Table
of Contents
Abstract
Objective: To conduct a technology assessment
on the effectiveness of non-pharmacological interventions for
post-discharge care in heart failure patients.
Data Sources: Published English language
randomized controlled trials identified in a Medline search
through July 2007 and relevant bibliographies.
Methods: Certain interventions, specifically,
education on self-care management have become usual care, rather
than a specific intervention of interest. Thus, increased access
to providers and interventions such as telephone support, clinic
visits, home visits, home telemonitor, and multidisciplinary
discharge care were deemed interventions of interest. The main
outcome of interest was the rate of readmission. To assess
the relative effects of these interventions compared with usual
care on readmission, we grouped studies that utilized similar
interventions for post-discharge care and performed meta-analyses
using a random effects model.
We performed a qualitative assessment on other outcomes of
interest and noted the differences across studies between the
intervention and control groups. These outcomes included mortality,
length of hospital stay, quality of life and combined endpoints.
Results: A total of 49 randomized controlled
trials that enrolled 10,572 patients evaluated interventions
utilizing delivery models during or after hospitalization,
and in the outpatient clinics. There was considerable heterogeneity
across studies with regard to individual components of intervention,
duration of intervention, length of followup, and description
of usual care. Most of the studies were graded good or fair
methodological quality. All studies included interventions
to educate patients about heart failure symptoms and disease
management, and self-care behavioral management. The majority
of the studies also evaluated interventions that included education
about diet and sodium restriction, medication review, and daily
weight monitoring.
We identified studies that compared increased clinic visits,
home visits, home telemonitor, and multidisciplinary care with
usual care reduced the risks of readmission. Often the interventions
in these studies utilized a combination of secondary components,
with telephone followup being the most common. However, when
telephone followup was utilized alone, there was no significant
difference in all cause readmissions between comparison groups.
Studies with intermediate- to long-term followup (>month
and >12 month), interventions that were initiated in the
inpatient setting, and patient ages older than 75 years were
associated with a statistically significant reduction in all
cause readmissions.
Compared with usual care, one-fourth of the 20 studies reported
a significant reduction in all-cause mortality when interventions
were initiated during an index hospitalization. Similar significant
reduction of length of stay during readmissions was reported
when interventions were initiated during an index hospitalization.
When interventions were initiated after discharge from an index
hospitalization, only one out of 18 studies reported intervention
decreased rates of mortality and readmissions, and reduced
length of hospital stay during readmissions.
Six randomized controlled trials with a total of 2,654 patients
assessed interventions that began in the outpatient clinics.
The majority of the studies utilized a pharmacist-led intervention
that mostly included medication review. Mortality data was
reported in five studies, number of readmissions in four studies,
cost incurred in one study, QOL changes in four studies, and
composite end point of mortality or readmissions in two studies.
Overall, the results do not support the superiority of any
particular intervention strategy. Conclusions: Interventions
that utilized increased clinic visits, home visits, and multidisciplinary
care reduced the risk of readmissions. Studies with intermediate-
to long-term followup, interventions initiated in the inpatient
setting, and patient ages greater than 75 years were associated
with significant reduction of all cause readmissions in the
intervention group. These interventions often utilized a combination
of components. There was no distinct combination of intervention
components that was associated with improved clinical outcomes.
The evidence was sparse for interventions beginning in the
outpatient clinics.
Introduction
The Coverage and Analysis Group at the Centers for Medicare
and Medicaid Services (CMS) requested from the Technology Assessment
Program (TAP) at the Agency for Healthcare Research and Quality
(AHRQ) a technology assessment report to evaluate the effectiveness
of non-pharmacological interventions for post-discharge care
in patients with heart failure (HF) and their relevance to
the Medicare population. AHRQ assigned this report to the following
Evidence-based Practice Center: Tufts-New England Medical Center
Evidence-based Practice Center (Tufts-NEMC EPC) (Contract Number
290-02-0022).
In the United States, HF is the most common hospital discharge
diagnosis among elderly. In many developed countries, the prevalence
of HF approaches 1 to 4 percent of the population and medical
expenditures have been estimated at 1 to 5 percent of health
care spending in some settings.1 HF
is an increasingly common condition because recent improvements
in medical and surgical therapies along with advancements in
diagnostic techniques have increased survival in patients with
ischemic cardiovascular disease.2 Nonetheless,
HF carries a substantial risk of death. After an initial diagnosis
of HF, increasing age and co-morbidity increases the 30-day
and 1-year mortality. The current 1-year mortality estimates
range from 18 to 60 percent for elderly with comorbidity.3,4,5 About
40 percent of patients are readmitted within 1-year following
their first admission for HF and hospitalization accounts for
approximately 70 percent of the costs of HF management.2,6
The post-discharge-related adverse events and increased readmissions
are often due to potentially modifiable factors, that may include
patient-, clinician-, and hospital-related characteristics.7,8,9 As
a result, management of a HF patient has evolved from the traditional
model of crisis intervention toward a more proactive model
of managing the disease. Drug therapy remains the core of therapy
for HF. Although invasive procedures are indicated for some
patients, the majority of patients are managed with both medications
and lifestyle counseling.
Various strategies to manage HF are based on comprehensive
care and intensive followup, and are often organized within
a formal disease management program. In general, these programs
coordinate care across disciplines, provide education to patient
and caregiver, enhance patient self-management skills, implement
effective followup, and base medication decisions on current
clinical practice guidelines for HF.10 The
intervention component in these disease management programs
may include education on symptoms and disease management, encouragement
of proper self-management behaviors, monitoring of symptoms
and weight, dietary advice, sodium restriction, medication
review, exercise recommendations, proactive telephone support,
social and psychological support, education reinforcement,
and home visits. Combinations of components are often employed,
and there are considerable variations in the content, intensity,
and duration of the components, the setting, and the personnel
who coordinate the care. Studies of various interventions reported
mixed results concerning their effectiveness.11,12
Over the past several years, telephone-based symptom monitoring,13,14 automated
symptom monitoring,15 and
Internet automated physiologic monitoring by patients (with
review by a cardiologist) have been introduced.16 These
are designed to improve outcome and quality of life in elderly
HF patients, and they focus on the transition from hospital-to-home
and supportive care for self-management.17 Another
intervention strategy introduced in the recent years is pharmacist-led
medication support.18 Given
the shortage of specialist nurses in countries such as the
UK, the use of pharmacists is seen as extending the scope of
post-discharge support. However, published studies indicate
that the use of such support failed to benefit the elderly.18,19
The Robert Wood Johnson Foundation (RWJF) and the Institute
for Healthcare Improvement (IHI) have started an initiative
called Transforming Care at the Bedside (TCAB) to facilitate
transition to home. They have created a framework to build
safe and reliable care and emphasize vitality and teamwork,
patient-centered care, and value-added care processes. Currently,
this framework is being tested and has shown some early benefits.
Many non-pharmacological interventions to support post-discharge
care have been examined extensively in published systematic
reviews or meta-analysis.12,20-25 Many
previously published studies have varied their eligibility
criteria and inclusion of primary studies; thus evaluating
different studies. This report aims to comprehensively evaluate
data on the effectiveness of non-pharmacological interventions
for post-discharge care in patients with HF and their relevance
to the Medicare population.
Scope and Key Question
CMS, AHRQ, and EPC staff jointly determined the key question
and the definition of terminologies.
- In HF patients 50 years and older, what is the effectiveness
of interventions to support post-discharge care compared
with the usual care to prevent readmission?
- What is the relationship of the following parameters
to the outcome readmission?
- Internal and external validity of the studies
(includes inclusion and exclusion criteria of
the studies).
- Length of followup.
- Concurrent discharge planning in disease management
programs.
- Place of delivery of discharge planning (home,
inpatient, outpatient).
- Components of discharge planning and whether
components were individually tailored or generalized.
- Intensity of discharge planning, number and
frequency of interventions.
- Patient characteristics.
- Other study characteristics that may affect
outcomes.
In addition to the rate of readmission, which is the main
outcome of interest, CMS requested evaluation of other outcomes
that were deemed clinically important. These included all cause
mortality, length of hospital stay, costs, quality of life,
and combined endpoint consisting of mortality and hospitalization.
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