Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial

Denver Research Institute

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Other: CASA Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01739686

11-0969 (Other Identifier)

5R01NR013422-02

Details and patient eligibility

About

Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years of age or older
• Able to read and understand English
• Consistent access to a telephone
• Patients have a primary care or other provider who is willing to facilitate intervention medical recommendations
• A diagnosis of heart failure with at least one of the following:

[hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; Brain natriuretic peptide(BNP) ≥ 100 or N-terminal prohormone of brain natriuretic peptide(NT-proBNP) ≥ 500; EF≤40%]

• Report a low health status (KCCQ-SF≤70)
• Bothered by at least one target symptom:

[Pain; Depression; Fatigue; Breathlessness]

Exclusion criteria

• Previous diagnosis of dementia
• Active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an AUDIT-C ≥ 8, or self-reported substance abuse in the past 3 months
• Comorbid metastatic cancer
• Nursing home resident
• Heart Transplant recipient
• LVAD recipient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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317 participants in 2 patient groups

CASA Intervention

Experimental group

Description:

The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components: * A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression. * A social worker provides structured counseling targeting adjustment to illness and depression if present. * A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. Most of the nurse and social worker visits are by phone.

Treatment:

Other: CASA Intervention

Usual Care

No Intervention group

Description:

Patients in the control group will continue to receive care at the discretion of their providers, which may include referral to cardiology, palliative care, or mental health. If patients self-report depression on baseline surveys, this information will be given to their provider, and patients will be given resources. Patients will have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency.