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6/01 cJCIRC/DaIeDuepes-sz

 

Risk Assessment Tool to Identify
Medication Noncompliance in Congestive Heart Failure
Patients in Ambulatory Care

BY

Patricia D. Koning

A SCHOLARLY PROJECT
Submitted to
Michigan State University
in partial fulfillment of the requirements
for the degree of

MASTER OF SCIENCE IN NURSING

College of Nursing

1999

ABSTRACT
Risk Assessment Tool to Identify

Medication Noncompliance in Congestive
Heart Failure Patients in Ambulatory Care

BY

Patricia D. Koning

Congestive heart failure (CHF) is a fatal disease
syndrome that has an increased incidence rate in persons
over the age of 65. This syndrome is associated with a high
morbidity and mortality rate that has continued to increase
over the past four decades while rates for coronary artery
disease and cardiovascular accident have declined
dramatically.

Congestive heart failure has a major negative impact on
the older adult, the family, society as a whole, and the
health care industry. The older adult's quality of life
declines with the decline in functional status; limitations
become part of daily life. The family may have to take on a
new role as caregiver which places an increased burden on
the involved members. The economic burden that falls on all
parties, including society and the health care industry, is
astronomical.

The major concern with congestive heart failure is the
repeated exacerbations. Causes of these exacerbations vary;
however, a repeated theme in the literature is medication
noncompliance (Dracup, 1996; Dracup et al., 1994; Chin &
Goldman, 1997; Bennett et al., 1998; Montamat, Cusack, &

Vestal, 1989). The issue of noncompliance must be addressed

upon initial diagnosis with patients and families in order
to prevent the exacerbations; reduce the readmission rates;
and preserve quality of life for this specific population.

The focus of this scholarly project is the development
of a tool to assess for barriers that contribute to
noncompliance with medications in the older adult diagnosed
with congestive heart failure. With the initial assessment
by the Advanced Practice Nurse (APN), barriers would be
identified with the patient. The goal of this project will
be risk reduction of medication noncompliance based on the
elimination of the barriers.

The Health Belief Model provides the basis for
identification of the perceived barriers and perceived
benefits of compliance with the prescribed therapeutic
regimen. The focus of this project will be the perceived
barriers. The tool will identify areas of education that
should be a part of the routine care of the older adult with
CHF and his/her support network. The roles of the APN
within this defined environment will also be discussed, as

well as implications for further research.

ACKNOWLEDGMENTS

I want to express my sincere gratitude to the members
of my committee who helped guide me through this process.
Thanks to Laura Struble, PhD, RN, who was very supportive
and always available to offer encouragement. Thanks to
Patty Peek, MSN, RN and Brigid Warren, MSN, RN, who provided
insight and words of encouragement and kindness.

I want to also express my sincere appreciation to my
husband, Don, for his words of encouragement. I could not

have achieved my goals without his support and dedication.

iv

TABLE OF CONTENTS

Page
LIST OF FIGURES . . . . . . . . . . . . . . . . . . . . . Vi
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . 1
Problem Statement . . . . . . . . . . . . . . . . . . 6
Purpose . . . . . . . . . . . . . . . . . . . . . . . 6
Conceptual Framework . . . . . . . . . . . . . . . . . 7
Review of Literature . . . . . . . . . . . . . . . . . 21
Project Development . . . . . . . . . . . . . . . . . 39
Procedure for Using Tool . . . . . . . . . . . . . . . 42
Evaluation of Tool . . . . . . . . . . . . . . . . . . 43
Implications for Advanced Nursing Practice . . . . . . 45
Implications for Education . . . . . . . . . . . . . . 49
Implications for Research . . . . . . . . . . . . . . 51
Conclusion . . . . . . . . . . . . . . . . . . . . . . 52
LIST OF REFERENCES . . . . . . . . . . . . . . . . . . . 54
Appendices
Appendix A . . . . . . . . . . . . . . . . . . . . . 60
Appendix B . . . . . . . . . . . . . . . . . . . . . 66

Appendix C . . . . . . . . . . . . . . . . . . . . . 67

LIST OF FIGURES

Page
Figure 1: Health Belief Model Components and Linkages . . 11
Figure 2: Barriers and Health Belief Model for the CHF

Patient 0 O O O O O O O O O O O O O O O O O O O 2 2

vi

INTRODUCTION

Congestive heart failure (CHF) is a highly lethal,
progressive disease process; the number of deaths related to
CHF has dramatically increased over the past four decades,
the same period during which coronary artery disease and
stroke deaths have declined by 50%. The unadjusted
mortality rates rose by 82.5% from 1979 to 1992, fourfold
since 1968, and sixfold since 1955. Overall, 92% of deaths
from CHF occur in individuals 65 years of age and older
(Massie & Shah, 1997) which makes CHF a significant problem
in the elderly population.

Heart disease is the leading cause of death in the
United States and congestive heart failure is a common form
of heart disease that contributes to the morbidity and
mortality rates. Congestive heart failure is one of the
fastest growing cardiovascular problems in the United States
and it primarily affects the older adult 65 years of age and
older. The readmission rate for patients with CHF is
extremely costly and the decline in functional status
affects their quality of life. With the aging of the
population, the economic burden will continue to increase in
terms of health care dollar expenditures. In addition,
quality of life issues for this large segment of the
population with CHF will also need to be addressed.

Congestive heart failure affects an estimated four

million persons in the United States with 400,000 new cases

1

diagnosed annually, resulting in an average mortality rate
of 10 percent at one year and 50 percent after five years
(Dracup, 1996; AHCPR, 1994). This syndrome is responsible
for over 11 million primary care visits and over 3.5 million
hospitalizations annually, making it the leading cause of
admission for the older adult (Packer 8 Cohn, 1999). Chin
and Goldman (1997) report that CHF is currently the most
common reason for patients in the Medicare program to be
admitted to a hospital and “readmissions, as opposed to long
lengths of stay, appear to be the main contributor to
increased costs in the heart-failure population” (p. 643).
Results from the Framingham Study (McKee, Castelli, &
McNamara, 1971), which is a very important prospective long-
term cohort study designed to determine risk factors for the
development of cardiovascular disease, estimate that the
prevalence of CHF increases progressively with age--from
approximately 1% in persons aged 50 to 59 years to a
prevalence of approximately 10% in those aged 80 to 89
years. The prevalence doubles with each decade of life in
that age range (McKee et al., 1971).

Congestive heart failure is a progressive disease and
places an economic burden on society. Packer and Cohn
(1999) estimate the annual direct expenditures for CHF to
range from $20 to $40 billion; these figures include primary
care cost delivery, hospital and nursing home expenses, and
costs of medications, home health care, and other medical

durables. Indirect costs are not accounted for in these

figures which would be the cost of lost productivity. Even
with advancement in treatments, the prevalence of CHF has
not shown any major decline and this is a concern with the
aging of the population.
Problem Statement

The treatment of CHF is essential in primary care.
Guidelines developed by the Agency for Health Care Policy
and Research (AHCPR, 1994) are available to the primary
health care provider that offer recommendations in specific
patient management areas. Some management areas include:
primary prevention of heart failure in the patient with
asymptomatic left-ventricular systolic function; initial
evaluation and diagnosis of CHF; pharmacological management
of CHF; patient education and counseling; and the importance
of close patient monitoring and follow-up. These are only a
few of the important aspects that need to be addressed in
the management of patients with heart failure. The major
problem with this population of patients is the high
morbidity and mortality rates and the frequent readmission
rates due to exacerbations of the congestive heart failure.

The important question is why such a high rate of
treatment failure and readmission rate? A common and
seemingly preventable reason is patient noncompliance with
medication regimens. Happ and colleagues (1997) found that
reported rates of noncompliance with medications ranged from
20-58%. Other research has documented similar rates (Dracup

et al., 1994; Dracup, 1996; Chin & Goldman, 1997; Bennett et

3

al., 1998; Monane, Bohn, Gurwitz, Glynn, 6 Avorn, 1994;
Reed, 1997; Montamat, Cusack, & Vestal, 1989).

Medication compliance in the elderly population with
CHF is an important issue in promoting and maintaining
quality of life. The elderly population is the largest
consumer of medications, accounting for 30% of prescription
medications and 40% of over-the-counter (OTC) medications
(Salom & Davis, 1995). The average older adult takes an
average of 7.5 medications per day and an individual 75
years of age and older takes threefold more drugs than
younger persons (Murray, Birt, Manatunga, & Darnell, 1993;
Rajaei-Dehkordi & McPherson, 1997). One-third of the 1.5
billion prescriptions filled annually are for people 65
years of age and older (Esposito, 1995).

Multiple issues have to be taken into consideration
when prescribing medications to the older adult. The
increased incidence of chronic illness and the altered
process of drug metabolism and absorption are essential
considerations that if disregarded in the older adult can
produce detrimental outcomes. Another major issue that is
neglected, although not purposefully, is the assessment of
barriers to medication compliance. Barriers related to
medication noncompliance that have been documented in the
literature include: access to care, visual and cognitive
impairment, functional impairments, cultural and language
differences, poor understanding of purpose and importance of

the medication, lack of family and social support,

4

depression, packaging of the medication, financial
constraints, adverse effects, and polypharmacy (Wallsten et
al., 1995; Murray et al., 1993; Monane et al., 1994;
Corlett, 1996; Conn, Taylor, 6 Miller, 1994; Kelly, 1996).
Drug therapy in the older adult is complicated by
multiple physiological factors, but the compliance versus
noncompliance factor also has to be addressed by the primary
care provider. According to Montamat and co-researchers
(1989), one-third to one-half of the elderly population are
noncompliant with their medications; ninety percent of these
are undertaking and seventy percent are altering how they
take their medications. An inverse relationship exists
between medication and compliance—-as the number of
prescription medications increase, compliance decreases. In
a research study by Monane and co-researchers (1994), more
than 7000 elderly patients who needed daily Digoxin for
their heart failure, on average, refilled their prescription
often enough to have Digoxin available 111 days of the year
or 30% of the time. Another study of 249 elderly male
veterans enrolled in a general medicine clinic reported a
medication compliance rate of 73% (Graveley 6 Oseasohn,
1991). Drug-related morbidity and mortality is also
important with noncompliance. Johnson and Bootman (1995)
reported drug-related morbidity and mortality in the
ambulatory setting as estimated to cost $76.6 billion per

year in the United States.

The projected growth rate of the elderly population is
35 million Americans 65 years of age and older by the year
2000 and an increase of 64 million by 2030 (Esposito, 1995).
When assessing these projected figures, there is cause for
concern. With the limited resources, rising cost of health
care, and the demand for quality care, there needs to be a
mandate toward preventive care, health promotion, and
education programs to improve self-care skills.

Advanced practice nurses (APNs) play an important role
in the care and management of elderly patients with CHF.
The APN is able to address the needs of the older adult by
utilizing her/his clinical knowledge and skills to arrest
the continuous cyclical pattern of frequent emergency room
presentations and rehospitalizations. APNs have the ability
to individually assess each patient, address the potential
barriers and other influencing circumstances, and assist the
older adult to find resources to minimize the barriers.
With the increasing number of older adults with limited
incomes, access, medical coverage, and the rising costs of
health care, the incidence of complications and related
costs due to medication noncompliance is likely to be on the
increase (Conn et al., 1994).

Purpose

The purpose of this scholarly project is to develop an
assessment tool to determine medication compliance in
patients with CHF in ambulatory care. The tool will aid the

health care provider in assessing for barriers that

6

contribute to noncompliance. Risk assessment will be
derived through the use of a series of open-ended, non-
threatening questions. The tool will also document the
medications a patient is concurrently taking, including
prescription, OTC, vitamins, and herbal products. The tool
will help the health care provider identify whether the
patient understands and complies with the dietary sodium
restriction, monitoring of daily weights, schedule of
immunizations (pneumococcal and influenza), regular exercise
program, and signs and symptoms indicative of exacerbation
of CHF. The use of recreational drugs, alcohol use, tobacco
use, and caffeine intake will be documented with the tool,
since these may have detrimental effects on the
cardiovascular system as well as other organ systems. The
scope of the assessment tool will be to encompass the broad
issue of noncompliance with the prescribed therapeutic
regimen in the CHF patient, while focusing on the barriers
that contribute to medication noncompliance.
Conceptual Framework

The Health Belief Model (HBM) provides the framework
for this project because it has been used in studying
compliance with therapeutic regimens in people with chronic
illness, which may include a majority of older adults. The
HBM is a psychosocial causal model developed in the 19503 as
an attempt to explain failure of people's participation in
disease prevention and detection programs. In the late

1960s and early 1970s, the model was expanded to apply to

.7

people's responses to symptoms and their behaviors in
response to diagnosed illness; this model places a strong
focus on people's compliance with medical regimens (Strecher
6 Rosenstock, 1997). According to Strecher and Rosenstock
(1997), the Health Belief Model (HBM) has been a widely used
framework in health behavior and the overall premise
follows:

“In general, it is believed that individuals will take
ecticn to ward off, to screen for, or to control an ill-
health condition if they regard themselves as susceptible to
the condition, if they believe it to have potentially
cezicnc_consequences, if they believe that a ccuzee_cf
eccicn available to them would be beneficial in reducing
either their susceptibility to or the severity of the
condition, and if they believe that the enticineted_hezzieze
to (or costs of) taking the action are outweighed by its
benefits? (p. 44). The constructs of perceived benefits and
barriers provide a guide for studying health behaviors such
as compliance with medications. Benefits are the perceived
positive aspects of performing health behaviors and barriers
are perceived negative aspects or costs of performing health
behaviors. Interventions based upon the HBM have been shown
to be effective in changing and improving compliance with
health-promoting activities (Strecher 6 Rosenstock, 1997).

The major concepts of the Health Belief Model will be
briefly summarized to provide a basic understanding of its

application to screening behaviors, preventive actions,

8

illness behaviors, and sick-role behaviors. The concept of
perceived_enecectibiiity relates to a person's perception of
his/her risk of acquiring an illness or disease process. In
this proposal, the patients have already been diagnosed with
CHF; therefore, this concept will be reformulated to include
the patient's acceptance of the diagnosis and perception of
potential severity of exacerbations of the syndrome based
upon compliance with medication and diet regimens. Strecher
and Rosenstock (1997) do note that reformulation of this
concept for cases of medically established diagnoses is
acceptable and has been done in other studies.

Perceiged_eeyerity identifies consequences of
contracting an illness and the sequelae associated with the
diagnosis. Perceived severity includes evaluation of
clinical, medical, and potential social consequences of an
illness.

Perceived severity and perceived susceptibility have
been combined and identified as the perceixed_thzeet. The
perceived threat is an important postulate of the HBM
because the patient must perceive his/her health as
threatened in order to consider action to change behavior.

Eezceiyed_henefite may be defined as taking a
particular action to reduce the threat of the disease or the
severity of the disease once diagnosed. The specific action
that is taken will depend upon one's belief's regarding the
efficaciousness of the advised action. The positive effects

of the action must be accentuated.

Perceiyec_harrieze are the perceived negative
consequences or costs related to taking an action. The
barrier is the obstacle preventing the patient from
undertaking the suggested health behavior (Strecher 6
Rosenstock, 1997).

Cnee_tc_ec;icn are the stimuli that the HBM propose
must occur to trigger the appropriate behavior. The trigger
can be internal, such as perception of a bodily symptom of
illness, or external, such as an environmental event--media
information or an educational program. Also, a person's
past experience may play a role as a trigger to action.

Other variables that may have an influence on an
individual's perception and influence health-related
behavior choices are demographics, sociopsychological
factors, and structural factors. Sociopsychological factors
may include social support and resources and self-esteem
issues. Structural factors include duration of the
prescribed regimens and costs of regimens.

Seif;efficecy is an important perception of the
patient. Self-efficacy can be defined as the confidence a
patient has in him/herself to undertake the desired action
and produce the desired outcome. The patient must have
guidance through this process with progressive goal setting
and positive verbal reinforcement to help reduce anxiety and

promote an environment of change (See Figure 1: HBM ).

10

 

I Likelihood of Action]

Individual Perceptions
of threat of illnessl
disease process

I Modifying Factors I

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Demographics Perceived benefits
Psychosocial __ minus perceived
Structural carriers to behavior
Knowledge change
Perceived W/ Perceived threat Likelihood of
severitlof the disease of disease behavior change

 

 

 

 

l

Cues to action:
symptoms
illness
educafion
media information

 

 

 

 

Figure 1: Health Belief Model components and linkages (adapted from Strecher 8.
Rosenstock. 1997)

11

W

This section will define a number of important terms
relative to CHF and the conceptual framework that will be
used throughout this project. This will provide the reader
with a better understanding of these specified concepts.

ccngeetiye_heert_fai1nze is the inability of the heart
to pump blood at a rate sufficient to meet the metabolic
demands of the body; cardiac output is reduced resulting in
decreased perfusion to the tissues. It is not a specific
disease but rather a clinical syndrome that may be caused by
numerous cardiac disorders (Johnson 6 Lalonde, 1997). Heart
failure, as a syndrome, is characterized by the following:
signs and symptoms of intravascular and interstitial volume
overload including shortness of breath, edema--especially of
the lower extremities, and rales auscultated in the lungs;
and manifestations of inadequate tissue perfusion including
fatigue, poor exercise tolerance, and decreased oxygen
saturation (AHCPR, 1994).

Congestive heart failure is the result of systolic
dysfunction, diastolic dysfunction, or a combination of
both; therefore, many patients develop heart failure as a
result of reduced myocardial contractility and reduced
ventricular filling. Causes of heart failure related to
systolic dysfunction include: ventricular hypertrophy
resulting from pressure overload or volume overload; dilated
cardiomyopathies; and reduced muscle mass possibly resulting

from a myocardial infarction. Diastolic dysfunction may be

12

caused by the following: mitral or tricuspid stenosis;
pericardial disease; and increased ventricular stiffness
related to ventricular hypertrophy, infiltrative myocardial
diseases, or myocardial ischemia and infarction. According
to the most recent update on the Framingham study (Ho,
Pinsky, Kannel, 6 Levy, 1993), ischemic heart disease is the
underlying etiology in 59% of males and 47% of females with
heart failure; hypertension is the second leading cause in
30% of males and 37% of females. Less common etiologies
include the cardiomyopathies and valvular heart disease.

Qider_ecn1; will be the term used in this project to
define the population of persons aged 65 years of age and
older. In areas where the term “population” is more
appropriate, the phrase “elderly population” may be used to
define the same cohort. The number of people over the age
of 65 is growing rapidly in the United States. According to
Moody (1994), four percent of the population was over 65
years of age in 1900, and in 1994, the figure was up to 13%,
with a predicted increase to 20% by the year 2030.

NQDQQleiance is defined as failure to follow or
divergence from a prescribed regimen (Cargill, 1992). With
the elderly population using approximately 30% of the
prescription drugs and 40% of non-prescription drugs per
year, it is not surprising that older adults are more likely
to have difficulties with medication compliance (Ennis 6

Reichard, 1997). Compliance is inversely related to the

13

number of medications that a patient is concurrently taking;
the simpler the regimen, the better (Murray et al., 1993).
Three common forms of medication noncompliance are seen
in the older adult population: overuse, underuse, and
alterations of dosages and schedules. Overuse is sometimes
related to forgetfulness or the frame of mind that more will
speed recovery. Underuse is related to forgetfulness or
cognitive changes, but can also be related to medication
side effects, adverse drug reactions, drug interactions,
resolve of symptoms, and costs of the medications.
Alterations of dosages and schedules can be related to any
reasons mentioned in the preceding sentences and due to
medication response interfering in the patient's activities,
especially seen with diuretics. Salzman (1995) describes
the characteristics of noncompliance in the older adult:
taking someone else's medication accounted for 10%;
inappropriate discontinuation, up to 40%; continuing to take
previously discontinued medication, more than 20%.
Noncompliance leads to poor clinical outcomes which in
turn adds to health care costs. Noncompliance can reduce
life expectancy and is a cause of readmissions (AHCPR,
1994). The length of stay is not usually an issue, it is
the repeated admissions for exacerbation of congestive heart
failure. Farley (1986) reported that the National Council
on Patient Information and Education estimated that
approximately 125,000 persons in the United States die each

year as a result of drug misuse and that up to one-half of

14

the 1.6 billion prescriptions dispensed yearly are taken
incorrectly, which results in prolonged illness, avoidable
side effects, drug interactions, increased hospitalizations,
and overuse of health care services. The council estimated
that 25 to 30 percent of these prescriptions are taken by
the older adult and that this number will increase to nearly
50 percent by the year 2000.

A barrier can be defined as any obstacle that
interferes with compliance of the prescribed medication and
therapeutic regimen for the treatment of CHF. The American
Heritage Dictionary (1991, p. 159) defines barrier as
“something that acts to hinder or restrict,” The barrier
can be any factor that the patient and/or health care
provider identifies as impeding the implementation of the
prescribed therapy. Barriers can be any of the factors
already mentioned such as access, financial constraints,
polypharmacy, insufficient social support, and adverse drug
reactions; however, a barrier can also be a patient's belief
or perception. When a patient identifies a barrier to
compliance with the medication regimen, this barrier must be
removed in order for compliance to begin or resume.

Barriers or perceived barriers have to be addressed early
with the older adult diagnosed with CHF in order to prevent
exacerbations. The barriers identified within this project
will be expounded upon under the literature review; these
include: access, visual impairment, cognitive impairment,

lack of understanding by the patient and health care

15

provider, cultural and language differences, lack of
support, depression, packaging of medications, financial
constraints, adverse drug reactions, and polypharmacy.

Riek_redncticn is the reduction or elimination of the
modifiable factors that place a person at risk for a
specific disease entity (Fleury, 1992). “Nursing is
concerned with helping individuals to understand, adopt, and
maintain lifestyle practices that will reduce their risk of
disease and disability’ (Fleury, 1992, p. 229). Individual
risk reduction through initiation and maintenance of
cardiovascular health behaviors includes substance abuse
cessation, hypertensive management, regular regimen of
physical exercise, dietary modification, and compliance with
the prescribed medication regimen for symptom management.
Perceived barriers are believed to influence motivation to
health behavior change in cardiovascular risk reduction
(Biggs 6 Fleury, 1994). A
E . H JHEJ'Elli] 131115

The HBM presents a framework to examine the barriers to
medication compliance in older adults diagnosed with CHF
which will be the focus of this project. Barriers and
perceived barriers have been identified as the most powerful
HBM dimension; however, they are the dimension frequently
left unmeasured in empirical research (Fleury, 1992; Hill 6
Berk, 1995). A literature search did produce articles that
examined the issue of compliant behaviors with therapeutic

regimens for several diagnoses including: hypertension,

16

diabetes, and cancer. The theme recurrent in the literature
was the importance of the patient's perceptions of perceived
severity of the disease, perceived benefits of the
prescribed therapy, and the perception that the barriers to
the successful implementation of the prescribed behaviors
could be surmounted (Given 6 Given, 1983; Given 6 Given,
1984; Given, Given, Gallin, 6 Condon, 1983; Given, Given, 6
Simoni, 1978; Nyamathi 6 Shuler, 1989). When using the HBM,
patients must acquire certain beliefs, knowledge, and
behaviors in order to successfully manage their chronic
disease. In essence, the patient must be aware of his/her
beliefs; recognize the barriers to and the benefits of
complying with the prescribed therapeutic regimen; know how
to integrate the prescribed behaviors into his/her daily
lifestyle; know how to secure support for these prescribed
behaviors from his/her support network, including family
members and friends; and, ultimately, how to self-monitor
needed behaviors (Given 6 Given, 1983).

Patients diagnosed with CHF can be a major challenge to
the health care provider due to their complex health
problems. Successful management of CHF requires major
lifestyle changes and adjustments not only by the patient
but also by their families and other support network.
Medication regimens may consist of multiple medications that
have to be taken once to possibly three times a day.

Dietary habits and activities may have to be modified which

can create conflicts with the patient's desires, traditions,

17

and culture. Signs and symptoms of reoccurring CHF must be
monitored to promote prompt treatment and to prevent severe
deterioration requiring readmission to the acute care
setting.

There are psychological adjustments that the patient
must face which include the burden of living with new
limitations and the acknowledgment that life expectancy may
be shortened (Dracup et al., 1994). Thus, the patient may
experience the grieving process as a result of the
associated realities of the disease process. Health care
providers need to be aware of the barriers encountered by
the older adult and their family as they attempt to follow
the prescribed therapeutic regimen that will enable them to
function at a level of “normalcy”.

Congestive heart failure is complex and patients have
to be educated about the disease process and the prescribed
therapeutic regimen including medications, dietary
restrictions, and activities. Patients should be educated
about the symptoms associated with the disease and
understand when to notify their health care provider
regarding the worsening of symptoms. For example, the
patient should understand that he/she will experience
increased fatigue and dyspnea with exertion but an increase
in these symptoms should alert him/her to notify the health
care provider. Patient education should be an ongoing
process and the patient's understanding should be evaluated.

Education at the time of discharge from the acute care

18

setting may not always be the best time for education;
patients are worried about going home and the stress level
may be higher which is not conducive to learning. Education
should be repeated with each outpatient visit and should
include family members or other support persons. It is also
important to be aware of and sensitive to differences in
patients' levels of learning, language, and culture, which
may impact the degree of understanding and compliance.

Thus, the HBM could be used by the Advanced Practice
Nurse (APN) as a guide to determine barriers and to assess
risk of noncompliance with medication regimens in the older
adult with CHF. Compliance with other prescribed
therapeutic regimens (dietary restrictions and activity)
could also be assessed using this model and are just as
pertinent to care of the CHF patient; however, the focus of
this project will be based upon noncompliance with the
medication regimen.

Following initial diagnosis, the APN would evaluate the
medications that the patient is concurrently taking and
address the importance of compliance with the prescribed
regimen. The benefits of complying with the regimen would
be explained to the patient and family member or support
person. Questions relative to potential barriers would be
addressed at this time to prevent early complications from
noncompliance. The patient would be encouraged to verbalize
any questions or concerns relative to the prescribed

therapeutic regimen.

19

With the HBM as a guide, the APN would identify the
patient's perceptiOns of susceptibility/severity of the
disease and the acceptance of the diagnosis along with the
patient's understanding of causes of exacerbations. The
influence of modifying factors such as demographics,
psychosocial, structural, and knowledge, would be addressed
on an individual basis. An assessment of cues to action is
critical to determine the triggers necessary to stimulate
the appropriate healthy behavior. The modifying factors
mentioned above and the cues to action impact the perceived
threat of the chronic disease process. Perceived threats
that may accompany a diagnosis of CHF include: increased
mortality and morbidity; increased rates of readmission into
the acute care setting; increased costs; decreased
functional status; and decreased quality of life.

The APN would address the patient's perception of
barriers to treatment and benefits relative to treatment as
they relate to the issue of compliance. Strategies to
intervene and decrease the barriers would be a mutual
process between the older adult and the APN. Risk
assessment and goal setting would be a repetitive process to
reinforce successful problem-solving strategies to promote
compliance with medication regimens. Goal setting with the
patient is important to increase knowledge related to the
disease process; increase awareness of potential barriers
and address ways to overcome the barriers; increase

awareness of benefits to compliance with the medication

20

regimen; and to assist him/her in identifying and using
social support (Given 6 Given, 1983). Support and education
are important to the guidelines utilized by the APN to
address the issue of noncompliance with this specified
population. See Figure 2 for the modified HBM developed for
this project with emphasis on barriers and compliance.
Review of Literature

In this section relevant literature pertaining to the
treatment of CHF, compliance issues, and treatment barriers
will be further discussed. The discussion will include
literature concerned with the prevalence of CHF in the
elderly population and the increasing burden placed upon
patients, families, and the health care industry. Causes of
treatment failure will be discussed as well as a detailed
discussion on barriers that have been identified to promote
noncompliance. The discussion will include recent research
findings and expert opinion applicable to these issues.
deuieu

A review of the literature produces a multitude of
articles addressing the issue of compliance with medications
in the elder CHF population. The Agency for Health Care
Policy and Research (AHCPR) has addressed CHF as a major
public health concern and has developed a clinical guideline
to assist health care practitioners in the prevention and
treatment of this chronic illness syndrome (AHCPR, 1994).
Multiple research has been conducted on incidence,

prevalence, causes of CHF, and effective treatment regimens

21

Individual Perception
of threat of illness/
disease process

 

 

 

Perception and
acceptance of diseas
and potential severity

of exacerbations

 

lModifying Factorsl

Demographics

Psychosocial
Structural
Knowledge

 

 

 

 

 

 

Perceived threat
of CHF

 

 

 

 

Cues to action:
symptoms
exacerbations
educafion
media information
past experiences
support network

 

 

 

lLikelihood of A6601

 

 

Perceived benefits of
treatment minus
perceived Barriers

to treatment:
access
visual impairment
cognitive impairment
lack of understanding
lack of support
cutturellanguage
packaging of mods
financial constraints
poiypharmacy
adverse drug reactions
depression

 

 

Likelihood of
compliance with
prescribed medication
regimen

 

 

 

Figure 2: Barriers and HBM Model for the CHF Patient
(bolded boxes are the focus)

22

 

(Massie 6 Shah, 1997; Dracup et al., 1994; Rich et al.,
1995; Seager, 1995; Dracup, 1996; Monane et al., 1994; Rich,
Baldus Gray, Beckman, Wittenberg, 6 Luther, 1996; Happ et
al., 1997; Chin 6 Goldman, 1997; Deedwania, 1997; Bennett et
al., 1998). The most recent article relative to the care of
the CHF patient advocates prescribing a drug regimen,
consisting of at least two to four different types of
medications, as soon as Stage II of the New York Heart
Association Classification (NYHA Classification) (Appendix
B) (Packer 6 Cohn, 1999).

Numerous articles, research and descriptive, also exist
devoted to describing potential causes of the frequent
occurrence of treatment failure. Some of these articles
describe underutilization of angiotensin-converting enzyme
inhibitors (ACE-I) of health care providers; however, a
major theme identified in this literature is noncompliance
with medications and dietary restrictions, specifically
sodium restriction (Deedwania, 1997; Bennett et al., 1998;
Bennett, Milgrom, Champion, 6 Huster, 1997; Kegel, 1995;
Brass-Mynderse, 1996; Massie 6 Shah, 1997; Dracup, 1996;
Rich et al., 1995; Rich et al., 1996; Happ et al., 1997;
Monane et al., 1994; Col, Fanale, 6 Kronholm, 1990).
TreatmenLEailnre

Studies have focused on treatment failure because of
the economic burden that is placed upon society and
individuals and their families. Medicare estimates for

hospital costs related to care of CHF patients in 1991 was

23

$5.5 billion which exceeded the $3.2 billion spent on
hospitalizations for myocardial infarctions and was twice
the Medicare hospital expenditures for all forms of cancer
that same year (Massie 6 Shah, 1997). Total treatment costs
for hospitalizations alone are estimated to be $8 to $15
billion and this is considered a conservative estimate
(Packer 6 Cohn, 1999). With the prevalence of CHF being
diagnosed in the elderly population, the incidence will
continue to increase with the predicted aging of the
population. A major dilemma has been created between the
rising costs of high quality health care in a managed care
and capitated environment and the cyclical treatment
failures associated with care of the older adult with CHF.
MedicatioLNoncomnliance

Medication noncompliance, as mentioned above, has
played a major role in treatment failure with the older
adult. Reported rates of noncompliance range from 20-58%
(Happ et al., 1997; Dracup 1996; Dracup et al., 1994).
Older adults may have more problems with compliance because
of their multiple chronic illnesses; decreased functional
status, especially mobility issues; isolated living
situations; limited, fixed income; and out-of-pocket expense
for medications.

C01 and co-researchers (1990) found significant higher
rates of history of noncompliance with medications
associated with older adults living alone, using two or more

medications on an as needed basis, using two or more

24

pharmacies, without assistance taking their medications, and
having multiple health care providers. This study also
reported the most common form of noncompliance was underuse
which accounted for 81% of all noncompliance. Overuse
accounted for 17% and 2% was misuse. 9Fifty-four percent of
all noncompliance was reported as being intentional, and 46%
as being unintentional” (p. 842) .

Noncompliance with medications and therapeutic regimens
have been blamed for the high readmission rate of the older
adult with CHF. Rates of readmission range from 29-47%
within three to six months following initial discharge and
reasons for readmission are thought to be preventable (Rich
et al., 1995). The main factor identified in the high
readmissions are behavioral factors such as the
noncompliance issues, but social factors have also been
documented including social isolation and poor support
networks. In the previous mentioned research article by Col
and associates (1990), factors were identified that were
associated with a higher risk of hospitalization resulting
from noncompliance; these included: poor recall of
medication regimen; having numerous health care providers;
being female; medium income category (defined in this study
$10,000 to $15,000 per year); prescribed multiple
medications; and having the opinion that medications are
expensive. Col and colleagues also reported that in their
study, patients with cardiac conditions tended to have the

highest rate of history of noncompliance (31.1%) and the

25

proportion of patients whose admission was directly related
to noncompliance was highest among cardiac admissions
(47.6%).

W

Massie and Shah (1997) report in 1993, there were
875,000 hospital discharges with CHF as the primary
diagnosis and approximately 2.5 million discharges with CHF
listed as an associated problem. The number of hospital
days for CHF was 6.5 million in 1993. Massie and Shah also
note that hospitalization rates increase with age, from 12
per 10,000 persons under 65 years of age to 328 per 10,000
over 74 years of age. They report that hospital rates are
15% higher in women and African-Americans.

Happ and colleagues (1997) reported that older adults
with CHF have the highest rehospitalization rate of all
adult patient groups; ranging from 29-47%. In their
article, Happ and co-researchers report associated factors
contributing to the preventable hospitalizations to include
inadequate patient and caregiver education; poor symptom
control; inadequate discharge planning; noncompliance with
medications and diet; lack of sufficient social support; and
insufficient hospital discharge follow-up.
WWW

Barriers to compliance with prescribed medication and
therapeutic regimens are discussed throughout the literature
relative to the elderly population and CHF. As can be

inferred from previous discussion, identification of

26

barriers promoting noncompliance is critical to reduce
health care costs, early readmissions to hospitals,
mortality and morbidity, and to improve the quality of life
and functional status of the affected older adult. Barriers
to be addressed include: polypharmacy; access to health
care; visual and cognitive impairment; functional
impairment; poor understanding of medications and
therapeutic regimens; cultural and language differences;
lack of social support; depression; packaging of
medications; financial constraints; and side effects of
prescribed medications or adverse drug reactions.
Polyphamacx

Polypharmacy is common in the older adult due to
treatment of their chronic disease states. The older adult
has, on average, more than three chronic medical conditions
that require treatment with several medications and this
results in this population consuming approximately threefold
the amount of medication of the younger population (Murray
et al., 1993). Polypharmacy is also common with patients
seeing more than one health care provider because
medications usually are added to an already complex regimen;
the multiple providers usually do not have a complete list
of the current medications that the older adult is already
taking and most are not in the habit of carrying their “bag”
of medications to their office visit. Some older adults do
not report OTC medications, vitamins, and herbal products as

part of their medication regimen which can create problems

27

with drug interactions also. If each provider is not fully
informed of each patient's full medical history and each
medication that he/she is taking, the result can be
mismanagement and fragmented care. Another issue pertinent
to this discussion is the use of multiple pharmacies. Using
one pharmacy to obtain all medications can be important. If
the pharmacy is equipped with a computer, as most are these
days, medications are easily tracked and this helps the
pharmacist be more alert to potential medication
interactions and duplications.

Polypharmacy is not consistently defined in the
literature. Hsia Der and colleagues (1997) and Murray and
colleagues (1993) consider three or more medications to be
polypharmacy, while another does not define a specific
number, but reports polypharmacy as taking “several”
medications (Rajaei-Dehkordi 6 McPherson, 1997). Hanlon and
colleagues (1996) define polypharmacy as taking five or more
medications. However, all articles concerning polypharmacy
do note its related possible adverse consequences. Adverse
consequences related to polypharmacy include the risks of
adverse drug reactions, drug interactions, noncompliance,
and morbidity and mortality (Johnson 6 Bootman, 1995;
Rajaei-Dehkordi 6 McPherson, 1997; Murray et al., 1993; Hsia
Der et al., 1997; Happ et al., 1997; Wallsten et al., 1995;
Wilcox, Himmelstein, 6 Woolhandler, 1994). Hanlon and co-
researchers also report polypharmacy associated with

inappropriate prescribing in the older adult. They report

28

that approximately 51% of medications for the elderly are
overused and that up to 90% are misused which creates
unnecessary medication-related complications in the elderly
population. Wilcox and colleagues (1994) discuss the issue
of inappropriate prescribing and polypharmacy to report that
many associated symptoms such as sedation and cognitive
impairment may easily go unrecognized and many times result
in falls or other complications.

Johnson and Bootman (1995) address the issue of
medication-related morbidity and mortality. Morbidity and
mortality can both be a result of overuse, underuse, or
misuse of medications. The authors associate noncompliance
with a major economic burden. They estimate that the cost
of health expenditures for prescription drugs in 1994 was
over $73 billion. According to their research and their
quotes from The Task Force for Compliance of 1993 that was
involved in the push for health care reform, the direct
costs related to noncompliance exceeded more than $50
billion. These costs are related to the hospitalizations
secondary to noncompliance and adverse drug reactions from
inappropriate prescribing. Johnson and Bootman make
reference to the older adult as being high risk for
medication-related complications and negative therapeutic
outcomes based upon physiological effects of aging on the
disposition of medications; multiple disease processes;
multiple, concurrent medication regimens; and issues of

noncompliance.

29

Agnew

Access to health care can be a factor relevant to the
area of noncompliance also. Access to health care can be
limited due to geographical location and [or constraints
related to managed care issues and third-party payers.
Noncompliance can be an issue when there are limited
providers in an area, especially in rural areas; patients
may not be able to make appropriate appointments to maintain
proper management of their disease processes.
Transportation to the primary care visit may also create an
access problem. Access to too many providers can also
create noncompliant issues as seen in research articles by
Col and co-researchers (1993) and Cargill (1992), especially
with prescribing multiple medications.
LACR_Q£_flndezSLandinQ

Poor patient-provider relationships may also promote
noncompliance. If patients do not understand the reason for
prescribed medications and the therapeutic effects that
should result from their use, they may not take them as
prescribed. Poor communication can be the root of a major
problem between the patient and the provider according to an
article by Montamat and colleagues (1989). Assumptions by
the health care provider can also contribute to poor
understanding. For example, if the provider assumes the
patient understands the reasons for the medications and
potential side effects without assessing the patient's level

of understanding, a situation can be created that promotes

30

noncompliance with the prescribed therapeutic regimen based
on a knowledge deficit by both the patient and the provider.

Cargill (1992) states that a high percentage of older
adults misunderstand prescribed medications and feel that
they are being over-medicated. When a patient is
noncompliant with a prescribed therapeutic regimen, the
health care provider may feel anger or guilt and place blame
on the patient for wrongdoing; this scenario has negative
effects on the patient—provider relationship. Basically,
the end result is anger on both sides resulting in increased
patient noncompliance with the provider's medical advice and
possibly with the patient changing providers.
W

Cultural and language differences can play a role in
poor communication and lack of understanding (Dracup et al.,
1994; Esposito, 1995; Kegel, 1995). Monane and colleagues
(1994) documented a higher noncompliance rate with Hispanics
suggesting a cultural or language barrier between patient
and provider. Therefore, the health care provider needs to
make certain that the patient has a clear understanding of
the prescribed therapeutic regimen. However, it is also of
utmost importance that the provider make certain that he/she
understands the patient.
2' . J : l . l

Economic burden placed upon the older adult resulting
from multiple medications is a major barrier to medication

compliance. Patients with CHF may be concurrently taking

31

multiple medications. The most up to date evidence from the
Steering Committee and Membership of the Advisory Council to
Improve Outcomes Nationwide in Heart Failure suggest that
CHF be managed with up to four categories of medications
including ACE-I, diuretics, beta-blockers, and an inotropic
agent--Digoxin (Packer 6 Cohn, 1999). Therefore, just for
the diagnosis of CHF with a functional class of stage II
(Appendix), the patient could be on at least four
medications.

With a fixed, limited income, the older adult is under
financial constraints. Medicare is an older adult's primary
insurance and it does not pay for medications. Most older
adults do not meet the requirements to have Medicaid;
therefore, the medications are a monthly out-of-pocket
expense. According to Ennis and Reichard (1997), the
typical older adult averages 33 prescriptions annually; this
includes refills as well as new prescriptions. The
estimated average out-of-pocket expense for these
medications was approximately $1,125 in this study. The
most common form of noncompliance associated with financial
burden is underuse of medications which leads to
exacerbations of CHF and the economic burden of repeated
hospitalizations.

E l' J I . I

As a person ages, multiple physical changes start to

occur. Alterations in functional status may cause problems

with independence related to activities of daily living

32

(ADLs) and instrumental ADLs (IADLs). Functional
limitations that affect medication use may include visual
disturbances, sensory impairment in the hands, and disorders
that affect manual dexterity (Ennis 6 Reichard, 1997).
Mobility may be limited and the older adult may find it
difficult to move about. Joints may become stiff due to
arthritis which may make it difficult to open medication
containers (Farley, 1986; Whyte Mphil, 1994). Child-proof
caps on medication bottles and other packaging of
medications may cause noncompliance due to the older adult
being unable to open the container and visual disturbances
may be an issue with opening medication containers also.
Atkin, Finnegan, Ogle, and Shenfield (1994) looked at the
ability of a sample of geriatric patients in opening
standard medication packages and removing the tablet. The
standard packaging included a screw-top bottle, a blister
platform, a foil sheet, a ‘push and turn' child-resistant
bottle, a flip-top bottle, and a compartmentalized 7-day
medication organizer. Atkin and co-researchers found that
78.3% of the 111 patients were unable to break a tablet or
open one or more of the containers and of the 111 patients
taking medications upon entry into the study, 46 (41.4%)
were unable to perform one or more tasks necessary to gain
access to medications in their own treatment regimen.
Factors that were associated with inability to open
containers were poor vision, impaired general cognitive

function, and female gender.

33

W
Visual impairments may make it difficult to read the

small print on labels; therefore, noncompliance with
medications may occur. Commonly occurring visual problems
in the older adult are presbyopia, iatrogenic drug side
effects, macular degeneration, cataracts, glaucoma, and
ocular manifestations of systemic disease such as
arteriosclerosis and diabetes mellitus. The prevalence of
visual impairment among community-dwelling older adults
range from 10% for those age 65 to 74 and 26% over the age
of 85 (Kelly, 1996). Misuse may be the end result due to
visual disturbances. As stated earlier, misuse is a form of
noncompliance and even though it may not be intentional, the
results can be deleterious.
: 'l' I . l

Cognitive changes are a concern in the elderly
population. Estimates of prevalence of cognitive impairment
in community-dwelling older adults range from 3-20% of the
population (Conn et al., 1994). Conn and co-researchers
(1994) report.'forgetting’ias the most frequent reason given
for noncompliance (60.2%). Other reasons reported by Conn
and colleagues to cause noncompliance was that the
medication was not perceived as helpful, the time the
medication was to be taken did not fit into their routine,
and the medication caused undesired side effects. Of
interest, Conn and co-researchers (1994) looked at MMSE

scores relative to cognitive function and the rate of

34

noncompliance. In this study, lower MMSE scores were not
associated with higher rates of noncompliance. Conn and her
associates report that patients with lower MMSE scores were
more likely to have an adult child or other caregiver
assisting with medication administration. Other studies
also report similar results with forgetfulness being the
main cognitive impairment and patients with dementia-type
impairments having assistance with medications from
caregivers whether community-dwellers or institutionalized
(Reed, 1997; Ennis 6 Reichard, 1997; Conn, Taylor, 6
Messina, 1995).
LaCK_Qfi_$QCial_SHRRQZI

Another influencing factor found in the literature
relative to noncompliance is lack of social support.
Support from family, friends, and/or a support group has
been described as important to the issue of compliance.
Fleury, Peter, and Thomas (1996), found that support from
family and friends is one of the few variables consistently
associated with success in compliance to cardiovascular
health behaviors. Rich and co-researchers (1996) reported
that noncompliance in the older adult CHF patient was higher
when the patient lived alone; living alone was found to be a
significant independent predictor of reduced compliance.
Dracup and colleagues (1994) also reported that patients
diagnosed with CHF were more compliant when their family
members supported the required therapeutic changes. Dracup

(1996) reports that “family support is almost as critical as

35

the patient's commitment to making the lifestyle adjustments
necessitated by a diagnosis of CHF” (p. 65) . Positive
social relationships may be essential to compliance with
medication and therapeutic regimens in the older adult.
Depression

An issue that may be closely related to lack of social
support is depression, and there is documented research that
depression affects compliance. Depression has been
documented in the elderly population and it has been
documented in patients with cardiovascular disease.
Freedland, Carney, and Rich (1991) reported 17% of older
adult inpatients with CHF and 15-22% of older adult
inpatients with coronary artery disease meet the criteria
for the diagnosis of depression. A research study by Carney
and co-researchers (1995) reported a 45% compliance rate
with medications in the depressed elderly patients with
cardiovascular disease. These researchers concluded that
the poor compliance rate to the prescribed medication rate
could be at least partially responsible for the higher rates
of medical morbidity and mortality reported in older adult,
depressed cardiac patients. Carney and colleagues (1995)
associated depression in the older adult with poor social
support; functional impairment; heightened sensitivity to
physical discomforts including side effects related to
medications; and cognitive impairment of attention,

concentration, and memory. Each of these factors, solely,

36

has been associated with noncompliance in the elderly
population.
Wm

Adverse drug reactions or associated side effects of
medications influences compliance with medications in the
elderly population. An adverse drug reaction may be defined
as.fiany adverse event associated with a drug as normally
used or in abuse, overdosage, or in withdrawal of the drug"
(Lamy, 1990, p. 293). .Adverse drug reactions are a main
contributor to noncompliance. The older adult may be more
susceptible to adverse reactions since the metabolism of
medications is altered; older adults may respond
unpredictably to medications due to age-related diseases and
alterations in physiology (Kegel, 1995). Polypharmacy is
also associated with increased risk of adverse drug
reactions especially due to drug interactions.

Montamat and colleagues (1989) describe adverse drug
reactions as all too common in the older adult; overall
incidence of adverse drug reactions is said to be two to
threefold that found in the younger population. It is also
thought that the incidence is underestimated since adverse
reactions are not easily recognized by the older adult and
the reactions could be mistaken for characteristics of a
disease process. The cost of adverse drug reactions is
documented throughout the literature as extremely high due
to the rate of hospitalizations that occur as a result of

the noncompliance (Johnson 6 Bootman, 1995). Hospital

37

admissions related to adverse drug reactions is estimated to
account for 10-16% of all hospitalizations of the elderly
(Rajaei-Dehkordi 6 McPherson, 1997; Col et al., 1990;
Botelho 6 Dudrak, 1992).

Col and colleagues (1990) found that 16.8% of
hospitalizations among the older adults they included in
their study to be a direct result of an adverse drug
reaction. The types of adverse drug reactions described
included: side effects related to the medications; toxic
reactions; allergic reactions, and idiosyncratic reactions.
They found that there was an increased risk of adverse drug
reactions related to polypharmacy, which they defined as
taking two or more medications and patients using two or
more pharmacies to purchase prescriptions.

In summary, the literature supports the premise that
noncompliance in the older adult with CHF is a very common
problem and needs to be acknowledged early by all health
care providers that provide care to this population to
decrease the possibility of occurrence. Proactive treatment
of the older adult with CHF could decrease morbidity and
mortality and improve functional status and quality of life.
Multiple barriers to medication compliance in the CHF
population have been discussed. Health care providers need
to become more aware of issues relative to noncompliance and
the potential deleterious consequences associated with this
population. Action must be taken on the part of the

provider in order to improve the quality of health care

38

provided to these patients; reduce hospital readmission
rates which should help decrease costs incurred by the
patient and family, society, as a whole, and the health care
industry; and improve the quality of life for the older
adult diagnosed with CHF.

Project Development

The focus of this project is to develop a tool to
identify the risk of noncompliance with the prescribed
medication regimen of the older adult with CHF. The
assessment tool would be used in an ambulatory care setting
by an APN and the initial administration time would be
approximately fifteen minutes. The initial assessment and
information-gathering appointment would take the longest
amount of time, but subsequent visits would be updating the
information in the event that a change occurred in the data,
which may only take five to ten minutes.

Initially, the first part of the tool would address
data that the patient would be able to answer ahead of the
scheduled appointment time and would include data relative
to patient demographics, medical diagnoses/problems, names
of physicians seen by the patient, and information regarding
dates of preventive care exams, such as vision exam,
auditory exam, and immunizations. The tool would elicit
complete information relative to concurrent medications
being taken by the patient and would also include
information regarding dietary restrictions, and a weight

range.

39

The second part of the tool contains the specified
barriers discussed within this project. Each barrier is
categorized with bullet questions/statements to guide the
APN in her/his assessment of-the patient's risk of
medication noncompliance. would place the patient at risk
for noncompliance. To assess for barriers relative to
noncompliance, the APN would have to ask non-threatening,
open-ended questions that would elicit the information.
Examples of questions that have been used to address
medication noncompliance in the older adult with CHF based
upon the constructs of the HBM are found in the literature
(Conn et al., 1994; Bennett et al., 1997). Each barrier
that has been identified within the review of literature in
this project has two or more bullet questions/statements
prompting a response that would ascertain the older adult's
risk of noncompliance. Most responses to the
questions/statements would be either “yes” or “no”; however,
many do require detailed explanations from the patient. The
responses would assist the APN in addressing areas of
knowledge deficit with the patient. Patient demonstration
is also included in specific categories of barriers because
it is important when assessing functional and visual
impairments; the APN will be able to assess for any
difficulties related to these categories.

The risk of noncompliance would be determined based
upon the information gathered, and then the specific

barriers could be mutually identified by the patient and the

40

APN. The risk assessment of barriers contributing to
noncompliance would identify older adults that are “at risk”
or'fnot at risk?. Identification of barriers that have a
greater negative impact on compliance have not been
established in the literature; therefore, these limitations
are noted within the scope of this project. To date,
research does not exist that would determine the degree of
influential importance of specific barriers to medication
noncompliance; therefore, a scale of the level of risk
('low", ”medium'i, and “high") cannot be calculated at this
time.

In general, an older adult would be placed in one of
two categories--“at risk” or “not at risk“. Older adults
that fall into the “not at risk” category would be the
patients who did not have any identifiable barriers and
those who may have only one identifiable barrier but have
the means to problem-solve and eliminate the barrier. All
other older adults with CHF would fall into the “at risk”
category. Being “at risk” would set the next steps in
motion of establishing mutual interventions and goals to
eliminate the barriers (the details of this discussion is
out of the scope of this project). With barriers
eliminated, compliance with the prescribed medication
regimen would be possible and the older adult would have
some control over the clinical syndrome which may promote a
more independent functional status and a higher quality of
life.

41

Procedure for Using Tool

This tool is intended to be administered to the older
adult diagnosed with CHF in the ambulatory care setting. As
previously.described, the first part of the tool can be
filled out by the patient without or with assistance from
family, friends, or office personnel. The basic information
in this part should already be documented within the
patient's medical record and at subsequent visits would only
require an update if a change had occurred. The first part
of the tool would alert the APN to the number of chronic
illnesses/problems, names of health care providers,
concurrent medication use, and health habits relative to
preventive care. This information would provide the APN
with a quick assessment of potential risk-related barriers
to medication compliance which could be addressed initially
and may provide the APN with more insight prior to the
subsequent questions on the second part of the tool. The
APN may even gain answers to some of the
questions/statements on the second part of the tool which
could minimize time asking questions.

The APN would complete the second part of the tool with
the patient which would consist of the open-ended, non-
threatening questions aimed at identifying risk-related
barriers that contribute to medication noncompliance. The
time intended for this second part would be approximately
fifteen minutes. A space is provided to the left of each

barrier category for the APN to place a check indicating

42

that she/he discussed this category with the patient. There
are spaces to the right of the questions/statements under
each barrier category for the APN to place a check or write
“yes" if a risk is identified. At the end of the of this
second part, a “comments” section is provided for the APN to
put any additional notes specific to the patient. A place
is included for the APN's and the patient's signature to
signify mutual agreement of the gathered information. Upon
completion of these questions, the APN would be able to
determine if the older adult is “at risk” or “not at risk”.

The tool should be updated with each subsequent visit
to provide close follow-up and monitoring of changes. The
tool would be placed in the front of the patient's chart for
easy access and would remain part of the permanent medical
record. The tool could also be used in tracking and
monitoring of outcomes with the older adult CHF patient once
interventions were instituted to reduce risk-related
barriers that contribute to medication noncompliance.

Evaluation of Tool

Evaluation of the tool is important to ensure that it
is reliable and identifies risk-related barriers that
contribute to medication noncompliance in the CHF patient.
APNs working in an ambulatory care setting with older adults
diagnosed with CHF could review the tool and determine if it
assesses for barriers that are relevant to the population of
CHF patients seen in their setting. Another method that

would assess the usefulness of this tool would be to

43

perform a chart review on older adults that utilized the
tool: The chart review would indicate the older adults “at
risk? and the barriers that had been identified. The
interventions and education that had been instituted in
response to the identified barriers would be documented in
the charts. It would be important to look for a decrease in
the number of hospitalizations and in the number of primary
care visits related to exacerbation and symptom relief of
CHF in comparison to the numbers prior to use of the risk
assessment tool. Another area of interest would be to
determine if the health care provider was providing closer
monitoring and follow-up of the older adult “at risk" which
may positively impact the medication compliance rate also.
The main outcome with this risk assessment tool is to
reduce barriers that contribute to medication noncompliance
in older adults with CHF. If the risks of barriers are
reduced, compliance with medications will be optimized.
Medication compliance should result in: the older adult's
perception of some control over the disease process,
improved symptom management, maintenance and/or improvement
in functional status and quality of life, and decreased
costs to the patient, family, society, and the health care
industry. Outcomes would be measured by the decrease in
number of hospital readmissions and emergency room visits
due to less occurrence of exacerbations; and improved
symptom management, including daily weight monitoring and

patient's report of less incidence of edema, orthopnea,

44

dyspnea on exertion, and paroxysmal nocturnal dyspnea,
measurable with the use of the NYHA classification. Another
outcome that would be important to measure would be patient
satisfaction with the treatment process and the patient's
knowledge of CHF and prescribed medications (Spertus, 1997).
The AHCPR (1994) guidelines for CHF also suggest measuring
quality of life with the Health-Related Quality of Life
(HRQOL) scale.

Implications for Advanced Nursing Practice

The diagnosis of CHF is associated with dramatic
lifestyle modifications. The success of the prescribed
therapeutic regimen requires patient compliance with
medications, as well as dietary restrictions and regular
exercise schedules. The diagnosis alone can be devastating
to the older adult, but he/she is faced with the stress of
having to modify a.“set lifestyle”, take multiple
medications that may alter daily schedules, and accept the
change in functional status related to fatigue, dyspnea, and
other symptoms associated with CHF.

Management of the older adult with CHF can be a
challenge for any health care provider, but someone must
play a key role in assisting the older adult and their
family and/or support person(s) adapt to and understand the
required changes. The APN's role in the care of the older
adult with CHF is documented throughout the literature
(Dracup, 1996; Dracup et al., 1994; Fleury et al., 1996;

Brass-Mynderse, 1996; Happ et al., 1997; Kegel, 1995; Packer

45

6 Cohn, 1999). The APN can play multiple roles in the care
of the older adult including: clinician, collaborator,
counselor, educator, evaluator, advocate, consultant, and
change agent. Although, all of these roles are important, a
select few will be discussed within the scope of this
project. .

The older adult with CHF requires close monitoring and
assessment for early signs of exacerbations. With a strong
clinical base in cardiology and CHF, the APN is capable of
providing quality care that incorporates advanced
assessment, diagnostic, and management skills (Kegel, 1995).
The APN can assess the patient's response to treatment and
“implement educational, psychosocial, and physiological
interventions that lead to physiological stability"(Kegel,
1995, p. 78).

The APN, as educator, is involved in ongoing education
with the patient and the family. Education is always part
of the plan of care with a thorough assessment of the
patient's and family's level of understanding. Patients and
families should receive written instructions regarding
medications and other prescribed therapeutic regimens and
they should receive brochures or pamphlets that explain the
course of CHF and management strategies. Without the
understanding of the disease process, purpose of
medications, and other important strategies to manage CHF,
patient compliance is at risk. Knowledge deficit is a major

barrier and one that can be eliminated by the APN. A list

46

of suggested topics for patient, family, and caregiver
education and counseling is included in Appendix III.

As counselor, the APN provides support to the older
adult and family and allows for expression of concerns and
fears relative to the diagnosis and management of CHF. The
APN may assist the patient and family with problem-solving
skills and interventions to eliminate barriers that
contribute to medication noncompliance. Assessment of
coping behaviors in adjusting to the lifestyle modifications
is also an area for the counselor.

As consultants and collaborators, APNs have an
important role in the shift to prevention as health
promotion educators, community leaders, and caregivers
(Fleury et al., 1996). The APN can provide cost-effective
high quality health care that addresses the needs of the
older adult and the family. The APN can monitor and track
outcomes and effectiveness of care delivery.

The APN can function in a collaborative role with other
health care team members to provide a holistic approach to
the care of the older adult with CHF. Rich and co-
researchers ( 1995) concluded that a “nurse-directed,
multidisciplinary treatment strategy could significantly
reduce hospital admissions and improve the quality of life
for elderly patients with CHF” (p. 1194). DeBusk (1997)
also supports the role of the APN in the management of the
care of the CHF patient. Dr. DeBusk is involved in a

program, MULTIFIT, which is a physician-supervised, nurse-

47

mediated, home-based system for managing care of patients
with chronic diseases. This comprehensive program relies
“heavily on patient education, reinforced by nurse-mediated
phone contact with patients to provide feedback based on
patient's reports of symptoms, weight, and other clinical
and functional information" (p. 2). There is an emphasis
placed on compliance to treatment regimens.' This program
has tracked two types of outcomes to monitor progress with
the CHF patients: primary outcomes which include
hospitalization rates, emergency room visits, and clinic
visit; secondary outcomes which include following functional
status as measured by NYHA classification and self-reports
of symptom control, dietary sodium intake, weight diaries.
The evaluation of the program demonstrated that the
interventions were effective; Dr. DeBusk reported that the
outcomes exceeded the expectations of the investigators and
he credits the improvements to the nurse-managed part of the
program.

Another setting where the APN is functioning is in
nurse-managed CHF clinics. The nurse-managed clinic
provides a continuum of care and patients' needs are a main
part of the focus. Areas of focus include pharmacological
management, nutritional management, exercise training
through referrals to the system's cardiac rehabilitation
program, and educational and counseling programs (Brass-
Mynderse, 1996). The clinic receives patients from

referrals from physicians, including cardiologists, and any

48

patient admitted to the hospital with CHF is seen by the
APN. Patients are followed closely for the first 6 months
with a preset schedule of clinic appointments. After 6
months with continual progress, the patients are mainly
monitored by phone. The clinic strives to provide high
quality care through control and avoidance of high-cost
chronic disease (Brass-Mynderse, 1996).

In summary, the APN has the capability of effectively
providing high quality, cost-effective care to the older
adult with CHF. With the tracking and monitoring of
outcomes, APNs can validate their worth to the patient,
society, peers, and the health care industry. The APN who
has the skills and knowledge to care for the older adult
with CHF can educate, provide support, assess, and intervene
to help the patient decrease noncompliant behaviors and
maintain quality of life.

Implications for Education

With the projected increase of the aging of the
population, the incidence of CHF will not abate and
disappear from the list of chronic diseases. Therefore, it
is essential that education be a priority. Academic
settings that provide education to prepare APNs to practice
in the primary care setting, as well as the acute care
setting, must include CHF as a chronic and fatal syndrome.
The APN must have a complete understanding of CHF in order

to provide quality care to the affected patient. The care

49

must be holistic since CHF requires major life
modifications.

Education must focus on risk reduction of CHF. Risk
reduction would emphasize prevention and control of
hypertension, smoking cessation, management of blood lipid
levels, and tight control of blood glucose levels in
diabetics. Education related to well-balanced dietary
regimens to limit intake of fats and cholesterol and a
regular exercise program would also be accentuated. A goal
of a risk reduction program would be to decrease the
incidence of ischemic heart disease which is the primary
cause of CHF and to prevent or control hypertension, as
stated above, since it is the secondary cause. APNs must be
able to provide primary preventive Care as well as secondary
care in order to effect the continuous increase in the
incidence of CHF.

Education of the APN must include management of the CHF
patient. Management should include symptom management and
reduction with improved functional status and quality of
life. All academic settings involved in the education of
master-prepared APNs must emphasize management of the CHF
patient that is grounded on evidence-based outcomes. APNs
must also understand the importance of monitoring and
tracking outcomes. Tracking outcomes is significant to the
future of the APN; it can be a “value-added” component that
may secure a position for the APN in the primary care

environment.

50

Education of the multidisciplinary team that cares for
the older adult with CHF is of utmost importance. The APN
is capable of providing education to her/his peers and
coworkers. Health care providers need to understand what
CHF means to the patient. Care that is provided with a
sincere and empathic attitude is much more effective with
chronic diseases. Risk reduction in cardiac diseases must
start with education; primary prevention is the key to
successful aging.

Implications for Research

Current research abounds with information relative to
CHF and its management. The research indicates that the
prevalence of CHF will continue to increase with the aging
of the population. There is much discussion on treatment
and treatment failure; however, the research that deals with
the problem-solving of decreasing treatment failure is
limited. There are a few articles discussed within this
project that denote the success of multidisciplinary teams
and this seems to be a successful and practical approach.
However, much more research is needed regarding prevention
of treatment failure.

More research is needed to understand the barriers to
compliance. For example, a research question that looked at
barriers and their influence on compliance would be
important in determining if one type of barrier has a
greater impact on compliance as compared to another barrier.

Interventions need to be identified and researched to

51

discover which ones are effective to promote compliant
behaviors. For example, an experimental research design
could be used to observe for differences between a treatment
group that receives specific interventions to improve
medication compliance versus a control group. Possible
outcomes to address in the experimental study would be
decreased hospitalizations and readmission rates, improved
symptom management, and the patient's perception of quality
of life. It would also be relevant to document what type of
follow-up--frequent office visits, frequent phone follow-
ups, or a combination of both--provides the most successful
outcome of medication compliance in the older adult with
CHF. Research is important to determine factors that
facilitate medication compliance as well as factors that do
not facilitate compliance. In summary, more research
studies are needed to guide the care of the older adult with
CHF toward compliance with prescribed regimens which will
produce effective outcomes.
Conclusion

Management of CHF in the older adult can be a
challenge. The therapeutic regimen guidelines are well
documented by the AHCPR as well as throughout the research
literature; however, treatment failures are common in this
population. Noncompliance has been discussed throughout
this project as being a major contributor to failure of
treatment. Barriers that contribute to noncompliance must

be addressed with the initial diagnosis of CHF. Patients

52

must be included as the primary participant in the plan of
care, and goals and interventions must be mutually decided
upon by all participants. The APN can play a proactive role
in the care of these patients and assist them in being
successful in the management of a clinical syndrome that
knows no cure. As providers of health care, we have an
obligation to work with our patients to achieve mutual goals
and form a partnership with our patients that will promote
an environment of mutual respect, understanding, and

compliance.

53

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57

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59

APPENDICES

APPENDIX A

W

Wham

9"

l0.

ll.

12.

The first part of the Risk Assessment Tool can be filled out by the patient prior to the
appointment with the APN. This can be mailed to the patient by the ofice stafi'
accompanied by instructions to assist in the completion of the form and to remind
him/her to bring all medications to the appointment. Ifa mailing is not feasible, the
patient can be instructed to come about 15 minutes prior to the appointment time.
Always remind the patient to bring all their medications with them.

Ifthe patient had any questions regarding filling out the papers, the front omce stafi‘
would be able to answer questions.

The APN would review the first part of the assessment tool at the appointment and
clarify any missing information with the patient.

In the second part of the Risk Assessment Tool, the APN would ask the patient (or
family member or caregiver) questions specific to listed categories that would identify
risks for potential barriers. The APN would place a check in the space provided to
the left of the category indicating that it was addressed with the patient.

The responses to the questions/statements would indicate the patient’s risk of
medication noncompliance. Ifrisks are present, the APN could identity the specific
areas by placing a check or a “yes” in the space provided to the right of the
questions/statements.

If barriers are mutually identified by the APN and the patient, then the patient is
considered to be “at risk”.

If no barriers are identified, then the patient is considered “not at risk”.

A patient could also be considered “not at risk” in the following scenario: if there
was identification of a potential barrier but interventions were in place at this time
that negated the risk.

If a patient is considered to be “at risk”, interventions must be put in place to
minimize the barriers, thus decreasing the risk and safeguarding medication
compliance.

Comments section is provided for any additional information that the APN considers
pertinent to the patient’s situation.

A space is provided for the APN and the patient to sign showing mutual agreement of
information elicited through the Risk Assessment Tool.

Information in the Risk Assessment Tool should be updated with any changes at
follow-up appointments. It is important for the APN to be aware of any changes that
may increase the risk of medication noncompliance. (ALWAYS ASK ABOUT
CHANGES!)

6O

RISK ASSESSMENT TOOL (Part I)

Instructions to the patient:

1.

2.

Please fill out the enclosed Risk Assessment Tool before your scheduled appointment.

Ifyou need assistance filling out the forms, ask a family member, fiiend, or call our
office and someone will be able to assist you. Phone #

. If more space is needed in order to provide the information, you may use the backside

of the form or a separate sheet of paper.

The second page of the Risk Assessment Tool asks for a listing of ALL your
medications, including over-the-counter medications such as vitamins, aspirin, Tylenol,
and herbal products. Please complete this page, but we also ask that you BRING
ALL YOUR MEDICATIONS TO YOUR APPOINTMENT. It is extremely
important that we are aware of ALL your medications because of potential drug
interactions.

. We encourage all our patients to keep a medication list with them at all times. Ifyou

do not have one, we will be happy to photocopy this completed list for you at your
appointment.

Please call if you have any questions.

61

RISK ASSESSMENT TOOL (Part I)

 

 

 

 

 

 

NAME DATE OF BIRTH SEX

PHONE (HOME): (OTHER): MARITAL STATUS____
OCCUPATION EDUCATION

DO YOU LIVE ALONE?___WITH SPOUSE?___OTHER?___ (check one)
INSURANCE (1)

 

(2)

MEDICAL DIAGNOSES/PROBLEMS:

(1) (7)
(2) (8)
(3) (9)
(4) (10)
(5) (11)
(6) (12)

 

 

 

 

 

 

 

HEALTH CARE PROVIDERS:

PREVENTIVE CARE: DATE LAST EYE EXAM: HEARING EXAM:
TYPE OF DIET: DO YOU FOLLOW IT?
EXERCISE (me a FREQUENCY):

 

DO YOU WEIGH YOURSELF DAILY? WEIGHT RANGEZG’AST WEEK)

USE OF (AMOUNTS): TOBACCO ALCOHOL
CAF F EINE DRUGS

 

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NAME OF PHARMACY:

 

MEDICATIONS— prescription (include pills, patches, eyedrops, ointments, liquids)

NAME DOSE HOW PURPOSE DOCTOR COLOR!
SHAPE

TAKEN

 

OVER-THE-COUNTER MEDS: (include vitamins, herbal products)

 

NAME DOSE HOW PURPOSE DOCTOR COLOR]
TAKEN SHAPE

 

 

 

 

 

 

 

 

 

 

 

 

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RISK ASSESSMENT TOOL (Part II)

The APN will ask questions specific to the following areas:

Social Support

needs assistance taking medications
lives alone

family/friends able to assist; other support
feels has adequate support

any history of Depression

 

_ Polypharmacy

taking multiple medications (>3)

multiple chronic illnesses

uses more than one pharmacy

system to help you remember to take medications
schedule of daily medications (00 vs. TID or QID)

_ Cognitive I Understanding

able to recall names of medications

able to explain purpose of medications

able to explain CHF

believes medication is effective

forgets to take medications (how many times/week?)

_ Financial

. has insurance to help pay for medications
. has problems purchasing medications

. ever had a prescription unable to get filled

_ Access

difficulty getting to pharmacy to pick up prescriptions
difficulty getting appointment to see Health Care Provider
sees multiple providers

insurance constraints

transportation

_ Functional I Visual

patient is able to demonstrate the following:

. able to read medication bottle label

. able to open medication container

. do any medications have to be broken for correct dosing

_ Adverse Drug Reactions

. experience problems with taking medications
(side effects / drug reactions or interactions)

. quit taking medication related to adverse reaction
(notified Health Care Provider?)

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Risk Identified

Cultural I Language
. beliefs that influence health care
. language barriers

COMMENTS:

(example)

 

 

 

 

 

 

APN signature

Patient signature

65

Date

Date

 

head

APPENDIX B

NEW YORK HEART ASSOCIATION
FUNCTIONAL CLASSIFICATION
(adapted from New York Heart Association)

Functional class:

Patients with cardiac disease but without limitations of physical
activity. Ordinary physical activity does not cause undue fatigue.
dyspnea, or palpitation.

Patients with cardiac disease that results in slight limitations of
physical activity. Ordinary physical activity results in fatigue,
palpitation. dyspnea, or angina.

Patients with cardiac disease that results in marked limitation
of physical activity. Although patients are comfortable at rest,
less than ordinary activity will lead to symptoms.

Patients with cardiac disease that results in an inability to carry on
physical activity without discomfort. Symptoms of congestive

failure are present even at rest. With any physical activity, increased
discomfort is experienced.

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APPENDIX C

Suggested Topics for Patient, Family, and
Caregiver Education and Counseling
(adapted from AHCPR No. 11: Heart Failure)

General Counseling

. Explanation of heart failure and the reason for symptoms
. The cause or probable cause of heart failure

. Expected symptoms

0 Symptoms of worsening heart failure

. What to do if symptoms worsen

. Self-monitoring with daily weights

. Explanation of treatment/care plan

. The role of family members or other caregivers in the treatment/care plan
. The availability and value of qualified local support groups
. Clarification of patient and family responsibilities

. Importance of tobacco cessation

Dietary Recommendations

0 Sodium restriction

. Avoidance of excessive fluid intake
. Fluid restriction (if required)

. Alcohol restriction/abstinence

Activity Recommendations

. Recreational, leisure, and work activity
. Exercise

. Sexual difficulties and coping strategies

Medications

. The benefits of medications for quality of life and survival

. Dosing

. Adverse effects and what to do if they occur

. Coping mechanisms for complicated therapeutic regimens

. Availability of lower-cost medications or financial assistance

Prognosis

. Life expectancy

. Advance directives

. Advice for family members in the event of sudden death

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