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BACKGROUND/RATIONALE:
Nearly 5 million Americans have CHF and the prevalence continues to increase as the population ages.1,26 CHF is the leading cause of hospital admissions in patients aged 65 years and older in the U.S., with nearly 1 million hospital admissions per year.1 CHF is characterized by frequent episodes of decompensation, with yearly admission rates of almost 50%.3 The costs of care for CHF are substantial, with total annual costs estimated at $28.8 billion.1,27 These national statistics are mirrored in the VA, where CHF is prevalent (~8%) and is a leading cause of hospitalization and resource utilization.2 The average VA patient with CHF has 1-2 hospitalizations per year, over 20 ambulatory care visits per year, and has a 5-year risk adjusted survival rate of only 36%.2
OBJECTIVE(S):
Chronic heart failure (CHF) is a leading cause of disability, hospitalization, and death in the VA and in the United States.1-3 Despite advances in available therapies for patients with CHF, population-based outcomes such as mortality and hospitalization rates have not improved substantially over the past decade.4 In addition, CHF has a major impact on patients' health status, including their symptom burden (e.g. dyspnea), functional status, and health-related quality of life, and yet few CHF interventions have targeted these critical 'patient-centered' outcomes.5-8
Disease management has emerged as a promising strategy to improve the outcomes of patients with CHF. Some previous studies have reported that CHF disease management can reduce rates of hospitalization, and a few have demonstrated reductions in mortality, reductions in cost, or improvements in quality of life.9-21 However, many of these studies have been small, single-center, and of short duration, and the association between disease management and improved outcomes has been inconsistent.20-25 Many CHF disease-management studies to date have relied solely on nurse case management rather than multidisciplinary collaborative care, have not leveraged health information technology, and have had a limited focus on patient self-care. In general, these programs have failed to empower patients in their care, providing inadequate attention to health status and self-care support, and failing to address key barriers such as comorbid depression. The effectiveness of disease management for CHF has not been evaluated in the VA.
We propose a multicenter randomized trial of patient-centered CHF disease management that includes case-finding, a collaborative care intervention with telemonitoring, and evidence-based CHF and depression management. This project is a collaborative effort of the CHF and ischemic heart disease (IHD) Quality Enhancement Research Initiative (QUERI) groups, Patient Care Services (PCS), and the Office of Care Coordination (OCC), with endorsement from Mental Health QUERI. The study is designed as an 'effectiveness' intervention to enhance broad implementation, if successful.
The primary aim of the proposed project is to:
1. Determine whether a patient-centered CHF disease management intervention in the VA results in better patient health status (i.e. symptom burden, functional status, and quality of life) than usual care;
The secondary aims of the proposed project are to:
1. Determine whether the disease management intervention results in reduced hospitalizations and mortality.
2. Determine whether the disease management intervention reduces depression and increases patient self-efficacy in the management of CHF, medication adherence, and satisfaction with treatment.
3. Determine whether the care of patients assigned to the disease management intervention is more consistent with national clinical practice guidelines than patients receiving routine care.
4. Evaluate the cost and incremental cost-effectiveness of the disease management intervention.
METHODS:
We propose a 3-year, multi-site randomized study to evaluate the effectiveness of a Patient-Centered Disease Management (PCDM) intervention for CHF. An overview of study design is in Figure 4. First, we will identify CHF patients from 4 VA Medical Centers and their affiliated clinics. Then, we will screen these patients with the KCCQ and invite eligible patients with diminished CHF-specific health status (i.e. KCCQ summary scores <50) to an enrollment visit. Enrolled patients will be randomized to a PCDM intervention versus usual care, and will be followed for 12 months.
The PCDM intervention will include:
Evaluation of CHF care by the collaborative care team, with diagnostic and therapeutic treatment recommendations based on current ACC/AHA national clinical practice guidelines.115
Daily telemonitoring and patient self-care support utilizing the Health Buddy system.
Screening and treatment for comorbid depression.
The Collaborative Care (CC) team at each site will consist
of a PCP, cardiologist, and psychiatrist who are local opinion leaders, as well as a nurse site coordinator.
The primary outcome will be change in overall CHF-specific
health status between baseline and 12-months, as reflected in
the KCCQ Summary Score.
Secondary outcomes will include: hospitalization and mortality, depressive symptoms, patients' self-efficacy in management of CHF, adherence to prescribed medications, patient satisfaction, the proportion of patients with guideline-concordant care, and cost-effectiveness of the intervention.
FINDINGS/RESULTS:
Enter text here.
IMPACT:
CHF affects ~8% of veterans and remains a leading cause of disability, hospitalization, and death. Despite advances in available therapies, significant gaps in CHF care persist, and the burden of disease at the patient level remains extremely high. This study directly addresses gaps in current CHF management and care delivery by evaluating a patient-centered disease management intervention that includes a collaborative care intervention with telemonitoring for both CHF and comorbid depression.
The proposed intervention is unique compared to prior CHF disease management studies based on: a) the emphasis on patient health status outcomes; b) the inclusion of depression management; c) the interdisciplinary collaborative care team (primary care, psychiatry, cardiology, nursing); d) telemonitoring for improved surveillance by the collaborative care team for both CHF and comorbid depression, and e) promotion of patient self-care both through telemonitoring and the depression intervention. While some of these aspects have been included in prior studies, they have not been evaluated as part of a multi-modal care delivery intervention that integrates these components. In addition, this will be the first formal evaluation of CHF disease management in the VA. There is high variation in CHF care strategies across the VA. A minority of sites report having some 'disease management' for CHF, but these programs are site-specific and generally are not multi-faceted, multi-condition (CHF and depression) interventions, as we propose to evaluate.
The goals and methods of this study are also highly aligned with the concepts for improved health care delivery promoted by the IOM, NHLBI, and the VA (see Section B.3.). Moreover, the proposed study reflects VA HSR&D and QUERI research priorities38,39,114, including: a) the partnership between QUERI groups; b) explicit ties between QUERI research and 'operational' components of the VA (here PCS and OCC); c) focus beyond a single disease entity (here CHF and depression); and d) studies of interventions that might be candidates for national VA implementation.
Finally, the focus on patient health status outcomes is important to emphasize. VA is a leader in patient health status assessment, and the ultimate goal of the VA HSR&D QUERI process is improvement in quality of life.38 This is paramount in CHF given its prevalence, the aging popula tion, and evidence that CHF patients value quality as much as quantity of life.53
PUBLICATIONS:
None at this time.
DRA:
Chronic Diseases, Health Services and Systems, Mental Illness
DRE:
Quality of Care, Treatment, Resource Use and Cost
Keywords:
Cardiovasc’r disease, Depression, Care Management
MeSH Terms:
none
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