Patient-Centered Heart Failure Trial

Background/Rationale: Chronic heart failure (CHF) is a leading cause of morbidity and
mortality in the VA. Disease management is a promising strategy to improve care and outcomes,
but evidence supporting CHF disease management is inconsistent and open questions remain.
Prior studies have not evaluated a multi-modal intervention combining multidisciplinary
collaborative care, telemonitoring, promotion of patient self-care, and an explicit
intervention for comorbid depression, which is a barrier to optimal CHF care and outcomes.
Moreover, the effectiveness of CHF disease management has not been evaluated in the VA.

Objective(s): We propose to evaluate a Patient-Centered Disease Management (PCDM)
intervention that includes case finding, collaborative care management for both CHF and
comorbid depression, and home telemonitoring. The primary aim will be to ascertain whether
the PCDM intervention results in better patient health status (i.e. symptom burden,
functional status, and quality of life) than usual care. Secondary aims will include
assessment of whether the intervention will reduce hospitalizations or mortality, result in
more guideline-concordant care, and reduce depression while increasing patient medication
adherence, self-efficacy and satisfaction with treatment.

Methods: We propose a 3-year, multi-site randomized study. VA patients with CHF from 4 VA
Medical Centers (Denver, Palo Alto, Richmond, and Seattle) and their affiliated clinics who
have diminished CHF-specific health status (Kansas City Cardiomyopathy Questionnaire
scores<50) will be eligible. We will randomize enrolled patients to a 12-month PCDM
intervention versus usual care (target 300 patients in each arm). The PCDM intervention will
include collaborative care management for CHF and comorbid depression and daily
telemonitoring. Patient self-care will be promoted through the telemonitoring intervention
and the depression intervention. The primary analysis will be a comparison of change in
health status (KCCQ scores) between enrollment and 12 months for the intervention versus
usual care groups. Secondary analyses will include comparison of rates of hospitalization and
death, depressive symptoms, the proportion of patients with guideline concordant CHF care,
medication adherence, 6-minute walk test, self-efficacy, and patient satisfaction. In
addition, cost-effectiveness analysis will be performed. All analyses will be intention to
treat.

Impact: If successful, the proposed intervention will improve the quality of care and
outcomes of veterans with CHF and be cost effective. The intervention has the potential to
serve as model for other disease management interventions in the VA, and is designed as an
'effectiveness' trial to enhance implementation. This study will be a joint effort of the CHF
and IHD QUERI groups, Patient Care Services, and Office of Care Coordination. The study
directly addresses several aims of the recently published 'QUERI: A New Direction' position
statement, including: a) partnership between QUERI groups; b) explicit collaborative ties
between QUERI and 'operational' components of the VA (i.e. Patient Care Services and Office
of Care Coordination); c) focus beyond a single disease entity (i.e. CHF and depression); and
d) clinical studies of interventions that might be candidates for national VA implementation.
Moreover, this study specifically engages patients in their care and emphasizes quality of
life outcomes, both of central import to the VA health care mission.

Inclusion Criteria:

- Diagnosis of Chronic Heart Failure;

- low health status.

Exclusion Criteria:

- Cognitive/psychiatric impairment (inability to complete questionnaires);

- nursing home resident;

- irreversible non-cardiac medical condition likely to affect 6-month survival or
ability to execute study protocol;

- prior heart transplantation.