Download Cost/Utility Ratio in Chronic Heart Failure: Comparison Between

Journal of the American College of Cardiology
© 2002 by the American College of Cardiology Foundation
Published by Elsevier Science Inc.
Vol. 40, No. 7, 2002
ISSN 0735-1097/02/$22.00
PII S0735-1097(02)02140-X
Cost/Utility Ratio in Chronic Heart Failure:
Comparison Between Heart Failure Management
Program Delivered by Day-Hospital and Usual Care
Soccorso Capomolla, MD, Oreste Febo, MD, Monica Ceresa, MD, Angelo Caporotondi, MD,
Giampaolo Guazzotti, MD, Maria Teresa La Rovere, MD, Marina Ferrari, NS, Francesca Lenta, NS,
Sonia Baldin, NS, Chiara Vaccarini, MD, Marco Gnemmi, MD, GianDomenico Pinna, MS,
Roberto Maestri, MS, Paola Abelli, MD, Sandro Verdirosi, MD, Franco Cobelli, MD
Montescano, Italy
This study compared the effectiveness and cost/utility ratio between a heart failure (HF)
management program delivered by day-hospital (DH) and usual care in chronic heart failure
(CHF) outpatients.
BACKGROUND Previous studies showed that about 50% of readmissions for CHF can be prevented by a
multidisciplinary approach However, the performance, effectiveness, and cost/utility ratio of
a process of HF outpatient management related to evidence-based medicine have not been
considered.
METHODS
A total of 234 prospective patients discharged by a HF Unit were randomized to two
management strategies: 122 patients to usual community care and 112 patients to a HF
management program delivered by the DH. Management (rate of readmissions, therapeutic
interventions), functional parameters (New York Heart Association [NYHA] functional
class, left ventricular diameters, and ejection fraction, deceleration time of early diastolic
mitral flow, peak oxygen uptake, and mitral regurgitation) and hard outcomes (cardiac death
and urgent cardiac transplantation) were evaluated. The cost/utility ratios of the two strategies
were compared.
RESULTS
After 12 ⫾ 3 months of follow-up, the individual rate access in DH was 5.5 ⫾ 3.8 days. The
DH subjects were readmitted to the hospital less frequently than were the usual-care group
patients (13 vs. 78, p ⬍ 0.00001). Patients allocated to usual-care management showed
heterogeneous changes in NYHA functional class (13% improved and 16% worsened p ⫽
NS); In contrast, the DH group showed significant changes in NYHA functional class (23%
improved and 11% worsened, p ⬍ 0.009). Hard cardiac events in the one-year follow-up
occurred in 25/234 (10.6%) patients; cardiac death occurred in 21/122 (17.2%) of the
community group and in 3/112 (2.7%) in the DH group (p ⬍ 0.0007). One DH patient
underwent urgent transplantation. Comparison of the two managerial models by Cox
regression analysis showed that DH management significantly protected against the appearance of hard events (relative risk [RR] 0.17; confidence interval [CI] 0.06 to 0.66). The
cost/utility ratio of the two management strategies was similar (usual care $2,409 vs. DH
$2,244). The incremental analysis revealed a cost savings of $1,068 for each quality-adjusted
life year gained. The cost/utility ratio for the integration of DH management of CHF was
$19,462 (CI $13,904 to $34,048).
CONCLUSIONS A heart failure outpatient management program delivered by a DH can reduce mortality and
morbidity of CHF patients. This management strategy is cost-effective and has an equitable
value from a societal point of view. (J Am Coll Cardiol 2002;40:1259 – 66) © 2002 by the
American College of Cardiology Foundation
OBJECTIVES
Heart failure (HF) is a growing public health problem. Both
the incidence and the prevalence of chronic heart failure
(CHF) are clearly increasing in industrialized countries, and
HF continues to be a significant cause of hospital admissions (1,2). In the U.S. it has been evaluated that about 20%
of patients with CHF require hospital management (3). In
Italy, the Survey on Heart Failure in Italian Hospital
Cardiology Units (SEOSI) study showed that about 65,000
patients with CHF are admitted to cardiology departments
in Italy each year (4). Including patients cared for in other
From Fondazione “Salvatore Maugeri,” IRCCS, Dipartimento di Cardiologia,
Istituto Scientifico di Montescano, Montescano, Pavia, Italy.
Manuscript received December 28, 2001; revised manuscript received May 13,
2002, accepted June 27, 2002.
hospital wards, a realistic projection might be that about
230,000 patients with CHF are hospitalized annually in
Italy (5). In the U.S., CHF costs about $38 billion, of which
approximately two-thirds of this amount are spent on
readmissions to hospital (6). Pharmacoeconomic studies
support the need to rationalize expenditures by containing
these repeated admissions (7). Recent studies demonstrate
how comprehensive management strategies can improve
outcomes and quality of life with fewer hospital admissions
and lower consumption of resources (8 –12). However,
different organizational patterns, types of patients, and care
settings make these other management algorithms poorly
applicable, thus influencing outcomes (13). In effect, although researchers identified the elements relevant to the
Capomolla et al.
Cost/Utility Ratio in CHF
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Abbreviations and Acronyms
ACE ⫽ angiotensin-converting enzyme
CHF ⫽ chronic heart failure
CI
⫽ confidence interval
DH
⫽ day-hospital
DRG ⫽ diagnosis-related group
EBM ⫽ evidence-based medicine
HF
⫽ heart failure
HFU ⫽ Heart Failure Unit
IV
⫽ intravenous
LVEF ⫽ left ventricular ejection fraction
NYHA ⫽ New York Heart Association functional class
QALY ⫽ quality-adjusted life years
RR
⫽ relative risk
VO2
⫽ oxygen uptake
process of care decisions, the different management patterns
and complexities of illness render both the process and the
link between management and outcome poorly defined.
In the early 1990s, a Heart Failure Unit (HFU) was
opened in the Medical Center of Montescano. In 1998, a
day-hospital (DH), dedicated and open to the community,
was established within the HFU, increasing the HF management options available. In this study we describe our
comprehensive HF outpatient management program and
evaluate cost-effectiveness of this different approach relative
to the usual program of care after discharge from an HFU.
METHODS
Study Design
This study was conducted in the setting of a “proof-ofconcept” phase of the disease management program (14).
Patients referred to our HFU had a prognostic evaluation,
their therapy was optimized, and they were then randomized to one of two management strategies: 1) usual care: the
patient returned to the community and was followed up by
a primary care physician with the support of a cardiologist;
2) DH care within the HFU, which implemented an
individualized HF management program. The primary
outcomes employed to evaluate any difference between the
two strategies were readmissions because of hemodynamic
instability and death from cardiac causes. Secondary outcome measurements considered were tailored therapy management, quality of life (using the time trade-off method),
and New York Heart Association (NYHA) functional class
(15). The study design included an evaluation of the
cost/utility ratio of the two strategies.
Patients
Patients with CHF referred to the HFU of Montescano
Medical Center and the Heart Transplantation Program of
the Cardiac Surgery Division of Policlinico S. Matteo,
Pavia, between January 1999 and January 2000 were considered. The diagnosis of CHF was supported by clinical
history, physical signs and symptoms, and by echocardio-
JACC Vol. 40, No. 7, 2002
October 2, 2002:1259–66
graphic findings (left ventricular ejection fraction [LVEF]
⬍40%). At referral, patients underwent an initial cardiac
prognostic stratification that included a clinical examination, functional status evaluation (NYHA functional class),
cardiopulmonary exercise test (peak oxygen uptake [VO2]),
echo-Doppler examination (LVEF, mitral regurgitation,
left end-diastolic and end-systolic diameters, and deceleration time of early diastolic filling wave), and right hemodynamic measurements (pulmonary wedge pressure, cardiac
index). After this first step the patients were prescribed
individual tailored therapy following heart practice guidelines and evidence-based medicine (EBM) (16 –18). At
discharge the patients were randomized either to receive
usual care or to enter the HF management program performed in the DH of the HFU.
Management Strategies
Usual care. Patients were referred to their primary care
physician and cardiologist. During follow-up the process of
care was driven by the patient’s needs into a heterogeneous
range of emergency room management, hospital admission,
and outpatient access. After 12 months all patients were
reevaluated at the HFU by repeating the baseline tests and
investigations.
Day-hospital. STAFF. The staff of the HF management
program consists of one cardiologist, four trained nurses
with consolidated experience, and two physiotherapists.
There is also part-time participation of a dietician, a
psychologist, and a social assistant. The objectives of the
multidisciplinary staff are prevention and functional recovery of consequences of acute hemodynamic instabilization.
The team members also have the task of creating, analyzing,
and correcting the organization that supports the process of
treatment identified in an individual care plan (19). There
are three different organizational levels (physician, nurse,
physiotherapist), each of which coordinates with the others
to achieve the treatment objectives. The team management
used current HF guidelines and EBM criteria.
PROCESS OF CARE. The process of care is discussed in
collaboration among the different health care professionals.
A plan of care is structured for each patient (20) and defines:
1) appropriateness of the access; 2) type of access (new
patient, patient activated in a program of cardiac transplantation, control or open access); 3) objective of the process
(prognostic stratification, therapeutic optimization, analysis
of the primary pathology, check of clinical stability, review
of cardiovascular risk factors, review of factors of risk for
hemodynamic instabilization); 4) use of tools (cardiac echoDoppler, cardiopulmonary exercise test, Holter monitoring,
right heart catheterization, psychological support, nutritional intervention, counseling); 5) markers of outcomes,
and finally 6) follow-up counseling.
TAILORED INTERVENTIONS. According to the characteristics of the patient and the phase of the illness, particular
areas of intervention are:
Capomolla et al.
Cost/Utility Ratio in CHF
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October 2, 2002:1259–66
1. cardiovascular risk stratification. In daily practice we
grade the patient’s severity of disease by NYHA functional class, left ventricular end-systolic diameter, deceleration time of early diastolic filling, natremia, and peak
VO2. Based on these criteria, we make a risk-ratio score
to manage the following strategy that incorporates the
therapeutic interventions and timing of follow-ups and
possible heart transplantation;
2. tailored therapy according to national and international
guidelines, and integration of physical training and
counseling on daily life activities;
3. checking clinical stability according to EBM criteria;
4. correction of the risk factors for hemodynamic instabilization;
5. health care education: during planned use of the DH,
nurses coordinate open discussion, focusing on knowledge about CHF, pharmacologic therapies, selfmanagement (daily weight monitoring, fluid restriction,
nutrition); moreover, physiotherapists educate patients
in self-managed physical training and tailor daily physical activity in relationship to exercise capacity as defined
by cardiopulmonary exercise testing;
6. counseling: this is a continuous process between different
staff members and the patient, taking place at different
times. The patient is made aware of his or her own
situation in such a way as to promote self-management
with realistic behavioral changes. In this framework
counseling becomes a tool for processing and restructuring the different but interrelated manifestations of the
illness.
Each morning the nursing staff gives the physician a
report on the status, care plan, and decision making
concerning the patients. The nursing team uses the
telephone extensively to provide counseling and continuity with community care.
PATIENT FOLLOW-UP. Access to the DH is modulated
according to the demands of the care process. If organ
function deteriorates during follow-up, or if signs/
symptoms of HF develop, the patient re-enters the DH
through an open-access program allowing extemporaneous
performance of a new care process (intravenous [IV] therapy, laboratory examinations, instrumental controls, therapeutic changes). If the decompensation requires full-time
observation, the patient is transferred to the HFU.
OUTCOME MEASUREMENTS. Three types of outcomes were
identified: readmission in hospital and pharmacologic tailored therapy were evaluated as management outcomes;
NYHA functional class, left ventricular diameters and
ejection fraction, deceleration time of early diastolic filling
wave, mitral regurgitation, peak VO2, and quality of life,
appraised by the time–trade-off method, were considered as
functional outcomes. Finally, death from a cardiac cause was
analyzed as a hard outcome. These outcomes were evaluated
after a mean follow-up of 12 months.
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Economic Analyses
Costs. The cost/utility analysis was performed in a societal
perspective (21). The initial and final admissions were not
included in the costs of managing the two groups. Cost of
readmissions and the management costs of the DH during
the follow-up were calculated using the Medicare diagnosisrelated group (DRG) reimbursement. We assessed the costs
of daily medical therapy by using the average dose of therapy
at exit from the two management processes to calculate the
number of tablets taken during the follow-up and multiplying this number by the cost per tablet reported in the annual
formulary (22). These costs were actualized by assuming an
annual rate of increase of 5% (23) and are expressed in U.S.
dollars.
Life expectancy. For the evaluation of life expectancy, the
two management strategies were considered outcome predictors, adjusting for age, gender, etiology, NYHA functional class, LVEF, peak VO2, baseline heart rate, and mean
arterial pressure. The association between predictor variables and outcome was assessed by fitting follow-up data
with a Cox proportional hazards regression model. All
patients who died from noncardiac causes and those who
underwent elective cardiac transplantation were considered
as censored observations. The end point of the study was
cardiac mortality or urgent heart transplantation. Event-free
distribution functions were estimated by the Kaplan-Meier
method. Life expectancy was calculated as the area under
each curve. The increase in life expectancy was evaluated as
the difference between the areas under the two curves (24).
Sensitivity analysis. The sensitivity analyses were performed by recalculation of the cost/utility ratio using an
analysis of the extremes; we varied survival (confidence
limits) and costs in both prospectives (higher and lower);
utility was also recalculated to reflect the current state of
health in the new scenario.
Statistical Analysis
Between-group comparisons of baseline clinical and functional parameters were performed by one-way analysis of
variance for continuous variables and by the chi-square test
for categorical variables.
For the purpose of the prognostic evaluation, the two
management strategies were considered as predictors of
outcome, adjusting for age, gender, etiology, NYHA functional class, LVEF, peak VO2, baseline heart rate, and the
mean arterial pressure. The combined end point was cardiac
mortality and urgent heart transplantation. Event-free distribution functions were estimated by using the KaplanMeier method. Associations between predictor variables
and outcome were assessed by fitting follow-up data with a
Cox proportional hazards regression model. All patients
who died from noncardiac causes and those who underwent
elective cardiac transplantation were considered as censored
observations. Prognostic information was expressed as relative risk (RR) with 95% confidence interval (CI). Descrip-
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October 2, 2002:1259–66
Table 1. Baseline Clinical, Doppler Echocardiographic, and
Hemodynamic Characteristics in All Patients and in the
Patients Grouped According to Management Strategies
All
Patients
Usual
Care
No. of patients
234
Age (yrs)
56 ⫾ 10
Gender (M/F)
196/38
Etiology (ischemic/idiopathic)
95/139
NYHA functional class
153/81
I–II/III–IV
Heart rate (beats/min)
82 ⫾ 13
Systolic pressure (mm Hg)
118 ⫾ 18
Peak VO2 (ml/min/kg)
17 ⫾ 4
LVEDD (mm)
70 ⫾ 10
LVESD (mm)
58 ⫾ 11
LVEF (%)
29 ⫾ 7
Cardiac rhythm (SR/AF)
196/38
Deceleration time E (ms)
167 ⫾ 48
Mitral regurgitation moderate/ 108 (40)
severe (ⱖ2⫹), n (%)
Therapy
High-ceiling diuretics, n (%) 194 (83)
K⫹ saver, n (%)
51 (22)
Digitalis, n (%)
87 (37)
ACE inhibitors, n (%)
227 (97)
Beta-blockers, n (%)
93 (40)
Nitrates, n (%)
108 (46)
122
56 ⫾ 9
102/20
50/72
80/42
Table 2. Goals and Tools of Care Process of Patients Exposed
to Heart Failure Management Program
Dayp
Hospital Value
112
56 ⫾ 8
94/18
45/67
73/39
NS
NS
NS
NS
80 ⫾ 14 81 ⫾ 16
120 ⫾ 18 114 ⫾ 16
17 ⫾ 4
17 ⫾ 4
70 ⫾ 9
68 ⫾ 10
59 ⫾ 9
57 ⫾ 9
31 ⫾ 8
29 ⫾ 10
99/23
97/15
163 ⫾ 50 155 ⫾ 55
60 (49)
48 (44)
NS
NS
NS
NS
NS
NS
NS
NS
NS
99 (81)
29 (24)
47 (39)
117 (96)
48 (39)
60 (49)
NS
NS
NS
NS
NS
NS
95 (85)
22 (20)
40 (36)
110 (98)
45 (40)
48 (43)
Continuous variables are described as mean ⫾ SD.
ACE ⫽ angiotensin-converting enzyme; AF ⫽ atrial fibrillation; LVEDD ⫽ left
ventricular end-diastolic diameter; LVESD ⫽ left ventricular end-systolic diameter;
LVEF ⫽ left ventricular ejection fraction; NYHA ⫽ New York Heart Association
class; SR ⫽ sinus rhythm; VO2 ⫽ oxygen uptake.
tive statistics are presented as mean ⫾ SD. A probability
value of ⬍0.05 was considered as statistically significant.
Statistical analyses were performed with the SAS/STAT
statistical package, release 6.12 (SAS Institute, Cary, North
Carolina).
RESULTS
Between July 1999 and December 2000, a total of 234
patients were admitted to our HFU with a diagnosis of
CHF; 122 patients were randomized to community care and
112 patients to DH-based management. No significant
clinical or instrumental differences were observed between
the patients in the two groups (Table 1). Their mean LVEF
was 29%. The goals and tools of the HF management
program are reported in Table 2.
Management Outcomes
During the management program, 53/112 (47%) patients
underwent cardiac risk reevaluation; in 50/112 patients
(45%) therapeutic variations were made. Overall, 85/112
(76%) patients participated in health education sessions and
had physical training programmed. After 12 ⫾ 3 months of
follow-up, 91 hospital admissions had been required for 56
patients; 78 (86%) of the admissions were for communitytreated patients, 13 (14%) for patients managed by the DH
(p ⬍ 0.00001). There were 49 open-access interventions in
27 patients. Table 3 summarizes the medical regimen at
Goals
Check clinical stability (EBM), n (%)
Cardiovascular risk stratification, n (%)
Tailored therapy, n (%)
Management of risk of heart failure, n (%)
Health education, n (%)
Counseling, n (%)
Physical training, n (%)
Open access, n (%)
Multidisciplinary intervention, n (%)
Tools
Access, n
Open access, n
ECG, n (%)
Laboratory examination, n (%)
Echo-Doppler, n (%)
Cardiopulmonary exercise test, n (%)
Right hemodynamics, n (%)
Holter monitoring, n (%)
Psychological assessment, n (%)
Nutritional counseling, n (%)
112 (100)
53 (47)
50 (45)
12 (11)
85 (76)
112 (100)
85 (76)
27 (24)
21 (19)
612
49
112 (100)
112 (100)
76 (68)
58 (52)
32 (28)
44 (39)
19 (17)
21 (19)
ECG ⫽ electrocardiogram; EBM ⫽ evidence-based medicine.
baseline and after the different management strategies. After
one year, the dosages of both long- and short-acting
angiotensin-converting enzyme (ACE) inhibitors, nitrates,
and beta-blockers were significantly higher in the DH group
than in the community group, whereas the dosages for diuretics and digitalis were lower. After one year, the frequency of use
of the various drugs remained substantially unchanged, while
the percentage of patients taking beta-blockers increased significantly in the DH group (40% vs. 71%, p ⬍ 0.0001) but not
in the community (39% vs. 40%, p ⫽ NS).
Functional Outcomes
The effects of the two management strategies on functional
outcomes are reported in Table 3. Patients allocated to
community management showed heterogeneous changes in
NYHA functional class (13% improved and 16% worsened,
p ⫽ NS). In the DH group, NYHA functional class
changed significantly (23% improved and 11% worsened,
p ⬍ 0.009).
Hard Outcomes
Hard cardiac events in the one year follow-up occurred in
25/234 (10.6%) patients; cardiac death occurred in 21/122
(17.2%) of the community group and in 3/112 (2.7%) in the
DH group (p ⬍ 0.0007). One DH patient underwent
urgent transplantation. Comparison of the two managerial
models using Cox regression analysis showed that DH
management significantly protected against the appearance
of hard events (RR, 0.17; CI 0.06 to 0.66).
Pharmacoeconomic Analyses
Pharmacologic costs. At discharge from the initial hospitalization, there was no difference between the two patient
groups in terms of dosage and rate of use of drugs. At one
Capomolla et al.
Cost/Utility Ratio in CHF
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October 2, 2002:1259–66
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Table 3. Outcomes in Patients Grouped According to Management Strategies
Usual Care
Management outcomes
1. Therapy
ACE inhibitors long-acting (mg/day)
ACE inhibitors short-term (mg/day)
Beta-blockers (mg/day)
High-ceiling diuretics (mg/day)
K⫹ saver (mg/day)
Digitalis (mg/day)
Nitrates (mg/day)
2. Patients rehospitalized (n (%))
3. No. of rehospitalizations (%)
4. Individual access
Functional outcomes
Systolic pressure (mm Hg)
Peak VO2 (ml/min/kg)
LVEDD (mm)
LVESD (mm)
LVEF (%)
Deceleration time E (ms)
Mitral regurgitation (ⱖ2⫹)
NYHA (I–II/III–IV)
Hard outcomes
Cardiac death
Urgent transplantation
Day-Hospital
Baseline
1 yr
Baseline
1 yr
15 ⫾ 9
100 ⫾ 40
13 ⫾ 12
74 ⫾ 50
40 ⫾ 31
0.140 ⫾ 0.05
68 ⫾ 40
—
14 ⫾ 7
101 ⫾ 31
10 ⫾ 19
70 ⫾ 57
35 ⫾ 33
0.130 ⫾ 0.07
60 ⫾ 34
—
—
12 ⫾ 10
103 ⫾ 39
14 ⫾ 29
85 ⫾ 107
40 ⫾ 29
0.230 ⫾ 0.08
40 ⫾ 29
37 (35)
78 (86)
—
—
20 ⫾ 8†*
139 ⫾ 26†*
34 ⫾ 23†*
61 ⫾ 44†
78 ⫾ 37†*
0.109 ⫾ 0.6†
84 ⫾ 46†*
9 (8)†
13 (14)†
5.5 ⫾ 3.8
120 ⫾ 18
17 ⫾ 4
70 ⫾ 9
59 ⫾ 11
31 ⫾ 7
163 ⫾ 50
2.4 ⫾ 0.4
80/42
113 ⫾ 18
16.4 ⫾ 4
71 ⫾ 10
59 ⫾ 10
30 ⫾ 9
163 ⫾ 52
2.5 ⫾ 0.9
73/49
114 ⫾ 16
17 ⫾ 4
68 ⫾ 10
61 ⫾ 10
29 ⫾ 10
155 ⫾ 55
2.7 ⫾ 0.5
73/39
117 ⫾ 20
17.8 ⫾ 5
68 ⫾ 10
54 ⫾ 12†*
34 ⫾ 7†
172 ⫾ 49
2.1 ⫾ 0.9*
91/22†*
—
—
21 (17.2)
—
—
—
3 (2.7)
1 (0.9)
Continuous variables are described as mean ⫾ SD. *p ⬍ 0.05 versus baseline DH. †p ⬍ 0.05 versus usual care.
ACE ⫽ angiotensin-converting enzyme inhibitor; E ⫽ early diastolic filling wave of mitral flow; LVEDD ⫽ left ventricular
end-diastolic diameter; LVESD ⫽ left ventricular end-systolic diameter; LVEF ⫽ left ventricular ejection fraction; NYHA ⫽
New York Heart Association functional class.
year, the annual cost per patient to maintain care was greater
in the DH group than in the community group ($741 vs.
$490 p ⬍ 0.000001) (Table 4).
Care management costs. Care management costs are the
largest component of direct costs of treating CHF patients.
The averaged annual cost of readmissions of community
patients was $178,553. In contrast, the averaged DH care
management cost was $167,785, of which $138,026 was for
managed care and $29,759 for readmissions. A cost comparison of the two strategies identified that the DH model
is cost-effective, with a cost-saving of $10,768.
Life expectancy. Actuarial survival at one year was 96% in
the DH patients and 78% in the community patients (log
rank p ⬍ 0.0002) (Fig. 1). The incremental life expectancy
was 0.083 years per patient. The cumulative incremental life
expectancy in the DH group was 9.8 years.
Time trade-off. At one year, the weighted mean utility
measured by the time trade off method was greater in the
DH than in the community group (0.72 ⫾ 0.17 vs. 0.63 ⫾
0.22, p ⬍ 0.008). This result identified that DH patients
were willing to trade 10 years of their present health for 7.2
years of excellent health, whereas patients in the community
group were willing to trade 6.3 years.
Quality-adjusted life years (QALY). Day-hospital management produced a higher QALY than that achieved in the
community group (79.4 vs. 70.5, p ⬍ 0.01).
Cost/utility analysis. The DH model showed a better
cost/utility ratio than that of community management
($2,244 vs. $2,409). Furthermore, the incremental analysis
revealed a cost-saving of $1,068 for each QALY gained.
Considering an increase of 0.080 QALY per patient, an
annual cost of $1,483 per patient and a 5% annual increase
Table 4. Economic Profile of Patients Grouped According to Management Strategies
Costs
Usual Care
Day-Hospital
p Value
Annual pharmacologic costs ($)
Health management costs ($)
Rehospitalization costs ($)
Strategy costs ($)
Cost/utility ($)
Incremental cost/utility ($) (95% CI)
490 ⫾ 164
—
1,332 ⫾ 1,992
178,553
2,409
741 ⫾ 206
1,243 ⫾ 868
268 ⫾ 801
167,785
2,244
19,462 (13,904–34,048)
0.000001
—
0.000001
—
—
CI ⫽ confidence interval.
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JACC Vol. 40, No. 7, 2002
October 2, 2002:1259–66
Figure 1. Probability of survival among patients managed with different strategies. A survival function was used to estimate life expectancy and the upper
and lower limits in the first year for day-hospital (squares) and usual care (circles) patients.
of costs ($1,557), the cost/utility ratio for the integration of
DH management of CHF was $19,462 (Table 4).
Sensitivity Analysis
As calculated from the one-year survival curves, the 95%
CIs of the 0.083-year year difference in life expectancy
between the two groups were 0.041 and 0.125 years. The
95% CIs for overall costs were $1,396 and $1,738. These
ranges would determine a cost/utility ratio from $13,904 to
$34,048 per QALY product.
DISCUSSION
We compared the cost/utility ratio of usual care of CHF
patients returned to the community with that of processes
and outcomes of care provided by a HF management
program based in a DH. Most of the patients were in
NYHA functional classes II and III, best suited to primary
therapeutic optimization in an HFU. This study showed
that outpatient CHF management may have a better cost/
utility ratio than usual care. Our results indicate that the
implementation of a structured program in a DH, inte-
grated to usual care, costs $19,462 per additional QALY
saved.
There are essentially two points of strength of our study:
1) the formalization of the process of care and 2) the use of
an EBM methodology. To define the care process, the
clinicians developed the “health care intervention,” identifying the following phases: appropriateness of access to the
program; the typology of the patient population; definition
of the goals; necessary tools for the organization of the
process; modality of the therapeutic intervention; identification and measurement of markers of outcome; evaluation
of cardiovascular risk, and definition of follow-up. The
EBM methodology offers valid and strong support to the
decision of the process of care. In particular, EBM provided
the informational and clinical elements to identify the best
use of the single procedures activated in the different health
care plans.
Furthermore, EBM allowed us to identify the best
algorithm to define individual cardiovascular risk, therapeutic treatment, and consequent follow-up. This procedure
allows 1) reduction of the use of ineffective and inefficient
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October 2, 2002:1259–66
procedures for the type of clinical case being managed; 2)
avoidance of repetition of procedures caused by occasional
evaluations of the clinical syndrome; and 3) simulation
analysis of consequences of behavior that would subtract
resources. Such simulations have allowed us to overcome
possible reticence of the health staff in modifying their
empirical health care practices.
In this perspective the management of CHF patients
changes profoundly: health care is not management of an
acute event and/or clinical symptoms—a characteristic of
the usual care with interventions in emergency room, and
often, of the primary care physicians, cardiologists, and/or
surgeons— but a continuous modulation of cardiovascular
risk with interventions to prevent hemodynamic imbalance
and to optimize therapy to improve quality of life and
prognostic outcome.
This link among process of the care, control of management, and application of EBM has allowed two primary
objectives to be reached: 1) better performance effectiveness
and 2) reduced absorption of resources and their better
allocation.
Performance effectiveness. A positive effect of the management program of CHF outpatients might be continuous
optimization of therapy such as more titration of long- and
short-acting ACE inhibitors. Although 97% of the patients
were taking ACE inhibitors, in the DH-managed patients
the mean dose of the ACE inhibitors was about 25% higher
than usual care patients.
Similar considerations can be made about beta-blocker
treatment: at the end of the management, 71% of the DH
subjects were receiving beta-blockers versus 40% of
community-treated patients. Likewise, the average dose of
beta-blockers was 58% higher in the DH subjects at the end
of management, and essentially unchanged in the patients
receiving usual care. Moreover, in about 45% of the patients
cardiovascular risk reevaluation led to therapeutic variations.
Although we have not yet analyzed the data on compliance
and effectiveness of the health education sessions and
controlled physical training, 76% of patients were offered a
way of self-management of their illness.
Open access was another important component of the
program management. This modality of access is reserved
for patients who exhibited markers and symptoms of hemodynamic imbalance during follow-up, despite therapeutic
modifications performed at home. Open access to the DH
allows extemporaneous execution of new care processes (IV
therapy, laboratory examinations, instrumental controls, and
therapeutic adjustments) by the HF care team. This implies
that hospital admission—the largest part of usual-care
management costs—is managed and integrated in a program of continuous definition of cardiovascular risk by
echo-Doppler hemodynamic monitoring, cardiopulmonary
exercise testing, measurement of biohumoral parameters,
and therapeutic effectiveness evaluated by the same care
team.
Conversely, in usual care, hospital admission is often a
Capomolla et al.
Cost/Utility Ratio in CHF
1265
reactive solution to failure of a care process managed by
different providers and at different times during the initial
course of hemodynamic imbalance. In our experience the
open-access service reduced potential hospital admissions by
79%. These combined interventions on therapeutic strategy
and managerial organization justify the impact of this new
care process on the outcomes in comparison to usual care.
Rehospitalization was reduced by 72%. The impact of our
managed program in DH on rehospitalization due to CHF
was similar to that in other studies.
In a 90-day follow-up of elderly patients, Rich et al. (9)
showed a 56% reduction of readmission for HF. In the
multifit approach, total hospitalization rates for HF declined by 74% over 12 months (12). Hanumanthu et al. (10)
showed that a HF program can reduce hospitalizations for
decompensated HF by 63%. Fonarow et al. (8) examined
the impact of a HF program on reducing hospitalization.
They showed that rehospitalizations fell from 92% in the
previous six months to 26% during the study period. A
recent study by Hershberger et al. (25) in an outpatient
setting demonstrated that a heart failure program can reduce
the risk of rehospitalization by 52%. However, some studies
show that intensive management by primary-care physicians
increases hospital readmission and cost management (26).
Using the HFU as a benchmark, we have transferred the
experience gained in the HFU into the external setting of
the DH with its lower organizational costs while retaining
the know-how. This has allowed the creation of a qualified
provider able to strengthen and increase the effects initiated
by a HF program delivered by the HFU (27,28). This HF
program has already had an important impact on mortality,
which has been low in patients referred to the HFU, but the
effect has been enhanced in the subgroup followed up in the
DH program, in whom the annual mortality rate has been
reduced by 79% in comparison to that in the group referred
to the HFU and subsequently followed up with usual care.
The explanation of this result can, to a large extent, be
attributed to the better optimized therapy. This study is the
first to report effective titration of beta-blockers in 71% of
the population. The BRING-UP study (29) underlined
how driven titration of therapy could increase the number of
beneficiaries of the treatment.
Resource allocation. Heart failure is the pathology making
most demands on health care and absorbing the greatest
amount of economic resources. In consideration of this
socioeconomic burden, the application of new managerial
models should satisfy two important conditions: 1) improve
the quality of the performance and 2) not increase the costs.
Our model satisfies these two conditions. The effectiveness
of the performance is clearly improved. The variation of
resources from usual care— used for the management,of
discontinuous and diversified treatments of an acute
event—to the HF management program in a DH has a
better cost/utility ratio with a cost-saving per QALY incremental product of $1,068. When the model is considered as
integration to the usual care, the incremental analysis
1266
Capomolla et al.
Cost/Utility Ratio in CHF
identifies it as favorable. This service has an equitable value
from a societal point of view. In fact, the cost patient/year
places it between that of pacemaker implantation ($1,516),
annual management of chronic pain ($2,996), and geriatric
orthopedic rehabilitation ($5,555). If we compare the incremental cost/utility ratio, it is cost-effective and placed
between that of ACE-inhibitor treatment in CHF ($7,777),
an intravascular ultrasound-guided procedure ($6,439), a
two-vessel coronary artery bypass graft surgery ($17,500),
and home hemodialysis ($23,794) (30). We have treated the
two management strategies as complementary models. Nevertheless, in a new definition of the scenario, the DH could
be considered as a provider in the community, supplying the
usual care and reducing the total resources absorbed by this
pathology.
Study limitations. Various limitations of our study must be
acknowledged. Elderly patients and those affected by diastolic HF are poorly represented in our study population.
The assessment of the costs could be underestimated because we did not evaluate costs for minor health care services
nor indirect costs. Direct and indirect nonhealth care costs
were not evaluated. Nevertheless, these factors should be
equally distributed between the two study groups and thus
should not invalidate the final compared results. The analysis of QALY are referred to the first year of follow-up. But
the titration of better therapy could improve survival curves
beyond one year, increasing their divergence and the final
result. The relationship between the different components
of the care process, their absorption of the resources, and
relative contributions to the outcomes have not been evaluated. In summary, this randomized prospective study
showed that, compared to usual care, a HF management
program delivered by a DH improves the cost/utility ratio of
managing CHF.
Reprint requests and correspondence: Dr. Soccorso Capomolla,
Department of Cardiology, Montescano Medical Center, Via per
Montescano, 27040 Montescano, Pavia, Italy. E-mail:
[email protected].
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