CareMgmt_Feb_Mar_2016

CareManagement
OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS AND COMMISSION FOR CASE MANAGER CERTIFICATION

Vol. 22, No. 1 February/March 2016

INSIDE THIS ISSUE

CONTINUING EDUCATION ARTICLES: SPECIAL SECTIONS:
16 PharmaFacts for Case Managers
5 Models of Cardence Synthesis CE
Approvals, warnings and the latest information
By Douglas McCarthy, Jamie Ryan, and Sarah Klein on clinical trials—timely drug information case
Successful care models have several common attributes: managers can use.
targeting patieanning and patient monitoring; and more.
Read inside to find out more. 21 LitScan for Case Managers

10 Mobile Hty Net CEU The latest in medical literature and
report abstracts for case managers.
By Andrew Broderick, MA, MBA, and
Farshid Haque, MS 27 NNNeeewwwsss Certified Case Manager News
The use of cell phones in patient care is at an early stage of
deployment acconsiderable potential benefit in effectively Trends, issues, and updates in health care.
engaging patients.
DEPARTMENTS:
14 CE Exam CE 2 From the Editor-in-Chief

Members: Take exam online or print and mail. Patient Engagement and Mobile Health Technologies
Nonmembers: Join ACCM to earn CE credits.
3 News from CCMC

CCMC Requiring Ethics-Related CEs

4 Legal Update

CMS Proposes Major Changes in Discharge Planning
for Hospitals

30 How to Contact Us
30 ACCM Membership Benefits

31 Membership Application

join/renew
ACCM online at

academyCCM.org

or use the application
on page 31

FROM THE EDITOR-IN-CHIEF CareManagement
OFFICIAL JOURNAL OF THE ACADEMY OF CERTIFIED CASE MANAGERS
Gary S. Wolfe AND COMMISSION FOR CASE MANAGER CERTIFICATION

Ethics and the Case Manager Editor-in-Chief
Gary S. Wolfe, rn, ccm
E thics is the branch of philosophy Conduct and the code of ethics governing
that involves systematizing, the profession in which the individual’s Editorial Board
defending, and recommending eligibility for certification is based. Barbara Aubry, rn, cpc,
concepts of right and wrong
conduct. The term ethics derives from A common framework used in the chcqm, faihcq
the Ancient Greek word ἠθικός ethikos, analysis of medical ethics is the recogni- Vivian Campagna, rn-bc, msn, ccm
which is derived from the word ἦθος tion of four basic moral principles, which
ethos—habit or custom. As a branch are to be judged and weighed against Catherine M. Mullahy, rn, bs,
of philosophy, ethics investigates the each other, with attention given to the ccrn, ccm
questions “What is the best way for people scope of their application. The four prin-
to live?” and “What actions are right or ciples are: Patrice V. Sminkey, rn
wrong in particular circumstances?” In • Respect for autonomy—the patient’s Deborah Smith, rnc, mn
practice, ethics seeks to resolve questions Adele Webb, rn, phd, aacrn,
of human morality by defining concepts right to refuse or choose their treatment
such as good and evil, right and wrong, (Voluntas aegroti suprema lex.) cpnap, faan
virtue and vice, justice and crime. • B eneficence—acting in the best interest
of the patient (Salus aegroti suprema lex.) Executive Editor
Medical ethics is a system of moral • Non-maleficence—“first, do no harm” Jennifer Maybin, ma, els
principles that applies values and judg- (primum non nocere).
ments to the practice of medicine. The • Justice—the distribution of scarce Certified Case Manager News Editor
first code of medical ethics was published health resources and the decision of Jennifer Maybin, ma, els
in the 5th century. In the medieval and who gets what treatment (fairness and
early modern periods, the field was equality). (Iustitia.) Art Director and Webmaster
indebted to religious teachings. By the Laura D. Campbell
18th and 19th centuries, medical ethics Other values that are sometimes dis-
emerged as a more self-conscious dis- cussed include: Circulation Manager
course. In 1847, the American Medical • R espect for persons—the patient (and Robin Lane Ventura
Association adopted its first code of eth-
ics. While the secularized field borrowed the person treating the patient) have Member Services Coordinator
largely from Catholic medical ethics, in the right to be treated with dignity. Kathy Lynch
the 20th century a distinctively liberal • T ruthfulness and honesty—the concept
Protestant approach was articulated by of informed consent has increased in Senior VP Finance & Administration
thinkers. In the 1960s and 1970s, build- importance since the historical events Jacqueline Abel
ing upon liberal theory and procedural of the Doctors’ Trial of the Nuremberg
justice, much of the discourse of medical trials and Tuskegee syphilis experiment. Publisher, President
ethics went through a dramatic shift and Howard Mason, rph, ms
largely reconfigured itself into bioethics. These values provide a useful frame-
Now we are in the 21st century and medi- work for understanding conflicts, but they Vol. 22, No. 1, February/March 2016.
cal ethics continues to evolve. do not give answers about how to handle CareManagement (ISSN #1531-037X) is published
any particular situation. Sometimes, no electronically six times a year, February, April,
Today, the case manager is con- good solution to a dilemma in medical June, August, October, and December, and its
stantly faced with ethical dilemmas. ethics exists, and, on occasion, the values contents are copyrighted by Academy of Certified
Ethical dilemmas include access to care, of the various participants also conflict. Case Managers, 2740 SW Martin Downs Blvd.
withholding treatment, right to self-de- Sometimes the guiding values also are #330, Palm City, FL 34990; Tel: 203-454-1333;
termination, informed consent, and the in conflict. These conflicts present addi- Fax: 203-547-7273.
list goes on and on. The case manager tional challenges for the case manager. Subscription rates: $120 per year for ACCM
is guided by their certification Code of members; $150 for institutions.
For the case manager to effectively Opinions expressed in articles are those of
handle ethical dilemmas, they first must the authors and do not necessarily reflect the
understand the Code of Conduct for their opinions of the editors or the publisher or the
Academy of Certified Case Managers. One or two
continues on page 29 copies of articles for personal or internal use may
be made at no charge. For copying beyond that
number, contact Copyright Clearance Center,
Inc. 222 Rosewood Dr., Danvers, MA 01923,
Tel: 978-750-8400.

CareManagement is indexed in the CINAHL® Database
and Cumulative Index to Nursing & Allied Health
Literature™ Print Index and in RNdex.™

2 CareManagement February/March 2016

NEWS FROM
THE COMMISSION FOR CASE MANAGER CERTIFICATION

Focusing on the Case Management Process

By Patrice V. Sminkey, RN, CEO, Commission for Case Manager Certification

I n the most recent role and physical, psychosocial, and other needs on review, evaluation, monitoring, and
function study conducted by the of the individual (the “client” receiving reassessment, which could result in a
Commission for Case Manager case management services). Rooted in minor adjustment or complete change in
Certification (CCMC), survey advocacy, the case management process the plan of care. The transitioning phase
respondents reported more than 35 allows case managers to pursue goals supports the client as he/she moves across
different job titles (as well as 30 work that are focused on improving the client’s the health and human services continuum,
settings). Although care/case manager clinical, functional, emotional, and depending on health condition and need to
was the most frequently reported job psychosocial status. At every phase, the access care and resource. This is followed
title (nearly 54% of respondents), other case manager educates and empowers the by communicating post-transition with
titles included care/case coordinator, client and his/her support system or family the client and/or the support system/
utilization reviewer, workers’ to evaluate and understand options for family. The last phase is evaluating, to
compensation specialist, discharge care and treatment; determine what will measure results of the case management
planner, disease manager, and more. best meet their needs; and take actions in plan of care, which also involves outcomes
Titles sometimes referred directly to pursuit of goals and to meet their interests reports and findings disseminated to key
a professional discipline (eg, social and expectations.2 stakeholders.
worker or mental/behavioral health
counselor); others reflected some No matter how experienced they are or Given such emphases as identifying
primary aspect of the professional’s how long they’ve practiced, case managers the individual’s needs and goals,
responsibilities (eg, transitions of care).1 should reflect on each of the nine phases of empowering decision making, coordinating
the case management process, to recognize care among multiple providers and
Case management spans professional that, no matter where or how one practices, facilitating communication among all
backgrounds. Although the majority of this is the unifying force. Although stakeholders, and evaluating against
case managers are nurses, others come described here in a linear fashion, the specific goals and desired outcomes, the
from social work, rehabilitation, Workers’ phases of the case management process case management process enhances the
Compensation, mental and behavioral are iterative, cyclical, and recursive— delivery of care and resources across the
health, pharmacy, and more. They work in applied until the needs and interests of the health and human services spectrum. For
insurance, hospitals, ambulatory/outpatient, individual are met. this reason, in this era of post-healthcare
independent practice, government agencies, reform, case management is increasingly
home care, and other settings. The case management process begins in the spotlight, particularly for its care
with screening, focusing on the review of coordination component. CM
Given such a range of professional key information to identify the need for
diversity, what brings the practice services. This is followed by assessing, References
together? It is the case management to collect information in greater depth
process—holistic, addressing the about the person’s situation. The next 1. Tahan HA, Watson AC, Sminkey PV. What
phase is stratifying risk, to determine if case managers should know about their roles
Patrice V. Sminkey, RN, is CEO of the the person is low, moderate, or high risk, and functions: a national study from the
Commission for Case Manager Certification, the in order to determine the appropriate Commission for Case Manager Certification.
first and largest nationally accredited organiza- level of intervention. The planning phase Prof Case Manage. 2015;20(6):1-25.
tion that certifies case managers. To date, more establishes objectives, short- and long-term
than 60,000 case managers have been certified, goals, and actions. In the implementing 2. Case Management Body of Knowledge.
and currently more than 40,000 case managers or care coordination phase, specific case Case Management Knowledge. Commission
are board certified as Certified Case Managers. management activities and interventions for Case Manager Certification. 2015. http://
are executed. The follow-up phase focuses www.cmbodyofknowledge.com/content/
case-management-knowledge-2. Accessed
February 21, 2016.

February/March 2016 CareManagement 3

CCMC Shares Highlights of to inspire and entertain with David excuses that get in the way of our
Rendal, leading author and motiva- success by examining the challenges
Its Successful First New World tional speaker, who discussed learning of accountability and the practical
how to improve your own productiv- approach of dealing with real-world
Symposium ity and performance by discovering scenarios with Donna Wright, MS,
uniqueness and flaunting weakness as a RN, President of Creative Healthcare
The Commission for Case Manager strength. Management.

Certification (CCMC) celebrated a Attendees were greeted by a robust The conference closed with
and diverse hall of nearly 50 exhibitors Alexandra Drane, Founder of the Eliza
milestone January 21-23, 2016, in Las and sponsors representing multiple Corporation, who discussed the quality
health care services, providers, and of working and personal relationships
16 New Vegas with a successful launch of the companies. Exhibitors and attendees and the impact of stress on mind, body,
first-ever New World Symposium with were provided with multiple opportu- and spirit. Drane shared creative ways
nities to network during receptions, to enable and support positive change.
nearly 600 people representing allied events, and open exhibit hours.
Attendees had the opportunity to
health in attendance. In addition, Day 1 of the conference earn over 16 CE credits* towards main-
included pre-conference sessions high- taining their CCM Certification,
I’d like Conference objectives included: lighting the day-to-day practice of case with the added benefit of earning cred-
• CREATE AWARENESS of the management across practice settings. its towards licenses and certifications
Topics covered Workers’ Compensation, from multiple allied health
current and future landscape influ- case management trends and aware- organizations in nursing, social work,
ness, and the wide world of professional and other related fields.
encing the patient, family and care case management.
The Commission announced
provider(s) across the care contin- On Day 2, the conference opened the 2017 New World Symposium will
up with a Breakfast Symposia regard- take place January 26-28, 2017, at
uum. ing the Science of Support Surfaces: the Gaylord Texan in Grapevine, TX
Nomenclature, Design for Performance, (Dallas, TX). Registration for the 2017
• EMPOWER THE LEADERSHIP and Selection. Hill Rom’s Director conference will open in Spring 2016.
of Case Management and Clinical Support opportunities are already
ally with ROLE of the case manager through Services, Tricia Litzinger, RN, BSN, available for the event. For more infor-
m across education, advocacy and ethical CCM, CDS, WCC, led the session about mation on the conference, speakers,
practice. how to align the right level of care to and presentations, visit the symposium
improve outcomes while reducing costly website at https://symposium.ccmcerti-
• ESTABLISH A FORUM for discus- complications and resource consump- fication.org.
tion using the knowledge of the science
sion related to outcomes through of surfaces.

k for- research and evidence based prac- Concurrent sessions for Day 2
ood as tice. included topics like motivating the
• PROVIDE RESOURCES, knowl- unmotivated client with Dr. Judy
Hibbard and client assessment tools
edge and skill development related and tips with Catherine Mullahy, RN,
BS, CRRN, CCM, President, Mullahy
to the practice of case management & Associates. Day 2 concluded with
an exhilarating session on the topic
f what I across practice settings. of leadership for change management
• PROMOTE NETWORKING with with former Under Secretary, Veterans
Benefits Administration of Veterans
colleagues to establish a more inte- Affairs, Allison Hickey.

grated community of health care On Day 3 of the event, the attend-
ees took a humorous look at the
inder for team members related to better
care, lower cost and healthier patient

populations.

Sessions were filled with timely

topics relevant to today’s case man-

agement practice. A few speaker

tten highlights were:

Keynote speaker Susan Dentzer

“awakened the force” with a stirring

presentation that made the case

d to for making “best the new norm” to

achieve greater value in health care.

Dr. Kavita Patel drove home

the Triple Aim with the session on

exploring the cultural, technological,

and workforce issues that contribute to

optimizing a fully functioning team-

based practice.

The conference sessions continued

4 CareManagement February/March 2016

NEWS FROM
CARF…THE REHABILITATION ACCREDITATION COMMISSION

Document management system allows employees to
access policies, trainings, and data anytime, anywhere

By Howard M. Goldberg, Chief Quality and Compliance Officer, Institute for Community Living. Administrative Surveyor,

CARF International included NAVEX PolicyTech Software ICL has seen improvement in efficiency
and Medworxx. The ICL team was as employees are able to retrieve pol-
I n New York State, the behavioral looking for a solution that would enable icy and training information without
health field is governed by a large essential documents to be organized, having to contact a supervisor or the
assortment of laws and regulations
to ensure that consumers are being
treated in the best possible way and in accessed remotely, and tracked to see Department of Quality. ICL is also able

accordance with government-approved who viewed them. ICL’s criteria to quantitatively measure how many

practices. The amount of regulations, included having a repository where employees access the system, allowing

including their frequent updates, it could put content, including docu- it to better hold them accountable. ICL

poses a challenge for organizations to ments, trainings, procedure statements, continues to improve on the documents

ensure that employees are up-to-date contracts, and leases. ICL needed the that it shares with employees, noting

on the latest rules and trainings and content to be web based so that employ- recently that hyperlinks can be added

have access to the most current version ees wouldn’t have to log on to ICL’s so staff can click to find explanations

of policies. This becomes especially network to access it. ICL also wanted to for specific policies. Even YouTube

difficult when a large portion of an be able to edit the documents online videos can be added into the system.

organization’s employees is rarely in an (rather than having to upload revised ICL’s document management system

office and isn’t readily able to log on to documents) and gather feedback from has become a vital tool that ICL uses to

agency networks. employees. help people get better.

That was the challenge faced by In 2015, ICL received exemplary

ICL, a behavioral health agency that pullquote recognition from CARF for its effec-
has more than 1,000 employees spread tive use of the document management

across the five boroughs of New York system to improve communication,

City and as far away as Montgomery information sharing, and potential

County, Pennsylvania. In addition to a outcomes. The exemplary said, in part,

large number of remote employees, ICL that ICL’s positive use of the “signifi-

offers many programs and services that In addition to meeting the require- cantly increases the availability and

each have their own set of policies that ments listed above, the document man- accessibility of all business data, orga-

need ongoing review, updating, and cat- agement system enables ICL to create nizational information, policies, and

aloging. To address the issue of keeping workgroups so that specific documents procedures. This important investment

remotely stationed employees up-to-date can be shown to select people. These helps to improve access to data for all

on regulations and policies relevant to workgroups allow participants to create staff members.”

these service areas, senior policy and workflows, edit drafts, and involve key There are numerous off-the-shelf

compliance staff at ICL began to investi- people in the process. The ICL Board document management systems

gate document management systems. of Directors, for example, has its own available for companies of different

After sifting through numerous dedicated section within the system sizes. In addition to the options

requests for proposals (RFPs) and that allows members to remain up-to- considered by ICL, others can be

meeting with a number of different date on company activities. The system located quickly using an internet

companies offering document manage- also offers the ability to create tempo- search. For further information about

ment systems, ICL chose the services rary access. This is helpful for CARF ICL’s document management system,

of PowerDMS, which offers a system surveyors to access documents that ICL contact Howard Goldberg at

that meets most of ICL’s needs. Other is using and sharing with its employees. [email protected] or (212) 385-

systems considered by the ICL team By implementing these processes, 3037. CM

February/March 2016 CareManagement 5

LEGAL UPDATE

What Hospital Discharge Planners Need
to Know About Private Duty Home Care

By Elizabeth Hogue, Esq.

Hospital discharge planners of the cost of such services. They may planners, regardless of whether they
and case managers need to also erroneously conclude that patients are certified as case managers, because
know more about private and their families cannot afford these they are practicing as case managers.
duty home care. services. Discharge planners/case man-
In order to be appropriate for home agers should not jump to conclusions These standards make it clear that
health or hospice services paid for about who can afford these services. case managers have a duty to advocate
by any payor, including the Medicare Instead, private duty home care services on behalf of patients. As advocates
Program, patients must either be able for patients, discharge planners/case
to care for themselves or they must have pullquote managers have an obligation to make
a primary caregiver. Patients’ family sure that patients understand all of the
members or others may be willing to should be offered to every patient and options available to them, including the
fulfill this role on a voluntary basis. If family who may benefit from them. option to pay privately for home care
not, discharge planners/case managers This conclusion is consistent with legal services.
should offer patients and/or their fam- and ethical requirements that govern
ily members the option to pay privately the practice of case management. Case managers/discharge plan-
for a primary caregiver who can meet ners also have an ethical obligation to
patients’ needs in between visits from From a legal point of view, dis- inform patients about the availability
professional staff from home health charge planners/case managers who of private duty services. Autonomy is an
agencies and hospices. These types of work in hospitals must comply with important ethical principle applicable
services may be referred to by post- Conditions of Participation (CoPs) that to the practice of case management/
acute providers as private duty home govern hospitals. Specifically, discharge discharge planning. This ethical princi-
care services. planners/case managers are required to ple generally requires case managers to
develop appropriate discharge plans, if provide information to patients so that
The option to pay for private duty necessary, for all patients. According to they can make informed choices.
home care services should be offered Interpretative Guidelines for the CoPs,
to all patients who cannot care for development of appropriate discharge Patients cannot make choices about
themselves and who have no voluntary plans undoubtedly includes private duty the care they wish to receive unless
primary caregivers. Patients who can home care services for patients who they have information about all services
care for themselves or have voluntary may benefit from them. available, including private duty ser-
primary caregivers may also wish to vices. Discharge planners/case manag-
contract for additional assistance, so In addition, the Case Management ers, therefore, have a clear ethical obli-
discharge planners/case managers Society of America (CMSA has pub- gation to provide information about
should offer this option to all patients lished national standards of care for private duty home care services to all
who may benefit from these services. case managers. They are likely to patients who may benefit from them.
apply to all case managers/ discharge
Discharge planners/case managers Patients are in the drivers’ seat
may be reluctant to offer these services when it comes to decisions about their
to patients and their families because care, but they cannot make appropriate
choices unless they have information
Elizabeth Hogue, Esquire, is an attorney who about all of the types of care available
to them. Consequently, discharge plan-
represents health care providers. She has pub- ners/case managers have legal and
ethical obligations to make sure that
lished 11 books, hundreds of articles, and has patients have information about private
duty home care services. CM
spoken at conferences all over the country.

6 CareManagement February/March 2016

CE for CCM & CDMS Approved for 2 hours of CCM, CDMS and nursing education credit Exclusively for ACCM Members

CE I Care Management of UTI Caused by
Gram-Negative Bacilli in Women and Children

By Puja Shahi, PhD

Urinary tract infections (UTI) in the US cause more than 1 million emergency department (ED)
visits and 7 million outpatient visits every year. These account for one of the most frequent clinical
indications for prescription of antibiotics and 6 billion health care expenditures.

U rinary tract infections (UTIs) of infection, the type and degree of clinically with general symptoms like
affect almost half the world’s illness, and mostly importantly, the fever and vomiting can often lead to
population and are more presence of other predisposing fac- inconclusive or incorrect diagnosis. The
common among women in tors (which can lead to complicated delay in proper antibiotic treatment
their reproductive years, children, infections).4 Patients’ outcomes can allows bacteria to further multiply and
and hospitalized patients. In fact, the significantly affect use of health ser- migrate to upper parts of the urinary
number 1 infection acquired in the vice resources; hence, it is imperative system, leading to complicated infec-
hospital setting is UTI (based on Jan to understand categories of UTI4 and tions.6 Patients with functional or ana-
2015 data from the Centers for Disease their care management guidelines. tomical abnormalities, where the urine
Control and Prevention [CDC]). path is not cleared properly, are at
Infection Types significantly higher risk of developing
Causes Asymptomatic Infection ureteritis and pyelonephritis from an
Ninety percent of the clinically pre- Asymptomatic bacteriuria (ABU) is uncomplicated infection.7
sented cases of UTI are due to enteric characterized by the absence of usual
Gram-negative bacilli (GNB). Studies symptoms of UTI (such as fever and Appropriate care management can
performed over a period of 7 years frequent painful urination) and is more significantly decrease the occurrence
identified Escherichia coli as the number common in women than men. Studies of complicated infections in pregnant
1 causative agent in these infections, show no significant improvement of women, patients with urinary catheter-
followed by Enterococcus, Klebsiella, and clinical outcomes with use of antibiotics ization, and with anatomical obstruc-
Proteus.1,2 Urine in normal healthy in overall healthy individuals. Thus, tion (benign prostatic hypertrophy,
individual is sterile or free of any antibiotics are recommended only in abdominal or pelvic masses (cancer),
microorganism. The presence of bac- pregnant women, children aged 5-6 and stones (in bladder, ureters, or
teria in urine can be caused by either years, and patients scheduled for inva- kidneys).
contamination during specimen collec- sive genitourinary procedures.5
tion or infection from colonization by Acute or Chronic/Recurrent infection
microbes. Bacterial colonization, also Symptomatic and Complicated Infection Acute infections are classified as one-
known as bacteriuria, is confirmed by Infections in the lower urinary sys- time infections that can be resolved
culturing urine sample from patients. tem—urethritis (urethra) and cystitis with antibiotic therapy. Usually, there
A colony-forming unit (CFU) of ≥105/ (bladder)—are uncomplicated, but is no damage to the kidneys, and
mL of GNB is considered the standard those associated with upper the uri- patients do not develop pyelonephritis
for defining UTI.3 Diagnosis is made nary system—ureter (ureteritis) and again. Chronic infections, on the other
on the basis of clinical findings and pyelonephritis (kidneys)—usually need hand, are seen in patients with urinary
the pathogen identified via urinalysis. immediate medical attention and are birth defects. Anatomical blockages
The antibiotic course and specific classified as complicated. Urethral or lead to abscess formation and require
case management depend on the site bladder infection cases, when presented nephrostomy to drain the abscess.
Recurrent UTI (rUTI), defined as two

February/March 2016 CareManagement 7

CE for CCM & CDMS Approved for 2 hours of CCM, CDMS and nursing education credit

uncomplicated infections in 6 months patients who have a risk of developing (ESBLs) and carbapenemases in these
or three infections within 1 year can multidrug-resistant (MDR) infec- pathogens is of great concern because
occur because of inadequate antibiotic tions—those with a history of recent these drugs are often the last line of
intake, noncompliance with medication hospitalization, who reside in a nursing treatment.
regimens, drug resistant microbes, or home/long-term care facility, with
reinfection by rectal flora. a urological procedure in the past 3 Identifying patients at high risk for MDR
months, receiving hemodialysis, or with UTIs is important for guiding empirical anti-
Current Trends in Treatment of an indwelling catheter. Choice of anti- microbial therapy and care management.
GNB Infections in Women microbial agent also depends on local
The selected antibiotic should be effective for resistance patterns, patient-specific UTI in Women
common uropathogens but should not expose factors, including anatomical site of Cystitis is more common in women
patient to unwarranted risks. infection, severity of disease, pharma- than men. Women have shorter ure-
cokinetic and pharmacodynamic prin- thras than do men; this facilitates easy
Most antibiotics like carbenicillin, ciples, and cost-effectiveness. European migration of uropathogens like E coli
ampicillin, trimethoprim/sulfame- Association of Urology (EAU) 2013 up the urinary tract. Although bacte-
thoxazole (TMP-SMX), ciprofloxacin, guidelines recommend use of drugs ria like Staphylococcus saprophyticus,
and nitrofurantoin are very effective like TMP-SMX (if local resistance is less Klebsiella species, Proteus mirabilis, and
in clearing infections because they than 20% for E coli), nitrofurantoin, fos- Enterococcus faecalis can also cause
concentrate in the urine (Table 1). fomycin trometamol, or pivmecillinam infections, 80% of these infections are
Empirical treatment for UTI infection as first-line therapy. Fluoroquinolones caused by uropathogenic E coli (UPEC).
involves treatment with ampicillin and may be used only as alternative ther- Nearly 50% of women develop UTIs
aminoglycosides or a third-generation apy because resistance to these first- during their lifetimes, and incidence
cephalosporin to minimize side effects. line antimicrobial agents has become increases with age. rUTI can occur
The treatment is then modified to be increasingly common.8 The presence even when women are treated with
case specific; for example, antibacte- of extended-spectrum beta-lactamases antibiotics—either because of indepen-
rial treatment should be aggressive in dent inoculation of the urinary tract or
establishment of latent bacterial cells.
TABLE 1 COMMONLY USED ANTIBIOTICS FOR GNB AND CONSIDERATIONS IN Bacteria can colonize the underlying
USE OF THE SAME.7 or superficial bladder epithelial tissue,
escaping the toxic effects of drugs
Antibiotic Active against Considerations (quiescent intracellular reservoirs)
and increase the risk of acute uncom-
Nitrofurantoin Klebsiella, Enterobacter, Bacteriostatic at low and bacteriocidal at high plicated/complicated cystitis or pyelo-
monohydrate/mac- ESBL Escherichia coli concentrations; used in pregnancy; low resis- nephritis. These infections commonly
rocrystals tant rates; prophylactic use occur in healthy women with such fac-
tors as high blood sugar and pregnancy
Trimethoprim- Klebsiella, Enterobacter, First line of treatment; prophylactic; allergic posing additional risk. Simple cases
sulfamethoxazole Proteus, Escherichia coli reactions seen and high resistance rates of UTI may also become complicated
(TMP/ SMX) if the vaginal introitus is colonized by
gastrointestinal (GI) pathogens and in
Fosfomycin Klebsiella, Proteus, Lower efficacy than some other recommended women who use spermicides, have low
trometamol Escherichia coli agents; lower resistance rate estrogen levels, have intercourse during
infection, or have a genetic predispos-
Pivmecillinam General Gram-negative Lower efficacy; lower resistance rate ing factor.8 Treatment recommenda-
bacteria tions are shown in Table 2.

Carbenicillin Pseudomonas aeruginosa, Can cause bleeding and hypokalemia, lower Acute cystitis/urethritis cases man-
Escherichia coli, some toxicity and resistance; higher stability and ifest with symptoms such as urinary
Proteus species efficacy than ampicillin urgency and frequency, dysuria, lower
abdominal discomfort, and cloudy
Ciprofloxacin Pseudomonas aeruginosa, For acute pyelonephritis and nosocomial UTI, urine. Initial diagnosis is based on past
Klebsiella, Escherichia coli, an increased risk of tendinitis and tendon rup- medical history—individual or family
Proteus species ture, especially in patients >60 years

8 CareManagement February/March 2016

Exclusively for ACCM Members

TABLE 2 RECOMMENDATIONS FROM INTERNATIONAL CLINICAL PRACTICE in some cases when local resistance is
GUIDELINES FOR TREATMENT OF UTI IN WOMEN.4 not known because pyelonephritis can
lead to systemic infections. Empirical
Infection Antibiotic/Dosage therapy in these patients should include
intravenous long-acting parenteral
Asymptomatic No treatment unless pregnant or impending Antibiotic urologic proce- antibiotics. Delivering antibiotics intra-
dure with bleeding anticipated venously in the hospital ensures that
the medicine is reaching the kidneys.
Acute Cystitis/Urethritis • Nitrofurantoin monohydrate/macrocrystals The therapy starts with the use of
a broader-spectrum agent such as a
• 100 mg orally for 5 days fluoroquinolone; an aminoglycoside,
with or without ampicillin; an extend-
• Trimethoprim-sulfamethoxazole (TMP-SMZ) 160/800 mg orally ed-spectrum cephalosporin/penicillin,
(one double-strength (DS) tablet) for 3 days with or without an aminoglycoside; or
a carbapenem. Later, when laboratory
• Fosfomycin trometamol 3 g single dose results are available, therapy can be
narrowed down to a pathogen-specific
• Pivmecillinam 400 mg for 5 days antimicrobial agent.9

Acute Pyelonephritis An initial 400-mg dose of intravenous ciprofloxacin; oral ciprofloxacin UTI in Pregnancy
(500 mg twice daily) for 7 days, ciprofloxacin (1000 mg once daily for 7 The incidence of bacteriuria (ABU,
days), or levofloxacin (750 mg once daily for 5 days) symptomatic cystitis, or pyelonephritis)
in pregnant women is slightly higher
health issues, sexual activity, and cur- certain cases, and confusion (especially than among nonpregnant counterparts,
rent symptoms. Infection is confirmed in elderly women). Frequency of uri- and the consequences for both mother
by urinalysis—the causative agent nation increases. Urine is cloudy and and baby in former case are more
and antimicrobial drug susceptibility foul smelling, with or without hema- severe. During pregnancy, increased
are identified. Although the standard turia. Diagnosis by blood testing for progesterone levels reduce smooth
definition of GNB requires the load bacterial growth and ultrasound can muscle tone, resulting in slow peristalsis
of uropathogens to be >105 CFU/mL, help identify factors underlying disease and urethral relaxation causing hydro-
recent case studies have shown clinical progression such as abscesses, stones, nephroses. The pressure of the growing
pathology in women with 103 CFU/mL. and blockages. If the patient is able to uterus on the bladder can also lead to
Current clinical practice guidelines get around and can consistently take vesicouretral reflux and an increase in
recommend use of recommended oral antibiotics (is not confined to bed urine pH (due to higher glucose, amino
antimicrobials based on local availabil- or regularly vomiting), oral ciproflox- acid, and hormone levels). Diagnosis
ity of the drug and cost, the patient’s acin (500 mg twice daily) for 7 days, is more restrictive in this category
allergy and compliance history, tol- with or without an initial 400-mg dose because the potential risks concern
erance levels, and local resistance of intravenous ciprofloxacin or once- both expectant mother and unborn
rates. Fluoroquinolones (ciprofloxin, daily oral fluoroquinolone, including child. The same applies to the use of
ofloxacin) are highly efficacious in ciprofloxacin (1000 mg for 7 days) or antibiotics—nearly all antimicrobial
3-day regimens but can have adverse levofloxacin (750 mg for 5 days), is the drugs can cross the placenta, and some
side effects in some cases; hence, they choice of therapy. If the uropathogen of them may trigger teratogenic effects.
are used only as alternative therapy. is susceptible to TMP-SMX, an oral The most common UTI treatments
Nitrofurantoin, TMP-SMX, fosfomycin, dose of 60/800 mg of this antibiotic during pregnancy are antibiotics such
and pivmecillinam are recommended twice daily for 14 days is recommended. as penicillin or cephalosporins such as
because beta-lactams like amoxicillin Beta-lactams are less effective in treat- cephalexin.10
or ampicillin have inferior efficacy and ing pyelonephritis. In all these cases, if
cause more adverse effects. the community resistance exceeds 10% ABU. Studies of pregnant women
for fluoroquinolone or if pathogen’s with ABU have shown a high risk for
Acute pyelonephritis may start susceptibility is unknown, 1 g of ceftri- acute pyelonephritis later in pregnancy
symptoms similar to those of lower axone or a consolidated 24-hour dose or for preterm birth. Therefore, routine
UTI infections but progress into more of an aminoglycoside is recommended.
severe symptoms like back pain, flank February/March 2016 CareManagement 9
pain, fever accompanied by chills, feel- Hospitalization is required to
ings of malaise, nausea and vomiting in treat more severe pyelonephritis and

CE for CCM & CDMS Approved for 2 hours of CCM, CDMS and nursing education credit

TABLE 3 TREATMENT OPTIONS FOR VARIOUS UTI INFECTIONS IN hydration, urine and blood cultures,
PREGNANT WOMEN ultrasound, and basic laboratory anal-
ysis.13 Table 3 summarizes treatment
Infection Antibiotic/Dosage options for various types of UTI in
pregnant women.
Asymptomatic bacteri- • Amoxicillin 500 mg twice a day for 3-7 days
uria (ABU) • Cephalexin 500 mg twice a day for 3-7 days UTI in Children
UTI is more common in boys younger than
Acute cystitis/urthritis • Amoxicillin 500 mg twice a day for 7 days 1 year, but after the first year more infections
• Cephalexin 500 mg twice a day for 7 days are seen in girls.14 Most of these cases are
asymptomatic but can result in severe illness
Mild or moderate acute • Ceftriaxone 1 g once a day like growth failure, severe GI manifestations,
pyelonephritis • Cefepime 1 g once a day to twice daily fever, irritability, lethargy, abnormal urina-
• Aztreonam 1 g twice daily tion (oligouria, polyuria, malodorous urine),
and jaundice. It is associated with high
Severe acute pyelone- • Ticarcillin with clavulanic acid 3.1 g 4 times a day morbidity and mortality rates in newborns.
phritis • Piperacillin with tazobactam 3.375 g 4 times a day
• Meropenem 0.5 g 3 times a day Several studies have shown a direct
• Ertapenem 1 g once a day relation between untreated UTI in
• Doripenem 1 g 3 times a day pregnant women and neonatal UTI,15
which is the most common bacterial
screening for bacteriuria is done case is of longer duration, the principle infection in children younger than 2
by urine analysis. According to the is the same as with treatment of ABU: years. Diagnosis is important because of
Infectious Disease Society of America testing microbial susceptibility before life-threatening sepsis in the newborn
(IDSA),9 two consecutive voided urine antibiotic prescription. Follow-up urine and potential risks of renal scarring in
samples with bacterial monoculture cultures at 1–2 weeks and then once a infants/school-aged children. Febrile
of ≥105 CFU/mL or a single catheter- month are recommended. In patients UTI is the most common infection after
ized urine sample with ≥102 CFU/mL with recurrent acute cystitis, prophylac- throat and ear infection in preschool
is defined as bacteriuria. Repeated tic treatment is given to suppress micro- and school-aged children.
tests are recommended in women at bial growth.12
high risk—those with diabetes, sickle Developing guidelines of care
cell anemia, immunological defects, Acute pyelonephritis is seen in second management for UTI in children has
urinary tract abnormalities, or history or third trimester pregnant women, been a challenging. First, there are not
of recurring UTIs before pregnancy. occurring as a result of undiagnosed enough studies to support the toxicity
Studies also suggest that women with or improperly treated ABU. Old age or adverse effects of drugs (ethical
no bacteruria in the first trimester may and nephrolithiasis, as well as the issue). Second, diagnosis and treatment
still develop infection in the second other aforementioned risk factors, can may be delayed as clinical presentation
or third trimester; hence, screening increase the incidence of pyelonephri- in infants is usually nonspecific. Third,
at each trimester is suggested. Since tis. Symptoms include positive urine reliable urine specimens for culture
antibiotics resistance is rapidly evolving, culture, fever >38ºC, lumbar pain, cannot be obtained without invasive
treatment for infection should be based skeletal and joint pain, nausea and vom- methods (urethral catheterization or
on microbial sensitivity testing.11 iting with or without dysuria, polyuria, suprapubic aspiration [SPA]). Finally,
and 105 CFU/mL of monobacterial pop- children and adolescents with pyelone-
Cystitis/urethritis. Urinalysis showing ulation. Twenty percent of these women phritis double their risk of renal scar-
cloudy appearance with 102-103 CFU/ end up having septicemia—hence, par- ring when suffering from predisposing
mL is a diagnostic feature of this infec- enteral antibiotics are recommended conditions like vesicoureteral reflux.16,17
tion. Some other symptoms are dysuria, for the first 48 hours in all cases. The
an increase in frequency and urgency 2005 IDSA guidelines recommend hos- Case management of pediatric
of urination, and abdominal and supra- pitalization for at least 48 hours in all patients. Studies have shown oral anti-
pubic pain. Although treatment in this suspected cases of pyelonephritis with biotics to be as effective as IV antibi-
otics in most cases of simple pediatric
cystitis. Hospitalization is required in
critical cases such as patients with signs

10 CareManagement February/March 2016

Exclusively for ACCM Members

TABLE 4 TREATMENT OPTIONS FOR VARIOUS UTI INFECTIONS IN a fluoroquinolone that is reported to
CHILDREN AND INFANTS cause arthropathy in weight-bearing
joints in juvenile animals. Penicillin,
Infection Antibiotic/Dosage cephalosporins, and sulfonamides are
known to cause hypersensitivity reac-
Less than 2 months • Cefotaxime 150 mg/kg/day IV/IM divided every 6-8 h tions. Hence, the IDSA and European
OR Society of Microbiology and Infectious
Any age but toxic/ • Ceftriaxone 75 mg/kg/day IV/IM as a single dose or divided every 12 Disease suggest use of nitrofurantoin as
unwell/unable to h (ceftriaxone should not be used in infants younger than 6week) or the first agent. Comparable cure rates
tolerate orally and a low rate of bacterial resistance
• Ampicillin 100 mg/kg/day IV/IM divided every 8 h plus gentamicin have made nitrofurantoin a drug of
3.5–5 mg/kg/dose IV every 24 h if patient younger than 7 days; choice especially in children. It has
otherwise gentamicin 5-7.5 mg/kg/dose IV every 24 h high efficacy for treating uncompli-
cated lower UTIs but has poor tissue
• Transition to oral antibiotic active after 24-48 h for total of 14-day penetration and low circulating levels;
course hence, it is not a drug of choice for
treating upper UTIs, pyelonephritis,
Less than 2 months • C ephalosporin, trimethoprim (or co-trimoxazole) or prostatitis, and intraabdominal abscess.
with upper UTI/ co-amoxicillin-clavulanate oral for 10 days It is an oral antibiotic taken with food
pyelonephritis (to improve bioavailability) and is also a
drug of choice during pregnancy. Table
2 mo-2 y with cystitis • Nitrofurantoin 5-7 mg/kg by mouth divided every 6 h for 3-10 days 4 shows treatment options for UTI in
(Should not be used in children with symptoms consistent with pyelo- children and infants.
nephritis as it is poorly concentrated in the bloodstream and has poor
tissue penetration) or Conclusion
According to the American Urological
• TMP-SMZ 6-12 mg/kg/day by mouth divided every 12 h Association, 40% of nosocomial infec-
tions are UTIs. In 2008, the National
2 mo-2 y with pyelone- • Initial therapy with IV antibiotics for 3-4 days followed by oral ther- Healthcare Safety Network found 13%
phritis apy to complete a 10-14 day course is equivalent to 10-14 days of IV of E coli and Klebsiella, 17% of P aerugi-
therapy nosa, and 74% of Acinetobacter baumannii
from ICUs to be multidrug resistant.
• Initial oral therapy with cefixime or amoxicillin-clavulanate is equiva- This is because of the ability of these
lent to IV ceftriaxone for 3 days followed by oral therapy bacteria to synthesize extended-spec-
trum beta-lactamases (ESBLs). Care
• IV gentamicin may be dosed daily, rather than 3 times a day, for chil- management plays a major role in con-
dren who require IV treatment or who are infected with multiresistant trolling the increasing morbidity and
organisms recurrence rates in UTI. In general,
the treatment consists of hydration, and
of renal obstruction, patients who are resistance must be considered when in cases with urinary tract obstruction,
unable to tolerate oral fluids and med- choosing empiric therapy, especially removal of the foreign body or catheter
ications, or when oxygen is required.18 with ampicillin. Knowledge of the local if feasible, and judicious use of antibiot-
Care in hospital settings is also absolute antibiotic resistance helps in guiding ics. Because most antibiotics are
for children or infants with sepsis, antibiotic choice. Common choices excreted in urine, their concentration
infants younger than 2 months with for empiric oral treatment are either is high enough to clear UTIs. However,
presumed pyelonephritis, and for all second- or third-generation cepha- with complicated infections such as
patients older than 1 month. Short- losporin or amoxicillin/clavulanate, pyelonephritis, tissue concentration of
course (3-day or 5-day) oral antibi- or TMP-SMZ. Amoxicillin has high the drug should be taken into consider-
otic therapy has been shown to be as resistance rates; therefore, in cases of ation. CE I
effective as 10-day or 14-day courses pediatric pyelonephritis, initial treat-
for nonfebrile UTIs. For febrile UTIs, ment should include a cephalosporin, Continues on page 28
the minimum treatment duration amoxicillin-clavulanic acid, TMP-SMZ,
should be 7 days and may extend to or an aminoglycoside. February/March 2016 CareManagement 11
10–14 days. Empiric antibiotics should
be chosen for coverage of the most There is rise in antibiotic resistance
common uropathogens, namely E coli to commonly used agents such as fluo-
and Enterococcus, Proteus, and Klebsiella roquinolones and TMP-SMZ. In addi-
species. The possibility of antibiotic tion, there are known safety concerns
with certain drugs like ciprofloxacin,

CEU for CCM & CDMS Approved for 2 hours of CCM and CDMS ethics education credit

Approved for 2 hours ethics credit

CE II Ethical Dilemmas in Case Management

By Elizabeth A. Dailey MBA, HCM, MSN, RN; Mareesa Hopkins MSN, RN; David A. Zaworski MSN, RN

Introduction dilemmas that surround case managers specific to their discipline, including
Health and wellness cannot simply be in today’s society, and an analysis of the that of the Certification of Disability
defined as the absence of disease or tools available to assist in identifying, Management Specialists (CDMS;
disability. Patients anticipate a good clarifying, and resolving ethical issues see Box 1 for the codes of several
quality of life as well as living a healthy that arise. organizations).
life. With global concerns focusing
on lifespan longevity, an increase in Case management has emerged According to Corvol and col-
the number of patients with chronic over the last 30 years as a pivotal posi- leagues,4 the four principles that
conditions, and the availability and tion that fosters the careful steering of provide the framework for ethical deci-
access to a variety of health care health care funds while maintaining sion-making within the case manager
information sources, the need for a consistent and primary focus on role include beneficence (possessing
ethical, quality health care is essential. quality care and patient advocacy.1 The a desire to do good), nonmaleficence
Ethical issues occur with increasing function of case managers is reflected (avoiding harm), justice (equal and fair
frequency in the health care field and in their numerous roles, including treatment), and autonomy (respecting
require consideration of many factors that of coordinator, developer, imple- self-determination). The use of these
in determining the best actions to take menter, monitor, and evaluator. Case principles in practice comes from a
to ensure positive outcomes. managers are pivotal members of the patient, or person-centered philosophy.
interdisciplinary team and work tire- Case managers begin to demonstrate a
Case managers are in a unique lessly to ensure that the unique needs patient-centered viewpoint by commu-
position to effect change and promote of the patient and family are met nicating therapeutically with patients
positive patient outcomes when ethical while employing significantly limited and their families in order to deter-
dilemmas are identified in the work- resources.2 mine what matters most to them. The
place. The increasingly complex role patient-centered philosophy promotes
of the case manager in health care The National Association of Social the reduction of barriers which may
settings requires a thorough under- Workers (NASW) and the American prevent patient from accessing services
standing of the process that involves Nurses Association (ANA) give rise and receiving quality care.5
collaboration in the coordination of to specific codes of ethical conduct
care from needs assessment through reflective of the scope of practice Examples/Types
an evaluation of the care provided. and professional expectations of Ethical dilemmas can occur in a variety
This article considers the background the nurse and social worker role. of settings, take on many forms, and
of ethical decision making in case Similarly, the purpose of The Code may present significant challenges to
management, a look into the ethical of Professional Conduct for Case the case manager. According to Corvol
Managers3 is to provide case managers and colleagues,4 ethical situations
Bios??? with a framework for practice. Case are most often one of three types:
managers are expected to adhere to refusal of care, decisions related to the
12 CareManagement February/March 2016 the principles outlined in the code to sharing and accumulating personal
provide safe, quality care. Because of health information, and the function
the number of hats a case manager of the case manager as it relates to the
must wear, case managers are held to distribution of resources.
The Code of Professional Conduct
for Case Managers as well as the code Case managers caring for a patient

Exclusively for ACCM Members

BOX 1 CODES OF ETHICS

CDMS The fundamental spirit of caring and respect with which the Code is written is based who is refusing care, assistance, or help
upon five principles of ethical behavior. These include autonomy, beneficence, of any kind are attempting to create a
nonmaleficence, justice, and fidelity, as defined below: balance between the ethical principles
of autonomy and beneficence. Case
• Autonomy: To honor the right to make individual decisions. managers have a fundamental duty to
establish trust with their patients and
• Beneficence: To do good to others. advocate for their needs while also
Nonmaleficence: To do no harm to others. respecting their choices and decisions.
The dilemma arises when an individual
• Justice: To act or treat justly or fairly. has been identified as needing help and
is refusing this assistance. An example
• Fidelity: To adhere to fact or detail. of this type of dilemma includes the
patient with a worrisome health con-
See the entire CDMS Code of Professional Conduct dition and persistent symptoms who
refuses to be hospitalized.4 Case manag-
NASW The mission of the social work profession is rooted in a set of core values. These ers who encounter these types of ethical
core values, embraced by social workers throughout the profession’s history, are situations must be prepared to provide
the foundation of social work’s unique purpose and perspective: substantial education and support to
their patients, including in-depth dis-
• Service cussion regarding the risks and benefits
associated with each of their options.
• Social justice
While defending the patient’s
• Dignity and worth of the person decision is most often the appropriate
choice, case managers must be
• Importance of human relationships prepared to intervene with the patient
who is cognitively impaired to the point
• Integrity that the ability to make responsible
judgements is compromised. Special
• Competence consideration should be given to
vulnerable populations including
See the entire NASW Code of Ethics children, ethnic minorities, the elderly,
and the uninsured. When confronted
CCMC Principles with acute situations where there is a
concern for the preservation of life the
• B oard-Certified Case Managers (CCMs) will place the public interest above their case managers must act according to
own at all times. established ethical guidelines to help in
preserving life while at the same time
• B oard-Certified Case Managers (CCMs) will respect the rights and inherent dignity addressing the wishes of the patient
of all of their clients. and family if appropriate.

• B oard-Certified Case Managers (CCMs) will always maintain objectivity in their Case managers utilize a number
relationships with clients. of complex assessment instruments in
order to collect information related
• B oard-Certified Case Managers (CCMs) will act with integrity and fidelity with to their patients. Many tools lead
clients and others. practitioners to ask questions of a
financial, sexual, or religious manner
• B oard-Certified Case Managers (CCMs) will maintain their competency at a level in order to connect them with the
that ensures their clients will receive the highest quality of service.
February/March 2016 CareManagement 13
• B oard-Certified Case Managers (CCMs) will honor the integrity of the CCM
designation and adhere to the requirements for its use.

• B oard-Certified Case Managers (CCMs) will obey all laws and regulations.

• B oard-Certified Case Managers (CCMs) will help maintain the integrity of the
Code, by responding to requests for public comments to review and revise the
code, thus helping ensure its consistency with current practice.

• B ecause case management exists in an environment that may look to it to solve
or resolve various problems in the health care delivery and payor systems, case
managers may often confront ethical dilemmas. Case managers must abide by the
Code as well as by the professional code of ethics for their specific professional
discipline for guidance and support in the resolution of these conflicts.

See the entire CCMC Code of Professional Conduct

CEU for CCM & CDMS Approved for 2 hours of CCM and CDMS ethics education credit
pullquote

resources most appropriate for their Methods/Tools Implementation
specific situation.4 While collaborating Health care workers endeavor to Ethical decision making depends on
with the interdisciplinary team and provide the best possible solutions the application of knowledge that
organizing the care of the patient, for ethical dilemmas that occur is consistent and evidence based.
consideration should be given to the in health care while prioritizing Case managers come from diverse
ethical principles of beneficence and patient’s interests and goals. It can be backgrounds in their professional
non-maleficence. Working to help our a challenge for providers to manage training and previous work experience.
patients and families experience the ethical decisions due to the unique This variation in educational
best possible outcomes while preventing needs of each patient. Consequently, background and experience requires
from causing them any harm through the value of ethical decision-making a focus on workplace training that
our actions or omissions. should be appraised not only in terms applies to the identification of ethical
of its outcome but also the process used dilemmas, use of a framework or
Case managers should work hard to to arrive at the decision.6 model to identify the values and
ensure that each patient’s information principles involved, and the reasoning
is protected and only shared with other There are a number of decision- or justification for the decision.9 The
health care providers who are directly making tools that strive to simplify the organizational mission, vision, and
involved in the care of that patient. Case process of making ethical decisions policies can also influence a case
managers are ethically accountable and work to clarify the source of moral manager’s ethical decision-making
to each of their patients and must perplexity. Moffat7 describes the need process and need to be considered
strive to respect each patient’s privacy for introspection regarding personal as a part of any training program.
when sharing or collecting personal values and perceptions that can Leadership and managers have the
information. With the advent of influence the ethical decision making responsibility to develop and implement
electronic medical records (EMR) there process. Decision-making models training regarding ethical decision
is potential risk for dissemination of help identify gaps in understanding making and be prepared to serve as an
unintended information. The emphasis and facilitate interdisciplinary exemplar in practice.
on confidentiality may overshadow communication with a patient-centered
the concerns for the availability and approach. Models that are consistently Training protocols should address
integrity of the information. applied to ethical situations can the basic tenets of ethical care
assist in the application and analysis including the care of the individual
Case managers are frequently throughout the decision making in a vulnerable condition, respect for
employed by organizations in which process. Thompson and coauthors8 individual autonomy, maintaining
there are various regulatory and developed the DECIDE Decision- competency in practice, adherence
financial limitations related to the Making Model. The acronym stands to all laws, and consistency in the
availability of resources.2 Additionally, for define the problem, establish the provision of care.1 Organizational
the resources that are accessible vary criteria, consider the alternatives, leaders should feel comfortable acting
based on the financial constraints of identify the best alternative, develop as role-models, coaches, and as a
each patient as well as the policies and implement a plan of action, and resource to case managers who struggle
and procedures in place which direct evaluate the solution/outcome. Use with ethical decisions in their practice.
how much care can be provided, how of this model will help case managers
often, in which setting, and by what when making ethical decisions through An important initial step in man-
professional. As case managers strive to the logical progression of the model. aging an ethical dilemma is to identify
provide quality care that is fair for all the specific issue, as well as the level
persons, the ethical principles of justice of the problem. Is this issue impactful
and beneficence should be considered. only to the patient? Will the decision

14 CareManagement February/March 2016

Exclusively for ACCM Members

made reach an entire group or pop- Behavioral signs of moral distress for Case Manager Certification (CCMC).
ulation? Case managers must be pre- and burnout may include low self-es- Revised January 2009. http://ccmcertification.
pared to identify the ethical principles teem, isolation, blaming, indifference, org/sites/default/files/downloads/2012/
involved as well as how the dilemma skepticism, and depression.7 To mitigate Code%20of%20Professional%20Conduct%20
originated. During this initial phase, the effects of moral distress, case man- for%20Case%20Managers.pdf. Accessed
case managers can address any infor- agers should seek professional mentors, February 14, 2016.
mation gaps that may be present. Case establish clear boundaries, and main- 4. Corvol A, Moutel G, Gagnon D, et al.
managers have a duty to ensure that the tain appropriate self-care measures, Ethical issues in the introduction of case
patient and family have all of the infor- including hygiene, diet, and exercise. management for elderly people. Nurs Ethics.
mation necessary to make an informed Case managers who are unable to prop- 2013;20(1):83-95.
and ethical decision. Case managers erly care for themselves are at risk for 5. Joo JY, Huber DL. An integrative review of
play a pivotal role in collaboration with providing ineffective care to the vulner- nurse-led community-based case management
the patient, family, and entire inter- able patients under their care. effectiveness. Int Nurs Rev. 2014;61(1):14-24.
disciplinary team in determining the 6. Park E. An integrated ethical decision
prevalent values and decisions. Conclusion making model for nurses. Nurs Ethics.
The evolving influence of technology, 2012;19(1):139-159.
Following the initial identification health care reform, and evidence-based 7. Moffat M. Reducing moral distress in case
and assessment of the situation, practice make the role of the case managers. Prof Case Manage. 2014;19(4):173-
case managers should formulate a manager essential to the 188.
possible course of action as well as interprofessional team. The functions 8. Thompson I, Melia K, Boyd K. Nursing
a determination of the benefits and of the case manager are vast, from that Ethics. 4th ed. Edinburgh, Scotland: Churchill
risks associated with each potential of change agent, to patient advocate Livingstone Publishers; 2011.
option. It is important to emphasize and coordinator of services. It is 9. Bicking C. Empowering nurses to partici-
that case managers must avoid taking important for the case manager to have pate in ethical decision-making at the bedside.
personal responsibility for system an understanding of basic ethical J Contin Educ Nurs. 2011;42(1):19-24.
or organizational deficiencies and principles and how these principles can
limitations. Each patient situation is very be applied to their practice. The case NEW! CE exams may be taken
different and each outcome may vary manager must be prepared to identify online! Click the link below to take the
greatly depending on multiple factors ethical dilemmas, information gaps test online and then immediately print
and decisions that are made throughout that may exist, and provide education your certificate after successfully completing
that patient’s care.2 A pertinent plan and support to patients and their the test. Members only benefit! Exams
should be created in association with families in order to formulate an expire June 30, 2016.
the patient, keeping in mind their appropriate plan of care. The use of an
unique perspective, values, and goals. established model such as the DECIDE Take this exam online >
model can provide the case manager
Once a specific course of with focus and direction in resolving – or print, complete and mail the exam
action is selected and subsequently ethical dilemmas in the workplace on pages 14–15.
implemented, it is essential that case while limiting personal bias and
managers spend time reflecting upon opinion. CE II You must be an ACCM member to take the
the decisions that were made and exam, click here to join ACCM.
reconcile those decisions with their References
own personal beliefs. Case managers February/March 2016 CareManagement 15
are unable to make professional 1. Case Management Society of America
decisions based upon personal (CMSA). CMSA Standards of Practice for Case
principles therefore increasing the Management. Rev ed. Little Rock, AR: CMSA;
likelihood of personal anguish, 2010.
burnout and moral distress. Moral
distress can be described as a human 2. Ramos M. The overwhelming moral and
reaction to ethical conflicts and ethical reality of care management practice.
limitations and can impact a case New Definition. 2015;29(2):1-3.
manager’s ability to effectively perform
essential job functions.7 3. Code of Professional Conduct for Case
Managers with Standards, Rules, Procedures
and Venalities. Adopted by the Commission

CE for CCM & CDMS, Contact Hours for RNs Exclusively for ACCM Members

CE exams may be taken online! Click the links below to take the test online and then immediately print your certificate after successfully
completing the test. Or print, complete and mail the exam on the next page. Members only benefit! Exams expire June 30, 2016.

exam I Take this exam online > exam II Take this exam online >

Case Management of Gram-Negative Bacilli– Ethical Dilemmas in Case Management
Caused UTI in Women and Children
1. What are the major concerns causing health care providers to focus on
1. UTIs account for how much in health care expenditures? ethical issues?
a. $2 billion a. Lifespan longevity
b. $4 billion b. Increasing number of patients with chronic conditions
c. $6 billion c. Availability and access to a variety of health care information sources
d. $8 billion d. All of the above

2. What is the number one causative agent in UTIs? 2. The specific Codes of Ethical Conduct developed by professional
a. Klebsiella associations and certifying bodies are meant to provide a framework
b. E. coli for practice.
c. Proteus
d. None of the above a. True b. False

3. Diagnosis of UTI based on clinical findings and the pathogen 3. The framework for ethical decision making includes:
identified via urinalysis. a. Beneficence
b. Non-maleficence
a. True b. False c. Justice
d. Autonomy
4. The antibiotic course and specific case management depends e. All of the above
on the:
a. Site of infection 4. What are the most common types of ethical situations?
b. Type and degree of illness a. Refusal of care
c. Presence of other predisposing factors b. Decision related to sharing and accumulating personal health information
d. All of the above c. Function of the case manager as it relates to the distribution of resources
d. All of the above
5. Appropriate case management can significantly decrease the
occurrence of complicated infections in pregnant women, 5. Case managers who encounter ethical situations must be prepared to
patients with urinary catheterizations, and/or women with provide substantial education and support to their patient.
anatomical obstructions, abdominal or pelvic mass, and stones.
a. True b. False

a. True b. False 6. Special consideration need not be given to vulnerable populations when
applying the tenets of ethical decision making.
6. The selected antibiotic should be effective for common
uropathogens but should not expose patients to unwarranted a. True b. False
risks.
7. When connecting patients with resources, the case manager may have to
a. True b. False ask questions about:
a. Financial matters
7. What percentage of women develop a UTI during their b. Sexual beliefs
lifetime? c. Religion
a. 30% d. All of the above
b. 40%
c. 50% 8. Decision-making models help identify gaps in understanding and
d. 60% facilitate interdisciplinary communication with a patient-centered
approach.
8. An initial 500-mg dose of intravenous ciprofloxacin is
recommended for treatment of acute pyelonephritis in women. a. True b. False

a. True b. False 9. Ethical decision making depends on the application of knowledge that is
consistent and evidenced based.
9. UTI is more common in boys younger than 1 year, but after the
first year more infections are seen in girls. a. True b. False

a. True b. False 10. Case managers must recognize signs of moral distress in themselves
when reconciling ethical dilemmas with their own beliefs. Signs of moral
10.According to the American Urological Association, what distress include:
percentage of nosocomial infections are UTIs? a. Low self-esteem
a. 20% b. Isolation
b. 30% c. Blaming
c. 35% d. All of the above
d. 40%

16 CareManagement February/March 2016

CE for CCM & CDMS, Contact Hours for RNs Exclusively for ACCM Members

exam I Case Management of Gram-Negative Bacilli–Caused UTI in Women and Children

Objectives:
1. State the symptoms of UTI._____________________________________________________________________________________________________
2. Describe current trends in treatment of gram-negative bacilli infections in women._____________________________________________________
3. State three treatment options in the treatment of UTI.______________________________________________________________________________
Please indicate your answer to the exam questions on page 14 by filling in the letter:

1. _____ 2. _____ 3. _____ 4. _____ 5. _____ 6. _____ 7. _____ 8. _____ 9. _____ 10. _____

exam II E thical Dilemmas in Case Management

Objectives:
1. State the four principles that provide the framework for ethical decision making. ______________________________________________________
2. Review two examples of ethical dilemmas in case management. ______________________________________________________________________
3. Describe three decision-making tools in resolving ethical dilemmas. __________________________________________________________________

Please indicate your answer to the exam questions on page 14 by filling in the letter:

1. _____ 2. _____ 3. _____ 4. _____ 5. _____ 6. _____ 7. _____ 8. _____ 9. _____ 10. _____

Continuing Education Program Evaluation Please indicate your rating by circling the appropriate number using a scale of 1 (low) to 5 (high).

exam I exam II

1. The objectives were met. 1 2 3 4 5 12345
2. The article was clear and well organized. 1 2 3 4 5 12345

3. The topic was both relevant and interesting to me. 1 2 3 4 5 12345

4. The amount and depth of the material was adequate. 1 2 3 4 5 12345
5. The quality and amount of the graphics were effective. 1 2 3 4 5 12345
6. I would recommend this article. 1 2 3 4 5 12345
7. This has been an effective way to present continuing education. 1 2 3 4 5 12345

8. Additional comments:_

Please print:
Certificant’s Name: ___________________________________________________ CCM ID#___________________________________________________

Email Address: ___________________________________________________ CDMS ID#_________________________________________________

Mailing Address: ___________________________________________________ RN ID#___________________________________________________

___________________________________________________ *ACCM Membership#______________________________________

___________________________________________________ *ACCM Expiration Date:____________________________________

____ CE contact hours applied for: CCM RN CDM
*CE exams cannot be processed without above information.

Each educational manuscript has been approved for 2 hours of CCM and CDMS education credit by The Commission for Case Manager Certification and the Certification of Disability
Management Specialists Commission. Provider #00059431. Each manuscript has also been approved for 2 contact hours of nursing credit by the California Board of Registered Nursing.
Provider # CEP 8083. Exams are for ACCM members only.* ACCM members must indicate their membership number and membership expiration date in the space provided on the
answer sheet. Exams cannot be processed without this information.** To receive credit for either exam, you must score 80% or above. Exams June 30, 2016.

Please note: Exams may be taken online at www.academyCCM.org. Click the link in the journal, take the exam, and immediately print your certificate after successfully completing
the test. Mailed exams should be sent to: Academy of Certified Case Managers, 1574 Coburg Road #225, Eugene, Oregon 97401. Please allow 4 to 6 weeks for processing of mailed exams.

This CE exam is protected by US Copyright law. ACCM members are permitted to make one copy for the purpose of exam submission. Multiple copies are not permitted.

*If you are not an ACCM member and wish to become one, please use the application found on page 31 and submit it with this exam and dues.
**If you have lost or misplaced your membership information, please print the exam and mail it to the address above with a check in the amount of $5.00 made payable to

ACCM; your exam will be processed and your membership number and expiration date will be emailed to you.

February/March 2016 CareManagement 17

PharmaFacts for Case Managers

New Approvals table above.
Renal Impairment, including hemodialysis: No dosage adjustment of
Zepatier™ (elbasvir and grazoprevir) tablets Zepatier is recommended. Refer to ribavirin prescribing information
for ribavirin dosing and dosage modifications.
Indications and Usage Dosage Forms and Strengths
Zepatier is a fixed-dose combination product containing elbasvir, a Tablets: 50 mg elbasvir and 100 mg grazoprevir
hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV Contraindications
NS3/4A protease inhibitor, and is indicated with or without ribavirin Zepatier is contraindicated in patients with moderate or severe
for treatment of chronic HCV genotypes 1 or 4 infection in adults. hepatic impairment (Child- Pugh B or C) due to the expected signifi-
cantly increased grazoprevir plasma concentration and the increased
Dosage and Administration risk of alanine aminotransferase (ALT) elevations.
Testing prior to initiation: Zepatier is contraindicated with organic anion transporting polypep-
• Genotype 1a: Testing for the presence of virus with NS5A resis- tides 1B1/3 (OATP1B1/3) inhibitors, strong inducers of cytochrome
P450 3A (CYP3A), and efavirenz.
tance-associated polymorphisms is recommended. If Zepatier is administered with ribavirin, the contraindications
• O btain hepatic laboratory testing. to ribavirin also apply to this combination regimen. Refer to the
• R ecommended dosage: One tablet taken orally once daily with or ribavirin prescribing information for a list of contraindications for
ribavirin.
without food. Drugs that are Contraindicated with Zepatier
HCV/HIV-1 co-infection: Follow the dosage recommendations in the

TABLE 1

Dosage Regimens and Durations for Zepatier in Patients
with Genotype 1 or 4 HCV with or without Cirrhosis

Patient Population Treatment Duration

Genotype 1a: Treatment-naïve or Zepatier 12 weeks
PegIFN/RBV-experienced* without
baseline NS5A polymorphisms† Drug Class Drug(s) within Clinical Comment*
Genotype 1a: Treatment-naïve or Class that are
PegIFN/RBV-experienced* with Zepatier + 16 weeks Contraindicated
baseline NS5A polymorphisms† ribavirin
Anticonvulsants Phenytoin May lead to loss of
Genotype 1b: Treatment-naïve or Zepatier 12 weeks Antimyco­bacterials Carbamazepine virologic response to
PegIFN/RBV-experienced* Rifampin ZEPATIER due to signifi-
cant decreases in elbasvir
Genotype 1a or 1b: PegIFN/RBV/ Zepatier + 12 weeks and grazoprevir plasma
PI-experienced‡ ribavirin concentrations caused by
strong CYP3A induction.
Genotype 4: Treatment-naïve Zepatier 12 weeks May lead to loss of
virologic response to
Genotype 4: Zepatier + 16 weeks ZEPATIER due to signifi-
PegIFN/RBV-experienced* ribavirin cant decreases in elbasvir
and grazoprevir plasma
*Peginterferon alfa + ribavirin. concentrations caused by
†Polymorphisms at amino acid positions 28, 30, 31, or 93. strong CYP3A induction.

‡Peginterferon alfa + ribavirin + HCV NS3/4A protease inhibitor.

18 CareManagement February/March 2016

PharmaFacts for Case Managers

Herbal Products St. John’s Wort May lead to loss of tors is not recommended as they may increase the plasma concen-
HIV Medications (Hypericum virologic response to tration of Zepatier.
HIV Medications perforatum) ZEPATIER due to signifi- • C onsult the full prescribing information prior to and during treat-
Efavirenz† cant decreases in elbasvir ment for potential drug interactions.
Atazanavir and grazoprevir plasma
Darunavir concentrations caused by Use in Specific Populations
Lopinavir strong CYP3A induction.
Saquinavir May lead to loss of Pregnancy
Tipranavir virologic response to Risk Summary
ZEPATIER due to signifi- No adequate human data are available to establish whether or not
cant decreases in elbasvir Zepatier poses a risk to pregnancy outcomes. In animal reproduc-
and grazoprevir plasma tion studies, no evidence of adverse developmental outcomes was
concentrations caused by observed with the components of Zepatier (elbasvir or grazoprevir) at
CYP3A induction. exposures greater than those in humans at the recommended human
May increase the risk dose (RHD). During organogenesis in the rat and rabbit, systemic
of ALT elevations due exposures (AUC) were approximately 10 and 18 times (for elbasvir)
to a significant increase and 117 and 41 times (for grazoprevir), respectively, the exposure
in grazoprevir plasma in humans at the RHD. In rat pre/postnatal developmental studies,
concentrations caused by maternal systemic exposures (AUC) to elbasvir and grazoprevir were
OATP1B1/3 inhibition. approximately 10 and 78 times, respectively, the exposure in humans
at the RHD.
Immuno­suppressants Cyclosporine May increase the risk
of ALT elevations due The background risk of major birth defects and miscarriage
to a significant increase for the indicated population is unknown. In the U.S. general pop-
in grazoprevir plasma ulation, the estimated background risk of major birth defects and
concentrations caused by miscarriage in clinically recognized pregnancies is 2%–4% and
OATP1B1/3 inhibition. 15%–20%, respectively.

*This table is not a comprehensive list of all drugs that inhibit OATP1B1/3 or If Zepatier is administered with ribavirin, the combination
regimen is contraindicated in pregnant women and in men whose
strongly induce CYP3A. female partners are pregnant. Refer to the ribavirin prescribing
information for more information on use in pregnancy.
†Efavirenz is included as a strong CYP3A inducer in this table, since co-administra-
Data
tion reduced grazoprevir exposure by ≥80% Animal Data
Elbasvir: Elbasvir was administered orally at up to 1000 mg/kg/day
Warnings and Precautions to pregnant rats and rabbits on gestation days 6 to 20 and 7 to 20,
• ALT elevations: Perform hepatic laboratory testing prior to ther- respectively, and also to rats on gestation day 6 to lactation/post-
partum day 20. No effects on embryo-fetal (rats and rabbits) or pre/
apy, at treatment week 8, and as clinically indicated. For patients postnatal (rats) development were observed at up to the highest dose
receiving 16 weeks of therapy, perform additional hepatic labora- tested. Systemic exposures (AUC) to elbasvir were approximately 10
tory testing at treatment week 12. For ALT elevations on Zepatier, (rats) and 18 (rabbits) times the exposure in humans at the RHD. In
follow recommendations in full prescribing information. both species, elbasvir has been shown to cross the placenta, with
• R isk associated with ribavirin combination treatment: If Zepatier fetal plasma concentrations of up to 0.8% (rabbits) and 2.2% (rats)
is administered with ribavirin, the warnings and precautions for that of maternal concentrations observed on gestation day 20.
ribavirin also apply.
Grazoprevir: Grazoprevir was administered to pregnant rats (oral
Adverse Reactions doses up to 400 mg/kg/day) and rabbits (intravenous doses up to 100
In subjects receiving Zepatier for 12 weeks, the most commonly mg/kg/day) on gestation days 6 to 20 and 7 to 20, respectively, and
reported adverse reactions of all intensity (greater than or equal to also to rats (oral doses up to 400 mg/kg/day) on gestation day 6 to
5% in placebo-controlled trials) were fatigue, headache, and nausea. lactation/post-partum day 20. No effects on embryo-fetal (rats and
In subjects receiving Zepatier with ribavirin for 16 weeks, the most rabbits) or pre/postnatal (rats) development were observed at up to the
commonly reported adverse reactions of moderate or severe intensity highest dose tested. Systemic exposures (AUC) to grazoprevir were
(greater than or equal to 5%) were anemia and headache. ≥78 (rats) and 41 (rabbits) times the exposure in humans at the RHD.

Drug Interactions February/March 2016 CareManagement 19
• Co-administration of Zepatier with moderate CYP3A inducers is

not recommended as they may decrease the plasma concentration
of Zepatier.
• Co-administration of Zepatier with certain strong CYP3A inhibi-

PharmaFacts for Case Managers

In both species, grazoprevir has been shown to cross the placenta, with compensated liver disease (with or without cirrhosis). An
with fetal plasma concentrations of up to 7% (rabbits) and 89% (rats) overview of the 6 trials (n=1373) contributing to the assessment
that of maternal concentrations observed on gestation day 20. of efficacy in genotype 1 or 4 is provided. C-EDGE TN, C-EDGE
COINFECTION, C-SCAPE, and C-EDGE TE also included subjects
Females and Males of Reproductive Potential with genotype 6 HCV infection (n=28). Because Zepatier is not
If Zepatier is administered with ribavirin, the information for riba- indicated for genotype 6 infection, results in patients with genotype
virin with regard to pregnancy testing, contraception, and infertility 6 infection are not included in Clinical Studies.
also applies to this combination regimen. Refer to ribavirin prescrib-
ing information for additional information. Zepatier was administered once daily by mouth in these trials.
For subjects who received ribavirin (RBV), the RBV dosage was
Pediatric Use weight-based (less than 66 kg = 800 mg per day, 66 to 80 kg =
Safety and efficacy in pediatric patients have not been established in 1000 mg per day, 81 to 105 kg = 1200 mg per day, greater than 105
pediatric patients less than 18 years of age. kg = 1400 mg per day) administered by mouth in two divided doses
with food.
Clinical trials of Zepatier with or without ribavirin included
187 subjects aged 65 years and over. Higher elbasvir and grazopre- Sustained virologic response (SVR) was the primary endpoint
vir plasma concentrations were observed in subjects aged 65 years in all trials and was defined as HCV RNA less than lower limit of
and over. A higher rate of late ALT elevations was observed in sub- quantification (LLOQ) at 12 weeks after the cessation of treatment
jects aged 65 years and over in clinical trials. However, no dosage (SVR12). Serum HCV RNA values were measured during these clin-
adjustment of Zepatier is recommended in geriatric patients ical trials using the COBAS AmpliPrep/COBAS Taqman HCV test
(version 2.0) with an LLOQ of 15 HCV RNA IU per mL, with the
Gender exception of C-SCAPE where the assay had an LLOQ of 25 HCV
Higher elbasvir and grazoprevir plasma concentrations were RNA IU per mL.
observed in females compared to males. Females experienced a
higher rate of late ALT elevations in clinical trials. However, no dose Clinical Trials in Treatment-Naïve Subjects with Genotype 1
adjustment of Zepatier is recommended based on gender. HCV (C-EDGE TN and C-EDGE COINFECTION)
The efficacy of Zepatier in treatment-naïve subjects with genotype
Race 1 chronic hepatitis C virus infection with or without cirrhosis was
Higher elbasvir and grazoprevir plasma concentrations were demonstrated in the C-EDGE TN and C-EDGE COINFECTION trials.
observed in Asians compared to Caucasians. Asians experienced a
higher rate of late ALT elevations in clinical trial. However, no dose C-EDGE TN was a randomized, double-blind, placebo-
adjustment of Zepatier is recommended based on race/ethnicity. controlled trial in treatment-naïve subjects with genotype 1 or 4
infection with or without cirrhosis. Subjects were randomized in
Renal Impairment a 3:1 ratio to: Zepatier for 12 weeks (immediate treatment group)
No dosage adjustment of Zepatier is recommended in patients with or placebo for 12 weeks followed by open-label treatment with
any degree of renal impairment including patients receiving hemo- Zepatier for 12 weeks (deferred treatment group). Among subjects
dialysis. Administer Zepatier with or without ribavirin according to with genotype 1 infection randomized to the immediate treatment
recommendations. Refer to the prescribing information for ribavirin group, the median age was 55 years (range: 20 to 78); 56% of the
tablets for renal dosage adjustment of ribavirin in patients with CrCl subjects were male; 61% were White; 20% were Black or African
less than or equal to 50 mL/minute. American; 8% were Hispanic or Latino; mean body mass index was
26 kg/m2; 72% had baseline HCV RNA levels greater than 800,000
Hepatic Impairment IU per mL; 24% had cirrhosis; 67% had non-C/C IL28B alleles
No dosage adjustment of Zepatier is recommended in patients with (CT or TT); and 55% had genotype 1a and 45% had genotype 1b
mild hepatic impairment (Child-Pugh A). Zepatier is contraindicated chronic HCV infection.
in patients with moderate hepatic impairment (Child-Pugh B) due
to the lack of clinical safety and efficacy experience in HCV-infected C-EDGE COINFECTION was an open-label, single-arm trial
Child-Pugh B patients, patients with severe hepatic impairment in treatment-naïve HCV/HIV-1 co- infected subjects with geno-
(Child-Pugh C) due to a 12-fold increase in grazoprevir exposure in type 1 or 4 infection with or without cirrhosis. Subjects received
non-HCV infected Child-Pugh C subjects. Zepatier for 12 weeks. Among subjects with genotype 1 infection,
the median age was 50 years (range: 21 to 71); 85% of the subjects
The safety and efficacy of Zepatier have not been established in were male; 75% were White; 19% were Black or African American;
patients awaiting liver transplant or in liver transplant recipients. 6% were Hispanic or Latino; mean body mass index was 25 kg per
m2; 59% had baseline HCV RNA levels greater than 800,000 IU
Overview of Clinical Trials per mL; 16% had cirrhosis; 65% had non-C/C IL28B alleles (CT or
The efficacy of Zepatier was assessed in 2 placebo-controlled trials TT); and 76% had genotype 1a, 23% had genotype 1b, and 1% had
and 4 uncontrolled Phase 2 and 3 clinical trials in 1401 subjects
with genotype (GT) 1, 4, or 6 chronic hepatitis C virus infection

20 CareManagement February/March 2016

PharmaFacts for Case Managers

genotype 1-Other chronic HCV infection. chronic kidney disease (CKD) Stage 4 (eGFR 15-29 mL/min/1.73
Clinical Trials in Treatment-Experienced Subjects with Genotype 1 m2) or CKD Stage 5 (eGFR <15 mL/min/1.73 m2), including subjects
HCV on hemodialysis, who were treatment-naïve or who had failed prior
Treatment-Experienced Subjects who Failed Prior PegIFN with RBV therapy with IFN or PegIFN ± RBV therapy. Subjects were random-
Therapy (C-EDGE TE) ized in a 1:1 ratio to one of the following treatment groups: EBR 50
C-EDGE TE was a randomized, open-label comparative trial in sub- mg once daily + GZR 100 mg once daily for 12 weeks (immediate
jects with genotype 1 or 4 infection, with or without cirrhosis, with treatment group) or placebo for 12 weeks followed by open- label
or without HCV/HIV-1 co-infection, who had failed prior therapy treatment with EBR + GZR for 12 weeks (deferred treatment group).
with PegIFN + RBV therapy. Subjects were randomized in a 1:1:1:1 In addition, 11 subjects received open-label EBR + GZR for 12 weeks
ratio to one of the following treatment groups: Zepatier for 12 weeks, (intensive pharmacokinetic [PK] group). Subjects randomized to the
Zepatier + RBV for 12 weeks, Zepatier for 16 weeks, or Zepatier + immediate treatment group and intensive PK group had a median
RBV for 16 weeks. Among subjects with genotype 1 infection, the age of 58 years (range: 31 to 76); 75% of the subjects were male;
median age was 57 years (range: 19 to 77); 64% of the subjects were 50% were White; 45% were Black or African American; 11% were
male; 67% were White; 18% were Black or African American; 9% Hispanic or Latino; 57% had baseline HCV RNA levels greater than
were Hispanic or Latino; mean body mass index was 28 kg/m2; 78% 800,000 IU/mL; 6% had cirrhosis; and 72% had non-C/C IL28B
had baseline HCV RNA levels greater than 800,000 IU/mL; 34% had alleles (CT or TT).
cirrhosis; 79% had non-C/C IL28B alleles (CT or TT); and 60% had C-SURFER: SVR12 in Subjects with Severe Renal Impairment
genotype 1a, 39% had genotype 1b, and 1% had genotype 1-Other including Subjects on Hemodialysis who were Treatment-Naïve or
chronic HCV infection. had Failed Prior IFN or PegIFN ± RBV, with or without Cirrhosis,
Treatment outcomes in genotype 1 subjects treated with Zepatier for with Genotype 1 HCV Treated with ZEPATIER for 12 Weeks
12 weeks or Zepatier with RBV for 16 weeks are presented in nelow.
Treatment outcomes with Zepatier with RBV for 12 weeks or without Regimen EBR + GZR
RBV for 16 weeks are not shown because these regimens are not
recommended in PegIFN/RBV-experienced genotype 1 patients. 12 weeks (Immediate Treatment Group)
Treatment-Experienced Subjects Who Failed Prior PegIFN + RBV +
HCV Protease Inhibitor Therapy (C- SALVAGE) N=122*
C-SALVAGE was an open-label single-arm trial in subjects with
genotype 1 infection, with or without cirrhosis, who had failed prior Overall SVR 94% (115/122)†
treatment with boceprevir, simeprevir, or telaprevir in combination
with pegIFN + RBV. Subjects received EBR 50 mg once daily + GZR Outcome for subjects without SVR
100 mg once daily + RBV for 12 weeks. Subjects had a median age
of 55 years (range: 23 to 75); 58% of the subjects were male; 97% On-treatment 0% (0/122)
were White; 3% were Black or African American; 15% were Hispanic Virologic Failure
or Latino; mean body mass index was 28 kg/m2; 63% had baseline Relapse <1% (1/122)
HCV RNA levels greater than 800,000 IU/mL; 43% had cirrhosis; Other‡ 5% (6/122)
and 97% had non-C/C IL28B alleles (CT or TT); 46% had baseline
NS3 resistance-associated substitutions. SVR by Genotype
Overall SVR was achieved in 96% (76/79) of subjects receiving EBR
+ GZR + RBV for 12 weeks. Four percent (3/79) of subjects did not GT 1a 97% (61/63)
achieve SVR due to relapse. Treatment outcomes were consistent GT 1b§ 92% (54/59)
in genotype 1a and genotype 1b subjects, in subjects with different
response to previous HCV therapy, and in subjects with or without SVR by Cirrhosis status
cirrhosis. Treatment outcomes were generally consistent in subjects
with or without NS3 resistance-associated substitutions at baseline, No 95% (109/115)
although limited data are available for subjects with specific NS3
resistance-associated substitutions. Yes 86% (6/7)
Clinical Trial in Subjects with Genotype 1 HCV and Severe Renal
Impairment including Subjects on Hemodialysis (C-SURFER) SVR by Prior HCV Treatment Status
C-SURFER was a randomized, double-blind, placebo-controlled trial
in subjects with genotype 1 infection, with or without cirrhosis, with Treatment-naïve 95% (96/101)

Treatment- 90% (19/21)
experienced
SVR by Dialysis Status

No 97% (29/30)

Yes 93% (86/92)

SVR by Chronic Kidney Disease Stage

February/March 2016 CareManagement 21

PharmaFacts for Case Managers

Stage 4 100% (22/22) Tablets: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200mcg,
1400 mcg, 1600 mcg.
Stage 5 93% (93/100) Contraindications
None
*Includes subjects (n=11) in the intensive PK group. Warnings and Precautions
Pulmonary edema in patients with pulmonary veno-occlusive dis-
†SVR was achieved in 99% (115/116) of subjects in the pre-specified ease. If confirmed, discontinue treatment.
Adverse Reactions
primary analysis population, which excluded subjects not receiving Adverse reactions occurring more frequently (>5%) on Uptravi com-
pared to placebo are headache, diarrhea, jaw pain, nausea, myalgia,
at least one dose of study treatment and those with missing data vomiting, pain in extremity, and flushing.
Drug Interactions
due to death or early study discontinuation for reasons unrelated to Strong CYP2C8 inhibitors: increased exposure to selexipag and its
active metabolite. Avoid concomitant use.
treatment response. Use in Specific Populations
Nursing mothers: discontinue Uptravi or breastfeeding.
‡Other includes subjects who discontinued due to adverse event, lost Severe hepatic impairment: Avoid use.
Clinical Studies
to follow-up, or subject withdrawal. Pulmonary Arterial Hypertension
The effect of selexipag on progression of PAH was demonstrated in a
§Includes genotype 1 subtypes other than 1a or 1b. multi-center, double-blind, placebo-controlled, parallel group, event-
driven study (GRIPHON) in 1156 patients with symptomatic (WHO
Clinical Trials with Genotype 4 HCV Functional Class I [0.8%], II [46%], III [53%], and IV [1%] ) PAH.
Patients were randomized to either placebo (N = 582), or Uptravi (N
The efficacy of Zepatier in subjects with genotype 4 chronic = 574). The dose was increased in weekly intervals by increments of
200 mcg twice a day to the highest tolerated dose up to 1600 mcg
HCV infection was demonstrated in C-EDGE TN, C-EDGE twice a day.
The primary study endpoint was the time to first occurrence up to
COINFECTION, C-EDGE TE, and C-SCAPE. C-SCAPE was a ran- end-of-treatment of: a) death,
b) hospitalization for PAH, c) PAH worsening resulting in need
domized, open-label trial which included treatment-naïve subjects for lung transplantation, or balloon atrial septostomy, d) initiation
of parenteral prostanoid therapy or chronic oxygen therapy, or e)
with genotype 4 infection without cirrhosis. Subjects were random- other disease progression based on a 15% decrease from baseline in
6MWD plus worsening of Functional Class or need for additional
ized in a 1:1 ratio to EBR 50 mg once daily + GZR 100 mg once daily PAH-specific therapy.
The mean age was 48 years, the majority of patients were white
for 12 weeks or EBR 50 mg once daily + GZR 100 mg once daily + (65%) and female (80%). Nearly all patients were in WHO Functional
Class II and III at baseline.
RBV for 12 weeks. In these combined studies in subjects with geno- Idiopathic or heritable PAH was the most common etiology in the
study population (58%) followed by PAH associated with connective
type 4 infection, 64% were treatment-naïve; 66% of the subjects were tissue disease (29%), PAH associated with congenital heart disease
with repaired shunts (10%), drugs and toxins (2%), and HIV (1%).
male; 87% were White; 10% were Black or African American; 22% At baseline, the majority of enrolled patients (80%) were being
treated with a stable dose of an endothelin receptor antagonist (15%),
had cirrhosis; and 30% had HCV/HIV-1 co-infection. a PDE-5 inhibitor (32%), or both (33%).
Patients on selexipag achieved doses within the following groups:
In C-SCAPE, C-EDGE TN, and C-EDGE COINFECTION trials 200-400 mcg (23%), 600-1000 mcg (31%) and 1200-1600 mcg
(43%).
combined, a total of 66 genotype 4 treatment-naïve subjects received Treatment with Uptravi resulted in a 40% reduction (99% CI: 22
to 54%; two-sided log-rank p-value < 0.0001) of the occurrence of
Zepatier or EBR + GZR for 12 weeks. In these combined trials,

SVR12 among subjects treated with Zepatier or EBR + GZR for 12

weeks was 97% (64/66).

In C-EDGE TE, a total of 37 genotype 4 treatment-experienced

subjects received a 12- or 16-week Zepatier with or without RBV

regimen. SVR12 among randomized subjects treated with Zepatier +

RBV for 16 weeks was 100% (8/8).

Zepatier is manufactured by Merck Sharp and Dohme, Inc. a subsid-

iary of Merck and Co.

Uptravi® (selexipag) tablets, for oral use

Indications and Usage
Uptravi is a prostacyclin receptor agonist indicated for the treatment
of pulmonary arterial hypertension (PAH, WHO Group I) to delay
disease progression and reduce the risk of hospitalization for PAH.
Dosage and Administration
Starting dose: 200 mcg twice daily.
Increase the dose by 200 mcg twice daily at weekly intervals to the
highest tolerated dose up to 1600 mcg twice daily.
Maintenance dose is determined by tolerability.
Moderate hepatic impairment: Starting dose 200 mcg once daily,
increase the dose by 200 mcg once daily at weekly intervals to the
highest tolerated dose up to 1600 mcg.
Dosage Forms and Strengths

22 CareManagement February/March 2016

LitScan
FOR CASE MANAGERS

LitScan for Case Managers reviews medical literature and reports abstracts that are of particular interest to
case managers in an easy-to-read format. Each abstract includes information to locate the full-text article
if there is an interest. This member benefit is designed to assist case managers in keeping current with clinical
breakthroughs in a time-effective manner.

Oncologist. 2015 Nov 27. pii: theoncologist.2015-0162. [Epub reduced HIV transmission. National HIV Surveillance System
Clin Infect Dis. 2016 Jan 29. pii: civ1224. [Epub ahead of print] (NHSS) data are used to monitor progress toward reaching the
National HIV/AIDS Strategy goals to improve care among persons
CD4 cell count: declining value for antiretroviral living with HIV and to reduce HIV-related disparities. CDC used
therapy eligibility. NHSS data to describe retention in HIV care over 3 years and
describe differences by race/ethnicity. Among persons with HIV
Ying R, Granich RM, Gupta S, Williams BG. infection diagnosed in 2010 who were alive in December 2013,
Antiretroviral therapy (ART) policy for people living with human 38% of blacks with HIV infection were consistently retained in
immunodeficiency virus (HIV) has historically been based on care during 2011-2013, compared with 50% of Hispanics/Latinos
clinical indications, such as opportunistic infections and CD4 cell (Hispanics) and 49% of non-Hispanic whites (whites). Differences
counts. Studies suggest that CD4 counts early in HIV infection in consistent retention in care by race/ethnicity persisted when
do not predict relevant public health outcomes such as disease pro- groups were stratified by sex or transmission category. Among
gression, mortality, and HIV transmission in people living with blacks, 35% of males were consistently retained in care compared
HIV. CD4 counts also vary widely within individuals and among with 44% of females. Differences in HIV care retention by race/
populations, leading to imprecise measurements and arbitrary ethnicity were established during the first year after diagnosis.
ART initiation. To capture the clinical and preventive benefits Efforts to establish early HIV care among blacks are needed to
of treatment, the global HIV response now focuses on increasing mitigate racial/ethnic disparities in HIV outcomes over time.
HIV diagnosis and ART coverage. CD4 counts for ART initiation
were necessary when medications were expensive and had severe Clin Res Hepatol Gastroenterol. 2016 Jan 25. pii: S2210-
side effects, and when the impact of early ART initiation was 7401(15)00294-6. doi: 10.1016/j.clinre.2015.12.003. [Epub ahead
unclear. However, current evidence suggests that although CD4 of print]
counts may still play a role in guiding clinical care to start prophy-
laxis for opportunistic infections, CD4 counts should cease to be Alterations in serum levels of fetuin A and sele-
required for ART initiation. noprotein P in chronic hepatitis C patients with
concomitant type 2 diabetes: a case-control study.
MMWR Morb Mortal Wkly Rep. 2016;65(4):77-82. doi:
10.15585/mmwr.mm6504a2. Ali SA, Nassif WM, Abdelaziz DH.
BACKGROUND: Insulin resistance (IR) and type 2 diabetes
Disparities in consistent retention in HIV care: 11 mellitus (T2DM) are serious extrahepatic manifestations of chronic
states and the District of Columbia, 2011-2013. hepatitis C virus (HCV) infection. However, the mechanism
underlying the IR in chronic HCV is obscure. Hepatokines are
Dasgupta S, Oster AM, Li J, DPE, Hall HI. group of liver-derived protein, which affect the glucose and lipid
In 2013, 45% of new human immunodeficiency virus (HIV) infec- metabolism in several tissues. Fetuin A (also known as human
tion diagnoses occurred in non-Hispanic blacks/African Americans α2-HS-glycoprotein) is one of the hepatokines, which was recog-
(blacks) (1), who represent 12% of the US. POPULATION: nized as a natural inhibitor of the insulin receptor tyrosine kinase
Antiretroviral therapy (ART) improves clinical outcomes and in liver and skeletal muscle. Additionally, selenoprotein P has
reduces transmission of HIV, which causes acquired immunode- emerged as an important hepatokine, which primarily acts as sele-
ficiency syndrome (AIDS) (2). Racial/ethnic disparities in HIV nium transporter and has been reported to be implicated in glucose
care limit access to ART, perpetuating disparities in survival and homeostasis in human. OBJECTIVE: The aim of the current

February/March 2016 CareManagement 23

LitScan American adults, the proportion with cirrhosis has increased rap-
FOR CASE MANAGERS idly. Cirrhosis prevalence remains high in individuals unaware of
their HCV infection. These data highlight the urgency for HCV
case-control study was to investigate the serum levels of both fetuin screening regardless of symptoms, systematic assessment for liver
A and selenoprotein P in chronic hepatitis C patients with or with- fibrosis in those with HCV infection and institution of antivirals
out T2DM and to correlate their levels with other biochemical to prevent advanced liver disease.
parameters of insulin resistance. MAIN FINDINGS: Our results
showed that, serum fetuin A levels increased significantly in HCV Am J Cardiol. 2015 Dec 31. pii: S0002-9149(15)30077-1. doi:
patients compared with controls (P<0.01) and surplus increase was 10.1016/j.amjcard.2015.12.032. [Epub ahead of print]
found in HCV with concomitant T2DM (P>0.001). However, sele-
noprotein P levels significantly elevated only in patients with both Effect of early intervention with positive airway
HCV and T2DM (P<0.05) compared with the healthy subjects. pressure therapy for sleep disordered breathing
Both fetuin A and selenoprotein P were positively correlated with on six-month readmission rates in hospitalized
fasting blood glucose. Yet, only fetuin A was significantly correlated patients with heart failure.
to the HOMA-IR (r=0.28; P=0.03).CONCLUSIONS: These
results indicate crucial roles played by fetuin A and selenoprotein P Sharma S, Mather P, Gupta A, et al.
in the IR caused by HCV and that both hepatokines may be targets Rehospitalization for congestive heart failure (CHF) is high
for the development of therapies to treat or inhibit insulin resistance within 6 months of discharge. Sleep disordered breathing (SDB)
associated to HCV. However, further studies on large scale should is common and underdiagnosed condition in patients with
be conducted to confirm our findings. CHF. We hypothesized that early recognition and treatment
of SDB in hospitalized patients with CHF will reduce hospital
J Hepatol. 2016 Jan 22. pii: S0168-8278(16)00014-3. doi: readmissions and emergency room visits. Patients admitted for
10.1016/j.jhep.2016.01.009. [Epub ahead of print] CHF underwent overnight polysomnography within 4 weeks of
discharge. Patients diagnosed with SDB were provided therapy
Increasing prevalence of cirrhosis among US adults with positive airway pressure therapy. Patients were identified as
aware or unaware of their chronic hepatitis C virus having good compliance if the device use was for a minimum of
infection. 4 hours 70% of the time for a minimum of 4 weeks during the
first 3 months of therapy. Hospital admissions for 6 months before
Udompap P, Mannalithara A, Heo N, Kim D, Ray Kim W. therapy were compared with readmission within 6 months after
BACKGROUND AND AIMS: Cirrhosis from hepatitis C virus therapy in patients with good and poor compliance. A total of
(HCV) infection is a major cause of end-stage liver disease and 70 patients were diagnosed with SDB after discharge. Of the 70
hepatocellular carcinoma worldwide. We determine the prevalence patients, 37 (53%) were compliant with positive airway pressure
of cirrhosis among HCV-infected American adults including those therapy. Compliant patients were more likely to be older (64 ± 12
unaware of their infection. METHODS: Using the National vs 58 ± 11 years) and women (54% vs 33%) and less likely to be
Health and Nutrition Examination Survey (NHANES) data, we patient with diabetes (40% vs 67%) versus noncompliant patients.
identified participants aged⩾20 years with detectable serum HCV Although both groups experienced a decrease in total readmissions,
RNA. The prevalence of advanced fibrosis and cirrhosis was deter- compliant patients had a significant reduction (mean ± SE: -1.5 ±
mined for Eras 1 (1988-94), 2 (1999-2006) and 3 (2007-12) by 0.2 clinical events vs -0.2 ± 0.3; p <0.0001). In this single-center
using FIB-4 > 3.25 and APRI > 2.0, respectively. RESULTS: Out analysis, identification and treatment of SDB in admitted patients
of 52,644 NHANES examinees, 49,429 were tested for HCV, of with CHF with SDB is associated with reduced readmissions over
whom 725 met the inclusion criteria (positive HCV RNA with 6 months after discharge. Adherence to the treatment was associ-
available data for FIB-4 and APRI). Based on APRI, 6.6% (95% ated with a greater reduction in clinical events.
confidence interval [CI]: 2.2-11.0) of HCV-infected adults in Era
1, 7.6% (95% CI: 3.4-11.8) in Era 2 and 17.0% (95% CI: 8.0- Clin Cardiol. 2016 Feb 3. doi: 10.1002/clc.22520. [Epub ahead of
26.0) in Era 3 had cirrhosis. In the multivariable regression anal- print]
ysis, this era effect was attributable to increasing age (odds ratio
[OR]:1.04, 95%CI: 1.02-1.07), diabetes (OR: 2.33, 95% CI: 1.01- Depression and multiple rehospitalizations in
5.40) and obesity (OR: 2.96, 95% CI: 1.15-7.57). Cirrhosis was
as common among respondents who were unaware of their infec-
tion as those who were aware (both 11%). Results were identical
when FIB-4 was used. CONCLUSIONS: Among HCV-infected

24 CareManagement February/March 2016

LitScan PRA of 0%, and 16 were highly sensitized (PRA > 80%). Age,
FOR CASE MANAGERS female sex, and pre-VAD PRA were independently associated with
post-VAD PRA. A 10-year increase in age was associated with a
patients with heart failure. 5% decrease in post-VAD PRA (p = 0.03). Post-VAD PRA was
19% higher in women vs men (p < 0.01). A 10%-increase in pre-
Freedland KE, Carney RM, Rich MW, Steinmeyer BC, Skala VAD PRA was associated with a 4.7% higher post-VAD PRA (p
JA, Dávila-Román VG. < 0.01). During a mean follow-up of 12 ± 11 months, 90 patients
BACKGROUND: There have been few studies of the effect of underwent cardiac transplantation. A 20% increase in post-VAD
depression on rehospitalization in patients with heart failure PRA was associated with 13% lower probability of transplant
(HF), and even fewer on its role in multiple rehospitalizations. (hazard ratio, 0.87; 95% confidence interval, 0.76-0.99). A high
HYPOTHESIS: Depression is an independent risk factor for PRA was not associated with adverse post-transplant outcomes.
multiple readmissions in patients with HF. METHODS: A cohort CONCLUSIONS: Younger age, female sex, and pre-VAD PRA
of 662 patients with HF who were discharged alive after hospital- were independent predictors of elevated PRA post-VAD. Higher
ization were interviewed to evaluate symptoms of depression and PRA was significantly associated with lower transplant probability
were followed for 1 year. All-cause readmissions were documented but not increased rejection, graft failure, or death after transplant.
by chart review. A marginal proportional rates model was used to
model the effect of depression on the rate of rehospitalization with Chest. 2016 Jan 21. pii: S0012-3692(16)00467-0. doi: 10.1016/j.
adjustment for known predictors of HF outcomes. RESULTS: chest.2015.12.039. [Epub ahead of print]
Depression symptoms predicted multiple readmissions (adjusted
hazard ratio [HR]: 1.08, 95% confidence interval [CI]: 1.03- Age-related differences in the rate, timing, and
1.13, P = 0.0008). Compared with patients without depression, diagnosis of 30-day readmissions in hospitalized
those who met the Diagnostic and Statistical Manual of Mental adults with asthma exacerbation.
Disorders, Fourth Edition (DSM-IV) criteria for major depression
at index were at the highest risk for multiple rehospitalizations Hasegawa K, Gibo K, Tsugawa Y, Shimada YJ, Camargo CA Jr.
(HR: 1.51, 95% CI: 1.15-1.97, P = 0.003). CONCLUSIONS: BACKGROUND: Reducing hospital readmissions has attracted
Depression is an independent risk factor for multiple all-cause attention from many stakeholders. However, the characteristics of
readmissions in patients with HF. 30-day readmissions after asthma-related hospital admissions in
adults are not known. It is also unclear whether older adults are at
J Heart Lung Transplant. 2015 May;34(5):685-92. doi: 10.1016/j. higher risk of 30-day readmission. OBJECTIVES: To investigate
healun.2014.11.024. Epub 2014 Dec 8. the rate, timing, and principal diagnosis of 30-day readmissions
in adults with asthma and to determine age-related differences.
Factors associated with anti-human leukocyte METHODS: Retrospective cohort study of adults hospitalized for
antigen antibodies in patients supported with asthma exacerbation using the population-based inpatient samples
continuous-flow devices and effect on probability of 3 states (California, Florida, and Nebraska) from 2005 through
of transplant and post-transplant outcomes. 2011. Patients were categorized into 3 age groups: younger (18-
39 years), middle-age (40-64 years) and older (≥65 years) adults.
Alba AC, Tinckam K, Foroutan F, et al. Outcomes were 30-day all-cause readmission rate, timing, and
BACKGROUND: One major disadvantage of ventricular assist principal diagnosis of readmission. RESULTS: Of 301,164 asth-
device (VAD) therapy is the development of human-leukocyte ma-related admissions at risk for 30-day readmission, readmission
antigen (HLA) antibodies. We aimed to identify factors associ- rate was 14.5%. Compared to younger adults, older adults had
ated with HLA antibodies during continuous flow (CF)-VAD significantly higher readmission rates (10.1% vs. 16.5%; OR, 2.15
support and assess the effect on transplant probability and out- [95% CI, 2.07-2.23]; P <0.001). The higher rate attenuated with
comes. METHODS: We included 143 consecutive heart failure adjustment (OR, 1.19 [95% CI, 1.13-1.26]; P <0.001), indicating
patients who received a CF-VAD as a bridge-to-transplant at 3 that most of the age-related difference is explained by sociodemo-
institutions. Factors associated with post-VAD peak panel reactive graphics and comorbidities. For all age groups, readmission rate
antibodies (PRA) among several measurements were identified was highest in the first week after discharge and declined thereaf-
using multivariable linear regression. A parametric survival model ter. Overall, only 47.1% of readmissions were assigned respiratory
was used to assess transplant waiting time and probability, risk of diagnoses (asthma, COPD, pneumonia, and respiratory failure).
rejection, and a composite outcome of rejection, graft failure, and
death. RESULTS: Thirty-six patients (25%) were female; mean February/March 2016 CareManagement 25
age was 47 ± 13 years. Eighty-one patients (57%) had a pre-VAD

LitScan a survival benefit from transplantation versus dialysis. STUDY
FOR CASE MANAGERS DESIGN: Retrospective cohort study of wait-listed patients
using data for functional status from a national dialysis pro-
Older adults were more likely to present with non-respiratory vider linked to United Network for Organ Sharing registry data.
diagnoses (41.7% vs. 53.8%; P <0.001). CONCLUSIONS: After SETTING & PARTICIPANTS: Adult kidney transplantation
asthma-related admission, 14.5% had 30-day readmission with candidates added to the waiting list between 2000 and 2006.
wide range of principal diagnoses. Compared to younger adults, PREDICTOR: Physical Functioning scale of the Medical
older adults had higher 30-day readmission rates and proportions Outcomes Study 36-Item Short Form Health Survey, analyzed as
of non-respiratory diagnoses. a time-varying covariate. OUTCOMES: Kidney transplantation;
J Pediatr. 2016 Jan 26. pii: S0022-3476(15)01656-X. doi: survival benefit of transplantation versus remaining wait-listed.
10.1016/j.jpeds.2015.12.066. [Epub ahead of print] MEASUREMENTS: We used multivariable Cox regression to
Risk of asthma from cesarean delivery depends on membrane assess the association between physical function with study out-
rupture. comes. In survival benefit analyses, transplantation status was
Sevelsted A, Stokholm J, Bisgaard H. modeled as a time-varying covariate. RESULTS: The cohort
OBJECTIVE: To assess our prospective mother-child cohort and comprised 19,242 kidney transplantation candidates (median
the national registry data to analyze the risk of asthma by delivery age, 51 years; 36% black race) receiving maintenance dialysis.
mode and whether cesarean delivery before or after membrane Candidates in the lowest baseline Physical Functioning score
rupture affects this risk differently. STUDY DESIGN: The quartile were more likely to be inactivated (adjusted HR vs high-
Copenhagen Prospective Studies on Asthma in Childhood2000 is est quartile, 1.30; 95% CI, 1.21-1.39) and less likely to undergo
a high-risk birth cohort of 411 Danish children. Asthma was diag- transplantation (adjusted HR vs highest quartile, 0.64; 95% CI,
nosed prospectively by physicians at the research site, and asso- 0.61-0.68). After transplantation, worse Physical Functioning
ciations with cesarean delivery were investigated using Cox pro- score was associated with shorter 3-year survival (84% vs 92% for
portional hazard models. From the Danish national prospective the lowest vs highest function quartiles). However, compared to
registry we included data from 1997-2010. Childhood asthma was dialysis, transplantation was associated with a statistically signif-
defined from recurrent use of inhaled corticosteroids filled at phar- icant survival benefit by 9 months for patients in every function
macies. Cesarean delivery was classified as either before or after quartile. LIMITATIONS: Functional status is self-reported.
rupture of membranes, and the risk of asthma was compared with CONCLUSIONS: Even patients with low function appear to live
vaginal delivery. Results were adjusted stepwise for age and calen- longer with kidney transplantation versus dialysis. For wait-listed
dar year, sex, birth weight, gestational age, multiple births, parity, patients, global health measures such as functional status may be
and maternal factors (age, smoking/antibiotics during pregnancy, more useful in counseling patients about the probability of trans-
employment status, and asthma). RESULTS: In the Copenhagen plantation than in identifying who will derive a survival benefit
Prospective Studies on Asthma in Childhood2000 cohort, the from it.
adjusted hazard ratio for asthma was increased by cesarean Clin J Am Soc Nephrol. 2015;10(3):428-34. doi: 10.2215/
delivery relative to vaginal birth 2.18 (1.27-3.73). Registry data CJN.03510414. Epub 2015 Feb 3.
replicated these findings. Cesarean delivery performed before Utilization of acute care among patients with ESRD discharged
rupture of membranes carried significantly higher risk of asthma, home from skilled nursing facilities.
(incidence rate ratio to vaginal delivery 1.20 [1.16-1.23]) than Hall RK, Toles M, Massing M, et al.
cesarean delivery after rupture of membranes (incidence rate ratio BACKGROUND AND OBJECTIVES: Older adults with ESRD
to vaginal delivery 1.12 [1.09-1.16]). CONCLUSIONS: We con- often receive care in skilled nursing facilities (SNFs) after an acute
firmed cesarean delivery to be a risk factor for childhood asthma. hospitalization; however, little is known about acute care use after
This effect was more pronounced for cesarean delivery performed SNF discharge to home. DESIGN, SETTING, PARTICIPANTS,
before rupture of membranes. & MEASUREMENTS: This study used Medicare claims for
Am J Kidney Dis. 2015 Nov;66(5):837-45. doi: 10.1053/j. North and South Carolina to identify patients with ESRD who
ajkd.2015.05.015. Epub 2015 Jul 7. were discharged home from a SNF between January 1, 2010 and
Functional status, time to transplantation, and survival benefit of August 31, 2011. Nursing Home Compare data were used to ascer-
kidney transplantation among wait-listed candidates. tain SNF characteristics. The primary outcome was time from
Reese PP, Shults J, Bloom RD, et al. SNF discharge to first acute care use (hospitalization or emergency
BACKGROUND: In the context of an aging end-stage renal department visit) within 30 days. Cox proportional hazards mod-
disease population with multiple comorbid conditions, trans- els were used to identify patient and facility characteristics asso-
plantation professionals face challenges in evaluating the global
health of patients awaiting kidney transplantation. Functional
status might be useful for identifying which patients will derive

26 CareManagement February/March 2016

LitScan
FOR CASE MANAGERS

ciated with the outcome. RESULTS: Among 1223 patients with CONCLUSION: Diagnosis<18 years, histological cirrhosis at first
ESRD discharged home from a SNF after an acute hospitalization, diagnosis and SLA/LP antibodies are major risk factors for a poor
531 (43%) had at least one rehospitalization or emergency depart- short- and long-term outcome. These patients are in need of high
ment visit within 30 days. The median time to first acute care use surveillance. Separating patients with positive SLA/LP antibodies
was 37 days. Characteristics associated with a shorter time to acute into a third group may be reconsidered. DRB1*04:01 positivity
care use were black race (hazard ratio [HR], 1.25; 95% confidence has been identified in association with a favorable clinical outcome.
interval [95% CI], 1.04 to 1.51), dual Medicare-Medicaid cover- Am J Clin Nutr. 2016 Feb 3. pii: ajcn114389. [Epub ahead of
age (HR, 1.24; 95% CI, 1.03 to 1.50), higher Charlson comor- print]
bidity score (HR, 1.07; 95% CI, 1.01 to 1.12), number of hospi- Association between alcohol consumption and the risk of incident
talizations during the 90 days before SNF admission (HR, 1.12; type 2 diabetes: a systematic review and dose-response meta-anal-
95% CI, 1.03 to 1.22), and index hospital discharge diagnoses of ysis.
cellulitis, abscess, and/or skin ulcer (HR, 2.59; 95% CI, 1.36 to Li XH, Yu FF, Zhou YH, He J.
4.45). Home health use after SNF discharge was associated with BACKGROUND: Previous cohort studies have shown that mod-
a lower rate of acute care use (HR, 0.72; 95% CI, 0.59 to 0.87). erate alcohol consumption was associated with a lower risk of
There were no statistically significant associations between SNF type 2 diabetes (T2D). However, whether these associations differ
characteristics and time to first acute care use. CONCLUSIONS: according to the characteristics of patients with T2D remains con-
Almost one in every two older adults with ESRD discharged home troversial. OBJECTIVE: The purpose of this study was to explore
after a post-acute SNF stay used acute care services within 30 days and summarize the evidence on the strength of the association
of discharge. Strategies to reduce acute care utilization in these between alcohol consumption and the subsequent risk of T2D by
patients are needed. using a dose-response meta-analytic approach. DESIGN: We iden-
Hepatology. 2015 Nov;62(5):1524-35. doi: 10.1002/hep.27983. tified potential studies by searching the PubMed, Embase, and
Epub 2015 Aug 25. Cochrane Library databases up to 24 March 2015. Prospective
Prediction of short- and long-term outcome in patients with auto- observational studies that evaluated the relation between alcohol
immune hepatitis. consumption and the risk of T2D and reported its effect estimates
Kirstein MM, Metzler F, Geiger E, et al. with 95% CIs were included. RESULTS: Analyses were based on
Autoimmune hepatitis (AIH) is a chronic inflammatory disease 706,716 individuals (275,711 men and 431,005 women) from 26
characterized by a loss of tolerance toward the hepatocellular studies with 31,621 T2D cases. We detected a nonlinear relation
epithelium. Liver transplantation (LT) represents the ultimate between alcohol consumption and the risk of T2D, which was
therapeutic option for a fulminant course or end-stage liver dis- identified in all cohorts (P-trend < 0.001, P-nonlinearity < 0.001),
ease. The aim of this study was to elucidate the clinical, serolog- in men (P-trend < 0.001, P-nonlinearity < 0.001), and in women
ical, and genetic features of remission, relapse, and overall and (P-trend < 0.001, P-nonlinearity < 0.001). Compared with the
LT-free survival. Between 2000 and 2014, 354 AIH patients from minimal category of alcohol consumption, light (RR: 0.83; 95%
Hannover Medical School were included. Clinical, laboratory, and CI: 0.73, 0.95; P = 0.005) and moderate (RR: 0.74; 95% CI: 0.67,
histological reports were analyzed. DRB1 allele analyses were per- 0.82; P < 0.001) alcohol consumption was associated with a lower
formed in 264 AIH and 399 non-AIH patients. Cox’s regression risk of T2D. However, heavy alcohol consumption had little or no
analysis was performed to identify factors significantly associated effect on subsequent T2D risk. Furthermore, the summary RR
with survival. Patients diagnosed in childhood were at higher risk ratio (RRR; male to female) of the comparison between moderate
for relapses (P=0.003), requirement for LTs (P=0.014, log rank), alcohol consumption and the minimal alcohol categories for T2D
and had a reduced life expectancy (P<0.001, log rank). Detection was significantly higher, and the pooled RRR (current smoker
of soluble liver antigen/liver pancreas antigen (SLA/LP) antibod- to never smoker) of light alcohol consumption was significantly
ies was significantly associated with reduced overall and LT-free reduced. CONCLUSIONS: Light and moderate alcohol consump-
survival (P=0.037; P=0.021). Cirrhosis, which was evident in 25% tion was associated with a lower risk of T2D, whereas heavy alco-
at first diagnosis, was found to be a predictor of poor survival and hol consumption was not related to the risk of T2D.
requirement for LT (P=0.003; P=0.009). DRB1*04:01-positive
phenotype was associated with a higher rate of complete remis- February/March 2016 CareManagement 27
sions and with a lower frequency of cirrhosis and LTs. There
were no significant differences for subsequent relapses or sur-
vival in patients achieving either partial or complete remission.

Earn Required Ethics CEUs by
Reading CareManagement Journal!

Our sponsor organization, the Commission for Case Manager Certification (CCMC), now requires
CCMs to earn 8 Ethics CEUs by 2018 to renew the prestigious CCM® credential.
To help our readers meet this requirement, CareManagement will publish at least one Ethics CE
article (worth 2 Ethics CEUs) each year (two articles are planned for 2016). Over 4 years, you
can earn the Ethics CEUs you need by reading the articles in CareManagement and passing the
associated tests.
How many Ethics CEUs will CCMC require?

■ CCMs expiring in 2016: two (2) Ethics CEUs will be required for renewal.
■ CCMs expiring in 2017: four (4) Ethics CEUs will be required for renewal.
■ CCMs expiring 2018 and after: eight (8) Ethics CEUs will be required for renewal.

The first Ethics CE article for 2016 will be published in the February-March issue.

CEU for CCM & CDMS Approved for 2 hours of CCM and CDMS ethics education credit

Certified Case Manager News • Certified Case Manager News

Joint Commission Recognizes 1,043 SHOPPING WISELY
Hospitals for Outstanding Performance IS KEY TO SAVING
on Key Quality Measures MONEY ON HEALTH
INSURANCE
The Joint Commission announced the on 49 accountability measures reported
release of America’s Hospitals: Improving by more than 3,300 Joint Commission- Shop around. According to Kaiser Health
Quality and Safety: The Joint Commission’s accredited hospitals in 2014. ■ News, 2016 may be a costly year in
Annual Report 2015, summarizing data terms of health t to consumers since the
lowest-cost silver plan is the most pop-
Health Care Leaders Support Government ular plan across the board in the health
Action to Curb Drug Spending exchange marketplace. ■

Modern Healthcare surveyed health care Nasal Spray to Combat
executives and found that 90% of CEOs Opioid Overdose
polled say that rising prescription drug Approved by FDA
costs are undermining compabegun devel-
oping guidelines and tools to help physi- Adapt Pharma Inc. was granted approval
cians and patients assess efficacy, toxicity, of a new nasal spray for opioid overdose,
and costs of treatments. ■ called Narcan. The spray can be used
by anyone to treat someone who has
WHOOPING COUGH Wall Street Journal overdosed on oxycodone, morphine, or
AND EPILEPSY TIE Panel’s Perspectives heroin. It will be offered at a discount to
on Affordable Care Act emergency workers, firefighters, and the
A study published in JAMA has found police. ■
a connection between infant whooping Depending on the numbers you choose,
cough and an increased risk for epilepsy. the ACA can be a huge boon or a huge Are Patient Satisfaction
Although the absolutient satisfaction bust. The Wall Street Journal recently pub- Surveys Harmful?
ratings, which are important in hospital lished the opinions of several pundits on
reimbursement and star ratings. ■ what’s working or not with the Act. ■ What could go wrong when a hospital
surveys patienort to please patients
Communication: The DEPRESSION IS • C linicians telling patients what they
Biggest Factor in BEST TREATED
Reimbursement Rates BY HUMANS, NOT want to hear
COMPUTERS • Incorporation of hospital processes that
Hospitals are spending big money on
trying to improve reimbursement rates Although there are numerous online are only geared to manipulate patient
with costly ma akin to a hotel, but programs to help people fight depression, responses on satisfaction surveys
the Harvard Business Review says that a UK study reports that the programs • Decreased healthcare quality and
communication between patients and are not effective, mognitive behavioral increased cost ■
caregivers has the largest effect on therapy programs was low despite reg-
reimbursement. ■ ular telephone support. About 25% of Exclusively for ACCM Members
patients dropped out of the study within
4 months. ■

February/March 2016 CareManagement 29

CE for CCM & CDMS Approved for 2 hours of CCM, CDMS and nursing education credit Exclusively for ACCM Members

Models of Care for High-Need, 3. Barber AE, Norton JP, Spivak AM, Mulvey 2014;8(2):59.
High-Cost Patients: An Evidence MA. Urinary tract infections: current and
Synthesis continued from page 9 emerging management strategies. Clin Infect 12. Matuszkiewicz-Rowińska J, Małyszko
Dis. 2013;57(5):719-724. J, Wieliczko M. Urinary tract infections in
This article was written based on the informa- pregnancy: old and new unresolved diagnos-
tion from referenced articles only and no inde- 4. Bryan C. Urinary tract infections. In: tic and therapeutic problems. Arch Med Sci.
pendent research or study was conducted for Infectious Disease. 2015;11(1):67-77.
this publication.
5. Raz R. Asymptomatic bacteriuria. Clinical 13. Kladenský J. Urinary tract infections
References significance and management. Int J Antimicrob in pregnancy: when to treat, how to treat,
Agents. 2003;(Suppl 2):45-47. and what to treat with. Ceska Gynekol.
1. De Francesco MA, Ravizzola G, Peroni L, 2012;77(2):167-171.
Negrini R, Manca N. Urinary tract infections 6. Urinary tract infections. In Shoskes
in Brescia, Italy: etiology of uropathogens and D, Morey AF, eds. The American Urological 14. Marahatta R, Dhungel BA, Pradhan
Association Educational Review Manual in Urology. P, Rai SK, Choudhury DR. Asymptomatic
NEW! CE exams may be taken 3rd ed. New York: Castle Connolly Graduate bacteriuria among pregnant women vis-
online! Click the link below to take the Medical Publishing; 2011:737-766. iting Nepal Medical College Teaching
test online and then immediately print Hospital, Kathmandu, Nepal. Nepal Med Coll J.
your certificate after successfully completing 7. Kim ED. Urinary tract obstruction. 2011;13(2):107-110.
the test. Members only benefit! Exams Medscape. http://emedicine.medscape.com/
expire April 30, 2016. article/438890-overview. Reviewed November 15. Ramlakhan S, Singh V, Stone J, Ramtahal
14, 2014. Accessed February 14, 2016. A. Clinical options for the treatment of uri-
Take this exam online > nary tract infections in children. Clin Med
8. Gupta K, Hooton TM, Naber KG, et al. Insights Pediatr. 2014;8:31-37.
– or print, complete and mail the exam International Clinical Practice Guidelines
on pages 14–15. for the Treatment of Acute Uncomplicated 16. Kehinde AO, Adedapo KS, Aimaikhu
Cystitis and Pyelonephritis in Women: A 2010 CO, Odukogbe AT, Olayemi O, Salako B.
You must be an ACCM member to take the Update by the Infectious Diseases Society Significant bacteriuria among asymptomatic
exam, click here to join ACCM. of America and the European Society for antenatal clinic attendees in Ibadan, Nigeria.
Microbiology and Infectious Diseases. Clin Trop Med Health. 2011;39(3):73-76.
antimicrobial resistance of common uropatho- Infect Dis. 2011;52(5):e103-120.
gens. Med Sci Monit. 2007;13(6):BR136-144. 17. Alizadeh Taheri P, Navabi B, Shariat
9. Nicolle LE, Bradley S, Colgan R, et M. Neonatal urinary tract infection: clinical
2. Daoud Z, Salem Sokhn E, Masri K, Matar al. Infectious Diseases Society of America response to empirical therapy versus in vitro
GM, Doron S. Escherichia coli isolated from Guidelines for the Diagnosis and Treatment susceptibility at Bahrami Children’s Hospital-
urinary tract infections of Lebanese patients of Asymptomatic Bacteriuria in Adults Neonatal Ward: 2001-2010. Acta Med Iran.
between 2005 and 2012: epidemiology and Clinical Infectious Diseases. Clin Infect Dis. 2012;50(5):348-352.
profiles of resistance. Front Med (Lausanne). 2005;40(5):643-654.
2015;2:26. 18. Shaikh N, Craig JC, Rovers MM, et al.
10. Chapman ST. Prescribing in pregnancy. Identification of children and adolescents at
Bacterial infections in pregnancy. Clin Obstet risk for renal scarring after a first urinary tract
Gynaecol. 1986;13(2):397-416. infection: a meta-analysis with individual patient

11. Khalesi N, Khosravi N, Jalali A, Amini L. data. JAMA Pediatr. 2014;168(10):893-900.  
Evaluation of maternal urinary tract infec-
tion as a potential risk factor for neonatal
urinary tract infection. J Family Reprod Health.

30 CareManagement February/March 2016

Ethics and the Case Manager CEUs will be required for renewal. Management” by Elizabeth A. Dailey,
continued from page 2 • For CCMs expiring in 2017, 4 ethics MNA, HCM, MSN, RN; Maressa
Hopkins, MSN, RN; and David A.
certification and the Code of Ethics CEUs will be required for renewal. Zaworski, MSN, RN.
for their profession. The case manager • F or CCMs expiring in 2018, 8 ethics
must be knowledgeable about the prin- I invite you to share ethical dilem-
ciples and values of ethics including CEUs or the equivalent of 10% of the mas you encounter and how they were
being aware of resources that are avail- total CEUs required for renewal. resolved. This is a wonderful oppor-
able to them after they have recognized tunity for you to share with your col-
an ethical dilemma. Resources may The Certification of Disability leagues first-hand information about
include Ethics Committees, courses Management Specialists Commission ethical dilemmas you encounter on
in ethics, journal articles, and other for some time has required 4 ethics a regular basis. If you have an Ethics
published readings in ethics. Every CEUs for renewal every 5 years. Committee or you organized one, tell
organization should have a process for us about it. I want to hear from you.
resolving ethical dilemmas. CareManagement will publish a
minimum of one 2-hour CE self-study Gary S. Wolfe, RN, CCM
The Commission for Case Manager program in ethics at least once a year. Editor-in-Chief
Certification (CCMC) now requires When possible, we will publish two [email protected]
some of the continuing education articles each year. This translates to at
required for certification renewal to be least 10 ethics CEUs for every 5-year ACCM: Improving Case Management
in ethics. The ethics continuing educa- renewal period. Articles on ethics will Practice through Education
tion requirement is phased in as follows: be available for 1 year. This is another
• F or CCMs expiring in 2016, 2 ethics benefit of membership in the Academy
of Certified Case Managers (ACCM).

In this issue of CareManagement,
we publish “Ethical Dilemmas in Case

February/March 2016 CareManagement 31