emergency Physicians, and the Society of Academic Emergency Medicine.1

TransitionPlanning

Specialist

Home Health Palliative

CareSub-Acute

RehabAcute

Hospitalization

Post-Acute/Long-Term Care Facility

Diagnostic& Treatment Center

OutpatientTherapies

Hospice

CommunityAgencies

Case/Disease Management

Primary Care

Shared Accountability Across Providers &

Organizations

Assessment – including social determinants of health – conducted by a social worker or case manager;

Develop an educational plan, and share with the care team

Collaborative assessment and medication plan completed by a physician, pharmacist, advance

practice nurse, physician assistant, nurse, social worker,

or case manager

Collaborative team careplanning and implementing

patient shared decision-making; Use patient assessment, including

social determinants of health

Bidirectional communication (provider to provider) at the next level

of care; Provide communication to patient and family caregiver(s)

Ensuring timely access to medica-tions and key health care providers, and communicating importance to

patients and their family caregiver(s)

Information sharing between the collaborative care teams: physician,

pharmacist, advanced practice nurse, physician assistant, nurse, social

worker, case manager, allied health professional, community health workers, community agencies

Ensuring that a health care provider is responsible for the care of the patient at all times,

with clear and timely communica-tion of the patient’s plan of care

Continuum of Care Health Health

Health Care Provider Engagement

Follow-UpCare

InformationTransfer

MedicationManagement

Patient and Family Engagement/

Education

Figure 1. Seven Essential Intervention Categories for Designing Transitions Strategies for CDI Patients

Find further information about these principles at http://www.ntocc.org/Toolbox/ Adapted from NTOCC. Figure Courtesy of Cheri Lattimer, RN, BSN

This document contains point-of-care resources that can be printed separately for use in daily practice

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THE BURDEN OF CDI ON PATIENTS, HEALTH CARE PROFESSIONALS, AND HEALTH CARE FACILITIES

CASE STUDY: A 29-year-old man presents with diarrhea for 3 days. He was prescribed prophylactic clindamycin for 5 days following dental surgery. His stool test is positive for C. difficile.

WHAT IS CLOSTRIDIOIDES DIFFICILE?

C. difficile infection (CDI) is the most common health care-acquired infection.2

• C. difficile is an anaerobic, gram-positive bacillus that forms heat-, acid-, and antibiotic-resistant spores, and colonizes the intestinal tract via the fecal-oral route3

• CDI can cause diarrhea, colitis, toxic megacolon, and death, depending on the virulence of the bacillus strain, host comorbidities, and the host immune response3

HOW DOES CDI IMPACT PATIENTS’ LIVES?

Studies report decreased functional capacity and considerable anxiety about physical symptoms among people with CDI, many of whom have multiple comorbidities.4–6 People with CDI also experience worsened quality of life, restricted daily activities, reduced work productivity, and increased personal cost burden (e.g., through medication costs).4–6 Such consequences can lead to chain reactions that affect the patient’s social life, work relationships, and income, and are intensified in the presence of recurrences.

WHAT CDI EPIDEMIOLOGY TRENDS SHOULD HEALTH CARE PROFESSIONALS BE AWARE OF?

According to the Centers for Disease Control and Prevention (CDC), approximately half a million individuals in the US were diagnosed with CDI in 2011.7 CDI has also increased considerably in the last two decades in community settings, such as long-term or residential care facilities, as well as in patient populations without prior antibiotic exposure.8–12

• Approximately two thirds of people with CDI had health care-associated infection

• One third had community-associated infection; about 18% of these people had no contact with medical care

• Health care-associated CDI has more severe outcomes than community-associated infection, including higher recurrence rates (20.9% vs 13.5%) and higher mortality (9.3% vs 1.3%).7 Community-acquired CDI may be severe and associated with need for hospitalization11

The CDC defines hospital-acquired CDI as symptom onset more than 48 hours after hospital admission.13 Community-acquired CDI is defined as symptom onset within the community or ≤48 hours after admission to a health care facility, provided that symptom onset was more than 12 hours after the last discharge from a health care facility.

Defining Hospital- and Community-Acquired CDI

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WHAT IS THE IMPACT OF CDI ON HEALTH CARE FACILITIES?

The number of hospitalizations for CDI increased by 339% between 2000 and 2014.14–15 Hospitalization for CDI is associated with the following:

• Increased length of hospital stay16

• Approximately $6.3 billion in annual health care costs in acute-care facilities17

• Higher likelihood of discharge to another health care facility versus home, such as hospice, nursing home, home health care, skilled nursing facility, or long-term care facility18

• Poor long-term patient outcomes, reduced quality of life, and increased risk for irritable bowel syndrome18,7

• Higher risk for readmission (~30% of patients discharged from a hospital are readmitted)

• Financial penalties for health care faciltities:19 the Centers for Medicare and Medicaid Services (CMS) penalizes hospitals with excess readmissions rates and a high rate of complications after admission, including for CDI, by decreasing reimbursement for inpatient Medicare or by withholding payment associated with Inpatient Prospective Payment System programs20

The CDC has identified CDI as an urgent health threat and publicly reports laboratory-identified C. difficile as a patient safety metric.21 In addition, the CMS, the CDC, and the National Quality Forum have established the CDI score as a quality measure that compares hospital-acquired CDI rates with a national benchmark (shown as a Standardized Infection Ratio).22

CDI Performance and Quality Measures:

GUIDELINE-RECOMMENDED CDI DIAGNOSIS, TREATMENT, AND MANAGEMENT

CASE STUDY (Cont’d): The patient described above is an emergency room resident physician at a public hospital. He wants to find out how he acquired CDI.

WHAT ARE THE RISK FACTORS FOR CDI?

C. difficile spores have a lengthy survival time (~5 months), and surveillance studies have identified toxigenic C. difficile in a range of community environments, including homes, parks, stores, animals, and fast food restaurants.8 Table 1 describes risk factors for CDI in both health care and community settings.

Table 1. Risk Factors for CDI

Health Care-Associated CDI23,24 Community-Associated CDI25,11

Antibiotic use (ampicillin, carbapenems, cephalosporins, clindamycin, and fluoroquinolones are frequently associated with CDI)

Increasing outpatient prescriptions for antibiotics

Prolonged and/or previous hospitalization Presence of multiple comorbidities

Advanced age (≥65 years) Younger age (<65 years)

Abdominal surgery Exposure to asymptomatic carriers of C. difficile

Underlying disease (e.g., malignancy, renal failure, inflammatory bowel disease)

Exposure to C. difficile in outpatient settings (e.g., physician offices and emergency departments)

Proton pump inhibitors and H2 blocker therapy Proton pump inhibitors and H2 blocker therapy

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HOW CAN WE PREVENT CDI IN HEALTH CARE AND COMMUNITY SETTINGS?

Antibiotic Stewardship

Antibiotic or antimicrobial stewardship is an important strategy to reduce inappropriate antimicrobial use and lower the chance of primary infection with C. difficile in hospitals. The goals of such stewardship include selecting the optimal dose, duration, and administration route of therapy to ensure the best clinical outcome for treating or preventing infection while maintaining minimal toxicity and impact on resistance.26 Antibiotic stewardship has been shown to reduce CDI, improve patient safety, and optimize resource utilization across the continuum of care. Antibiotic stewardship interventions include auditing, using guideline-recommended empirical therapy, restricting specific antibiotics, limiting treatment duration, de-escalating, cycling or mixing antibiotics, and switching from intravenous (IV) to oral therapy.27

While a physician-pharmacist team might not be available on-site at nursing and skilled nursing facilities, providers can consider other approaches that support the review and optimization of antibiotics, such as telemedicine consults with infectious disease experts.26

After administration of broad-spectrum antibiotics, it is imperative to restore the patient’s healthy gut organisms (microbiome). There are several ways to restore a healthy gut, including dietary strategies, prebiotics, or probiotics (Table 2).

Table 2. Risk Factors for CDI

Category Types

Healthy diet (e.g., Mediterranean diet)28

Fruits, vegetables, non-absorbable fiber, monounsaturated fatty acids, polyunsaturated fatty acids

Prebiotics29* Prebiotics containing oligofructose have been shown to have favorable effects on the microbiome to prevent recurrent CDI

Prebiotics29** Probiotics found to have beneficial restorative effects on the gut microbiome include Lactobacillus, Bifidobacterium, and other species.

Infection Control

C. difficile spores can be transmitted by health care providers and other workers (e.g., via poor hand hygiene), surfaces, and technologies.31 Strategies for preventing primary and recurrent CDI in health care settings include:

• Identifying risk factors for infection

• Establishing effective infection control measures: » Using soap dispensers instead of alcohol dispensers » Educating clinicians about effective handwashing technique » Implementing barrier nursing techniques when caring for patients with CDI

(e.g., wearing gloves and gowns) » Environmental disinfection27

Although there is currently insufficient evidence to recommend prebiotics or probiotics as a primary CDI prevention strategy, an increasing body of research points to the importance of probiotics in maintaining the gut microbiome and intestinal health. Fermented dairy products and other foods provide a rich source of probiotics that may increase bacterial diversity (e.g., Bifidobacteria and Lactobacilli) in the intestine. Studies suggest that probiotics could be effective in preventing CDI when given to patients treated with antibiotics with no history of CDI.30

Role of Probiotics for CDI Prevention

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Figure 2. Core Strategies for Preventing CDI in Health Care Facilities32

CASE STUDY (Cont’d): The patient was sent for laboratory assessment: hemoglobin 14.6 g/dL; white blood cell count (WBC) 6,200 x 106/L; creatinine 0.9 mg/dL; electrolytes normal.How was this patient diagnosed with CDI? Are there any additional tests required for CDI diagnosis or treatment selection?

HOW IS CDI DIAGNOSED?

The 2017 update to the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America (IDSA/SHEA) guidelines recommends that patients with at least three or more unexplained loose or unformed stools (grade 6–7 of the Bristol stool chart33) in 24 consecutive hours should be tested for CDI. 25,30

Testing is especially pertinent in patients with relevant risk factors, such as antibiotic exposure; therefore, detailed history-taking is of paramount importance (Figure 3). The nucleic acid amplification test (NAAT) can be used alone to test for CDI in patients with clinically significant diarrhea or as part of a two-step testing algorithm that includes enzyme immunoassay (EIA) screening for the glutamate dehydrogenase (GDH) antigen, followed by EIA for toxins A and B.30 Only one stool sample is required for diagnosis.

Confirm CDI via guideline-

recommended assessment and

diagnostic testing

Implement the core elements of hospital

antibiotic stewardship programs

Initiate contact precautions for suspected or

confirmed CDI

Create environmental cleaning protocols with a C.difficile sporicidal agent for patient-care areas and equipment

Educate healthcare personnel on CDI

prevention practices, audit adherence to

evidence-based hand hygiene measures, and monitor facility

CDI rates

Providers can share the Bristol Stool Chart (Figure 3A) with their patients to help them identify whether or not they have true diarrhea.

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Think twice before testing for low pre-test probability

High pre-testprobability

for CDI

• Risk Factors• Unexplained diarrhea

• ≥ 3 watery stools a day• Not on laxatives

Nucleic acid-based test, such as PCR for tcdA

or tcdB

A stool toxin testobtained as part of a multi-step testing

strategy

Low to intermediate pre-test probability

for CDI

• Questionablerisk factors

• Multiple causesof diarrhea

Patient with suspected CDI

GDH by EIA

GDH – positive

EIA – positive

Manage as CDI

PCR – positive& symptoms

PCR – negative

EIA – negative

PCR

EIA for tcdA/tcdB Rule out CDI

GDH – negative

Point-of-Care Algorithm for CDI TestingPrintable Resource for Use in Daily Practice

GDH = Glutamate Dehydrogenase; EIA = Enzyme Immunoassay; PCR = Polymerase Chain Reaction

Adapted from the 2017 IDSA/SHEA Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children.Figure Courtesy of Sahil Khanna, MBBS.

tcdA = C. difficile toxin A; tcdB = C. difficile toxin B

Adapted from the 2017 IDSA/SHEA Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children. Figure Courtesy of Sahil Khanna, MBBS.

Adapted from the 2017 IDSA/SHEA Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children.

Figure 3B. Probability TestingFigure 3A. Bristol Stool Chart

Figure 3C. Multi-Step Diagnostic Testing for Suspected CDI

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Type 1Separate hard lumps,like nuts (hard to pass)

Type 2Sausage-shaped but lumpy

Type 3Like a sausage but withcracks on its surface

Type 4Like a sausage or snake,smooth and soft

Type 5Soft blobs with clear-cutedges (passed-easily)

Type 6Fluffy pieces with raggededges, a mushy stool

Type 7Watery, no solid pieces.Entirely Liquid

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HOW WOULD YOU MANAGE PRIMARY CDI?

Management of Primary CDI

The first step in treatment for primary CDI is to discontinue the antibiotics with which the patient is currently being treated (if possible), and to initiate treatment with antibiotics that have a demonstrated benefit in treating CDI. The choice of therapy depends on CDI severity (Figure 4). 36,30

• Identifying risk factors for infection

• Establishing effective infection control measures: » Using soap dispensers instead of alcohol dispensers

» Educating clinicians about effective handwashing technique

» Implementing barrier nursing techniques when caring for patients with CDI (e.g., wearing gloves and gowns)

» Environmental disinfection27

Metronidazole has been shown globally to be inferior to vancomycin37 and is associated with a high rate of 30-day mortality.38 Data show similar efficacy for vancomycin and fidaxomicin, although the risk of recurrence is lower with fidaxomicin, which also preserves the intestinal microbiome during and after CDI treatment.39,40 Real-world evidence also suggests that use of fidaxomicin may reduce health care costs by reducing recurrence and mortality rates.41 Recent clinical trial data have shown that an oral, extended-pulsed fidaxomicin regimen (200 mg twice daily on days 1–5, then once daily on alternate date, days 7–25) is superior to vancomycin in achieving sustained clinical cure (70% vs 59%).42

*PO = Administered Orally; **PR = Administered Rectally; ***IV = Intravenous.

• Testing asymptomatic patients is unwarranted and can lead to over-diagnosis and unnecessary antibiotic treatment.21

• Delayed testing in symptomatic patients can lead to under-diagnosis of CDI

• The EIA has a lower sensitivity threshold, and using this test alone can also lead to under-diagnosis of CDI21,34

Diagnostic stewardship can limit inappropriate test ordering and support accurate interpretation of results. Strategies to support diagnostic stewardship include:35

• Campaigns to educate clinicians about appropriate test ordering

• Including best practice alerts in electronic medical records (EMRs) that enable clinicians to avoid testing in certain patients (e.g., patients who have had a recent laxative)

• Providing clinical decision support

• Implementing institutionally-agreed cascade or reflex testing policies21

• Initial episode, non-severe: » Vancomycin 125 mg 4 times per day (QID) for 10 days, OR

» Fidaxomicin 200 mg twice a day (BID) for 10 days

» If above agents are not available: PO* metronidazole 500 mg 3 times a day (TID) for 10 days

• Initial episode, fulminant:

» PO or PR** vancomycin 500 mg QID in combination with IV*** metronidazole 500 mg TID

Several Gaps Persist in CDI Diagnostic Testing

2017 IDSA/SHEA Guideline Recommendations for Treatment of Primary CDI30

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CASE STUDY (Cont’d): The patient was treated with vancomycin 125 mg QID for 10 days. His diarrhea resolved on day 5. He returns to see you in 2 weeks, after 10 days of treatment, complaining of loose stools. A detailed history reveals both day- and night-time watery stools. His stool test is positive for CDI.

The patient is subsequently treated with fidaxomicin for 10 days. At follow-up, he felt better, but his symptoms returned 2 weeks later with a stool test positive for CDI. This is his third episode of CDI.

What should be the next steps in managing this patient?

HOW WOULD YOU MANAGE RECURRENT CDI?

Definition

CDI recurrence is defined by the re-appearance of CDI symptoms in patients within 8 weeks of stopping treatment.30,43 Treatment goals for recurrent CDI aim to reduce initial recurrence in patients with primary CDI and to treat therapy-resistant patients with multiple episodes of CDI recurrence.44 On average, approximately 20–25% of people with CDI experience a recurrence within 30 days of completing treatment.45,46 The risk for subsequent recurrence after an initial recurrent CDI episode is estimated to increase by 35–65%.47,48

• Increasing age

• Decreased serum anti-toxin A immunoglobulin G (available in research settings)

• Medications (antibiotics and proton pump inhibitors)

• Presence of comorbidities » Inflammatory bowel disease

» Immunosuppression, malignancy, and chemotherapy

• Prolonged length of hospital stay

» Long-term care facility residence

• Contact with active carriers/people who are actively infected

• Prior C. difficile infection

• Prescribe antibiotics only if needed, use narrow spectrum drugs, and only prescribe for the shortest recommended duration

• Refer patients with 2nd CDI recurrence to an infection disease or gastroenterology specialist

• Establish facility-wide protocols for managing recurrence

• Treatment with fidaxomicin instead of vancomycin is associated with lower recurrence rates

• Consider treatment with bezlotoxumab for patients at high risk for recurrence

Risk Factors for Recurrent CDI3,49,50

Provider Strategies for Preventing CDI

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Definition

Figure 4 delineates a treatment algorithm for recurrent CDI.

• First recurrence: » Vancomycin 125 mg QID for 10 days, if metronidazole was used for initial episode

» Tapered or pulsed vancomycin or fidaxomicin 200 mg BID for 10 days, if vancomycin was used for initial episode

• Second or subsequent recurrence: » Tapered and pulsed vancomycin, OR

» Fidaxomicin 200 mg BID for 10 days, OR

» Vancomycin 125 mg QID or fidaxomicin 200 mg BID for 10 days followed by fecal microbiota transplantation (FMT), OR

» Vancomycin 125 mg QID for 10 days PO, followed by rifaximin 400 mg TID for 20 days

Patients who experience ≥3 episodes of CDI should be maintained on antibiotics and referred to an infectious disease or gastrointestinal specialist for FMT or clinical trial eligibility assessment.

2017 IDSA/SHEA Guideline Recommendations for Treatment of Recurrent CDI*

Managing Multiple CDI Recurrences

*Current guidelines were published before bezlotoxumab was approved.

Bezlotoxumab. Bezlotoxumab was approved in 2016 for secondary prevention in patients at high risk for recurrence.51 Bezlotoxumab is a monoclonal antibody that binds and neutralizes C. difficile toxin B while preserving the protective gut microbiome. Two clinical trials involving 2,500 patients found significantly lower rates of recurrent infection in patients treated with bezlotoxumab and standard oral antibiotic therapy than in those treated with standard oral antibiotic therapy alone.52 The recurrent infection rate in one trial was 17% vs 28% (P <0.001) in favor of bezlotoxumab and 16% vs 26% (P <0.001) in the other.

Fecal Microbiota Transplantation. FMT is considered an investigational option for patients who experience multiple episodes of recurrent CDI that do not resolve with antimicrobial therapy. This approach introduces processed donor stool and has been evaluated in randomized and open-label trials, which have reported cure rates ranging from 70–90% and durable alteration of intestinal microbiota.53,54

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Stool test positive for CDI

Non-fulminant CDI

Symptoms resolve

Recurrentdiarrhea

Stool test – positive

Stool test – negative Non-fulminant CDI

- PO vancomycin or fidaxomicin - Metronidazole: alternative in non-severe CDI- Consider bezlotoxumab in patients at high-risk for recurrence

Evaluate for other causes; manage as post-infectious functional disorder, functional diarrheaor irritable bowel syndrome

- PO vancomycin, if metronidazole was used initially- Vancomycin taper or fidaxomicin, if vancomycin was used initially- Rifaximin chaser, vancomycin taper, and FMT are options for multiple recurrences

- PO and PR vancomycin* plus IV metronidazole- Surgery consult recurrence

Fulminant CDI

Point-of-Care Algorithm for CDI TreatmentPrintable Resource for Use in Daily Practice

*If there is evidence of significant ileus.Adapted from the 2017 IDSA/SHEA Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children.Figure Courtesy of Sahil Khanna, MBBS.

Figure 4. CDI Treatment Algorithm

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CONSIDERATIONS IN TRANSITIONS OF CAREBARRIERS TO EFFECTIVE CARE TRANSITIONS IN CDI

Many patients with CDI not only have several comorbidities, but also require care across multiple settings (e.g., sub-acute care facilities, long-term care facilities, primary care, home health). In order to ensure that patients are equipped with knowledge that will enable them to engage in self-care, recognize CDI symptoms should they recur, and continue to receive appropriate treatment with CDI-specific therapies following discharge, it is important to carefully plan the transition to and from hospitals and to coordinate care between patients, caregivers, and members of the clinical team.

Effectively implemented transitions of care processes can reduce the risk for recurrence, hospital readmission, emergency room visits, and complications.55 However, there exist several system-, clinician-, and patient-level barriers to the implementation of effective transitions of care in CDI.

SYSTEM-LEVEL BARRIERS

Lack of Established or Suboptimal Transition Processes

Many health care systems lack comprehensive transition services to support a seamless discharge process from acute to post-acute settings and are focused on rapid versus customized discharge. As a result, patients with CDI may be prematurely discharged without the benefit of a transition plan. Ideally, prior to and at discharge, clinicians would have some designated time to provide verbal patient and caregiver education about hygiene practices, medication management, and symptom recognition that is supported by printed material. However, health care professionals report often feeling rushed at discharge, with little time to educate patients or design a transition plan.20 The expansion of performance measures and other system-level demands reduce the time available to health care providers to effectively plan for transitions.

Inadequate Information Transfer

Gaps in care can emerge when insufficient information is provided from one care setting to the other. Although EMR systems potentially provide a resource to support information-sharing and communication among members of the clinical team, interoperability between systems is not common, and not all EMR platforms support access to CDI discharge information. In addition, if patient discharge education materials on CDI are available in the EMR, they are often in formats that are inaccessible for patients with low literacy.

Suboptimal Medication Management

Suboptimal medication management and education at discharge can pose additional barriers to care transitions. If medications are not reconciled at discharge, clinicians at post-acute facilities may be unaware of patient medications, which can lead to medication errors, adverse events, and rehospitalizations. Additionally, medication cost and formulary issues can create gaps in care. For instance, some skilled nursing facilities are unwilling to accept patients whose medication costs are not fully covered by Medicare plans or avoid working with certain types of Medicare plans.56

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CLINICIAN-LEVEL BARRIERS

Lack of Familiarity with CDI

Many providers are unfamiliar with CDI epidemiology, prevention strategies for primary and recurrent infection, and the implications of health care-acquired CDI for readmissions. Accordingly, they are poorly equipped to provide patient education about primary prevention of CDI and strategies for preventing recurrence in patient-friendly language or formats.

Lack of Familiarity with Transition Roles and Responsibilities

In addition, clinicians in both hospital and post-acute settings may be unfamiliar with their own and others’ roles and responsibilities in the transition process, leading to communication breakdown between different providers. In the event of CDI recurrence following discharge, lack of clarity concerning transition responsibilities can also contribute to blame attribution about whether CDI was acquired in a health care facility or community setting, further fueling communication breakdown and preventing effective transition of care.

Suboptimal Information Transfer

Discharge from hospital settings can also be accompanied by delays in sharing discharge information with community providers. For instance, hospital-based providers may not be familiar with the range of services available for providing home health support or can be reluctant to create a transition plan for outside sites of care over which they have no control. In turn, community providers may be unfamiliar with managing patients who have been or are being treated for CDI. In some cases, patients may be discharged without any information being transferred from the hospital to the post-acute setting, or they may be discharged with instructions from multiple in-hospital providers.

PATIENT-LEVEL BARRIERS

Socioeconomic Factors

Level of income and education, employment status, and access to clean water, food, and housing are all factors that influence health outcomes. Patients with unmet non-medical needs (e.g., food insecurity, low health literacy, lack of transportation) are more likely to be emergency room users or to repeatedly miss medical appointments than patients who do not experience these social determinants of health.

Information Recall

Patients and their caregivers are often unable to recall discharge information or self-care instructions and may be ill-prepared to continue ongoing medication management in the home setting.57 While low health literacy poses a barrier to patient understanding of discharge information, many patients simply do not receive information about self-care or medication management. Some patients might not even be aware of their reason for hospitalization, or be aware that their condition warrants specialist follow-up following discharge.57 Caregivers and community providers are often excluded from the transition planning process, which makes it difficult for them to reinforce any patient education provided at discharge.

Medication Cost

Medication cost is an additional barrier to effective transition, and paying for medications is a primary challenge for patients, whether they are transitioning to their own home or another health care facility. If medication costs are not covered, community- or post-acute facility providers are likely to prescribe less expensive, inappropriate antibiotics and increase the risk of recurrence. These factors, together with ongoing comorbidities and likely polypharmacy, can lead to lower adherence of medications for managing CDI.

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There are many resources that you can direct your patients toward to assist with medication access and lowering medication cost/copays.

• C Diff Foundation: https://cdifffoundation.org/

• Medicare Pharmaceutical Assistance Program: https://www.medicare.gov/pharmaceutical-assistance-program/

• GoodRx: https://www.goodrx.com/

• Pharmaceutical industry-sponsored patient assistance programs

STRATEGIES FOR OPTIMIZING CDI CARE TRANSITION PATHWAYSSafe transitions of patients from hospital to home or another care facility require the successful completion of several tasks, including patient education about key elements of self-care and medication management, medication reconciliation, specialist referral if warranted, comprehensive transition planning documentation, and communication with staff at post-acute health care facilities.

IDENTIFY THE TRANSITION TEAM

• Identify the range of health care providers that need to be involved in care transitions, such as pharmacists, infection preventionists, primary care providers, case managers, and in-home/long-term care staff.58,59,60

» Clarify interprofessional roles and responsibilities in facilitating care transitions from acute to community settings and vice versa

» Establish a transition coach whenever possible to support post-discharge patient engagement and self-management. Social workers, case managers, patient navigators, or transition nurses are more likely to be equipped to lead transition planning than floor nurses or pharmacists61

• Designate a discharge team charged with establishing a patient-centered transition process. Of paramount importance, this team should:

» Create and deliver a consistent message to patients, caregivers, and post-acute facility providers

» Identify the information and formats necessary for a streamlined discharge packet

» Educate patients to engage in self-care and medication management at home

• Expand the composition of the transition team in rural areas and equip them with appropriate resources: » Use telehealth—an emerging strategy for sharing information with community providers (e.g., via

online and web-based video messaging)—and establish regular surveillance of vitals, virtual visits, and medication review62

» Liaise with first responders, such as paramedics and firefighters, who may be able to help with transportation, if patients are moving from one post-acute setting to another

Resources

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EMPOWER PATIENTS

• Educate and empower patients to be their own advocates by providing resources to enable them to know which questions to ask providers at discharge and throughout the transition process. Such questions might include:

» What do I need to know about my illness?

» How can I prevent spreading C. difficile to friends and family?

» What precautions can I take when I return home after discharge?

» What symptoms do I need to watch for?

» What is the best way to wash my hands?

» What should I know about cleaning my home?

» Who should I contact if I have questions or concerns about my illness?

• Engage patients in self-care and medication management by individualizing patient and caregiver education:

» Educate patient about precautions to take in the home environment to prevent recurrence and provide time for patients and caregivers to ask questions (the transition coach or nurse can do this when a patient with health care-acquired CDI is scheduled for discharge)

» Maximize patient/caregiver involvement in all phases of an intervention by promoting self-determination and informed decision-making

» Provide educational information to support the patient/caregiver’s participation in the plan of care (Table 3)

» Use specific health literacy best practices and communication models

The C diff Foundation provides resources for patients regarding home care and strategies for maintaining the home environment (https://cdifffoundation.org/cdiff-infection-homecare/)

The National Patient Safety Foundation’s Ask Me 3, or other teach-back methods, ensure patients are knowledgeable about their condition and feel supported to engage in self-care.63

Ask Me 3

1. What is my main problem?2. What do I need to do?3. Why is it important for me to do this?

C Diff Foundation Resources for Home Care

Engaging Patients in Self-Care

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CREATE DISCHARGE MANAGEMENT AND PROTOCOLS

• Consolidate discharge instructions into one document with simple instructions than can also be circulated to post-acute providers and incorporated into the hospital EMR:64

» Optimize information technology systems (e.g., EMR) and processes to support accurate and timely information transfer from site to site58

» A consolidated discharge summary can help to reduce communication deficits65,66,67

• Create a checklist for patients/providers or refer to the checklist provided at the end of this section to ensure that discharge is appropriately supported. Use this checklist to support discussions with patients about strategies to:

» Find medication payment assistance

» Manage medications as prescribed

» Reduce risk of transmission to household members

» Identify risk factors for recurrence

» Recognize symptoms of CDI: a color-coded symptom guide (e.g., Table 3) can help patients identify when they need to contact a provider

» Identify which provider to contact should symptoms occur

• Offer strategies to support medication adherence: » Begin the patient assistance process at diagnosis

» Initiate the prior authorization process at diagnosis

» Collaborate with in-hospital pharmacist(s) to develop and implement a plan for managing medications

• Social determinants of health—such as housing, food security, literacy, and occupational security—influence patient outcomes:

» Prior to discharge, transition planners can work with patients to uncover underlying social needs and identify their concerns, preferences, and needs

» If patients are transitioning to their own home, planners should assess their needs to determine home-based resources, such as community referrals and social work support

» Patients who lack functional literacy, live alone, are visually impaired, or lack food/medicine security or transport are likely to have additional needs about which transition planners should be aware

The CMS and the American Academy of Family Physicians have created assessment tools for social determinants of health that providers can use to support transition planning and identify potential resources for patients with social and environmental needs (e.g., Meals on Wheels).

https://innovation.cms.gov/Files/worksheets/ahcm-screeningtool.pdf

https://www.aafp.org/dam/AAFP/documents/patient_care/everyone_project/physician-short.pdf

Assessment Tools for Social Determinants of Health

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• Follow up with patients, community providers, and post-acute facilities 7–14 days after hospital discharge to optimize information transfer about the course of treatment and expected outcomes

• Establish protocols to ensure patients are referred to gastrointestinal or infectious disease specialists

• Ensure medication access by considering the following pharmacy strategies:

» If patients are transitioning to post-acute facilities, the pharmacist can reconstitute the medication and send it to the facility

» The medical director can write the prescription for liquid oral solution and submit it to the pharmacy

• In order to optimize patient education about medication management, in-patient pharmacists should establish communication with the transition team and be involved in discharge counseling early in the transition process

• When patients are discharged to a post-acute nursing facility, the discharge counseling team can liaise with the in-patient pharmacist to ensure that medications are available in a timely fashion

• Pharmacists involved in medication counseling at discharge should include information and support that will help patients being discharged to the home find assistance programs

• In the future, pharmacists could be involved in coordinating access to bezlotoxumab via infusion clinics

Role of the Infectious Diseases Pharmacist in CDI Transitions of Care

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Preventing CDI Recurrence in Community Settings: Tips for Patients

• Complete your antibiotic treatment as prescribed

• Use disinfection products that are EPA-approved to kill C. difficile spores

• Eat a healthy diet to restore your microbiome

• Contact your provider immediately, if diarrhea occurs

Green Zone: ALL CLEAR Green Zone Means: See provider as directed

• Able to drink liquids and eat normally

• Feeling better

• No fever

• Formed stools

• Infection is being treated

• The medications are working

• Increase activity slowly

Yellow Zone: CAUTION Yellow Zone Means: WARNING

• Feeling unwell

• Nausea and/or vomiting

• Loss of appetite and/or not drinking fluids

• Stomach cramping and/or pain

• Frequent, loose stools

• Fever or chills

• Call provider to discuss symptoms

• Might need to adjust your medications

Provider: _____________________Phone: _____________________

Red Zone: MEDICAL ALERT Red Zone Means: EMERGENCY

• Severe abdominal pain

• Unable to eat/drink and/or vomiting

• Shortness of breath

• Chest pain

• Feeling confused or cannot think clearly

• See a doctor NOW!

• Call 911 or go to the nearest emergency room

Table 3. Color Map for Patient Education: A Guide to Symptoms20

Adapted from Howard KA. DNP Project. San Francisco: University of San Francisco; 2015.

Point-of-Care Resource for Patient Education Printable Resource for Use in Daily Practice

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Point-of-Care Checklist for Transitions of Care Assessment and Coordination

m mYes No Does the patient and caregiver understand their CDI diagnosis/illness?

m mYes No Does the patient and caregiver understand their CDI symptoms?

m mYes No

Has the patient received a reconciled medication list of new medications prescribed during this hospital stay?

m mYes No Has the adherence assessment been completed?

m mYes No Has an assessment for substance use disorder been completed?

m mYes No

Have the follow-up instructions for lab tests, consultations, x-rays, and other relevant tests results been completed with providers and patient?

m mYes No

Review all prescribed medications, over-the-counter medications, and health/nutritional supplements:• Name of medication• Dose• Route• Frequency• Next refill

m mYes No Can the patient or caregiver tell you the reason she or he is taking the medication?

m mYes No Can the patient or caregiver tell you the effects of taking the medication?

m mYes No

Can the patient or caregiver tell you the symptoms or side effects of taking the medication?

m mYes No Do they know who to call if they have a problem or question regarding their medications?

m mYes No Can the patient or caregiver tell you the next refill date for the medication?

m mYes No

Has the patient or caregiver been given information on how long she/he needs to remain on the medication?

This NTOCC checklist is designed to enhance communication between providers, care settings, patients and caregivers. Adapt the checklist to address areas of concern that are relevant to individual patients, as well as to your specific care setting.

Assessment of Medical Issues:

Medication Assessment:

Printable Resource for Use in Daily Practice

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m mYes No Has the patient or caregiver’s health literacy been assessed with a formal tool?

m mYes No

Has the patient or caregiver been given easy-to-understand, clinically appropriate material in layperson’s language (written, digital, etc.)?

m mYes No

Has the patient or caregiver been provided materials and services in his/her preferred language?

m mYes No

Have clinical staff used graphic representations for a patient or caregiver with limited language proficiency or literacy?

m mYes No

Have clinical staff developed an educational plan based upon the patient’s or caregiver’s identified needs?

m mYes No

Have all self-management of medications and procedures to be delivered been provided to the patient or caregiver with accurate communication using teach-back methods?

m mYes No

Have staff evaluated the caregiver’s capacity to understand and apply health care information in assisting the patient?

m mYes No

Have barriers (financial, transportation, resources) to accessing care and medications been assessed and solutions to ensure access been identified?

m mYes No

Have the patient’s or caregiver’s ability to perform activities of daily living and meet basic needs been evaluated?

m mYes No

Have environmental barriers that may comprise the patient’s or caregiver’s ability to meet established treatment goals been assessed?

m mYes No Has a formal and informal support system been identified for the patient or caregiver?

m mYes No Has adequate and safe housing been established for the patient or caregiver?

m mYes No Has adequate food security been determined for the patient or caregiver?

m mYes No

Does the patient have a primary care physician? Ensure assessment and discharge information is sent to PCP. Date Completed

m mYes No

Does the patient have a specialist (e.g., gastroenterologist)? Ensure assessment/discharge information is sent to specialist. Date Completed

m mYes No

Is the patient being transitioned to post-acute services? Ensure assessment and discharge information is sent to facility. Date Completed

m mYes No

Ensure all appointments, referrals and follow-up care has been completed, and information has been provided to the patient or caregiver. Date Completed

Health Literacy & Linguistic Factors:

Social Factor Assessment:

Continuity/Coordination of Care:

Adapted from the NTOCC original Transitions of Care Checklist - Elements of Excellence in Transitions of Care: http://www.ntocc.org/Portals/0/PDF/Resources/TOC_Checklist.pdf

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RESOURCES TO SUPPORT TRANSITIONS OF CARE PATHWAYS IN CDI

• National Transitions of Care Coalition

• Institute for Healthcare Improvement

• Care Transitions Program

• Project BOOST (Better Outcomes for Older Adults Through Safer Transitions)

• Project RED (Re-Engineering the Discharge)

• Post-Acute Care Transitions (PACT) Toolkit

• Partnership for Patients Inter-Facility Infection Control Form

• C Diff Foundation (Education and advocacy resources for patients and healthcare facility providers)

TOOLS TO REDUCE PRIMARY CDI

• CDC Core Elements of Hospital Antibiotic Stewardship Program and checklist

• CDC Get Smart: When Antibiotics Work/Get Smart for Healthcare

• AHRQ Healthcare-Associated Infections Program

• National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination

• Quality scores (CMS quality reporting since 2013; Quality Innovation Networks)

• Appropriate controls (State Antibiotic Resistance Prevention Programs)

• National Strategy to Combat Antibiotic Resistant Bacteria

• Hospital Antibiotic Stewardship Program

• CMS Quality Innovation Network National Coordinating Center

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65. Kripalani S, LeFevre F, Phillips CO, Williams M V., Basaviah P, Baker DW. Deficits in Communication and Information Transfer Between Hospital-Based and Primary Care Physicians. Jama. 2007;297(8):831. doi:10.1001/jama.297.8.831

66. Centers for Medicare and Medicaid. The Hospital Conditions of Participation and Interpretive Guidelines.; 2004.

67. O’Leary KJ, Liebovitz DM, Feinglass J, et al. Creating a better discharge summary: Improvement in quality and timeliness using an electronic discharge summary. J Hosp Med. 2009;4(4):219-225. doi:10.1002/jhm.425

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© 2019 PRIME Education, LLC. All Rights Reserved. www.primeinc.org

Learning Objectives

� Apply evidence-based and expert consensus strategies for closing critical gaps in Clostridioides difficile infection (CDI) care transitions and coordination

� Incorporate evidence- and guideline-informed approaches for assessing risk in, diagnosing, and treating patients with primary or recurrent CDI

� Develop comprehensive hospital discharge plans that account for individual patient factors, including comorbidities and socioeconomic factors

� Apply interprofessional strategies for patient-centered CDI care, including patient/caregiver education, shared decision-making, and adherence promotion

Instructions to obtain credit:

1. Complete the activity in its entirety.

2. Visit PRIME®’s Credit Center at www.primeinc.org/credit.

3. Enter program code 72PR191.

4. Upon completion of the learner assessment tools, you will be able to print your certificate.

Release Date: September 16, 2019 Expiration Date: September 16, 2020

This activity is provided by PRIME Education. There is no fee to participate. This activity is supported by an educational grant from Merck & Co. Inc.

Accreditation Statements

In support of improving patient care, PRIME® is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team. This activity was planned by and for the healthcare team, and learners will receive 1.0 Interprofessional Continuing Education (IPCE) credits for learning and change.

Physician Credit Designation Statement PRIME Education, LLC (PRIME®) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PRIME® designates this Enduring material for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

Physician Assistant Accreditation Statement PRIME® has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.0 AAPA Category 1 CME credit. PAs should only claim credit commensurate with the extent of their participation.

Nurse Practitioner Accreditation Statement PRIME® is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number: 060815. This activity is approved for 1.0 contact hour of continuing education (which includes 0.2 hours of pharmacology).

Pharmacist Accreditation Statement This Application-based activity has been approved for 1.0 contact hour (0.1 CEUs) by PRIME® for pharmacists. The Universal Activity Number for this activity is JA0007144-0000-19-080-H01-P. Pharmacy CE credits can be electronically submitted to the NABP upon successful completion of the activity. Pharmacists with questions can contact NABP customer service ([email protected]).

Nurse Accreditation Statement PRIME Education, LLC (PRIME®) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. PRIME® designates this activity for 1.0 contact hour.

Case Manager Accreditation Statement The Commission for Case Manager Certification designates this educational activity for 1.0 contact hour for certified case managers. Credits for this program are pre-approved.

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Cheri Lattimer RN, BSNExecutive DirectorNational Transitions of Care CoalitionWashington, DC

Sahil Khanna, MBBSAssociate Professor of MedicineGastroenterology and HepatologyMayo ClinicRochester, MN

Nancy C CarallaFounder and Executive DirectorC Diff FoundationNew Port Richey, FL

James E Lett, II, MD, CMDFamily Medicine PhysicianMedical DirectorAvar ConsultingRockville, MDDirector of the National BoardNational Transitions of Care CoalitionWashington, DC

Kevin W Garey, PharmDProfessor and Chair Department of Pharmacy Practice and Translational ResearchUniversity of HoustonHouston, TX

The following individuals have identified relevant financial relationships with commercial interests to disclose:

Kevin W Garey, PharmD, MS, FASHP (Contributing Author)

Consultant – Merck and CoPrincipal Investigator of Research Grant – Merck and Co

Sahil Khanna, MBBS (Contributing Author)

Consultant – Premier IncPrincipal Investigator of Research Grant – Ferring Pharmaceuticals

The following individuals have no relevant financial relationships with commercial interests to disclose:

Cheri Lattimer, RN, BSN (Author)

James E Lett, II, MD, CMD (Author)

Nancy C Caralla (Author)

Kathleen A Jarvis, MS, RN, CCM (Reviewer)

Joyce M Knestrick, PhD, CRNP, FAANP (Planner)

Mark A Rubin, MD (Planner)

All PRIME staff participating in planning and content development have no relevant financial relationships with commercial interests to disclose.

Contributing Authors