Table
of Contents
Methods
This report is based on a systematic review of the literature
on non-pharmacological interventions for post-discharge care
that are currently in use. The approach and criteria used in
this technology assessment were agreed upon by consensus of
the EPC, CMS, and AHRQ. Several published systematic reviews
on this topic indicate that a large number of randomized controlled
trials (RCTs) are available. Therefore, we focus only on RCTs
in this report.
Search Strategy
We searched Medline, Medline In-Process & Other Non-Indexed
Citations, the Cochrane Library, CINHAL, and Ovid HealthStar
from 1990 through July 2007 to identify articles relevant to
the key question. We limited the start date of the search to
1990; the time point associated with rapid advances in the
medical management of HF, and changing healthcare needs of
patients and changes in practice patterns. We reviewed reference
lists of published systematic reviews on the same topic, selected
narrative reviews, and retrieved primary articles for potentially
relevant articles. We also searched ClinicalTrials.gov for
registered but not yet published studies and contacted authors
of these trials. We combined search terms for discharge plan,
case management, and heart failure, and limited the search
to English-language RCTs in adult humans. (See Appendix
A for complete search strategy.)
Study Selection
We included all comparisons of interventions for post-discharge
care that reported at least readmission and/or mortality outcomes
among patients with HF. We assessed titles and/or abstracts
of citations identified in literature searches. A low threshold
was used to retrieve articles for evaluation. Full-text articles
of potentially relevant abstracts were retrieved and reviewed
according to the criteria. Results published only in abstract
form were not included in our reviews because these reports
have generally not been peer-reviewed and therefore lack adequate
information to assess the validity of the data.
Population
The population of interest for this report is adults with
diagnosed HF. Although the Medicare-eligible populations are
age 65 years and above, in consultation with CMS, we used a
lower threshold for limiting studies with respect to the age
cut-off. Studies were accepted if the mean age of the population
was at least 50 years. We also included studies that had subjects
who were recruited during the index hospitalization, at the
time of discharge from the index hospitalization, or at the
outpatient HF clinic. In general, the studies excluded patients
discharged to settings other than home (i.e., nursing home
or long-term facility) because of the difficulty in followup.
We excluded studies with less than 10 patients per arm and
studies of secondary analysis of an RCT. When there were multiple
publications of the same study, we used the publication that
reported the largest number of subjects. We excluded two studies
that were included in previous systematic reviews (one had
an incorrect citation,26 and
the other could not be retrieved.27)
Settings
The site of initiation of an intervention was the key feature
of interest among the settings. In the first setting, the intervention(s)
was initiated while patients were still in the hospital prior
to discharge. In the second setting, the intervention started
for recently discharged patients in the outpatient clinic.
In the third setting, the intervention was initiated with patients
who had been attending a HF management clinic, and at least
a proportion of those have had a recent hospitalization within
3 months of study recruitment. However, in this report, the
patients recruited from the third setting were analyzed separately.
Interventions
We accepted descriptions of the components of interventions
as they were reported in published articles. Interventions
were implemented in hospitals, outpatient settings or in patients'
homes. Studies of interventions with any duration were included.
Education on symptoms and disease management
Patients received a simple explanation of the pathophysiology
of HF, symptoms, and treatment of HF and were offered advice
about when to seek expert help.
Instruction on self management behaviors
Instruction to increase the self-care behavior in patients
and includes assessment of self-care ability. Instruction occurs
about behaviors to be taken in relation to early signs of worsening
HF. The goal is for the patient to understand the role of fluid
retention in worsening symptoms and to seek care early. HF
diaries or notebooks are sometimes provided to aid self-management.
Diet advice, sodium restriction
Patients were advised to restrict their sodium intake to 1.5
to 2 grams per day, and instructed on how this level could
be achieved. The intervention may involve a dietician's visit
and an individualized sodium restricted diet or a list of dietary
recommendations.
Medication review
The name of each drug and its purpose, dosage, frequency,
and significant adverse effects, of specific HF drugs is reviewed
by a care provider, and HF drugs (e.g. beta blockers) up titrated
slowly as tolerated. It may involve a written medication schedule
for complicated medication regimens and increase a patients'
adherence to prescribed medications.
Education reinforcement
Review of education goals with patients on subsequent clinic
visits or telephone calls was designed to increase the self-care
behavior in patients and included an assessment of self-care
ability.
Exercise recommendations
This includes recommendations about moderate aerobic exercise
training, which can result in improved exercise duration, less
fatigue, faster pace of activities, and improved general well-being.
Weight monitoring
Instructions are given to the patients on weight monitoring
that may include daily or regular monitoring, and provide HF
failure diaries or notebooks to document weight for self-management.
Telephone support
A care provider telephoned the patients in weekly or biweekly
intervals for the proactive telephone followup of patients
at home after discharge from the hospital. This may involve
a review of symptoms and weight and/or questions, which follow
a computerized care plan. Support may be provided by a non-physician,
usually a nurse, but could also involve a dietician or pharmacist.
Increased clinic visits
Increased clinic visits were additional clinic visits to assess
or in response to a change in clinical stability.
Home visits
A member of the multidisciplinary HF team (usually a HF specialist
nurse, a pharmacist or dietician) visited the patient in his/her
home to assess clinical stability and implement care to correct
any variation from care plan.
Social and psychological support
The level of family or career support that is available to
the patient was assessed and recommendations were provided
to increase support where necessary. Both forms of support
are expected to help patients deal better with their social
function (e.g., in their role in the family) and, as a result,
influence the psychological state (e.g., anxiety or depression)
of the patient as he/she copes with the disease.
Multidisciplinary care
All members of the multidisciplinary care team are involved
in the care of HF patients. The followup visits include consultation
with a cardiologist, HF specialist nurse, physiotherapist,
dietician, and psychologist.
Comparators
The acceptable comparators of interest included those defined
as usual care, routine care, or standard care. Usual care is
generally not structured and consists of instruction on discharge
medications by the unit nurse or possibly specialist HF nurse,
and includes information on the next appointment with the cardiologist
or primary care physician. There were many variations in the
description of the usual care among the studies and in general,
usual care was not well defined. We also included studies that
compared one intervention versus another type of intervention.
Outcomes
We restricted our evaluation to outcomes deemed clinically
important and of greatest interest to CMS. Outcomes of interest
included:
- Readmission, all causes
- Mortality, all causes
- Length of hospital stay
- Quality of life, using any validated quality of life measures
or any measures of symptom relief
- Other outcomes such as costs or combined endpoint of mortality
and hospitalization
Data Extraction
Items extracted included study year, country where the trial
was conducted, setting, funding source, study design, eligibility
criteria, patient characteristics, components of intervention,
and outcomes (see Appendix B for
a sample data extraction form). We recorded the method of randomization,
allocation concealment, blinding, and whether results were
reported on an intention-to-treat basis. Details regarding
the duration of HF, history of myocardial disease or other
cardiovascular disease, angiotensin converting enzyme (ACE)
inhibitor and beta-blocker use, and the intervention were also
extracted. For each outcome of interest, baseline, followup,
and change from baseline data were extracted, including information
on statistical significance. For most outcomes, only data from
the last reported time point was included.
Quality Assessment
We assessed the methodological quality of studies based on
predefined criteria. We used a 3-category (A, B, and C) grading
system to denote the methodological quality of each study (defined
below). This generic scheme defines a grading system that is
applicable within a study design. For randomized trials, we
mainly considered the methods used for randomization, allocation
concealment, and blinding, as well as the use of intention-to-treat
analysis and the report of dropout rate. We also considered
the extent to which valid primary outcomes were described,
as well as whether information was clearly reported. Studies
were not rejected due to poor quality.
A (good)
Category A studies have the least bias, and their results
are considered valid. A study that adheres mostly to the commonly
held concepts of high quality includes the following: adequate
random allocation method; blinded evaluation; clear descriptions
of the population, setting, interventions, and comparison groups;
appropriate measurement of outcomes; appropriate statistical
and analytic methods and reporting; no reporting errors; less
than 20 percent dropout; clear reporting of dropouts; and no
other obvious bias.
B (fair/moderate)
Category B studies are susceptible to some bias, but not a
sufficient amount to invalidate the results. They do not meet
all the criteria in category A because they have some deficiencies,
but they have not deficiencies that are likely to cause major
bias. The study may be missing information, making it difficult
to assess limitations and potential problems.
C (poor)
Category C studies have significant bias that may invalidate
the results. These studies have serious errors in design, analysis,
or reporting; large amounts of missing information; or major
discrepancies in reporting.
Applicability Assessment
Applicability addresses the relevance of a given study to
the target population of interest. Every study applies certain
eligibility criteria when selecting study subjects. Most of
these criteria are explicitly stated (e.g., disease status,
age, comorbidities). However, some criteria may be implicit
or the recruited study population was affected by unintentional
biases, such as those related to location (e.g., multi-center
vs. single-center, intensive care vs. all inpatients). The
populations and the interventions that are of interest specified
by the key questions, as opposed to those of interest to the
study investigators, dictate the applicability of a study.
We categorized study populations into 1 of 3 levels of applicability
that are defined as follows:
Wide Sample
is representative of the Medicare population in relevant settings.
Patients' age (older adult), gender, spectrum of disease severity
and type, etc. are representative of the population of interest.
Moderate Sample is an important
subgroup of the population of interest. It is possibly limited
to a narrow or young age range, lower New York Heart Association
(NYHA) score, type of disease, gender etc.
Narrow Sample
represents only a narrow, atypical subgroup of the population
of interest.
Data Synthesis and Meta-analyses
For studies with binary outcomes, we calculated the relative
risk and 95% confidence interval. For studies with continuous
outcomes, we calculated the mean difference and standard error
of the mean difference.
There was significant heterogeneity among studies, with regard
to intervention components, intervention duration, or other
factors. In the presence of significant clinical heterogeneity
among studies of any interventions compared with usual care,
we did not perform meta-analyses to obtain a single effect
size estimate for the clinical outcomes of interest.
However, certain individual interventions, specifically, education
on symptoms and disease management, instruction on self management,
dietary advice (including sodium restriction), medication review,
exercise recommendations and weight monitoring have become
usual care. Thus, interventions consisting of increased access
to providers — telephone support, clinic visits, home
visits, home telemonitor, and multidisciplinary discharge care — were
deemed interventions of interest. To assess the effectiveness
of intervention compared with usual care on readmission, we
performed meta-analyses by grouping studies that utilized similar
interventions for post-discharge care.
We used DerSimonian and Laird's random effects model for all
meta-analyses, which generally provides a wider confidence
interval (more conservative) in the presence of heterogeneity
across studies.28 We
tested for heterogeneity using Cochran's Q (statistically significant
at P <0.05) and assessed its extent with I2,
which evaluates the proportion of between study variability
that is attributed to heterogeneity rather than chance.29
Subgroup analyses were performed to examine the impact of
study quality, followup duration, site of initiation of interventions
(inpatient versus outpatient), the effects of duration of intervention
(<3 months, 3 to 6 months, >6 months), country where
the study was conducted (US versus non US), and severity of
HF on the rate of readmission.
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