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DESCRIPTIVE REPORT
Congestive Heart Failure:
A Disease Management Approach in Long-Term Care Patients
Al Barber, Kelly. Hollenack, and Michael Bottorff
OBJECTIVE: To determine the cost effectiveness of
a
pharmacist-
directed disease management program for patients with heart failure.
PARTICIPANTS:Consultant pharmacists, nursing staff, nursing home
administrators and clinical staff, attending physicians.
DESIGN: A disease management approach for heart failure based on
MAIN OUTCOME MEASURES: Hospitalizationsfor heart failure (prima-
guidelines from the Agency for Health Care Policy and Research
(AHCPR).The key elements in this approach included program prepa-
ry or contributing diagnosis).
ration, clinical education, protocol implementation, outcomes measurement, and continuous quality improvement. Speciallytrained consultant pharmacists received approval for the heart failure program
from the administration and clinical staff at each long-term care facil-
ity and provided in-service programs for the nursing staff. Finally, recommendations were made to attending physicians to improve the
RESULTS:For every $1 invested in this program, $2.44 could be saved
in heart failure-related hospitalizationcosts.
CONCLUSIONS:Results indicate that this program is cost effective in
this setting.
KEYWORDS: Clinical guidelines, Congestive heart failure, Disease
pharmacotherapyfor heart failure patients within the facility.
management.
SETTING: Skilled long-term care facilities in Ohio.
J Managed Care Pharm 1999: 516-520
In
the opening paragraph of the clinical practice guideline
Heart Failure: Evaluation and Care of Patients with Leftyentricular Systolic Dysfunction, the Agency for Health Care
Policy and Research (AHCPR) stated, "More than two million
Americans have heart failure, and about 400,000 new cases are
diagnosed each year. Mortality is high, with five-year mortality
rates in the range of 50%. Many of the almost one million hospitalizations that occur each year for this condition might be
prevented by improved evaluation and care. "I
In a letter to providers dated November 8, 1995, the Ohio
Department of Human Services outlined why heart failure is a
major and growing public health problem:
~ Congestive heart failure (CHF) is the only major cardiovascular disease whose incidence is increasing.
~ In this country, $7 billion is spent annually for CHF hospiAUTHORS
.Â.
AL BARBER, M.A. RPH., is former Director of Research, NCS HealthCare,
Beachwood, OH; KELLY HOLLENACK, RPH., is Director of Clinical Programs,
NCS HealthCare; MICHAEL BOTTORFF, PHARM.D., is Professor of Clinical and
Hospital Pharmacy, College of Pharmacy, University of Cincinnati, Cincinnati, OH.
AUTHOR CORRESPONDENCE: Kelly Hollenack, RPh, NCS HealthCare, PO.
Box 248, Hilliard, OH 43026.
ACKNOWLEDGEMENT: The authors would like
to
acknowledgeLaurie
Epitropoulos,RPh., Diversified Pharmaceuticals, Columbus, OH, formerly with
NCS HealthCare, for her work in the early development of our heart failure disease
management program.
This research was funded in part
by grants from Merck &
Co. and
Boehringer-
talizations.2
~ Poor patient compliance with preventive programs and
therapy (i.e., diet and exercise) tends to greatly increase mor-
bidity and mortality
~ Significant variations in the treatment of heart failure has
led to the need for widely accepted guidelines for the management of this disease.
The American Medical Directors Association (AMDA) released Clinical Practice Guideline for Heart Failure in December
1996. Its goal was a simpler, user-friendly guideline that focused
on application in the long-term care institutional setting3
At the time the AHCPR guidelines were issued, NCS
HealthCare was an independent provider of pharmacy ser-
Mannheim.
vices to approximately 25,000 patients in the Midwest, primarily in Ohio. Because CHF is a significant problem for its
Copyright@ 1999 Academy of Managed Care Pharmacy, Inc. All rights reserved.
primarily elderly patient population, NCS decided to develop
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Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients
and implement a comprehensive, interdisciplinary diseasemanagement program that would include education of the
patient-care team, treatment recommendations to improve
therapy, monitoring of clinical and economic outcomes, and
continuous quality improvement. This process was developed
to be driven by consultant pharmacists working with the
patient-care team in each facility.
PLAN DEVELOPMENT
The first step in plan development was to conduct a literature
review and compile a reference library related to heart failure
and disease management. These materials were then utilized to
conduct provider education and to reference therapy recommendations.
Next, NCS established criteria for patient inclusion in the
program. Any patient with CHF, history of myocardial infarction, andJor new symptoms of systolic heart failure-left ventricle (LV) enlargement; ejection fraction <40%; and physical
signs and symptoms of heart failure, including orthopnea,
edema, and nocturnal dyspnea-was included. NCS decided
with known contraindications to ACE
inhibitor therapy such as serum creatinine >3.0 mgldL, serum
potassium >5.5 mEqlL, and systolic blood pressure dOO mm
to exclude patients
Hg. The program's primary objective was to use a diseasefocused approach based on consultant pharmacist recommendations in the treatment of CHF to reduce hospitalizations
recommendation was thoroughly researched and referenced.
Experience showed that legible, concise, and referenced recommendations have a much higher physician acceptanèe rate.
Finally, these recommendations were reviewed by an interdisciplinary team for accuracy and appropriateness for the patient
population.
Outcomes goals and measurement instruments were
developed that were easy to collect and interpret. The primary
purpose of any outcomes measure should be to demonstrate
that the intervention or therapy has value. NCS chose to
determine value from the payor perspective. The primary goal
was to reduce hospitalizations related to heart failure, especially rehospitalizations. A reduced hospitalization rate would
have obvious value for both the payor and the facility by
improving census and for the patient by improving quality of
life and maintaining function.
The Ohio Department of Human Services is the primary
payor for about 60% of the residents NCS serves in Ohio. In a
medical assistance letter mailed to all Ohio physician
providers in November 1995, the department stressed the
need for widespread adoption of the AHCPR guidelines. This
letter provided treatment guidelines and a drug therapy algorithm for the treatment of congestive heart failure.' Of note
was the department's willingness to pay for diagnostic testing
(including screening echocardiograms) and drug therapy that
has been shown to be cost effective in such trials as SAVE:
SOLVD,5 and CONSENSUS.6
education. NCS thought it essential to train consultant pharmacists not only about clinical guidelines but also how best
The final step was to develop a mechanism to complete
the disease management loop by using outcomes data to provide a continuous quality improvement process. By knowing
which parts of the process were the most cost effective, NCS
to communicate this information to other health care profes-
could concentrate its finite resources in those areas.
sionals. Another important part of this pharmacist education
program is periodic competency testing to ensure a uniform
level of knowledge and skills. Information about the proposed
METHODOLOGY
related to heart failure.
A timeline was developed beginning with pharmacist
then communicated by each pharmacist to the
nursing facilities they serve during quality assurance meetings
and directly to the administrator, director of nursing, and
program is
medical director.
The next step was to develop an in-service training program for nurses, nurses' aides, and other direct care providers.
This program included practical information related to the disease process, patient assessment, drug therapy, dietary concerns,
and desired goals (outcomes) of treatment. The program was
approved for one contact (0.1 CEU) for nurses by the Ohio
Pharmacist recommendations for the CHF disease management program included the addition of ACE inhibitor therapy
or an increase in the dose of current therapy to target doses,
based on guidelines developed by AHCPR and AMDA.
Patients were then placed into two groups based on physician
acceptance (RA) or rejection (RR) of these recommendations.
Heart failure hospitalizations were measured during the six
months following. Hospitalizations were defined as any hospital admission with LV enlargement with or without other
Nurses Association and presented by consultant pharmacists.
The primary goal of physician education is to provide
symptoms such as edema or jugular venous distention OVD).
Finally, the difference in the hospitalization rate as a percentage between the two groups (absolute risk reduction) was
information about the AHCPR guidelines and their clinical
rationale. NCS also addressed the specific educational needs of
attending physicians who are primarily trained in family prac-
determined. The statistical significance of this difference was
determined by using Fisher's exact test (left-sided), a nonparametric test for dichotomous variables.
tice or internal medicine.
An important phase in program development involved
creating intervention recommendations to be used by consultant pharmacists to request diagnostic testing, laboratory
monitoring, and drug therapy additions or changes. Each
Vol 5, No.6
Implementation
NCS consultant pharmacists were thoroughly trained and
provided with the resources needed to go into nursing facilities and train other members of the patient-care team. These
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Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients
Table 1. Consultant Pharmacists Recommendation Codes
and Descriptions
CODE
HFI
I
DESCRIPTION
Check ejection fraction due to new onset of symptoms of
heart failure.
HF2
Check ejection fraction due to history of myocardial
infarction (M!).
HF3
Addition of diuretic for patients with symptoms of volume
overload.
HF4
Addition of ACE inhibitor for patients with diagnosis of
.
heart failure.
HF5
HF6
Increase current ACE inhibitor therapy to target doses.
Addition of coronary vasodilator due to symptoms of heart
failure.
HF7
Alternative selection of calcium channel blocker without
negative ionotropic effect for heart failure (HF) patients
with concomitant angina or hypertension.
HF8
Dietary sodium restriction in
HF9
Monitor weight, avoid excessive fluid intake for HF
a
heart failure patient.
record as heart-failure related. The direct clinical outcomes
include physical findings, physical symptoms, adverse reactions, and changes in diagnostic testing (see Table 2). This
information was collected from the clinical record, nursing
and patient interviews, and hospital admission and discharge
records. Hospitalizations were recorded over
a six-month
period following the acceptance or rejection of the pharmacist
recommendation.
Surrogate outcomes markers are indirect measures of
effect often tied to changes in treatment, cost of
pre, and
quality of life. These factors include changes in drug therapy
(including oxygen), changes in activities of daily living, exercise tolerance, and hospitalizations (see Table 3). In the longterm care setting this information is readily available as part of
the care plan and Minimum Data Set (MDS). These surrogate
endpoints are markers of a clinical outcome. Hospitalization
obviously reflects a serious negative clinical event such as
pneumonia. However, pneumonia as an acute disease is difficult to value, whereas a hospitalization related to pneumonia
can be readily assigned a cost. Similarly, in a long-term care
a definite assignable cost associated with resiinability
dents'
to feed themselves (i.e., the salary and benefits
of the person who must feed them).
In the NCS program, cost effectiveness must be demon-
facility, there is
strated from the perspective of the payor. The cost of heart
patients.
pharmacists provided in-service training in each client facility
to the direct care staff, including nurses, nurses' aides, therapists, and others. These training programs emphasized the
symptoms and physical findings related to heart failure. Early
detection and treatment of volume overload is a critical step in
reducing hospitalization related to heart failure.
Nine specific, referenced recommendations or interventions for heart failure detection, diagnosis, monitoring, and
treatment, based primarily on the AHCPR guidelines (see Table
1), were provided to the consultant pharmacists for use during
their drug regimen review process. Physicians were encouraged
to communicate their rationale for not accepting the recommendations, to help the pharmacist and nursing staff under-
stand the physician perspective, and to help target patients
who might benefit the most from future recommendations
'Table 2. Cost-Effectiveness Analysis
Intervention
Pharmacist recommends addition of ACE inhibitor therapy
or increasing dose of current
therapy to target dose based on
AHCPR and AMDA guidelines
Total number of recommendations
Recommendations accepted (RA)
Heart failure (HF)-related
hospitalizations at six months
Recommendations rejected (RR)
Heart failure-related
hospitalizations at six months
302
139 (46%)
5
(4%)
163 (54%)
21 (13%)
Absolute risk reduction
9%*
(i.e., patients with comorbidities, such as chronic renal disease,
or other contraindications to a certain drug therapy recommended for CHF). Consultant and dispensing pharmacists also
Total number of interventions
II
shared the goal of preventing drug-drug and drug-disease
interactions, as might be the case with the addition of a potassium-sparing diuretic to a regimen that already included an
Cost per intervention
$205 (drug costs for six
months plus labor costs)
Cost per heart failure-related
hospitalization
$5,500 (includes only direct
hospitalization medical costs)
Cost of interventions to prevent
one heart failure-related
hospitalization
$2,255 ($205
Cost effectiveness
$5,500/$2,255
ACE inhibitor and
a
potassium supplement.
Outcome Measurement
NCS consultant pharmacists collected data on physician acceptance or rejection of pharmacist recommendations, direct clinical outcomes, and hospitalizations identified in the discharge
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required to prevent one
hospitalization
II)
x
=
for each $1 spent
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Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients
significant proportion of
total disease costs. Surrogate markers take on added importance as short-term predictors of long-term cost savings.
The selection of those surrogate markers that have high
failure hospitalizations represents
Table 3. Direct Clinical Outcomes and Surrogate
Outcomes
a
predictive value based on sound clinical trials is important.
The addition of a drug known to have benefit in heart failure
patients (i.e. an ACE inhibitor) or an increase in the dose of
such
a
drug toward target daily doses would be such
a
marker.
Change in Diagnosis: Congestive Heart Failure (CHF)
Compensated
Symptomatic
decompensated
Left ventricular (LV) dysfunction
or
Overt
Cardiomegaly
Diastolic failure
Systolic failure
Diagnostic Testing
RESULTS
Ejection fraction
NYHA functional class
Although much of the outcomes data is still being analyzed,
the results related to heart failure hospitalizations are very
encouraging. Out of 302 pharmacist recommendations for
Chest X-ray
Labs
Volume Overload Symptoms/Physical Findings
adding an ACE inhibitor or increasing the dose of existing
therapy, 139 (46%) were accepted and 163 (54%) were rejectthere were five hospitalizations (4%)
ed. In the RA
group,
compared with 21 hospitalizations (13%) in the RR group, for
an absolute risk reduction of 9%. Absolute risk reduction is
much more meaningful than relative risk reduction, which
can be very misleading when the event percentages are low,
as
in this example.
The risk reduction achieved in this program means that
for every 11 patients treated, one hospitalization related to
heart failure can be avoided. NCS estimated a cost per intervention of $205, which includes pharmacists' labor and drug
six-month period. Thus, the total cost to prevent
one hospitalization is $2,225 ($205 per intervention x 11
interventions). At an average direct cost per hospitalization of
costs for
a
$5,500, based on 1998 data from the Health Care Financing
Administration, the NCS program yields a benefit/cost ratio of
2.44 to 1, or $2.44 in hospital costs avoided for every $1
spent on intervention.
Hepatic engorgement
Orthopnea
Shortness of breath
Paroxysmal nocturnal dyspnea
Rales
Dyspnea at rest
Peripheral edema
Nocturia
Jugular venous distention
Sacral edema
Dyspnea on exertion
Other Symptoms/Physical Findings
Syncope
Pallor
Tachypnea
Weakness
Third heart sound
O'2~HOMES'
IStJ~f}:ÔGATE
Drug Therapy for Heart Failure Oxygen Use
Routine
Flow rate
As needed (PRN)
Number of times used in past
.
month.
Cognitive Patterns
Psychosocial Well-being
Activity Pursuit Patterns
The primary reason for physician rejection, when noted,
was that the patient was stable and additional therapy was not
needed. The typical recommendation to add an ACE inhibitor
called for lisinipril 2.5 mg daily If the patient was already on
an ACE inhibitor, the typical recommendation was to increase
the dose of the current therapy by 50%-100% (Le., captopril
12.5 mg bid to 12.5 mg tid or 25 mg bid). This therapy was
generally well tolerated with
Ascites
a
dropout rate of <5%.
Physical Functioning and Structural Problems
Activities of Daily Living (ADL) self-performance
'(ADL) support provided
Activities of Daily Living
Bathing
Mobility
Appliances/devices used
Change in ADL self-performance in last 90 days
Exercise Tolerance
Ambulatory with mechanical assist
Six-minute walk test
Discussion and Limitations
The lack of comparative group demographics presents one
limitation in this study's results. Was the recommendationrejected group sicker than the other group and therefore more
likely to have an increased rate of hospitalization? The NCS
program instructs the pharmacists to identify those patients
most likely to benefit from a change in therapy Often these
patients suffer unstable heart failure as indicated by recent
hospitalization or fluid overload requiring physician intervention. It is surprising to note that physicians most often rejected these recommendations because they considered their CHF
patients stable, with no need to change therapy
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Hospitalizations in previous 12 months due to ~eart failure
Continuous Quality Improvement
Disease management is the process of improving clinical outbe referred
comes. Therefore, disease management could also
to as "outcomes management." In order to manage and
improve outcomes, the process must be continually moni-
require~an active intervention
physician
response. The facility quality assurance
to improve
especially
the medical director can be invaluable
team and
tored and revised. This effort
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Congestive Heart Failure: A Disease Management Approach in Long-Term Care Patients
in this effort. Their buy-in to the disease management
process and guidelines can give a local legitimacy similar to
that provided by specialist committees in acute care. Longterm care facilities also are very interested in global facility
assets
ers will not succeed. Successful disease management programs
must always be a win-win proposition for all involved.
With the success of these early efforts, NCS is currently
outcomes data to show the value of their care. Positive outcomes related to specific diseases provide the facility with a
implementing this heart failure management program in all its
client facilities, which serve more than 220,000 residents in
32 states. Although this task will be formidable, the basic
significant marketing advantage over a facility with outcomes
data that are not conclusive or, worse yet, do not exist. From
principles of planning, implementation, outcomes measurement, and continuous quality improvement remain the same.
the facility perspective, predictable and measurable outcomes
have definite value.
1. Konstam M, Dracup K, Baker D, et al. Heart Failure: Evaluation and Care
of Patients With left-Ventricular Systolic Dysfunction. Clinical Practice
CONCLUSION
The need for planning prior to the implementation of any disease management program cannot be overemphasized.
Developing a step-by-step implementation process and identifying outcomes measures as an integral part of that process are
critical. Outcomes measurement cannot be "tacked on" to
a
disease management program and expected to show value.
NCS is currently integrating clinical software that will allow
pharmacists to track multiple patient outcome variables and
will include more data regarding patient demographics. This
effort will allow NCS to improve the clinical significance of
the benefits of its disease management programs.
Education and training are critical to provide the rationale
for the disease management process. Provider acceptance of
the guidelines and treatment algorithms is essential to improv-
ing patient outcomes. Education and training must also be
ongoing. New developments must be communicated to the
front-line practitioners in a timely manner.
For physicians, facility staff, patients, and their families to
accept a disease management program, the development and
maintenance of trust is necessary. Sound recommendations
based on accepted clinical guidelines help to ensure that trust.
Programs in which one player wins at the expense of the oth-
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References
...
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Guideline No. 11. AHCPR Publication No. 94-0612. Rockville, MD: Agency
for Health Care Policy and Research, Public Health Service, U.S. Department
of Health and Human Services. June 1994.
2. Tompkins A (Ohio Department of Human Services). Medical Assistance
leuer No. 356. 1995 Nov 8.
3. Musher J, JohnsonJ, Beier M, et al. Heart Failure: Clinical Practice
Guideline. American Medical Directors Association. 1996. Silver Spring, MD.
4. Pfeffer MA, Braunwald E, Moye LA, et al. Effect of captopril on mortality
and morbidity in patients with left -ventricular dysfunction after myocardial
infarction: results of the survival and ventricular enlargement trial. N Engl J
Med 1992; 327: 669-77.
5. SOlVD Investigators. Effect on enalapril on survivaJ in patients with
reduced left-ventricular ejection fractions and congestive heart failure. N Engl
J Med 1991. Aug 1; 325: 293-302.
6. CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe
congestive heart failure. N EnglJ Med 1987; 316: 1429-35.
Additional Readings
...
1. Gonzalez ER, Crane VS. Designing a disease management program:
get started. Formulary June 1995; 30: 326-40.
How to
2. langley PC, Langley-Hawthorne CE, Martin R, et al. Establishing the basis
for successful disease management contracting. Am J Man Care September
1996; Vol.2, NO.8: 1099-108.
3. Zitter M. The disease-centered approach to managing health care delivery
The Zitter Group; Special Report Disease Management.
Vo\. 5,
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