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The Benefit of Implementing a Heart Failure Disease Management Program
David J. Whellan, MD;
Laura Gaulden, NP;
Wendy A. Gattis, PharmD, BCPS;
Bradi Granger, RN;
Stuart D. Russell, MD;
Michael A. Blazing, MD;
Michael S. Cuffe, MD;
Christopher M. O'Connor, MD
Arch Intern Med. 2001;161:2223-2228.
ABSTRACT
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Background To handle the increasing complexity of congestive heart failure (CHF)
care, several new models for the care of patients with CHF have been developed
to replace traditional strategies. We undertook this study to evaluate the
potential benefit of implementing a CHF disease management program at a tertiary
care center, particularly in terms of  -blocker use and cost to the health
care system.
Methods After reviewing the literature regarding therapies and management strategies
for patients with CHF, we developed the Duke Heart Failure Program. All enrolled
patients had 1 of the following: recent CHF hospitalization, ejection fraction
less than 20%, or symptoms consistent with New York Heart Association class
III or IV. We compared preenrollment and postenrollment medication use and
resource utilization.
Results We enrolled 117 patients from July 1998 to April 1999. Mean enrollment
time was 4.7 months. -Blocker use and dose significantly increased (52%
vs 76% for -blocker, P<.01; 6% vs 13% of
target dose, P<.01). The hospitalization rate
decreased (1.5 vs 0 hospitalizations per patient-year, P<.01), while the number of clinic visits increased (4.3 vs 9.8
clinic visits per patient-year, P<.01). The Duke
University Health System saved a median of $8571 per patient-year.
Conclusions Implementing a CHF disease management program was associated with improved
CHF medication dosing and with decreased hospitalization for patients with
CHF. A CHF disease management program is an effective method for a health
care system to care for patients with CHF.
INTRODUCTION
CONGESTIVE heart failure (CHF) has a tremendous impact on the US health
care system. Presently, CHF affects an estimated 5 million Americans and has
an overall mortality rate of 50%.1-2
From 1979 to 1997, the numbers of deaths and hospitalizations attributed to
CHF have increased significantly.3 As more
patients survive myocardial infarctions, and as treatments continue to improve
for CHF, the number of patients who have CHF is expected to grow.4
For patients who have symptoms consistent with CHF, guidelines outline
appropriate interventions for these patients.1, 5-6
These guidelines describe the importance of proper diagnosis, evaluation,
and management of patients with CHF. In addition to these guidelines, which
only discuss proven therapies at the time of this article's publication, new
clinical trials are constantly revealing new therapies that may improve the
quality of care for patients with CHF. With each new guideline or published
clinical trial, the care of patients with CHF becomes more complicated.
To handle the increasing complexity of CHF care, a number of new models
for the care of patients with CHF has been developed to replace traditional
strategies. The common term for these new models is disease
management. Reports of successful disease management programs have
been published.7-13
These programs used a number of different approaches, including incorporation
of a CHF clinic, a predischarge team, or off-site case management, including
home visits. Each model implements a systematic approach to CHF care that
results in improved quality, whether that is measured in increased medication
use or decreased resource utilization. Since these studies were conducted
before there was strong evidence for -blocker use, none of them evaluated
the benefit of disease management programs on improving rates of -blocker
therapy.14-16
We undertook this study to evaluate the potential benefit of implementing
a CHF disease management program at a tertiary care center. We wanted to evaluate
the benefit in terms of medication use, particularly -blocker use, and
the cost to the health care system. Given the evidence regarding disease management
programs, we hypothesized that a disease management program would significantly
increase -blocker use while decreasing cost.
METHODS
The Duke Heart Failure Program (DHFP) was designed by incorporating
specific concepts from previously described disease management programs that
matched the needs of the Duke University Health System.7-9,11-13
Protocols were developed for management of medications, including angiotensin-converting
enzyme (ACE) inhibitors, -blockers, digoxin, diuretics, alternative
therapies for ACE inhibitor–intolerant patients, including angiotensin-receptor
blockers or hydralazine hydrochloride–nitrates, lipid-lowering agents,
and other strategies targeted at optimizing the control of concomitant illnesses
that may worsen the CHF state, such as hypertension and ischemic heart disease.
In addition, the CHF team designed protocols for exacerbations, including
shortness of breath, chest pain, and weight gain. The group developed a patient
education manual that reviewed topics such as the purpose of each medication,
the importance of adherence, potential adverse effects and appropriate actions
to take should adverse effects occur, low-salt and low-cholesterol diet, weight
monitoring, physical activity, and resources available to patients with CHF.
The manual included a daily diary for weights and diet. An inpatient consult
service and an outpatient CHF clinic were initiated. Unlike other studies
or programs, cardiopulmonary exercise testing or hemodynamic monitoring were
not routinely performed.
Based on these protocols and the severity of the patient's illness,
a follow-up schedule for clinic visits and telephone calls would be initiated
at the time of enrollment. The basic schedule for patients with New York Health
Association (NYHA) class IV disease included weekly clinic visits for the
first month and weekly telephone calls for the first 3 months. The frequency
of clinic visits and telephone calls could be modified by the physician. The
clinic schedule for NYHA class II and III patients was every 6 weeks with
biweekly telephone calls. This schedule would be updated based on changes
in medications and symptoms to provide a set number of follow-up contacts
for patients. During each clinic visit and telephone call, the nurse practitioner
or nurse specialist reviewed with the patient any changes in weight using
the weight diary from the education manual. There was no home-monitoring system
used as part of the program. All weights and vital signs, if taken by the
patient, were self-reported. The DHFP physicians approved all protocols, schedules,
and patient material.
Before enrollment began, primary care physician practices in the Duke
University Health System network were presented an outline of the program,
including enrollment criteria. We presented the DHFP to the internal medicine
house staff and attending physicians. Pocket cards with inclusion criteria
and referral telephone numbers were provided to house staff and placed at
all internal medicine nursing stations at Duke University Hospital.
Enrollment in the CHF program began July 5, 1998. At the time of enrollment,
patients underwent an initial evaluation. A medical history was obtained with
a focus on etiology of left ventricular dysfunction. The DHFP pharmacist reviewed
medications with patients and provided an evaluation of medications for the
DHFP physician. The nurse practitioner and pharmacist reviewed educational
material with the patients, with an emphasis on weight monitoring and a proper
procedure for contacting a DHFP nurse practitioner if symptoms worsened. Once
the DHFP physician had evaluated the patient and reviewed the data collected
by the CHF program team, the attending physician and the DHFP team initiated
a plan for any further diagnostic evaluation, medication titration, and follow-up.
The plan followed the prespecified protocols and schedule developed for the
program.
The DHFP team determined patient eligibility for the program at the
end of the initial evaluation based on the following criteria. All enrolled
patients had 1 of the following: recent CHF hospitalization, ejection fraction
less than 20%, or symptoms consistent with NYHA class III or IV. Patients
not meeting the enrollment criteria had a detailed clinical note including
an assessment and plan sent to the referring physician with a schedule for
follow-up in that physician's clinic.
The inpatient service for the program provided consultation for patients
either in the program or identified as potential enrollees. Before discharge,
patients would be scheduled for a follow-up clinic appointment to occur within
1 week. They would also be provided with education material and a telephone
number to contact the CHF program, if necessary.
The DHFP maintained all clinic notes and telephone follow-up records.
Data collection for analysis was performed at 3-month intervals; information
on demographics, patient characteristics, referring physicians, and medications
(ACE inhibitors and -blockers only) were obtained from the CHF program
records. Data on number of clinic visits, number of hospitalizations, length
of stay, and cost within the Duke University Health System were obtained from
the hospital administrative database and the physician hospital organization
at Duke University Medical Center. The medical center uses a data system that
incorporates true cost data, obtained through time-management studies and
integrating costs for ancillary services, materials, laboratories, and indirect
services. To obtain cost from the physician administrative database, Medicare-allowable
charge was used as a surrogate cost. Cost data from both the hospital and
physician databases were categorized as inpatient and outpatient costs based
on internal definitions. Patient data were obtained for only the 365 days
preceding enrollment.
The statistical analysis was done using JMP IN software (SAS Institute,
Cary, NC). Medians, 25th percentile, and 75th percentile for continuous baseline
characteristics were obtained. Categorical variables are expressed as percentages.
We performed comparisons as paired results of patient's preenrollment vs postenrollment
values. Except for length of stay and the cost of each discharge, continuous
variables were analyzed using the Wilcoxon signed rank test of the differences.
The average length of stay and cost per discharge were compared for only those
patients experiencing a hospitalization, and the Wilcoxon rank sum test was
used to test for significant differences between preenrollment and postenrollment
events. The categorical variables were compared using the Pearson  2 test. Differences between medication dose and percent of target dose
for a specific medication were compared between enrollment dosing and the
time of analysis, defined as the last recorded dose prior to April 15, 1999.
Differences between hospitalizations, clinic visits, and cost were compared
between preenrollment time up to 1 year and postenrollment time.
To account for the difference in the time accumulated by the participating
patients prior to enrollment and the time for the patient cohort after enrollment,
hospitalizations, clinic visits, total cost, inpatient cost, and outpatient
cost were multiplied by a constant. The constant was the total number of days
accumulated by all the patients during either the period before enrollment
or after enrollment, divided by 365 and the number of patients ([(1/sum of
patient-days in period for all patients in cohort)/365] x 117). Thus,
results were reported as hospitalization, clinic visit, or cost per patient
per year. The average length of stay and the cost per discharge were not multiplied
by the constant.
The institutional review board at Duke University Medical Center reviewed
and approved the DHFP prior to enrolling patients. Patients signed consent
forms giving permission to publish results without patient identification.
RESULTS
One hundred seventeen patients were enrolled between July 5, 1998, and
April 15, 1999. Table 1 shows
baseline characteristics at the time of enrollment. The median age of patients
was 62 years. Forty-seven percent of the patients lived more than 48 km from
Duke University Medical Center. The median ejection fraction was 23%; 50%
had symptoms consistent with NYHA class III or IV. A cardiologist participated
in the majority of patients' care prior to enrollment. Twelve patients died
while enrolled in the program. The median follow-up was 4.9 months.
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Table 1. Baseline Characteristics of Enrolled Patients*
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The use of ACE inhibitors was high in referred patients and did not
change significantly once patients were enrolled in the program (preenrollment
vs postenrollment, 78% vs 79%; P = .75). Although
the median percent of target dose of either ACE inhibitor at the time of enrollment
did not increase from 50%, there was a significant overall increase in the
percent target dose (median [25th, 75th percentiles], 50% [8%, 100%] vs 50%
[13%, 100%]; P<.01). Both the use and the percent
target dose of -blockers significantly increased from the time of enrollment
to the time of analysis (52% vs 76% use, P<.01;
percent target dose [25th, 75th percentiles]: 6% [0%, 25%] vs 25% [6%, 50%], P<.01) (Figure 1).
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Figure 1. Preenrollment and postenrollment -blocker
use and target dosing.
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To assess changes in practice pattern within the community, we evaluated
the use of ACE inhibitor and -blocker at the time of enrollment for
3 different periods in the program: early (months 1-3), intermediate (months
4-6), and late (months 7-10) (Table 2).
There were no significant differences between periods in the percentage of
patients taking an ACE inhibitor or a -blocker.
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Table 2. Percentage of Patients Taking Angiotensin-Converting Enzyme
(ACE) Inhibitor and -Blocker at the Time of Enrollment During Evaluation
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There were significant changes in the inpatient and outpatient events
(Table 3). There were 146 admissions
within 1 year of enrollment, 41 of which occurred within 30 days of enrollment.
There were 57 hospitalizations in the enrolled cohort. Hospitalizations significantly
decreased from a median of 1.5 hospitalizations per patient-year to 0 (P<.01). The distribution of patients by the number of
hospitalizations for the preenrollment and postenrollment cohort is shown
in Figure 2. The median average
length of stay decreased from 6 days prior to enrollment to 5 days postenrollment
(P = .08). Median total clinic visits and visits
to a cardiologist within the Duke University Health System significantly increased
after enrollment (4.3 vs 9.8 [P<.01] and 0 vs
7.4 [P<.01], respectively). Postenrollment cardiologist
visits included the DHFP clinic visits.
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Table 3. Hospitalization, Length of Stay, and Clinic Visits Before
and After Enrollment*
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Figure 2. Distribution of patients by number
of hospitalizations for the preenrollment and postenrollment cohort.
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Table 4 shows the costs
per patient-year and per discharge to the Duke University Health System patients
enrolled in the DHFP. Outpatient costs significantly increased after enrollment
by a median difference of $659, while inpatient costs significantly decreased
by a median difference of $6963. In addition, the cost per discharge significantly
decreased from a median of $10 659 preenrollment to $6896 postenrollment
(P = .02). The total cost of care decreased by a
median difference of $8571 (P<.01). This does
not include the cost of providing the program or any costs incurred by the
patient such as transportation.
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Table 4. Preenrollment and Postenrollment Costs in Dollars*
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We performed a similar cost analysis not including data from the 12
patients who died while enrolled in the program. After enrollment in the DHFP,
the cohort of surviving participants in the program had a significant increase
in outpatient costs by $606 (P = .04), while inpatient
costs significantly declined by $10 741 (P<.01).
Total median cost decreased by $10 857 (P<.01).
COMMENT
We found that implementing a CHF disease management program was associated
with improved CHF medication dosing and with decreased hospitalization for
patients with CHF. In addition, the cost of caring for referred patients decreased
for the health care system.
The improved medication use included initiation of -blockers and
increased dosing of ACE inhibitors and -blockers. The medication goals
of the program were to achieve doses used in clinical trials. The increase
in dose of ACE inhibitors, as a percent of the target dose, is consistent
with the findings from other studies of disease management programs; Fonarow
et al8 found that a CHF clinic at a tertiary
care center significantly improved ACE inhibitor dosing (mean ± SD,
95 ± 120 mg before evaluation vs 183 ± 142 mg of captopril or
equivalent). -Blocker dosing also increased, although the final median
dose did not achieve as high of a percent target as the ACE inhibitor median
dose. The lower final median dose of -blockers reflects the initiation
of -blockers after ACE inhibitors in the DHFP, the longer period required
for -blocker dose adjustments and limitations to -blocker therapy
such as blood pressure, heart rate, CHF symptoms, and comorbidities such as
pulmonary disease.
Although 2 additional referred patients tolerated initiation of an ACE
inhibitor, this increase in use was not significant. Patients were unable
to tolerate the medication for a number of reasons, including cough, worsening
renal function, hyperkalemia, and hypotension. The absence of a significant
impact in ACE inhibitor use by the CHF program results from the high use of
this drug (77%) at the time of the initial evaluation. Hanumanthu et al9 found a similar nonsignificant change in ACE inhibitor
use when studying the impact of a CHF clinic on CHF management (76% at baseline
vs 74% at 6 months, P value not significant). One
possible explanation for this lack of effect is that earlier studies showing
poor utilization of ACE inhibitors17-21
are outdated and may not reflect current practice patterns. The inability
for 20% of patients to tolerate any ACE inhibitor is not dissimilar to the
intolerance found in highly selected patients participating in recent clinical
trials.22
-Blockers' relatively new status as a beneficial medication for
patients with CHF may be reflected in a lower use of this medication by physicians.14-16 The lower use of -blockers
at the time of enrollment (52%) provided an opportunity to significantly increase -blocker
use to 76%. Even the 52% rate of -blocker use at the time of enrollment
was higher than expected, based on national trends showing lower use of -blockers.22 This may reflect that the referrals came from physicians
associated with an academic institution where new information is readily available,
or an expected improvement in current practice patterns that are not reflected
in previous publications.
The improvement in hospitalization confirmed the results of other CHF
disease management programs. Fonarow et al8
and Hanumanthu et al9 found that CHF clinics
were associated with decreased hospitalizations (429 admissions for the diagnosis
of CHF to 63, P<.001; 219 preenrollment to 116
postenrollment, P<.01). Predischarge planning
and close follow-up, used by Rich et al,7 reduced
hospitalizations by 13.2% (95% confidence interval, 2.1%-24.3%; P = .03). Clinical pharmacist and nurse practitioner case management
have also been shown to decrease hospitalization.10-12
The reduction in hospitalization was likely due to 2 aspects of the
program: increased use of proven therapies and close monitoring that included
easy access. In SOLVD (Studies of Left Ventricular Dysfunction),23
patients with CHF who were taking enalapril maleate had a 40% risk reduction
(95% confidence interval, 30%-48%) of hospitalization as early as 1 year. -Blockers
have been shown to reduce all-cause hospital admissions.15-16
Although ACE inhibitor and -blocker use can improve clinical outcomes
as early as 1 year, the median time of program participation was 4.9 months.
The improvements seen in hospitalizations and costs were not likely due only
to improved medication use. There is precedent for a disease management program
improving clinical outcomes in such a short period. Rich et al7
saw the benefit of their program in 3 months. In that study, there was no
significant difference between the intervention group and the control group
in the medicine regimen at time of discharge. A characteristic common to of
all these programs is the close monitoring of patients through telephone contact
or clinic visits. Not only did the DHFP incorporate scheduled contacts, but
a contact number was provided for patients to use 24 hours a day, 7 days a
week. Patients were educated to contact the program's nurse practitioner if
symptoms worsened. The scheduled calls and clinic visits and the emergency
contact system allowed the program providers to intervene when patients' conditions
were worsening but before they required hospitalization.
A potential third reason for improving outcomes in a short period is
the positive impact of disease management programs on patients' lifestyles.
Active participation in a program may be a surrogate marker for patients'
desire to make positive lifestyle changes such as daily weight measurement,
decreasing salt and fluid intake, and improving medication compliance. A major
emphasis of the program is patient education, including providing patient
manuals with weight and diet diaries.
The decrease in cost for caring for participating patients is an obvious
consequence of decreasing hospitalization. Hospitalizations represent not
only a significant morbidity to patients with CHF, but also the most significant
portion of the cost for caring for this patient group, up to 80%.24-25 Using inpatient data, both Rich et
al7 and Fonarow et al8
found a decrease in cost for the management of patients with CHF using a disease
management program. The DHFP found a median decrease of $8571, driven by the
median $6963 decrease in inpatient costs. Outpatient costs increased by $659,
due to an increase in clinic visits. The shift from inpatient care to outpatient
care was expected, given the emphasis on frequent clinic visits and close
monitoring of patients.
We performed the analysis without data from the patients who died while
enrolled in the program and found no significant change in the conclusions
of this study. We predicted that deaths would have made the results of the
study look more favorable for the program. However, the intensity of care
provided to patients at their request or their family's request is associated
with high resource utilization. Part of the program's education manual and
an emphasis for the program is to discuss patient wishes in emergencies and
development of a living will.
The program did decrease the median length of stay by 1 day (17%) and
the median cost per discharge by $3763 (35%). The reason for the greater percent
decrease in cost vs the percent decrease in length of stay is unclear. In
our practice, we have noted that the improved communication between the outpatient
clinic and the inpatient service allows for a decrease in repeating certain
tests. In addition, the physicians participating in patient care have come
to a consensus regarding the use of procedures such as right-sided heart catheterizations,
diagnostic cardiac catheterizations, and revascularization procedures.
The cost of implementing the program was approximately $175 000
or $1500 per patient. Expenses included percent time of staff (nurse practitioner,
secretary, pharmacist, and nurse specialist), physician time, materials (computer,
office supplies, and education manuals), and overhead for office space. We
estimated that the nurse practitioner and nurse specialist spent approximately
50% of their time on the program during the study. The pharmacist spent approximately
25% of a week working with program patients. Since other types of professionals
(including social workers and dietitians) were used sparingly, we did not
include them in our estimate for the expense of the program. A large portion
of the cost is fixed or fixed variable, and would not be expected to change
until enrollment reached certain threshold numbers. Thus, as more patients
are enrolled in a program, the cost of initiating and maintaining a CHF program
would not increase as much as the increased cost savings one would realize.
This has been the case for the DHFP as it has continued to grow.
The most obvious limitation of this study is that there was no randomization
of patients to the CHF program vs standard care. The investigators had to
use historical data from the patients as a control. There are a number of
biases that can occur using this type of analysis. It can be difficult to
know if the disease management program caused the improved outcomes. Patients'
conditions may have improved over time, thus explaining the improved outcomes.
However, given the natural course of cardiomyopathies, we believe that this
is unlikely. Trends within the community practice environment could have caused
some of the benefit. Yet, we did not find any significant change in the use
of ACE inhibitors or -blockers at the time of enrollment for participating
patients.
Another potential bias is the effect of hospital admissions that identified
patients for the program. Since patients admitted for CHF are more likely
not to be admitted over the initial postdischarge period, there is a chance
that the postenrollment outcome benefited from the expected low readmission
rate. This is described as regression to the mean. Although we do not have
any specific information regarding where referrals took place, we do know
that 41 hospitalizations took place within 30 days of enrollment. In addition,
there is no regression to the mean when considering average length of stay
or the costs per discharge.
In addition, the study was conducted at a single center; the results
may be specific to the Duke University Health System. As with other studies
of disease management programs, it is difficult to identify which components
of the program played a role in achieving the outcomes. The opportunity to
replicate this concept in other practice settings would be more feasible if
the critical components could be identified and a simpler program focusing
on these elements could be developed.
CONCLUSIONS
This study shows an association between enrollment in the DHFP and improved
medication use and decreased cost. The improvement in ACE inhibitor use seen
in other studies was extended to -blocker use in this study. A CHF disease
management program is an effective method both in terms of quality of care
and cost savings for a health care system to care for patients with CHF.
AUTHOR INFORMATION
Accepted for publication March 29, 2001.
Corresponding author and reprints: David J. Whellan, MD, Division
of Cardiology, Department of Medicine, Box 3356, Duke University Medical Center,
Durham, NC 27710 (e-mail: whell001{at}mc.duke.edu).
From the Duke University Medical Center, Durham, NC.
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Crit Care Nurse 2008;28:20-37.
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Multidisciplinary team for enhancing care for patients with acute myocardial infarction or heart failure
Coons and Fera
Am J Health Syst Pharm 2007;64:1274-1278.
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Adherence to guidelines is a predictor of outcome in chronic heart failure: the MAHLER survey
Komajda et al.
Eur Heart J 2005;26:1653-1659.
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Outcomes in heart failure patients after major noncardiac surgery
Hernandez et al.
J Am Coll Cardiol 2004;44:1446-1453.
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Consumer-Driven Health Care: Lessons From Switzerland
Herzlinger and Parsa-Parsi
JAMA 2004;292:1213-1220.
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The effectiveness of disease management programmes in reducing hospital re-admission in older patients with heart failure: a systematic review and meta-analysis of published reports
Gonseth et al.
Eur Heart J 2004;25:1570-1595.
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Heart failure clinics and outpatient management: review of the evidence and call for quality assurance
Gustafsson and Arnold
Eur Heart J 2004;25:1596-1604.
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The Use of {beta}-Blockers in a Tertiary Care Heart Failure Clinic: Dosing, Tolerance, and Outcomes
Tandon et al.
Arch Intern Med 2004;164:769-774.
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Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure
Rumsfeld et al.
J Am Coll Cardiol 2003;42:1811-1817.
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Sparing a little may save a lot: Lessons from the Studies of Left Ventricular Dysfunction (SOLVD)
Hernandez and O'Connor
J Am Coll Cardiol 2003;42:709-711.
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Improving Care for Patients With Chronic Heart Failure in the Community* : The Importance of a Disease Management Program
Akosah et al.
Chest 2002;122:906-912.
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Disease Management for CHF
JWatch Gastroenterology 2001;2001:12-12.
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Disease Management for CHF
JWatch General 2001;2001:7-7.
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