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IIR 06-068 – HSR&D Study

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IIR 06-068
Patient-Centered Disease Management for Heart Failure Trial
John Spalding Rumsfeld MD PhD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, CO
Funding Period: July 2008 - June 2012

BACKGROUND/RATIONALE:
Nearly 5 million Americans have CHF and the prevalence continues to increase as the population ages. 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. CHF is characterized by frequent episodes of decompensation, with yearly admission rates of almost 50%. The costs of care for CHF are substantial, with total annual costs estimated at $28.8 billion. These national statistics are mirrored in the VA, where CHF is prevalent (~8%) and is a leading cause of hospitalization and resource utilization. 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%.

Chronic heart failure (CHF) is a leading cause of disability, hospitalization, and death in the VA and in the United States. 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. 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.

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. 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. 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.


OBJECTIVE(S):
The Patient-Centered Disease Management for Heart Failure Trial (PCDM) was a multicenter randomized trial of patient-centered CHF disease management that included case-finding, a collaborative care intervention with telemonitoring, and evidence-based CHF and depression management. The study was designed as an 'effectiveness' intervention to enhance broad implementation.

The primary aim of the project was 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 project included:
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 identified CHF patients from 4 VA Medical Centers and their affiliated clinics. We screened these patients with the KCCQ and invited eligible patients with diminished CHF-specific health status (i.e. KCCQ summary scores <60) to an enrollment visit. Enrolled patients were randomized to PCDM intervention versus usual care, and followed for 12 months. Further, patients with comorbid depressed (PHQ-9>=10) at the baseline visit were entered in the depression care component of the intervention which was adapted from the successful IMPACT depression intervention.
The PCDM intervention included:
1. Evaluation of CHF care by a collaborative care team, with diagnostic and therapeutic treatment recommendations based on current ACC/AHA national clinical practice guidelines. Daily telemonitoring and patient self-care support utilizing the Health Buddy system.
2. Screening and treatment for comorbid depression.
3. The Collaborative Care (CC) team at each site consisted of a PCP, cardiologist, psychiatrist and a nurse site coordinator.
The primary outcome was change in overall CHF-specific health status between baseline and 12-months, as reflected in the KCCQ Summary Score.

All analyses were conducted using an intention-to-treat approach. The baseline characteristics of patients were summarized by study group and examined for differences. To examine the primary outcome, change in CHF-specific health status as measured by the KCCQ, a likelihood-based random effects model was used. We examined the magnitude and patterns of missing data to check the sensitivity of the model assumptions. Model parameters were estimated using SAS procedure MIXED (SAS Institute, Cary, NC).

FINDINGS/RESULTS:
We are in the process of analyzing the data comparing the change in health status between the usual care and the intervention arm. We will submit the results for publication upon completion.

IMPACT:
This study directly addressed gaps in current CHF management and care delivery by evaluating a patient-centered disease management intervention that included a collaborative care intervention for CHF and comorbid depression and behavioral activation intervention for comorbid depression. 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. This is paramount in CHF given its prevalence, the aging population, and evidence that CHF patients value quality as much as quantity of life.

PUBLICATIONS:

Journal Articles

  1. Bekelman DB, Plomondon ME, Sullivan MD, Nelson K, Hattler B, McBryde C, Lehmann KG, Potfay J, Heidenreich P, Rumsfeld JS. Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial. BMC cardiovascular disorders. 2013 Jul 9; 13:49.


DRA: Health Systems, Cardiovascular Disease, Mental, Cognitive and Behavioral Disorders
DRE: Treatment - Observational
Keywords: Cardiovasc’r disease, Care Management, Depression
MeSH Terms: none

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