Table
of Contents
Results
Our search yielded 273 abstracts of randomized controlled
trials, of which 190 were rejected after initial screening
using very broad eligibility criteria (i.e., all comparisons
of intervention for post-discharge care that reported at the
least readmission and/or mortality outcomes among patients
with HF). The review of reference lists of related systematic
reviews, selected narrative reviews, and primary articles yielded
an additional 13 citations. A total of 96 articles were retrieved
for full text examination. Of these, 14 articles were duplicate
reports, 28 articles were conducted among mixed population,
three studies were not randomized trials, and two studies that
could not be retrieved were excluded. Forty-nine unique randomized
controlled trials qualified for analysis in this report.8,13-18,30-71 Figure
1 summarizes the search and selection of articles. Appendix
B summarizes the data of the included studies.
The characteristics of included studies are reported according
to the settings where interventions were initiated among patients
either during or after an index hospitalization. Index hospitalization
is the time period indicating the beginning of study interventions
or the recruitment of patients for the study. The study characteristics
description is followed by a review of the key question, and
the additional outcomes of interest.
All studies restricted patients' recruitment to those who
were discharged to their homes or returned to their community.
Studies excluded populations for whom coexisting illnesses
were likely to reduce life expectancy and/or living in a nursing
home setting. Studies also excluded patients with dementia
or any psychiatric illnesses, poorly compensated HF, chronic
pulmonary diseases, unstable angina, and acute myocardial infarction.
The most commonly reported etiology of HF among patients in
the included studies was due to ischemic heart disease. Hypertension
was the most frequent coexisting medical disease in these patients.
The studies most frequently reported LV systolic dysfunction
measured as left ventricular ejection fraction (LVEF).
The severity of HF and the distribution of NYHA class among
included patients varied across studies. The studies reported
that the therapeutic management of HF patients was optimized
as guided by the clinical practice guidelines available at
the time of the trials. Among studies, overall at baseline
there were no significant differences in demographics, medication
use, and co-existing medical illnesses between the intervention
and usual care group.
In general, patients in the intervention group had their followup
in a HF clinic managed by a study or a specialist nurse under
the supervision of a cardiologist. The primary care physicians,
or sometimes cardiologists followed HF patients in the usual
care group. Generally in the usual care group, studies failed
to report care coordination of patients during their transition
from an inpatient setting to the post-discharge period or outpatient
clinic.
Figure 1. Flow diagram summarizes the search and selection
of articles
Key question 1: In HF patients,
what is the effectiveness of interventions to support post-discharge
care compared with the usual care to prevent readmission?
Description of studies with all cause readmission data
Overall 37 studies reported data on all cause readmissions
after an index hospitalization. Of which, 20 studies reported
interventions beginning in the inpatient setting, and 17 studies
that recruited patients beginning in the immediate post-discharge
period (Table 2a-3a.).8,14-16,18,30-32,34,35,37-39,41-46,48-62,64-66 In
34 of 37 studies there were a total of 2,054 readmissions in
3,147 patients in the intervention group and 2,589 readmissions
in 3,134 patients in the usual care group. Followup duration
of these studies ranged from 3 months to 16 months. The remaining
three studies reported data on the number of readmissions per
patient,15 on
the mean difference of readmissions57 or
on readmissions per patient.60
Thirty studies provided quantitative data on the number of
readmitted patients in the intervention and control group.8,14,16,17,30-33,36,37,39-42,44-50,52,54-57,59,60,62,65 These
studies were categorized according to the type of primary interventions
reported in each individual study and combined in meta-analyses.
The interventions in these studies included: only telephone
followup (13 studies),14,31,39,40,42,45,46,48,50,54,57,59,62 increased
visits to a cardiology clinic (5 studies),30,33,37,55,56 home
visits (4 studies),17,36,49,52 home
visits and increased clinic visits (1 study),65 home
telemonitoring (1 study),16 multidisciplinary
care (4 studies),8,32,44,47 self-care
instruction only by a care provider or through software (2
studies).41,60
Effectiveness of interventions to support post-discharge
care compared with the usual care to prevent readmission:
Only Telephone support
Thirteen studies that included a total of 2,167 HF patients
utilized only telephone support intervention, compared to usual
care, and reported readmissions.14,31,39,40,42,45,46,48,50,54,57,59,62 One
study that reported no readmission events in both arms was
excluded from this meta-analysis.31 Twelve
studies were combined in a meta-analysis (Figure
2).14,39,40,42,45,46,48,50,54,57,59,62 Nine
studies were conducted in the US,14,31,39,46,48,50,54,59,62 and
the remaining four studies were conducted in Europe.40,42,45,57 Only
two studies were graded poor quality;14,46 the
remaining studies were good to fair quality. Only one study
recruited patients whose mean age were 80 years.57 The
severity of HF varied among the studies. Two studies utilized
software assisted telephone followup by the study nurse or
a specialist nurse.14,62 Only
one study reported data on ACE-I titration over the telephone
followup.50
Our meta-analysis indicated a slight reduction in readmission
rates in the telephone followup group compared to the control
group, but this failed to reach statistical significance (Figure
2).
Clinic visits
Five studies that included a total of 1,155 HF patients reported
quantitative data on all cause readmissions among those who
had increased clinic visits to a HF or a specialty clinic.30,33,37,55,56 In
addition to increased clinic visits, all studies except one
utilized telephone followup as an intervention component. One
study was conducted in the US,37 and
the remaining studies were conducted in Canada and Europe.30,33,55,56 One
study was graded good quality,30 two
studies were graded fair quality,37,56 and
two studies were graded poor quality.33,55 Only
one study reported data on the care coordination during the
transition from inpatient setting to post-discharge followup.55 This
study reported no difference in readmissions between the increased
clinic visits group and the control group. The remaining four
studies reported reduced readmissions in the intervention group
compared with control group, although statistical significance
was reached in only two studies. Our meta-analysis identified
that the increased clinic visits group had a statistically
significant decreased risk for readmission compared with the
usual care group (overall RR 0.78; 95%CI 0.64 — 0.95),
with considerable between-study heterogeneity.
One poor quality multi-center study conducted in the UK combined
increased clinic visits with at least one home visit by the
study nurse and compared with the usual care group.65 This
study reported an almost 50 percent reduction in the readmissions
compared with the usual care group.
Home visits
Four studies that included a total of 633 HF patients compared
readmissions in the home visits intervention group with the
usual care group.17,36,49,52 Individually,
each of the four studies reported non-significant, lower rates
of readmission in the intervention groups. All four were single-center
studies conducted outside of the US. Three studies were graded
fair quality,17,49,52 and
one study was graded poor quality.36 The
meta-analysis of these studies showed a statistically significant
reduction in the readmissions in the intervention group compared
with the usual care group (pooled RR 0.82; 95%CI 0.69 — 0.97).
There was no significant between-study heterogeneity.
Home Telemonitor
Only one study of 426 HF patients evaluated readmissions in
the home telemonitor group compared with the usual care group,
and it reported no significant reduction in the readmissions
between the groups.16
Multidisciplinary care (MDC)
Four studies that included a total of 1,279 HF patients evaluated
readmissions in the multidisciplinary care group compared with
the usual care group.8,32,44,47 Three
studies were conducted in the US,8,44,47 and
one study was conducted in Italy.32 All
four studies were graded fair quality. All four studies noted
decreased readmissions with multidisciplinary care intervention,
but statistically significant results were noted in only two
studies.8,32 Two
studies followed patients for 3 months,32,44 and
the remaining two studies followed patient for 1-year. 8,47 The
combined estimate in our meta-analysis indicated statistically
significantly reduced readmissions in the multidisciplinary
care group compared with the usual care group (pooled RR 0.63;
95%CI 0.44 — 0.90). There was significant heterogeneity
between studies.
Self-care
Two studies that included a total of 438 HF patients evaluated
readmissions with interventions that included increased emphasis
on HF care compared with usual care.41,60 Increased
emphases on HF care were provided to patients either during
their regularly scheduled visits or through educational software.
Both studies were conducted in Sweden; one study was graded
fair and the other poor quality. The combined estimate for
reduction in readmissions was not significantly different between
the groups (pooled RR 0.97; 95%CI 0.83 — 1.14).
Key question 1a: What
is the relationship of the study and clinical parameters to
the outcome readmission?
When data were available, we analyzed the impact of characteristics
such as internal and external validity of the studies on readmission
rates. Factors considered for analyses included length of followup,
concurrent discharge planning in disease management programs,
place of delivery of discharge planning (inpatient, outpatient),
components of discharge planning and whether components were
individually tailored or generalized, intensity of discharge
planning, number and frequency of interventions, and patient
characteristics on the outcome of all cause readmissions (Table
1). Among these factors only intermediate- to long-term
followup (>6 month or >12 month versus <6 month),
interventions initiated in the inpatient setting, and the age
of the patient (>75 years) had a statistically significant
impact on all cause readmission.
Summary of evidence
- In the meta-analyses, interventions of home visits, increased
clinic visits, and multidisciplinary care along with a combination
of components of education reinforcement and telephone followup
reduced the risk of all cause readmission significantly compared
with the usual care group.
- The intermediate- to long-term (>6 month and >12
month) followup interventions initiated in the inpatient
setting, and the age of the patient (>75 years) had a
statistically significant impact on all cause readmission.
Figure 2. Meta-analyses of the effect of post-discharge
care interventions compared with the usual care on readmissions
Table 1. Meta-analyses by subgroups comparing interventions
for post-discharge care with the usual care in HF patients
Readmission risk intervention
vs. usual care |
Subgroups |
N studies |
Categories |
Relative risk(95% CI) |
I2 |
P value |
Country: USA |
11 |
Yes |
0.84 (0.74, 0.96) |
31.6% |
0.15 |
18 |
No |
0.85 (0.75, 0.96) |
60.2% |
0.001 |
Followup |
6 |
<6 mo |
0.86 (0.66, 1.11) |
49.9% |
0.08 |
12 |
>6 — <12 mo |
0.87 (0.78, 0.97) |
29.5% |
0.16 |
11 |
≥12 mo |
0.80 (0.67, 0.94) |
69.1% |
0.0 |
Center |
19 |
Single-center |
0.84 (0.74, 0.96) |
60.0% |
0.0 |
10 |
Multi-center |
0.84 (0.76, 0.94) |
25.2% |
0.21 |
Recruitment Setting |
19 |
Inpatient |
0.80 (0.71, 0.90) |
45.8% |
0.02 |
10 |
Outpatient |
0.92 (0.82, 1.03) |
46.9% |
0.05 |
Age |
2 |
<65 y |
0.45 (0.17, 1.22) |
83.7% |
0.01 |
15 |
65 y - <75 y |
0.90 (0.81, 1.0) |
49.6% |
0.02 |
12 |
≥75 y |
0.82 (0.73, 0.93) |
25.7% |
0.19 |
Quality |
2 |
Good (A) |
0.85 (0.59, 1.21) |
74.0% |
0.05 |
20 |
Fair (B) |
0.86 (0.77, 0.96) |
54.3% |
0.002 |
7 |
Poor (C) |
0.81 (0.68, 0.97) |
44.9% |
0.09 |
Severe HF |
20 |
Yes |
0.89 (0.81, 0.98) |
43.9% |
0.02 |
8 |
No |
0.76 (0.62, 0.94) |
59.0% |
0.02 |
1 |
ND |
0.68 (0.52, 0.90) |
NA |
NA |
Readmission outcome |
11 |
Primary outcome |
0.78 (0.67, 0.92) |
60.6% |
0.005 |
18 |
Combined endpoint |
0.88 (0.79, 0.98) |
44.5% |
0.022 |
Within each subgroup, categories that are statistically
significantly different appear in bold.
Interventions beginning
inpatient
Study characteristics
We identified 25 RCTs with a total of 4,795 patients; these
trials assessed the effectiveness of non-pharmacological interventions
for post-discharge care in HF patients that began in the inpatient
setting during an index hospitalization (Table
2.).8,15-17,30-50 The
majority of the trials compared interventions with usual care.8,15,16,30,32-34,36,39-45,47-50 One
trial compared 3 months intervention with an extended 6 months
intervention.40 One
study was a 3-arm trial that compared nurse telephone followup,
home telemonitor, and the usual care.16 Sixteen
trials included interventions led by nurses only.8,15-17,31,33,35-40,43,44,47,48 All
or most of the studies included interventions to educate patients
about HF symptoms and disease management. However, the studies
were unclear if the usual care group received educational information
on HF symptoms and disease management similar to the intervention
group. Only 10 of 25 studies emphasized exercise education
and educational reinforcement programs as part of the education
information on HF.17,31,32,37,39,40,43,45,46,50 All
or most of the studies utilized telephone followup as one of
the components in the intervention group. The main care provider
either followed patients actively at frequent intervals or
the provider was readily available to be contacted during business
hours. Additional interventions to follow HF patients included
home telemonitor (two studies), home visits (six studies),
increased clinic visits (four studies), and multidisciplinary
care (four studies). The description of usual care varied among
the studies (Appendix B). The
duration of interventions ranged from 1 week to 12 months.
The studies followed patients from 3 months to 16 months.
Sixteen studies were single-center, and nine studies were multi-center.
The studies mostly included patients with a mean age of 65
years and above. Eleven trials were conducted in the US,8,15,31,35,37-39,44,46-48 11
trials in European countries,16,30,32-34,36,40-43,45 two
trials in Canada,17,50 and
one in Australia.49 There
were three good (A),30,34,38 16
fair (B),8,15-17, 32, 37, 39,40,42-45,47-50 and
six poor (C) studies.31,33,35,36,41,46 The
six studies were graded poor (C) quality due to various methodological
reasons including lack of clear reporting of randomization
methods, lack of reporting on the number of patients who met
the eligibility criteria were enrolled and randomized, lack
of reporting of baseline data, and errors in reporting. Data
on available clinical outcomes included readmissions in 25
studies (Figure 3), mortality in 20 studies,15,16,30,32-47,49 length
of hospital stay in nine studies, cost incurred in 12 studies,
and QOL changes in 14 studies. Of the 25 included studies,
11 studies evaluated composite end point of mortality or readmissions
as the primary outcome.
Mortality
Twenty studies that began an intervention in the inpatient
setting during index hospitalization reported that mortality
rates in the intervention group ranged from 2 percent to 31
percent over the study duration of 3 to 16 months (Table
2a).15,16,30,32-47,49 The
mortality rates in the control or the usual care group ranged
from 1 percent to 49 percent over the study duration of 3 to
16 months. Only four studies reported statistically significant
decreased relative risk of mortality (0.16 to 0.62) in the
intervention group when compared with control group (Table
2a).15,30,32,42 These
studies were conducted in European countries and the US, recruited
more than 100 patients, and had a considerable heterogeneity
in the duration of followup, interventions utilized (active
telephone followup, increased clinic visits, and multidisciplinary
care) and care providers (nurses, pharmacists, and cardiologist)
(Figure 4). The intervention duration ranged
from 6 months to 1-year and the followup duration ranged from
6 months to 1.4 year.
An additional 10 studies reported statistically non-significant
decreased mortality rates in the intervention group compared
with control group (Figure 4).16,34,37-39,43,44,46,47,49 Data
with regard to intervention components were assessed across
all studies that reported a decrease in mortality. There was
no distinct combination of intervention components that were
associated with decreased rates of mortality except for one
intervention component — active telephone followup — which
was utilized along with increased clinic visits, home visits,
home telemonitoring or multidisciplinary care. Of note, across
studies there was considerable heterogeneity with regard to
individual components of intervention, duration of intervention,
length of followup, and description of usual care.
Six studies reported a statistically non-significant increased
relative risk of mortality (1.07 to 3.5) in the intervention
group when compared with control group.33,35,36,40,41,45 Five
of these six studies were conducted in single-centers; these
five studies utilized nurses as the main provider who could
be contacted by telephone when needed.33,35,36,40,45 Utilizing
educational software only as the intervention tool increased
the risk of mortality to almost four fold in the intervention
group compared with the control group.41
Length of stay during readmissions
Nine studies reported data on the length of stay as number
of days of stay in the hospital per patient in the intervention
group compared with the usual care group (Table
2a.).8,17,33,35,39,42,45,47,50 Only
three of nine studies reported statistically significant decreases
in the intervention group compared with the control group.33,47,50 In
these studies, the study quality ranged from fair (B) to poor
(C) quality, the recruitment was less than 100 to more than
200 patients, and the length of stay ranged from 3.9 to 6.4
days in the intervention group compared with 6.2 to 11.6 days
in the control group. The studies utilizing specialist nurses
led one or more of the following interventions: active telephone
followup, home visits, increased clinic visits, and multidisciplinary
care.
Quality of life
Fourteen studies provided data on patient-perceived health
status using one or more validated QOL instruments (e.g., MLHF,
SF-36) (Table 2a.).8,15,17,30,31,34-38,42,43,45,48 Although
the majority of studies reported improved scores in the intervention
group during followup compared with baseline scores, only three
of 14 studies reported statistically significantly improved
QOL scores in the intervention group compared with the control
group at followup.8,17,37 Two
studies were single-center, and one was multi-center. All recruited
less than 100 patients per group and received a fair (B) quality
grade. These three studies utilized one or more of nurse- or
multidisciplinary team-led interventions that included active
telephone followup, home visits, increased clinic visits, or
multidisciplinary care and 3 to 6 months of followup. There
was no discernible combination of intervention components when
studies reporting significant results were compared with those
reporting non-significant results.
Costs
Twelve studies reported quantitative data on the total costs
incurred in the intervention group compared with the control
group (Appendix C).8,30-34,37-39,43,44,49 Two
of 12 studies reported statistically significant lower total
costs in the intervention group compared with the usual care.38,44 Studies
were graded good (A) orfair (B), followed more than 200 patients
from 6 to 12 months, and were conducted in US. The studies
utilized one or more nurse-led interventions that included
home visits and multidisciplinary care, and education. The
remaining studies generally reported statistically non-significant
but lower total costs in the intervention group compared with
the usual care.8,30-34,37,39,43,49 There
was no distinct combination of intervention components that
was associated with decreased total costs.
Composite outcome of mortality or readmission
Ten studies reported data on the combined endpoint of mortality
or readmission. Eight of these reported this endpoint as their
primary outcome (Appendix C).30, 33-35,37,38,40,41,45,49 Six
studies of good (A)30,34,38 to
fair (B)37, 40,49 quality
reported statistically significant decreased rates for composite
outcome of mortality or readmission in the intervention group
compared with the control group. All six studies evaluated
composite endpoint as their primary outcome of interest. However
these six studies varied in the intervention evaluated, were
conducted in different countries (US, Europe, and Australia),
and randomized almost 50 to 200 patients per group. There was
no distinct combination of intervention components that was
associated with improved outcome.
Summary of evidence
- Almost three-quarters of the studies with interventions
beginning as inpatient were of good (A) to fair (B) methodological
quality and wide to moderate applicability to the population
of interest.
- The studies compared different combinations of intervention
components with usual care group.
- The majority of the studies utilized an education intervention
component and active telephone followup.
- Less than one-quarter of the studies utilized intervention
components that increase access to care providers. Most of
the studies utilized active telephone followup as one of
their components of intervention.
- Three-quarters of the studies reported data on mortality.
Studies were inadequately powered to ascertain meaningful
differences between the interventions and usual care groups
for mortality outcomes.
- Less than one-half of the studies reported data on length
of stay and quality of life. No studies reported on adverse
effects.
- There was considerable heterogeneity across studies with
regard to individual components of intervention, duration
of intervention, length of followup, and description of usual
care.
- Five of 20 studies that initiated interventions in the
inpatient setting noted statistically significantly decreased
risk of mortality in HF patients who had a broad array of
interventions (home visits, increased clinic visits, and
multidisciplinary care) compared with the usual care group.
All of these interventions utilized telephone followup as
one of their components of intervention.
- Interventions of home visits, increased clinic visits,
and multidisciplinary care also decreased length of stay,
and improved quality of life compared with usual care in
several studies.
Table 2. Study characteristics and intervention components
of randomized trials beginning inpatient in HF patients (part
1 of 2)
Study characteristics |
Education intervention components |
Author |
Year |
N |
Followup duration (mo) |
Intervention duration |
Education about HF |
Self management |
Weight monitoring |
Sodium restriction Diet advice |
Exercise motivation |
Medication review |
Education reinforcement |
Atienza |
200430 |
338 |
16 |
nd |
x |
x |
|
|
|
x |
|
Koelling |
200538 |
223 |
6 |
<1 wk |
x |
x |
x |
x |
|
|
|
DelSindaco |
200734 |
173 |
6 |
6 mo |
x |
|
|
|
|
x |
|
Cleland |
200516 |
426 |
8 |
7 mo |
|
|
x |
|
|
|
|
Laramee |
200339 |
287 |
3 |
3 mo |
x |
|
x |
x |
|
x |
x |
Rich |
19958 |
282 |
3 |
3 mo |
x |
|
x |
x |
|
x |
|
Goldberg |
200315 |
280 |
6 |
6 mo |
x |
x |
x |
x |
|
|
|
Tsuyuki |
200450 |
276 |
6 |
6 mo |
x |
x |
x |
x |
x |
x |
x |
Naylor |
200444 |
239 |
12 |
3 mo |
x |
x |
|
|
|
|
|
Capomolla |
200232 |
234 |
12 |
nd |
x |
x |
x |
x |
x |
|
|
Kasper |
200237 |
200 |
6 |
6 mo |
x |
|
|
x |
x |
x |
|
Nucifora |
200645 |
200 |
6 |
1 wk |
x |
x |
x |
x |
x |
|
|
Harrison |
200217 |
192 |
3 |
2 wk |
x |
x |
x |
x |
x |
|
|
Lopez |
200642 |
134 |
12 |
1 y |
x |
|
|
x |
|
x |
|
Ledwidge |
200540 |
130 |
3 |
3 mo |
x |
x |
x |
x |
|
x |
x |
Rich |
199347 |
98 |
3 |
3 mo |
x |
|
x |
x |
|
x |
|
McDonald |
200243 |
98 |
3 |
3 mo |
x |
|
x |
x |
|
x |
x |
Stewart |
199849 |
97 |
6 |
1 wk |
|
|
|
|
|
x |
|
Sethares |
200448 |
70 |
3 |
1 mo |
|
x |
|
|
|
|
|
Linne |
200641 |
230 |
6 |
2 wk |
x |
|
|
x |
|
x |
|
Cline |
199833 |
190 |
12 |
1 y |
x |
x |
x |
x |
|
x |
|
Jaarsma |
200036 |
179 |
9 |
nd |
x |
|
|
x |
|
|
|
Dunagan |
200535 |
151 |
12 |
2 wk |
|
x |
|
x |
|
x |
|
Rainville |
199946 |
34 |
12 |
>1 wk |
x |
x |
x |
|
|
x |
x |
Barth |
200131 |
34 |
3 |
3 mo |
x |
x |
x |
x |
|
x |
x |
Table 2. Study characteristics and intervention components
of randomized trials beginning inpatient in HF patients (part
2 of 2)
Study characteristics |
Increased access to providers
interventions |
Author |
Year |
Active telephone |
Telephone on demand |
Home telemonitor |
Home visits |
Increased clinic visits |
Multidisciplinary care |
Main Care Provider1 |
Quality |
Atienza |
200430 |
|
x |
|
|
x |
|
Cardiologist |
A |
Koelling |
200538 |
|
|
|
|
|
|
Nurse |
A |
DelSindaco |
200734 |
x |
|
|
|
x |
|
Cardiologist + Nurse |
A |
Cleland |
200516 |
x |
x |
x |
|
|
|
Nurse |
B |
Laramee |
200339 |
|
x |
|
|
|
|
Nurse |
B |
Rich |
19958 |
x |
|
|
x |
|
x |
Nurse (S) |
B |
Goldberg |
200315 |
|
|
x |
|
|
|
Nurse |
B |
Tsuyuki |
200450 |
x |
|
|
|
|
|
Research Coordinator |
B |
Naylor |
200444 |
|
|
|
x |
|
x |
Nurse (S) |
B |
Capomolla |
200232 |
x |
|
|
|
|
x |
MDC staff |
B |
Kasper |
200237 |
x |
|
|
|
x |
|
Nurse |
B |
Nucifora |
200645 |
|
x |
|
|
|
|
Nurse + Physician |
B |
Harrison |
200217 |
|
|
|
x |
|
|
Nurse |
B |
Lopez |
200642 |
x |
x |
|
|
|
|
Pharmacist |
B |
Ledwidge |
200540 |
|
x |
|
|
|
|
Nurse |
B |
Rich |
199347 |
x |
|
|
x |
|
x |
Nurse (S) |
B |
McDonald |
200243 |
x |
|
|
|
|
|
Nurse (S) |
B |
Stewart |
199849 |
|
|
|
x |
|
|
Nurse + Pharmacist |
B |
Sethares |
200448 |
x |
|
|
|
|
|
Nurse |
B |
Linne |
200641 |
|
|
|
|
|
|
Software |
C |
Cline |
199833 |
|
x |
|
|
x |
|
Nurse (S) |
C |
Jaarsma |
200036 |
|
x |
|
x |
|
|
Nurse |
C |
Dunagan |
200535 |
|
x |
|
|
|
|
Nurse |
C |
Rainville |
199946 |
x |
x |
|
|
|
|
Pharmacist |
C |
Barth |
200131 |
|
x |
|
|
|
|
Nurse |
C |
Mo, months of followup; N, Total number; Nurse (S), heart
failure specialist nurse; wk, week; y, year.
1. When specified nurse; these studies
were unclear to whether the nurse had any training in HF care.
Table 2a. Clinical outcomes in HF patients with interventions
beginning inpatient versus usual care (part 1 of
2)
Author |
Year |
Country |
Intervention |
N |
Results: Mortality |
Study y |
Duration (mo) |
%Event in Control |
RR (95% CI) |
Atienza |
200430 |
Spain |
1999-2000 |
16 |
338 |
29 |
0.62
(0.42, 0.93) |
Koelling |
200538 |
USA |
2001-2002 |
6 |
223 |
9 |
0.76
(0.30, 1.92) |
Del Sindacom |
200734 |
Italy |
2001-2002 |
6 |
173 |
37 |
0.85
(0.56, 1.30) |
Cleland |
200516 |
Europe |
2000-2002 |
8 |
426 |
24 |
0.73
(0.44, 1.22) |
Laramee |
200339 |
USA |
1999-2000 |
3 |
287 |
10 |
0.90
(0.44,1.82) |
Rich |
19958 |
USA |
1990-94 |
3 |
282 |
nd |
|
Goldberg |
200315 |
USA |
1998-2000 |
6 |
280 |
18 |
0.44
(0.22, 0.85) |
Tsuyuki |
200450 |
Canada |
1999-2000 |
6 |
276 |
nd |
|
Naylor |
200444 |
USA |
1997-2001 |
12 |
239 |
11 |
0.87
(0.41, 1.86) |
Capomolla |
200232 |
Italy |
1999-2000 |
12 |
234 |
17 |
0.16
(0.05, 0.51) |
Kasper |
200237 |
USA |
1996-1998 |
6 |
200 |
13 |
0.52
(0.22, 1.24) |
Nucifora |
200645 |
Italy |
1999-2001 |
6 |
200 |
8 |
1.79
(0.78, 4.07) |
Harrison |
200217 |
Canada |
1996-98 |
3 |
192 |
nd |
|
Lopez |
200642 |
Spain |
2000-2002 |
12 |
134 |
30 |
0.43
(0.21, 0.89) |
Ledwidge |
200540 |
Ireland |
nd |
3 |
130 |
21 |
1.25
(0.67, 2.35) |
Rich |
199347 |
USA |
1988-1989 |
3 |
98 |
49 |
0.43
(0.24, 0.77) |
Table 2a. Clinical outcomes in HF patients with interventions
beginning inpatient versus usual care (part 2 of
2)
Author |
Results: Readmission rate |
Results: LOS (d) |
Results: QOL |
Quality |
%Event in Control |
RR (95% CI) |
Mean diff (SE) |
Score |
Mean diff P-value |
Atienza |
58 |
0.71
(0.57, 0.89) |
|
|
|
A |
Koelling |
nd |
|
|
MLHF |
+3.0
ns |
A |
Del Sindacom |
nd |
|
|
MLHF |
nd
ns |
A |
Cleland |
47 |
0.95
(0.72, 1.26) |
|
|
|
B |
Laramee |
37 |
1.02
(0.74, 1.40) |
-0.9
(0.5) |
|
|
B |
Rich |
42 |
0.69
(0.50, 0.95) |
-36.6% |
HFQ+ |
+96%
.001 |
B |
Goldberg |
nd |
|
|
MLHF |
-4.5 |
B |
Tsuyuki |
28 |
0.95
(0.64, 1.39) |
-4.4
(0.9) |
|
|
B |
Naylor |
55 |
0.81
(0.63, 1.05) |
|
|
|
B |
Capomolla |
30 |
0.27
(0.13, 0.52) |
|
|
|
B |
Kasper |
36 |
0.71
(0.47, 1.09) |
|
MLHF |
-12.6
.001 |
B |
Nucifora |
43 |
1.14
(0.84, 1.54) |
-5
(2.8) |
MLHF |
+2.0
ns |
B |
Harrison |
31 |
0.74
(0.46, 1.19) |
-0.1
(1.2) |
MLHF |
-12.9
<.001 |
B |
Lopez |
48 |
0.68
(0.45, 1.03) |
-3.6
(2.9) |
|
|
B |
Ledwidge |
29 |
1.48
(0.93, 2.36) |
|
|
|
B |
Rich |
46 |
0.73
(0.44, 1.21) |
-1.4
(2.3) |
|
|
B |
CI, confidence interval; HFQ, Chronic Heart
Failure Questionnaire; Ctrl, control; d, days; diff, difference;
EQOL, Euroqol; Int, intervention; LOS, length of stay; mo,
month; MLHF, Minnesota Living with Heart Failure; m, mental
score; mo, months of followup; N, number; nd, not documented;
ns, not significant; p, physical score; QOL, quality of life;
RR, rate ratio; SE, standard error; wk, week; y, year; ↓ Lower
score indicates improved function; ↑ Higher score indicates
better function
Table 2b. Clinical
outcomes in HF patients with interventions beginning inpatient
versus usual care (part 1 of 2)
Author |
Year |
Country |
Intervention |
N |
Results: Mortality |
y |
Duration (mo) |
%Event in Control |
RR (95% CI) |
McDonald |
200243 |
UK |
1998-2000 |
3 |
98 |
6 |
0.92
(0.20, 4.34) |
Stewart |
199849 |
Australia |
nd |
6 |
97 |
10 |
0.20
(0.02, 1.62) |
Sethares |
200448 |
USA |
1999-2000 |
3 |
70 |
nd |
|
Linne |
200641 |
Sweden |
1998-2002 |
6 |
230 |
1 |
3.54
(0.4, 31.20) |
Cline |
199833 |
Sweden |
1991-1993 |
12 |
190 |
28 |
1.07
(0.68, 1.67) |
Jaarsma |
200036 |
Netherlands |
1994-1997 |
9 |
179 |
17 |
1.56
(0.88, 2.76) |
Dunagan |
200535 |
USA |
1999 |
12 |
151 |
15 |
1.17
(0.56, 2.44) |
Rainville |
199946 |
USA |
1996-1997 |
12 |
34 |
24 |
0.25
(0.03, 2.01) |
Barth |
200131 |
USA |
nd |
3 |
34 |
0 |
|
Table 2b. Clinical outcomes in HF patients with interventions
beginning inpatient versus usual care (part 2 of
2)
Author |
Year |
Results: Readmission rate |
Results: LOS (d) |
Results: QOL |
Quality |
%Event in Control |
RR (95% CI) |
Mean diff (SE) |
Score |
Mean diff P-value |
McDonald |
200243 |
nd |
|
|
nd |
-10.2
ns |
B |
Stewart |
199849 |
65 |
0.76
(0.53, 1.08) |
|
|
|
B |
Sethares |
200448 |
32 |
0.56
(0.24, 1.33) |
|
MLHF |
-4.70
ns |
B |
Linne |
200641 |
50 |
0.89
(0.67, 1.17) |
|
|
|
C |
Cline |
199833 |
39 |
0.70
(0.46, 1.08) |
-3.9
(nd) |
|
|
C |
Jaarsma |
200036 |
nd |
|
|
nd |
ns |
C |
Dunagan |
200535 |
nd |
|
-1.2
(nd) |
MLHFm
MLHFp |
-0.5 ns
-0.7 ns |
C |
Rainville |
199946 |
59 |
0.40
(0.16, 1.03) |
|
|
|
C |
Barth |
200131 |
0 |
|
|
|
nd
ns |
C |
CI, confidence interval; HFQ, Chronic Heart
Failure Questionnaire; Ctrl, control; d, days; diff, difference;
EQOL, Euroqol; Int, intervention; LOS, length of stay; mo,
month; MLHF, Minnesota Living with Heart Failure; m, mental
score; N, number; nd, not documented; ns, not significant;
p, physical score; QOL, quality of life; RR, rate ratio; SE,
standard error; wk, week; y, year; ↓ Lower score indicates
improved function; ↑ Higher score indicates better function
Figure 3. Forest plot of readmission risk, intervention
components sorted by study quality in interventions beginning
in the inpatient compared with the usual care group.
Ed, one or more of the educational component;
HTM, home telemonitor; MDC, multidisciplinary care; Active
Tel, active telephone followup; Tel cont, Telephone contact.
Figure 4. Forest plot of mortality risk and intervention
components sorted by study quality for interventions beginning
in the inpatient compared with the usual care group.
Ed, one or more of the educational component;
HTM, home telemonitor; MDC, multidisciplinary care; Active
Tel, active telephone followup; Tel cont, Telephone contact.
Interventions beginning
post-discharge
Study characteristics
We identified 18 RCTs with a total of 3,123 patients that
assessed the effectiveness of non-pharmacological interventions
for post-discharge care immediately after an index hospitalization
in HF patients (Table 3.).14,18,51-66 Patients
were recruited or consented to the trial during their index
hospitalization, but interventions began 1 to 3 weeks after
their discharge from the hospital. Sixteen trials compared
interventions versus usual care.14, 18,52-57,59-66 One
trial compared home visits intervention with a nurse telesupport
group.51 One
3-arm trial compared nurse telephone followup, home telecare,
and usual care.58 Twelve
trials included interventions led by nurses only.51-54,57-61,63-65 Interventions
included active telephone followup (eight studies); availability
of provider telephone contact (two studies); home telemonitoring
(two studies), multiple home visits (six studies), increased
clinic visits (two studies), and multidisciplinary care (one
study). The description of usual care varied among the studies.
The duration of interventions ranged from 2 weeks to 12 months.
The studies followed patients for 6 months to 12 months. In
general, a clinic visit for the patients in the intervention
group was scheduled at 2 to 3 weeks after discharge. In some
studies, the study nurse or pharmacist visited the patients'
home following their discharge to provide the first educational
intervention. Twelve studies were single-center, and six studies
were multi-center. The studies mostly included patients with
a mean age of 70 years and above. Six trials were conducted
in the US; nine trials were from European countries; one trial
was from Canada; and one each from Australia and New Zealand.
There were four good (A),18,62-64 seven
fair (B),51,52,54,56,57,59,60 and
seven poor (C) 14,53,55,58,61,65,66 studies.
The seven studies that were graded poor (C) quality had various
methodological deficiencies, including reporting errors and
a failure to clearly report randomization methods, eligibility
criteria, number enrolled and randomized, or baseline data.
Data on available clinical outcomes included mortality in
13 studies,18,52-54,56-60,63-66 readmissions
in 17 studies (Figure 5),14,18,51-62,64-66 length
of hospital stay in 10 studies,14,51,52,57-60,62,64,66 QOL
changes in nine studies,18,51,56,60-63,65,66 and
cost incurred in seven studies. Of the 18 included studies,
five studies evaluated composite end point of mortality or
readmissions as the primary outcome.55,59,63-65
Mortality
Thirteen studies that began an intervention in the 1 to 3
week period after discharge from an index hospitalization reported
mortality rates in the intervention group ranged from 1 percent
to 40 percent (Table 3a.).18,52-54,56-60,63-66 The
mortality rates in the control or the usual care group ranged
from 0 percent to 37 percent over the study duration of 3 to
16 months. Only one study reported statistically significant
decreased relative risk of mortality (0.36), and the remainder
of the studies reported non-significant decreased risk in the
intervention group when compared with usual care group.52,64 This
study was conducted in Europe, recruited less than 100 patients
per group, had 1-year of followup, utilized increased clinic
visits during their followup, and was graded good (A) quality.
The study also utilized nurse-led interventions and reported
the primary endpoint as the composite clinical outcome of mortality
or readmission.
Two studies reported statistically non-significantly increased
relative risk of mortality (1.20, 1.21) in the intervention
group when compared with usual care group.18,60 Of
note, these two studies utilized only educational interventions
and medication review, and did not utilize interventions of
increased access to providers (Figure 6).
Length of stay during readmission
Nine studies reported data on the length of stay during readmission
as the number of days of stay in the hospital per patient in
the intervention group compared with the usual care group (Table
3a.).14,52,57-60,62,64,66 The
tenth study compared nurse telemanagement with home visits
and provided data on the total number of hospitalization days.51
Only three studies reported statistically significant decreases
in the length of stay in the intervention group compared with
the control group.51,64,66 A
good (A) quality study from Sweden with 106 patients reported
a significant decrease in the length of stay per patient in
the intervention group compared with the usual care group (1.4
versus 3.9 days) during a 1-year followup.64 The
patients in the intervention group had the nurse-led education
along with increased clinic visits during followup. A fair
(B) quality study by Benatar that compared nurse telemanagement
with home visits reported a significant decrease in the total
number of hospitalization days in the nurse telemanagement
group during 1-year followup.51 The
third study, graded as poor (C) quality, utilized home visits
by study nurses along with multidisciplinary care intervention
and reported a significant decrease in the length of stay per
patient (9.3 versus 12.5 days) compared with the usual care
group.66 The
three studies utilized different interventions to increase
access to care providers, and there was no distinct combination
of intervention components that was associated with improved
outcomes.
Quality of life
Nine studies provided data on the patient-perceived health
status using one or more validated QOL instruments — MLHF,
SF-36, and Nottingham health profile (Table
3a.).18,51,56,60-63,65,66 Two
single-center studies reported significantly improved QOL scores
in the intervention group at followup.56,61 One
study was graded fair (B) and the other poor (C) quality. Both
studies utilized nurse or multidisciplinary team-led education
with medication review for compliance, and followed patients
for 6 months. In the intervention group, Ducharme reported
significantly improved self assessed scores of MLHF from baseline,56 while
Morcillo reported significantly higher on the physical and
mental health SF-36 scale from baseline.61 For
comparisons between the intervention and usual care group there
were no differences between those two groups.
Costs
Seven studies reported data on the total costs incurred in
the intervention group compared with the control group (Appendix
C).14,51,58,59,61-63 Two
studies that utilized active telephone followup or education
only in the intervention reported statistically significant
lower total costs compared with the usual care.59,61 One
study was graded fair (B) and the other poor (C) quality; they
followed less than 100 patients for 6 to 12 month, and was
conducted in US and Spain. Two other studies that evaluated
home visits reported higher total costs in the intervention
group, but were not statistically significant compared with
usual care or nurse telemanagement.51,58 The
remainder of the studies reported lower costs but were not
statistically significant in the intervention group compared
with the control group.14,62,63
Composite outcome of mortality or readmission
Five studies reported the combined endpoint of mortality or
readmission as their primary endpoint (Appendix
C).55,59,63-65 Three
studies of good (A) or fair (B) quality reported statistically
significant decreased risk for composite outcome of mortality
or readmission. All three studies varied in the intervention
evaluated, were conducted in different countries (US, Europe,
and Australia) and randomized less than 100 to 200 patients
in each. Across studies, there was no distinct combination
of intervention components that was associated with improved
outcomes.
Summary of evidence
- Almost two-thirds of the studies with interventions beginning
post-discharge were of good (A) or fair (B) methodological
quality and wide to moderate applicability to the population
of interest.
- The studies compared different combinations of intervention
components with usual care.
- The majority of the studies utilized educational intervention
components and active telephone followup.
- Less than one-quarter of the studies utilized intervention
components that increased access to care providers. Telephone
followup was either used alone or in combination with other
interventions in most of the studies.
- Across studies there was considerable heterogeneity with
regard to individual components of intervention, duration
of intervention, length of followup, and description of usual
care.
- In only one study, increased clinic visits along with telephone
support that was initiated after an index hospitalization
statistically significantly reduced mortality in the intervention
group compared with usual care group.
Table 3. Study characteristics and intervention components
of randomized trials beginning post-discharge in HF patients (part
1 of 2)
Study characteristics |
|
|
|
Education components |
Author |
Year |
N |
Followup duration (mo) |
Intervention duration |
Education about HF |
Self management |
Weight monitoring |
Sodium restriction / diet advice |
Exercise motivation |
Medication review |
Education reinforcement |
Holland |
200718 |
293 |
6 |
8 wk |
x |
|
x |
x |
x |
x |
x |
Stewart |
199963 |
200 |
6 |
2 wk |
x |
x |
x |
x |
x |
x |
|
Riegel |
200662 |
134 |
6 |
6 mo |
x |
x |
|
x |
|
x |
|
Stromberg |
200364 |
106 |
12 |
1 y |
x |
x |
x |
x |
|
|
|
DeBusk |
200454 |
262 |
12 |
1 y |
x |
x |
|
x |
x |
x |
x |
Ducharme |
200556 |
230 |
6 |
6 mo |
x |
|
|
x |
|
x |
|
Benatar |
200351 |
216 |
12 |
3 mo |
x |
|
|
|
|
x |
|
Mejhert |
200460 |
208 |
18 |
nd |
x |
x |
x |
x |
|
x |
|
Blue |
200152 |
165 |
12 |
1 y |
x |
x |
|
x |
x |
|
|
Ekman |
199857 |
160 |
6 |
6 mo |
x |
x |
x |
|
|
x |
|
Krumholz |
200259 |
88 |
12 |
1 y |
x |
x |
|
|
|
|
x |
Riegel |
200214 |
358 |
ND |
6 mo |
x |
x |
|
x |
|
x |
|
Doughty |
200255 |
197 |
12 |
1 y |
x |
x |
x |
x |
x |
x |
|
Wierzchowiecki |
200666 |
160 |
12 |
1 y |
x |
x |
x |
|
|
x |
|
Capomolla |
200453 |
133 |
12 |
1 y |
x |
x |
|
x |
|
|
|
Thompson |
200565 |
106 |
6 |
6 mo |
x |
|
|
|
|
|
|
Morcillo |
200561 |
70 |
6 |
6 mo |
x |
x |
x |
x |
|
x |
|
Jerant |
200158 |
37 |
6 |
6 mo |
x |
x |
x |
x |
|
x |
|
Table 3. Study characteristics and intervention components
of randomized trials beginning post-discharge in HF patients (part
2 of 2)
Study characteristics |
Increased access to providers |
Author |
Year |
Active telephone |
Telephone on demand |
Home telemonitor |
Home visits |
Increased clinic visits |
Multidisciplinary care |
Main Care Provider1 |
Quality |
Holland |
200718 |
|
|
|
|
|
|
Pharmacist |
A |
Stewart |
199963 |
|
|
|
x |
|
|
Nurse |
A |
Riegel |
200662 |
x |
|
|
|
|
|
Software + Nurse |
A |
Stromberg |
200364 |
|
|
|
|
x |
|
Nurse |
A |
DeBusk |
200454 |
x |
|
|
|
|
|
Nurse |
B |
Ducharme |
200556 |
x |
|
|
|
x |
|
Nurse+Cardiologist |
B |
Benatar |
200351 |
|
|
|
x |
|
|
Nurse |
B |
Mejhert |
200460 |
|
|
|
|
|
|
Nurse |
B |
Blue |
200152 |
|
|
|
x |
|
|
Nurse (S) |
B |
Ekman |
199857 |
|
x |
|
|
|
|
Nurse (S) |
B |
Krumholz |
200259 |
x |
|
|
|
|
|
Nurse (S) |
B |
Riegel |
200214 |
x |
|
|
|
|
|
Software + Nurse |
C |
Doughty |
200255 |
|
|
|
|
x |
|
GP+Nurse |
C |
Wierzchowiecki |
200666 |
x |
|
|
x |
|
x |
MDC staff |
C |
Capomolla |
200453 |
x |
x |
x |
|
|
|
Nurse |
C |
Thompson |
200565 |
|
|
|
x |
x |
|
Nurse (S) |
C |
Morcillo |
200561 |
|
|
|
|
|
|
Nurse |
C |
Jerant |
200158 |
x |
|
x |
x |
|
|
Nurse |
C |
Mo, Months ; N, Total number; Nurse (S), heart
failure specialist nurse; wk, week; y, year.
1. When specified nurse; these
studies were unclear to whether the nurse had any training
in HF care.
Table 3a. Clinical outcomes in HF patients with interventions
beginning after discharge versus usual care (part
1 of 2)
|
Intervention |
Mortality |
Author |
Year |
Country |
y |
Duration (mo) |
N |
%Event in Control |
RR (95% CI) |
Holland |
200718 |
UK |
2003-2005 |
6 |
293 |
17 |
1.21
(0.74, 1.96) |
Stewart |
199963 |
Australia |
1997-1998 |
6 |
200 |
28 |
0.64
(0.38, 1.09) |
Riegel |
200662 |
USA |
2002-2004 |
6 |
134 |
nd |
|
Stromberg |
200364 |
Sweden |
1997-1999 |
12 |
106 |
37 |
0.36
(0.17, 0.79) |
DeBusk |
200454 |
USA |
1998-2000 |
12 |
262 |
12 |
0.74
(0.44, 1.26) |
Ducharme |
200556 |
Canada |
1998-2000 |
6 |
230 |
17 |
0.63
(0.32, 1.24) |
Benatar |
200351 |
USA |
1997-2000 |
12 |
216 |
nd |
|
Mejhert |
200460 |
Sweden |
1996-1999 |
18 |
208 |
32 |
1.2
(0.83, 1.73) |
Blue |
200152 |
UK |
1997-1998 |
12 |
165 |
7 |
0.16
(0.02, 1.31) |
Ekman |
199857 |
Sweden |
1994-1996 |
6 |
160 |
28 |
0.96
(0.57, 1.59) |
Krumholz |
200259 |
USA |
1997-1998 |
12 |
88 |
30 |
0.69
(0.33, 1.45) |
Riegel |
200214 |
USA |
nd |
6 |
358 |
nd |
|
Doughty |
200255 |
NZ |
1997-1998 |
12 |
197 |
nd |
|
Wierzchowiecki |
200666 |
Poland |
nd |
12 |
160 |
5 |
0.75
(0.17, 3.24) |
Capomolla |
200453 |
Italy |
2000-2001 |
12 |
133 |
11 |
0.7
(0.24, 2.11) |
Thompson |
200565 |
UK |
nd |
6 |
106 |
15 |
0.59
(0.20, 1.74) |
Morcillo |
200561 |
Spain |
2001-2002 |
6 |
70 |
nd |
|
Jerant |
200158 |
USA |
1999-2000 |
6 |
37 |
0 |
5% in home telecare |
Table 3a. Clinical outcomes in HF patients with interventions
beginning after discharge versus usual care (part
2 of 2)
|
Results Readmission rate |
LOS (d) |
QOL |
Author |
Year |
Country |
%Event in Control |
RR (95% CI) |
Mean diff (SE) |
Score |
Mean diff P-value |
Quality |
Holland |
200718 |
UK |
nd |
|
|
MLHF |
+3.40
ns |
A |
Stewart |
199963 |
Australia |
nd |
|
|
|
|
A |
Riegel |
200662 |
USA |
57 |
1.03
(0.77, 1.37) |
+1.1
(1.6) |
|
|
A |
Stromberg |
200364 |
Sweden |
nd |
|
-2.5
(nd) |
|
|
A |
DeBusk |
200454 |
USA |
50 |
1.02
(0.85, 1.22) |
|
|
|
B |
Ducharme |
200556 |
Canada |
57 |
0.68
(0.52, 0.90) |
|
MLHF |
nd
ns |
B |
Benatar |
200351 |
USA |
12 |
1.85
(0.99, 3.43) |
|
MLHF |
+6.83
ns |
B |
Mejhert |
200460 |
Sweden |
66 |
1.02
(0.84, 1.24) |
-0.4
(nd) |
NHP |
-8.0
ns |
B |
Blue |
200152 |
UK |
60 |
0.93
(0.71, 1.20) |
-6.4
(3.4) |
|
|
B |
Ekman |
199857 |
Sweden |
57 |
1.07
(0.82, 1.39) |
-8
(4.1) |
|
|
B |
Krumholz |
200259 |
USA |
48 |
0.57
(0.32, 1.01) |
-5
(3.7) |
|
|
B |
Riegel |
200214 |
USA |
50 |
0.86
(0.68, 1.09) |
-1.3
(0.8) |
|
|
C |
Doughty |
200255 |
NZ |
61 |
1.05
(0.85, 1.31) |
|
|
|
C |
Wierzchowiecki |
200666 |
Poland |
nd |
|
-3.2 |
MLHF |
-15
ns |
C |
Capomolla |
200453 |
Italy |
nd |
|
|
|
|
C |
Thompson |
200565 |
UK |
44 |
0.51
(0.29, 0.91) |
|
MLHF |
+1.20
ns |
C |
Morcillo |
200561 |
Spain |
nd |
|
|
SF36+ |
+14.2
ns |
C |
Jerant |
200158 |
USA |
nd |
|
-5.2
(5.3) |
|
|
C |
CI, confidence interval; HFQ, Chronic Heart
Failure Questionnaire; Ctrl, control; d, days; diff, difference;
Int, intervention; LOS, length of stay; mo, month; MLHF, Minnesota
Living with Heart Failure; m, mental score; mo, Months; N,
number; nd, not documented; NHP, Nottingham health profile;
ns, not significant; p, physical score; QOL, quality of life;
RR, rate ratio; SE, standard error; SF, Short form; wk, week;
y, year; ↓ Lower score indicates improved function; ↑ Higher
score indicates better function.
Figure 5. Forest plot of readmission risk, intervention
components sorted by subgroup of study quality in interventions
after discharge compared with the usual care group.
Ed, one or more of the educational component;
HTM, home telemonitor; MDC, multidisciplinary care; Active
Tel, active telephone followup; Tel cont, Telephone contact;
* Home visits versus nurse telesupport.
Figure 6. Forest plot of mortality risk and intervention
components sorted by study quality in interventions after
discharge compared with the usual care group.
Ed, one or more of the educational component;
HTM, home telemonitor; MDC, multidisciplinary care; Active
Tel, active telephone followup; Tel cont, Telephone contact.
Interventions in the outpatient
clinics
We identified six RCTs with a total of 2,654 patients that
assessed the effectiveness of interventions among HF patients
in the outpatient clinics (Table 4.).13,67-71 Patients
were recruited during their visits to the outpatient clinics,
including specialist HF clinics, registered in the national
multi-center HF registry, general medicine or geriatric clinics,
and academic primary care group practice. In addition, a proportion
of patients were recruited from their inpatient setting in
two trials.67,71 Five
trials compared interventions versus usual care.67-71 One
trial also utilized some components from the usual care in
the intervention group.13 Four
trials included interventions led by a pharmacist,67-69,71 and
two trials were led by nurses.13,70 Five
studies included interventions to educate patients about HF
symptoms and disease management,13,68-71 and
one study utilized only medication review as an intervention.67 The
studies also evaluated interventions that included education
about diet and sodium restriction, self-care behaviors, exercise,
and daily weight monitoring. Three studies emphasized interventions
on active telephone followup. The studies did not utilize additional
interventions to followup HF patients that included home telemonitor,
multiple home visits, increased clinic visits, and multidisciplinary
care. The description of usual care varied among the studies.
The durations of interventions ranged from 6 to 12 months in
four studies and were not documented in two studies.
The studies followed patients from 6 to 16 months. The patients
in the intervention group had their followup in a clinic managed
by a nurse under the supervision of a cardiologist or a physician
or in outpatient pharmacies. The primary care physicians and/or
physician assistant or nurse practitioner managed the patients
in the usual care group. Two studies were single-center, and
four were multi-center. The studies mostly included patients
with a mean age of 60 years and above. Three trials were conducted
in the US, two trials in European countries, and one trial
in Argentina. There were three good (A),13,68,70 two
fair (B),67,69 and
one poor (C)71 quality
studies. The poor quality study had errors in reporting, and
lacked clear reporting of randomization methods and baseline
data.
The severity of HF, LVEF and distribution of NYHA class among
included patients varied across studies. All studies restricted
the recruitment of patients to those who were ambulant. The
most commonly reported etiology of HF and/or coexisting medical
disease was ischemic heart disease.
Data on available clinical outcomes included mortality in
five studies,13,67,68,70,71 number
of readmissions in four studies,67,69-71 cost
incurred in one study, QOL changes in four studies,13,67,70,71 and
composite end point of mortality or readmissions in two studies.13,67 No
study reported length of hospital stay during readmissions.
Mortality
Five studies that began an intervention in the outpatient
clinics reported mortality rates in the intervention group
ranging from 3 percent to 17 percent (Table 4a.).13,67,68,70,71 The
mortality rates in the control or the usual care group ranged
from 5 percent to 21 percent over the study duration. The studies
reported a non-significantly decreased relative risk of mortality
in the intervention group when compared with usual care group
(Figure 7).
Readmissions
Four studies reported data on the number of all cause readmissions
that included the number of all cause readmissions and/or patients
readmitted (i.e., with at least one readmission) (Table
4a.).67,69-71 Three
studies that followed patients for 6 months to 1-year reported
a total of 189 readmissions in 319 patients in the intervention
group, compared with 249 readmissions in 322 patients in the
usual care group.67,70,71 One
other study reported data on mean readmissions per patient.69 Only
one study reported a significantly decreased number of readmissions
in the intervention group compared with the usual care group.71 This
single-center study was conducted in Ireland, recruited less
than 50 patients per group, had 1-year of followup, and was
graded poor (C) quality. A pharmacist led the followup interventions
in this study that emphasized disease symptoms and management,
self-care behaviors, weight monitoring, and medication review.71
Two studies reported non-significantly decreased rates of
readmitted patients in the intervention group (31 percent and
34 percent) compared with usual care group (36 percent and
39 percent) (Figure 8).13,70
Quality of life
Four studies provided data on the patient perceived health
status using one or more validated QOL instruments — MLHF
and SF-36 (Table 4a.).13,67,70,71 Two
of the four studies reported significantly improved QOL scores
in the intervention group at followup.13,70 Both
were multi-center studies, graded good (A) quality, utilized
nurse education with active telephone followup, and followed
patients for 1 to 1.4 years. Both studies reported statistically
significantly improved QOL in the intervention group compared
with the usual care group. Sisk reported significantly improved
self-assessed scores of MLHF (38.6 versus 47.3, P<0.05),
and higher SF-12 physical scores (39.9 versus 36.3, P<0.05).70 The
DIAL trial reported significantly improved scores of MLHF during
followup in the intervention group compared with the usual
care group (30.6 versus 35, P=0.001).13
Costs
One study reported quantitative data on the total costs incurred
in the intervention group compared with the control group (Appendix
C).69 This
pharmacist-led medication review intervention study reported
lower total costs in the intervention group (—$2960 per
patient) compared with the usual care.69 The
multi-center study conducted in the US was graded fair (B)
quality and followed more than 300 patients for up to 1-year.
Composite outcome of mortality or readmission
Two studies reported data on the combined endpoint of mortality
or readmission (Appendix C).13,67 Of
these, the DIAL trial reported combined endpoint of mortality
or readmission as their primary outcome and noted statistically
significantly decreased relative risk in the intervention group
compared with the usual care group. The trial was conducted
in Argentina and randomized 1,518 outpatients with stable HF
to an active telephone followup or usual care. The study reported
a significant relative risk reduction of 20% (95% confidence
interval 3 to 34).13
Summary of evidence
- A limited number of studies evaluated interventions beginning
in the outpatient clinics.
- Studies compared different combinations of intervention
components with usual care.
- The majority of the studies utilized a pharmacist-led intervention
that mostly included medication review.
- Across studies, there was considerable heterogeneity with
regard to individual components of intervention, duration
of intervention.
- The data does not support any firm conclusions with regard
to superiority of any particular intervention strategy.
Table 4. Study characteristics and interventions components
beginning in the outpatient clinics among HF patients (part
1 of 2)
Study characteristics |
|
|
|
Education components |
Author |
Year |
N |
Intervention duration |
Education about HF |
Self management |
Weight monitoring |
Sodium restriction / diet advice |
Exercise motivation |
Medication review |
Education reinforcement |
Active telephone |
GESICA |
200513 |
1518 |
nd |
x |
x |
x |
x |
x |
x |
|
x |
Sisk |
200670 |
406 |
12 |
x |
x |
x |
x |
x |
|
|
x |
Gattis |
199968 |
181 |
6 |
x |
|
|
|
|
x |
|
x |
Murray |
200769 |
314 |
9 |
x |
|
|
|
|
x |
|
|
Bouvy |
200367 |
152 |
6 |
|
|
|
|
|
x |
|
|
Varma |
199971 |
83 |
nd |
x |
x |
x |
|
|
x |
|
|
Table 4. Study characteristics and interventions components
beginning in the outpatient clinics among HF patients (part
2 of 2)
Study characteristics |
Increased access to providers |
Author |
Year |
Telephone on demand |
Home telemonitor |
Home visits |
Increased clinic visits |
Multidisciplinary care |
Main Care Provider |
Quality |
GESICA |
200513 |
|
|
|
|
|
Nurse |
A |
Sisk |
200670 |
|
|
|
|
|
Nurse |
A |
Gattis |
199968 |
|
|
|
|
|
Pharmacist |
A |
Murray |
200769 |
|
|
|
|
|
Pharmacist |
B |
Bouvy |
200367 |
|
|
|
|
|
Pharmacist |
B |
Varma |
199971 |
|
|
|
|
|
Pharmacist |
C |
N, Total number of patients
Table 4a. Clinical outcomes in HF patients with interventions
beginning in the outpatient clinics versus usual care
|
Intervention |
Mortality |
Results Readmission rate |
LOS (d) |
QOL |
Author |
Year |
Country |
Study y |
Followup Duration (mo) |
N |
%Control group |
RR (95% CI) |
%Control group |
RR (95% CI) |
Mean diff (SE) |
Score |
Mean diff P-value |
Quality |
GESICA |
200513 |
1518 |
2000-01 |
16 |
1518 |
16 |
0.95
(0.75, 1.20) |
39 |
0.88
(0.77, 1.0) |
nd |
MLHF |
-4.4
0.001 |
A |
Sisk |
200670 |
406 |
2000-02 |
12
6 |
406 |
13 |
0.89
(0.52, 1.50) |
37 |
0.84
(0.64, 1.10) |
nd |
MLHF |
-8.7
<.05 |
A |
SF12p |
+3.2
<.05 |
Gattis |
199968 |
181 |
1996-97 |
12 |
181 |
5 |
0.61
(0.15, 2.46) |
nd |
|
nd |
|
|
A |
Murray |
200769 |
314 |
2001-04 |
6 |
314 |
nd |
|
nd |
|
nd |
|
|
B |
Bouvy |
200367 |
152 |
1998-00 |
12 |
152 |
21 |
0.66
(0.32, 1.36) |
nd |
|
nd |
|
+6.8
ns |
B |
Varma |
199971 |
83 |
nd |
16 |
83 |
17 |
0.98
(0.38, 2.54) |
nd |
|
nd |
MLHF |
-3.0
ns |
C |
CI, confidence interval; Ctrl, control; d, days;
diff, difference; Int, intervention; LOS, length of stay; mo,
month; MLHF, Minnesota Living with Heart Failure; m, mental
score; N, number; nd, not documented; ns, not significant;
p, physical score; QOL, quality of life; RR, rate ratio; SE,
standard error; SF, Short form; wk, week; y, year; ↓ Lower
score indicates improved function; ↑ Higher score indicates
better function
Figure 7. Forest plot of the mortality risk in studies
with interventions in outpatient clinics compared with the
usual care group.
Ed, one or more of the education component;
Active Tel, Active telephone followup; y, year
Figure 8. Forest plot of readmission risk in studies
with interventions in outpatient clinics compared with the
usual care group.
Review of recent published
systematic review
At least seven systematic reviews and/or meta-analyses have
been published since 2004 that reported comprehensive data
relevant to the present review.12,20-25 Because
of the span of publication years and variations in the eligibility
criteria, the number of studies included in each systematic
review ranged from 16 studies involving 1,627 patients (Taylor
200512), to 30
studies involving 8,158 patients (Holland 200522).
In majority of these systematic reviews, with the exception
of Gonseth 200421 and
Roccaforte 2005,25 the
results were stratified according to either the intervention
type or categories of organizational type of post-discharge
support.
McAlister 2004 found that the strategies that incorporated
followup by a specialized multidisciplinary team (either in
a clinic or non-clinic setting) reduced mortality, HF hospitalizations,
and all-cause hospitalizations.23 Interventions
that focused on enhancing self-care activities reduced hospitalizations
but had no effect on mortality. Telephone followup that advised
patients to seek care by their primary care physician in the
event of deterioration reduced hospitalization for HF but did
not reduce mortality.
Gonseth 2004 reported that strategies within disease management
programs, regardless of the type of organizational delivery,
whether they were home-based or clinic-based, reduced readmissions
for HF and all cause readmissions.21 This
review included both randomized and non-randomized studies
and reported that the disease management programs also reduced
the frequency of the combined endpoint of re-admission or death
among HF patients.
Phillips 2004 studied only strategies with comprehensive discharge
planning that included post-discharge support.24 Each
type of support resulted in significantly fewer readmissions
except for the strategy of increased clinic visits and frequent
telephone contact. However, overall, Phillips found that such
strategies for older patients with HF resulted in 25% relative
reduction in the risk of readmission, a trend toward 12% relative
reduction in all-cause mortality and for a smaller subset of
studies, improvement in QOL scores, and no increase in the
cost of medical care. In a later meta-regression analysis,
Philips 2005 found that "complex programs" that included
hospital discharge planning and no delay in post-discharge
clinical followup showed a trend toward 70% reduction in risk
for first readmission, two fewer days utilized per patient
per readmission, and a 70% reduction in risk of HF readmission
compared to usual care.11 Less
complex programs without hospital discharge planning resulted
in less than half the effect in reduction of risk of HF readmission.
A Cochrane systematic review published in 2005 (Taylor 2005)
concluded that there was weak evidence that case management
interventions are associated with a reduction in admissions
for HF, and that it was unclear which components of case management
interventions are effective.12
In another systematic review published in 2005, Roccaforte
reported that mortality and all-cause and HF-related hospitalizations
were significantly reduced by interventions to manage HF.25 This
review found that high quality studies and programs lasting
3 to 6 months were those most consistently associated with
a significant reduction in all outcomes considered. However,
a subsequently published RCT, which compared interventions
for 3 month with extended 6 month, found no measured clinical
advantage in terms of death and/or HF readmission in extending
a structured hospital-based disease management program beyond
3 months of discharge.40
In a systematic review on remote telemonitoring programs for
HF patients, Clark 2007 found that remote monitoring programs
for patients with HF reduced admissions to the hospital and
all cause mortality by nearly 20 percent while improving health-related
quality of life, but had no significant effect on all cause
admission to the hospital. Clark 2007 determined that telemonitoring
may be more effective at shortening hospital stay than in reducing
admissions, since it is likely to produce false alarms and
preemptive admissions in patients who are deteriorating but
not yet in crisis.20 Moreover,
telemonitoring may also lead to early discharge because the
patient has a high level of monitoring at home. Clark builds
on earlier systematic reviews by McAlister 2004 and Phillips
2004 on multidisciplinary interventions by examining uncertainties
relating to the specific effect of telephone-based programs.
The systematic review by Holland 2005 aimed to determine the
impact of select intervention components delivered at specific
sites on the outcomes.22 The
investigators were interested in the relative merits of the
site of care, whether the care was delivered in the home (home
visits), by telemonitoring, by telephone, in the clinic, or
in the primary care physician's office. Meta-analysis showed
a significant reduction in all cause readmission, though significant
heterogeneity was present. Subgroup analysis showed that home
visits reduced all cause readmission to the hospital, but specialty
clinic-based interventions had no effect on readmission. Meta-analysis
showed a significant reduction in HF readmission, which was
notable and similar for home- and telephone-type interventions.
Meta-analysis also showed a significant decrease in all cause
mortality, especially in the telemonitoring and telephone followup
interventions.