Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study

Background: Heart failure (HF) is a leading cause of preventable hospitalization and death
in the VA and many patients fall short of self-care goals. Numerous efficacy trials have
shown that HF care management supported by health information technology (i.e., HITCM) can
improve patients' outcomes, although VA care managers in 'real-world' health systems are
often overwhelmed by the need to provide monitoring and behavior change services. Informal
caregivers may help to fill the gaps in VA care management and enhance support for patients'
treatment adherence, behavior changes, and symptom monitoring. The challenge will be to
identify ways to leverage assistance from informal caregivers (ICGs) who lack the resources
to fill this role effectively.

Objectives: We will evaluate the impact of extending the reach of HITCM by incorporating a
protocol-driven model for improved monitoring and self-management support by a CarePartner
(CP). CPs will be adult children or friends living outside the patient's home who are
willing to play a structured role to support self-care. The specific aims of the trial are:
(1) to determine whether an intervention that uses automated patient monitoring and behavior
change calls with follow-up to HF patients' care manager and CP (HITCM+CP) improves key
patient-centered outcomes relative to a system that only uses the same technology to support
patients' care management (HITCM-only). Outcomes of interest include patients'
health-related quality of life, mental health, health service use, and mortality risk; (2)
to evaluate the impact of HITCM+CP on patients' self-care behaviors compared to HITCM-only;
and (3) to determine whether the intervention increases the quality and quantity of support
for HF patients' self-care compared to HITCM-only.

Methods: 372 HF patient-CP pairs will be recruited from the VA Louis Stokes (Cleveland)
Healthcare System. Patients will receive automated telephone assessment and behavior change
calls weekly for 12 months. For patients in both study arms, a care manager will monitor
patients' assessment results via a secure website and will receive reports concerning urgent
health problems by fax and pager. In the HITCM+CP group, patients' CPs also will receive
tailored e-mail reports based on patients' weekly assessments. HITCM+CP patients and their
CPs will use a structured protocol to review the patient's assessment results, identify
self-care goals and barriers, and ensure that the patient's in-home caregivers and
healthcare team remain involved. All patients and CPs will complete quantitative surveys at
baseline, 6, and 12 months. The study will include a mixed-methods approach including
qualitative interviews with patients, CPs and clinicians to evaluate intervention use and
the service's potential for translation. The primary outcome will be HF-related quality of
life at 12 months. Secondary outcomes will include self-care behavior, patient-CP
relationship indicators, hospitalization, and death.

Impact: This study will evaluate a model for leveraging ICGs and structuring their role in
HF patients' overall disease management. If effective, the service may provide the frequent
monitoring and behavior change assistance that patients need, allowing VA to extend its
impact beyond what current care management programs can realistically deliver.

Inclusion Criteria:

Veterans with heart failure (HF) treated at the VA Louis Stokes (Cleveland) facilities
will be eligible if they have New York Heart Association (NYHA) Class II-III diastolic or
systolic HF noted by inpatient or outpatient ICD-9 codes.

Exclusion Criteria:

Veterans treated at the VA Louis Stokes (Cleveland) facilities will be ineligible if they:

- have a serious mental illness or cognitive dysfunction, e.g., psychosis, dementia, or
active substance abuse (alcohol and/or other drugs);

- do not speak English fluently;

- are receiving palliative care due to advanced HF or other health problems;

- receive the majority of their HF care from providers outside of the VA;

- are unable to use a telephone to respond to weekly automated self-management support
calls; or

- are unable to nominate an eligible informal caregiver.