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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Other: CASA Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CASA Intervention<br>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. | Other: CASA Intervention<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Patient Health Questionnaire-9 (PHQ-9) score | The PHQ-9 is a 9-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-9 was developed in medically-ill outpatients, including patients with heart failure. | 6 months | 
| Difference in symptom distress, measured using the General Symptom Distress Scale | The General Symptom Distress Scale (GSDS)includes a measure of overall symptom distress and ability to manage symptoms. | 6 months | 
| Difference in Self-care of Heart Failure Index (SCHFI) | The SCHFI is a valid and reliable 22-item self-report measure of self-care that includes three self-care scales: maintenance, management, and confidence | 12 months | 
| Difference in Satisfaction with Healthcare |  | 6 months | 
| Difference in pain using the PEG | The PEG items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G). | 6 months | 
| Change in fatigue using the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue measure |  | 6 months | 
| Change in Dyspnea | PEG pain measure modified to assess breathlessness | 6 months | 
| Change in Sheehan Disability Scale | Measure of functioning | 12 months | 
| Change in Quality of Life at the End of Life (QUAL-E) | The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness. We will use the relationship with health care system, preparation, life completion, and global quality of life sub-scales. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of Life, Symptoms, Palliative care, Symptom management, Disease management, Health delivery