Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)
Brief Summary: Advanced heart failure affects nearly 6 million Americans, and less is known about how this illness affects the 80% of heart failure patients who are 65 years and older because research tends to focus on younger patients. Older patients with heart failure and their family caregivers, rarely have access to palliative supportive care services because the disease is unpredictable and palliative treatment may not be provided until after other medical treatments have been tried. Investigators are studying whether palliative care provided when advanced heart failure patients are still well will result in better quality of life, mood and less symptom distress compared to usual or standard heart failure care.

Specific Aims and Hypotheses:

Specific Aim 1: Determine whether ENABLE CHF-PC leads to higher advanced heart failure patient-reported quality of life (QOL) and mood (depression/anxiety); and lower symptom burden and resource use (e.g. hospital admissions and days, emergency visits) through 16 weeks post baseline.

• Hypothesis 1: Intervention participants will experience higher QOL and mood, and lower symptom burden and resource use through 16 weeks post baseline compared with those receiving usual HF care.

Specific Aim 2: Determine whether ENABLE CHF-PC leads to higher caregiver-reported QOL, mood (anxiety/depression), and self-reported health and lower caregiver burden through 16 weeks post baseline.

• Hypothesis 2: Intervention caregivers will report higher QOL, mood, and self-reported health, and lower caregiver burden through 16 weeks post baseline.


Options:
A: Inclusion Criteria:

1. A diagnosis of advanced heart failure as defined by ALL THREE of the following:

   • New York Heart Association Class III or IV (NYHA III or IV) (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest).

   AND
   * Hospitalization for heart failure within the last six months. AND
   * Age greater than or equal to 65.
2. Additionally ONE of the following must be met:

   * According to the attending physician's best judgment the patient's survival is limited to 2 years but may very well be less than 1 year (i.e. the physician would not be surprised if the patient died within one year from any cause) OR
   * Three heart failure hospitalizations in the last year OR
   * One of the following:

     * Two Systolic Blood Pressures \< 90 within the last 6 months in the ambulatory setting
     * Na \< 130 within the last 6 months
     * NTproBNP \> 3,000
     * EGFR \< 35
     * High diuretic use (160 mg po Lasix or 100 mg po torsemide or equivalent total daily dose)

Exclusion Criteria:

* New patient
* A transplant or mechanical circulatory support candidate
* Major psychiatric illness as determined by the attending that would make this study inappropriate.
* Any patient that has been excluded for transplant or mechanical circulatory support due to psychological or psychiatric co-morbidities.
B: Inclusion Criteria

* Symptomatic Heart Failure (NYHA II-IV)
* Hospitalized or recently for acute decompensation with at least one of the following high-risk features

  * Prior hospitalization for Heart Failure (HF) within 1 year
  * Age \> 80 years
  * Chronic Kidney Disease (estimated Glomerular Filtration Rate (eGFR) \< 45 mL/min/m2)
  * Systolic Blood Pressure \< 100 mm Hg
  * Serum sodium \< 130 meq/L
  * Cardiogenic Shock (Cardiac Index \< 2.0)
  * Serious Non-Cardiovascular Illness (e.g. advanced stage cancer, Chronic Obstructive Pulmonary Disease (COPD) , or the like.
* Ability to Provide Informed Consent
* Permission of attending physician

Exclusion Criteria

* Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
* Already enrolled in hospice or receiving outpatient palliative care
C: Inclusion Criteria:

1. Able to read and understand English
2. NYHF III/IV heart failure (physician-determined)

Exclusion Criteria:

1. Dementia or significant confusion (Callahan 6-Item Cognitive Screening score ≤ 3)
2. DSM-IV Axis I diagnosis (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
3. Patients will not be excluded if they do not identify a caregiver
4. Uncorrectable hearing loss.
D: Inclusion Criteria:

Patient participant:

* Patients must be 21 years old or older and must be diagnosed with advanced heart failure (New York Heart Association Class III and IV). Patients must be aware of their diagnosis
* Caregiver/Decision-maker participant: Subject must be 21 years old or older Participant must be either

  * appointed substitute decision maker or
  * most likely to be substitute decision maker for patient (if patient were to lose decision-making capacity)

Exclusion Criteria:

* Patient participant: Patients must not have any psychiatric or cognitive disorders
* Caregiver/Decision-maker participant: Cannot be a maid or foreign domestic worker

Answer: C