Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Denver Research Institute
- Enrollment
- 317
- Locations
- 3
- Primary Endpoint
- Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CASA Intervention
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.
Intervention: CASA Intervention (Other)
Usual Care
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.
Outcomes
Primary Outcomes
Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score
Time Frame: 6 months
The KCCQ is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The study will test whether there is a difference in KCCQ overall score between the intervention and control groups at 6 months.
Secondary Outcomes
- Difference in pain using the PEG(6 months)
- Difference in Patient Health Questionnaire-9 (PHQ-9) score(6 months)
- Difference in Satisfaction with Healthcare(6 months)
- Change in Dyspnea(6 months)
- Difference in symptom distress, measured using the General Symptom Distress Scale(6 months)
- Difference in Self-care of Heart Failure Index (SCHFI)(12 months)
- Change in Sheehan Disability Scale(12 months)
- Change in Quality of Life at the End of Life (QUAL-E)(12 months)
- Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure(6 months)
Investigators
David Bekelman, M.D.
Associate Professor of Medicine
Denver Research Institute