Journal of the American College of Cardiology

2002 by the American College of Cardiology

Published by Elsevier Science Inc.

Vol. 39, No. 1, 2002

ISSN 0735-1097/02/$22.00
PII S0735-1097(01)01699-0

Randomized Trial of an Education and

Support Intervention to Prevent
Readmission of Patients With Heart Failure
Harlan M. Krumholz, MD, FACC,* Joan Amatruda, RN, Grace L. Smith, MPH,
Jennifer A. Mattera, MPH, Sarah A. Roumanis, RN, Martha J. Radford, MD, FACC,*
Paula Crombie, LCSW, Viola Vaccarino, MD, PHD
New Haven and Middletown, Connecticut; and Atlanta, Georgia
We determined the effect of a targeted education and support intervention on the rate of
readmission or death and hospital costs in patients with heart failure (HF).
BACKGROUND Disease management programs for patients with HF including medical components may
reduce readmissions by 40% or more, but the value of an intervention focused on education
and support is not known.
METHODS
We conducted a prospective, randomized trial of a formal education and support intervention
on one-year readmission or mortality and costs of care for patients hospitalized with HF.
RESULTS
Among the 88 patients (44 intervention and 44 control) in the study, 25 patients (56.8%) in
the intervention group and 36 patients (81.8%) in the control group had at least one
readmission or died during one-year follow-up (relative risk 0.69, 95% confidence interval
[CI]: 0.52, 0.92; p 0.01). The intervention was associated with a 39% decrease in the total
number of readmissions (intervention group: 49 readmissions; control group: 80 readmissions, p 0.06). After adjusting for clinical and demographic characteristics, the intervention
group had a significantly lower risk of readmission compared with the control group (hazard
ratio 0.56, 95% CI: 0.32, 0.96; p 0.03) and hospital readmission costs of $7,515 less per
patient.
CONCLUSIONS A formal education and support intervention substantially reduced adverse clinical outcomes
and costs for patients with HF. (J Am Coll Cardiol 2002;39:839) 2002 by the American
College of Cardiology
OBJECTIVES

Heart failure (HF) has an extremely high rate of readmission after index hospitalization, with up to 44% of patients
rehospitalized within six months of discharge (1). Recent
studies have suggested that multidisciplinary disease management programs can substantially reduce the risk of
readmission, with as much as a 56% reduction in HF
readmissions and a 44% reduction for all-cause readmissions
(2). These interventions, however, have generally included
medical management components and, consequently, it is
difficult to identify the critical factors responsible for their
success.
Behavioral factors such as noncompliance with medications and diet and delay in seeking preventive care may
contribute to readmissions and premature mortality (3,4).
Thus, we hypothesized that an education and support
intervention intended to increase compliance and empower
patients to manage their disease would significantly reduce
From the *Section of Cardiovascular Medicine, Department of Medicine, Yale
University School of Medicine, New Haven, Connecticut; Yale-New Haven
Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut;
Qualidigm, Middletown, Connecticut; Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of
Medicine, New Haven, Connecticut; Yale-New Haven Hospital, New Haven,
Connecticut; and the Division of Cardiology, Department of Medicine, Emory
University School of Medicine, Atlanta, Georgia. At the time this work was
conducted, Dr. Vaccarino was affiliated with the Section of Chronic Disease
Epidemiology, Department of Epidemiology and Public Health, Yale University
School of Medicine, New Haven, Connecticut.
Manuscript received November 30, 2000; revised manuscript received September
17, 2001, accepted September 20, 2001.

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the rate of readmission and death for patients with HF. We

conducted a prospective, randomized trial of 88 patients to
assess the effect of the intervention on the rate of readmission and death and cost of hospital readmissions.

METHODS
Patients. We studied patients aged 50 years who met
clinical criteria for presence of HF on admission to YaleNew Haven Hospital (YNHH) between October 1997 and
September 1998. Consecutive admissions were screened
daily to identify eligible patients, who were required to have
either an admission diagnosis of HF or radiologic signs of
HF on the admission chest X-ray. These patients medical
records were reviewed within three days of admission to
verify a set of additional symptom and sign criteria, based on
a modification of the National Health and Nutrition Examination Survey I study and criteria by Schocken et al. (5)
and Harlan et al. (6). Excluded from the study were patients
transferred from other hospitals, patients admitted from
nursing homes, patients with HF secondary to high-output
states or noncardiac diseases and patients with terminal
illness in addition to HF (e.g., cancer with 6-month
expected survival). The Institutional Review Board of the
Yale University School of Medicine approved the study, and
all patients provided informed consent.
Study intervention. The study intervention was based on
five sequential care domains for chronic illness, including

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Abbreviations and Acronyms

CI
confidence interval
CVD cardiovascular disease
HF
heart failure
HR
hazard ratio
RR
relative risk
YNHH Yale-New Haven Hospital

patient knowledge of the illness, the relation between

medications and illness, the relation between health behaviors and illness, knowledge of early signs and symptoms of
decompensation and where and when to obtain assistance.
In the teaching module, each sequential domain supplemented knowledge acquired in previous domains. Operationalizing the intervention occurred in two phases. Initially, the patients understanding of the domains was
assessed and reviewed in order to provide information about
patient gaps in knowledge for the nurse to address. Subsequent follow-up sessions reviewed knowledge of care domains and provided support for patients to apply their
knowledge, participate in managing these domains and
effectively seek and access care. This support was designed
to reinforce the initial educational foundation theoretically
by empowering patients and offering strategies to improve
patients compliance.
For the initial phase, an experienced cardiac nurse educated patients during an hour-long face-to-face in-depth
session within two weeks of hospital discharge using a
teaching booklet. Home visits were performed for 45% of
intervention patients unable to travel to the hospital, but the
visits were not intended to provide additional assessments
that were more detailed than clinic sessions. Neither clinical
assessment of HF nor modification of current medical
regimen was a component of the baseline meeting.
During the subsequent telemonitoring phase, the nurse
contacted the patient by phone on a weekly basis for four
weeks, then biweekly for eight weeks and then monthly for
a total intervention period of one year. These calls reinforced care domains but did not modify current regimens or
provide recommendations about treatment. However, the
nurse could recommend that the patient consult his or her
physician when the patients status deteriorated abruptly or
the patient experienced a significant problem with medical
therapy requiring prompt attention, and, in doing so, the
nurse helped patients understand when and how to seek and
access care. Patients assigned to the control group received
all usual care treatments and services ordered by their
physicians.
Data collection and follow-up. A face-to-face baseline
enrollment interview provided demographic information.
Clinical information abstracted from patient medical
records included medical history, physical examination,
laboratory evaluation, results of cardiac tests and hospital
course.
One-year outcomes included deaths, ascertained through

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next-of-kin, hospital records, active monitoring of obituaries and information about readmissions obtained from
patients, their families, discharge summaries and hospital
records to confirm the event and classify the cause, based on
the assessment of a clinician blinded to the patients intervention allocation.
Cost analysis. For the readmissions that occurred at
YNHH (91%), the Transition Accounting System (Transition Systems, Inc., Boston, Massachusetts) was used to
calculate costs. For each admission, the quantity of each
resource used was multiplied by the unit cost of the resource,
and the individual resource costs were totaled. For rehospitalizations outside of YNHH, costs were based on an
equation derived from a prospective cohort of patients with
HF at YNHH (G. Smith, unpublished data, 2000), lengths
of stay and cost-to-charge ratios from billing information. A
similar percentage of the readmissions for both groups
occurred at YNHH (88% of the control group and 98% of
the intervention group).
The calculated cost of the intervention included an hourly
rate of $50 estimated for nursing and social work time.
Costs of in-hospital follow-up medical care included the
sum of costs of readmission for all patients in each group;
outpatient costs were not included. Costs associated with
start-up, research and monitoring (i.e., screening, randomization, data collection and follow-up) were also not included.
Study end points and statistical analysis. Analyses were
conducted according to the intention-to-treat approach,
with readmission or death as the primary outcome measure.
Secondary end points included number of all-cause, HF and
HF-related or other cardiovascular disease (CVD)-related
readmissions, cumulative number of days of hospitalization
during follow-up and the cost of readmissions. Other
analyses adjusted for the effect of early mortality on outcomes. The study was powered to detect a 40% relative
reduction in the total rate of readmission or death among
patients in the intervention group, based on the assumption
of a 75% rate of death or readmission for the control group.
Characteristics of the two study groups were compared by
the chi-square test for categorical variables and by the
Wilcoxon rank-sum test for continuous variables. The
primary outcome (rate of readmission or death) was compared using the Mantel-Haenszel chi-square, and relative
risks (RR) were calculated. Time to first readmission or
death was compared using the log-rank test. Subgroup
analyses stratified by cause of readmission, as well as all
outcomes adjusted for early mortality, were also conducted.
A Cox proportional-hazards model assessed readmissionfree survival, with data on patients who died without
readmission to the hospital censored at the time of death.
Based on the bivariate analysis and previous work identifying predictors of readmission within one year of discharge
from the hospital, we adjusted for age, gender, history of
HF and admission creatinine (1). An additional analysis was
performed adjusting for prior coronary artery disease, use of

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calcium channel blockers and use of beta-blockers. All

analyses were conducted using SAS 6.12 (SAS Institute,
Cary, North Carolina).

Table 1. Comparison of Intervention and Control

Baseline Characteristics
Characteristics

RESULTS
Study sample. A total of 390 patients was screened from
October 1997 through September 1998. Among them, 248
(63.6%) were not eligible due to at least one exclusion
criterion: admission from a nursing home (46 patients);
transfer from another acute-care facility (45 patients); conditions severely interfering with interview (45 patients);
admission for elective procedure (29 patients); already enrolled in study (23 patients); HF due to high output states
(15 patients); other terminal disease (11 patients); terminal
or skilled nursing care (10 patients); enrolled in other
studies (8 patients); no signs/symptoms of HF (8 patients);
other impairing conditions (4 patients); HF due to toxic
cardiomyopathy (3 patients); patient 50 years old (3
patients); or followed by another facility (2 patients). An
additional 54 patients (13.6%) were eligible but not enrolled, due to no interview because of death, discharge or
other medical reasons (22 patients), patient, physician or
family refusal (20 patients) or having no telephone or
residing in another state (12 patients).
Baseline characteristics. The median age of the patients
was 74 years; 57% were men and 74% were Caucasian. The
two groups were well balanced with respect to most characteristics, although the intervention group was slightly
older, had a lower rate of prior coronary artery bypass graft
surgery, percutaneous transluminal coronary angioplasty
and acute myocardial infarction and a lower use of calcium
channel blockers and beta-blockers (Table 1).
Readmissions. Among the 88 patients (44 intervention
and 44 control) in the study, 25 patients (56.8%) in the
intervention group and 36 patients (81.8%) in the control
group had at least one readmission or died during follow-up
(RR 0.69, 95% confidence interval [CI]: 0.52, 0.92; p
0.01). Only 12 patients (27.3%) in the intervention group
compared with 21 patients (47.7%) in the control group
experienced more than one readmission (RR 0.57, 95%
CI: 0.33, 0.99; p 0.05). Overall, there were 49 all-cause
readmissions in the intervention group and 80 in the control
group in the one year after discharge (p 0.06), indicating
a 39% reduction in readmissions. In the intervention group,
9 patients (20.4%) died, compared with 13 patients (29.5%)
in the control group (RR 0.69, 95% CI: 0.33, 1.45; p
0.33).
The number of patients experiencing HF or other CVD
readmissions or death was 22 (50.0%) in the intervention
group and 35 (79.6%) in the control group (RR 0.63, 95%
CI: 0.46, 0.86; p 0.004). These patients accounted for 35
readmissions in the intervention group and 66 in the control
group (p 0.03), for a 47% decrease in the total number of
HF or other CVD readmissions.
In the intervention group, 18 patients (40.9%) had at least

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85

Age
Male gender
White race
Prior myocardial infarction
Prior congestive heart failure
Prior CABG
Prior PTCA
Diabetes
Systolic blood pressure (mm Hg)
Sodium (mmol/l)
Blood urea nitrogen (mmol/l)
Creatinine (mol/l)
Ejection fraction (%)*
Activities of daily living score
Procedures during admission
Cardiac catheterization
PTCA
Discharge medications
Aspirin
Beta-blockers
Calcium channel blockers
ACE inhibitors
Digoxin

Intervention
(n 44)

Control
(n 44)

p
Value

75.9 8.7
21 (48)
31 (70)
24 (55)
31 (70)
7 (16)
5 (11)
23 (52)
162 38
138 4
11.1 6.4
141.4 61.9
38 17
5.6 1.1

71.6 10.3
29 (66)
34 (77)
29 (66)
35 (80)
16 (36)
9 (20)
23 (52)
157 35
137 5
12.5 8.2
150.3 79.6
37 16
5.5 1.2

0.050
NS
NS
NS
NS
0.029
NS
NS
NS
NS
NS
NS
NS
NS

8 (18)
1 (2)

6 (14)
0 (0)

19 (43)
14 (32)
8 (18)
28 (64)
22 (50)

19 (43)
22 (50)
17 (39)
24 (55)
17 (39)

NS
NS
NS
NS
NS
0.033
NS
NS

*Ejection fraction values were available for 87 (99%) patients.

ACE angiotensin-converting enzyme; CABG coronary artery bypass graft
surgery; PTCA percutaneous transluminal coronary angioplasty.

one HF readmission compared with 30 patients (68.2%) in

the control group (RR 0.60, 95% CI: 0.41, 0.89; p
0.01). These patients accounted for 22 total readmissions
for HF in the intervention group and 42 in the control
group (p 0.07), for a 48% decrease in these readmissions
(Table 2). All primary analyses and subgroup analyses
excluding patients with early mortality yielded comparable
results (not shown).
Median time from discharge to all-cause readmission or
death was 193 days in the intervention group, compared
with 126 days in the control group (Figs. 1 to 3). In
multivariate Cox proportional hazards models, after adjusting for age, gender, history of HF and admission serum
creatinine, the intervention group had a significantly lower
risk of all-cause readmission or death (hazard ratio [HR]
0.56, 95% CI: 0.32, 0.96; p 0.03), lower risk of HF or
other CVD readmission or death (HR 0.51, 95% CI:
0.29, 0.90; p 0.02) and lower risk of HF readmission or
death (HR 0.52, 95% CI: 0.28, 0.98; p 0.04) compared
with the control group (Table 3). Subsidiary analyses
adjusting for calcium channel blockers at discharge, betablockers at discharge or presence of coronary artery disease
(history of myocardial infarction, angioplasty or bypass
surgery) did not significantly change hazard estimates (not
shown).
Cost of care. The average cost of the study intervention
included an average of 5 h per patient with the nurse and 2 h
per patient with the social worker for the 30% of patients
needing a social worker for the educational sessions during

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Table 2. Readmission and Death Within One Year of Initial Discharge*

Patients readmitted or died

All-cause readmission or death
HF or other CVD readmission
or death
HF readmission or death
More than 1 readmission
More than 2 readmissions
Deaths
Number of readmissions
All-cause readmission
HF or other CVD readmission
HF readmission
Hospital days
All-cause readmission
HF or other CVD readmission
HF readmission

Intervention
(n 44)

Control
(n 44)

Reduction
(%)

RR
(95% CI)

p
Value

25 (56.8)
22 (50.0)

36 (81.8)
35 (79.6)

30.6%
37.2%

0.69 (0.52, 0.92)

0.63 (0.46, 0.86)

0.01
0.004

18 (40.9)
12 (27.3)
6 (13.6)
9 (20.4)

30 (68.2)
21 (47.7)
11 (25.0)
13 (29.5)

40.0%
42.8%
45.6%
30.8%

0.60 (0.41, 0.89)

0.57 (0.33, 0.99)
0.55 (0.23, 1.32)
0.69 (0.33, 1.45)

0.01
0.05
0.18
0.33

49
35
22

80
66
42

38.8%
47.0%
47.6%

0.06
0.03
0.07

10.2 16.8
6.3 9.2
4.1 6.4

15.2 17.5
12.3 14.3
7.6 12.1

0.09
0.03
0.1

*Values followed by parentheses indicate number of patients and percentages of the group. Continuous values are expressed as
mean SD. Percent reduction calculated by dividing the absolute percent difference between groups by the control group
percentage.
CI confidence interval; CVD cardiovascular disease; HF heart failure; RR relative risk.

the one-year follow-up period. The total estimated cost was

$530 per patient.
Hospital readmission costs were higher in the control
group by an average of $7,515 per patient ($21,935 in the
control group and $14,420 in the intervention group, p

0.02). After taking into consideration the average cost of

$530 per patient with intervention, the overall cost of
care was $6,985 less per patient in the intervention group.
For HF or other CVD readmissions, costs per patient
were $18,421 in the control group and $8,888 in the

Figure 1. Kaplan-Meier curve for all-cause related readmission or death.

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87

Figure 2. Kaplan-Meier curve for congestive heart failure (HF)/cardiovascular disease (CVD)-related readmission or death.

intervention group (p 0.01). For HF readmissions,

costs per patient were $9,575 in the control group and
$5,232 in the intervention group (p 0.04) (Table 4).

DISCUSSION
We report that an education and support intervention
without medical management components was highly effective in reducing readmissions and in-hospital costs
among patients with HF. Fewer patients in the treatment
group experienced readmission or death as well as multiple
readmissions, for a reduction in total number of admissions
and substantially lower costs in the first year after discharge.
Intervention patients also exhibited significantly longer
readmission-free survival. Reductions of nearly 40% in total
readmissions and nearly 50% in HF readmissions are
comparable to those reductions achieved by other more
intensive HF case-management programs. This program,
however, is distinctive in its focus on patient empowerment
through education on managing chronic illness and through
support for seeking appropriate care.
The percentage of patients with all-cause readmission
was reduced by over 30% and by 40% for HF readmission.
While the percentage of patients with all-cause readmission
is close to results found in previous studies (1), the subset of
readmissions related to HF was relatively high compared
with previous reports, with 68.2% of patients in the control
group having at least one HF-related readmission. Previous
studies, however, used only principal diagnosis codes to
classify readmissions, while our study provides the percent-

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age of patients readmitted for HF using a review of medical

records and discharge summaries. Thus, HF-related readmissions may be more prevalent in this patient population
than previously suggested, underscoring the importance of
this intervention in targeting and preventing readmissions
due to acute exacerbation of HF.
Independent value of education and support. This study
extends previous work on disease management for patients
with HF (2,710) by specifically evaluating the impact of
education and support without medication management
intervention on the outcome of these patients. While
multifaceted studies have suggested a benefit of comprehensive case management for HF patients, the optimal
intervention from a clinical and cost perspective has not yet
been defined. Our intervention is different from other published programs, as it focuses on enabling patients to take an
active role in managing their chronic illness based on knowledge and education and does not rely on physicians or nurses
actively intervening to adjust medical care and regimens.
Our study has some similarities to the study by Jaarsma et
al. (11) who demonstrated that a brief education and
support intervention by a nurse could increase self-care
behaviors among patients who had been hospitalized with
HF. Unlike our study, the nurse in the Jaarsma study made
a home visit to every intervention patient, and all of the
intervention occurred within 10 days of discharge. In
contrast to our findings, Jaarsma et al. (11) found no
significant change in resource utilization, although there
were trends that favored the intervention group.

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Figure 3. Kaplan-Meier curve for congestive heart failure (HF)-related readmission or death.

Rich et al. (2) randomized 282 patients to usual care

versus a nurse-directed multidisciplinary intervention and
reported that the intervention group had a 56% reduction in
HF readmissions. The intervention by Rich et al. (2) not
only included intensive education about HF but also nurse
participation in the medical management of the patients, in
some cases visiting homes to administer intravenous diuretics. Other recent studies of more intensive disease management of patients with HF have reported a benefit associated
with these programs. For example, Australian investigators
reported that a home-based intervention produced a 50%
reduction in deaths and unplanned admissions (7) and in a
later study reported a 40% reduction in a larger patient
sample (12). As in our study, the intervention may have
been most effective in reducing the frequency of multiple
readmissions.
The focus of these interventions, however, was on a home
visit by a nurse-pharmacist team that addressed medical
management and compliance as well as intensive medical
Table 3. Proportional Hazards Model: Intervention
Versus Control
Outcome

RR

95% CI

p Value

Time to first all-cause readmission

Time to first HF or CVD readmission
Time to first HF readmission

0.56
0.51
0.52

0.32, 0.96
0.29, 0.90
0.28, 0.98

0.03
0.02
0.04

All models were adjusted for age, gender, history of heart failure and admission serum
creatinine.
CI confidence interval; CVD cardiovascular disease; HF heart failure;
RR relative risk.

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follow-up. In our intervention, medical management was

left to the patients physicians and, thus, benefits were likely
mediated chiefly through the knowledge and efforts of the
patients. Although it was theorized that these outcomes
were achieved through promotion of patient compliance
and empowerment, this trial did not explicitly test the
mechanism of intervention. Future studies may explore
potential mechanisms for maximal benefits of education and
support.
Notably, the reductions in readmissions in our trial,
though sizable, were slightly less than those found in
management programs with pharmacologic components.
These differences could be attributed to interstudy variability or potential residual benefit from the pharmacologic
component of those interventions. Additionally, while the
benefits of the previous studies are apparent by 90 days,
differences in our treatment groups were significant only
after 180 days of follow-up. An education and support
paradigm emphasizes long-term change, reinforcement of
care domains and patients incorporation of these changes
into their lifestyle.
Table 4. Mean Readmission Costs ($ Per Patient)

All-cause readmission
HF or other CVD
readmission
HF readmission

Intervention

Control

p Value

14,420 31,453
8,888 13,411

21,935 23,701
18,421 21,308

0.02
0.01

5,232 9,852

9,575 15,801

0.04

CVD cardiovascular disease; HF heart failure.

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Study limitations. Although the intervention was conducted at a single center, the relative simplicity of our
education-focused intervention should make it easily applicable to a broad spectrum of patients with HF. Our
intervention was directed by an experienced nurse, and these
findings may not be reproducible when implemented by
someone without clinical knowledge of this condition.
Furthermore, since the intervention lasted only one year, the
optimal length of education and support through telemonitoring is unknown, and the minimum time period necessary
for patients to manifest benefits of this intervention is still
unknown.
The study sample size of 88 patients was relatively small,
but the study yielded a positive result. The randomization
groups were comparable with respect to demographic and
clinical characteristics, although differences in some characteristics were noted. Comparisons of outcomes were supplemented by a multivariate analysis that adjusted for
potential baseline differences in the randomization arms,
and the outcome was not changed.
Finally, despite the cost analysis that employed detailed
estimates from a comprehensive cost-accounting system,
this analysis did not account for all costs, specifically
nonhospital costs. However, hospital costs likely dominate
total patient costs in the first year after discharge. The study
by Rich et al. (2) included a more comprehensive analysis of
cost in a subset of their patients and found that the hospital
costs were responsible for the differences between the
groups.
Conclusions. Although many studies have shown the benefits of multidisciplinary interventions with medical components, this study suggests that education and support intended to prompt patient participation in the management
of chronic illness has independent effects on markedly
reducing poor outcomes. The magnitude of benefits from
this trial rivals the outcomes reported by more comprehensive programs, which have achieved reductions of 40% or
more. These results, building on the work of others, suggest

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89

that all patients with HF should be offered an education and

support program that extends beyond the hospitalization.
Reprint requests and correspondence: Dr. Harlan M. Krumholz, Yale University School of Medicine, 333 Cedar Street, PO
Box 208025, New Haven, Connecticut 06520-8025.

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