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.
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.
- What is the relationship of the following parameters to the outcome readmission?
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.