ENABLE CHF PC: ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers)

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT02505425
Collaborator
US Department of Veterans Affairs (U.S. Fed)
573
2
2
41.3
286.5
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Support
  • Behavioral: Usual HF Care
N/A

Detailed Description

As described.

Study Design

Study Type:
Interventional
Actual Enrollment :
573 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of ENABLE CHF-PC for Heart Failure Patients and Caregivers. (Comprehensive Heartcare For Patients and Caregivers)
Actual Study Start Date :
Nov 30, 2015
Actual Primary Completion Date :
Oct 20, 2018
Actual Study Completion Date :
May 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active Intervention

Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC

Behavioral: Behavioral Support
ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
Other Names:
  • ENABLE CHF-PC
  • Active Comparator: Usual HF Care

    Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.

    Behavioral: Usual HF Care
    Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Other Names:
  • Usual Heart Failure Care
  • Outcome Measures

    Primary Outcome Measures

    1. Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score [Baseline]

      Baseline patient-reported Quality of Life (QOL) was measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score, a heart failure-specific 23-item instrument. The KCCQ consists of 4 clinical domains: symptoms - frequency & severity; Physical Limitation; Quality of Life and Social Limitation and captures the patient's perspective of heart failure. Clinical summary scores range from 0 to 100. Higher KCCQ scores indicate better perceived health status. KCCQ clinical summary scores greater than or equal to 50 indicate good QOL.

    2. Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score [16 weeks]

      Patient-reported Quality of Life (QOL) was measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 16 weeks. The KCCQ consists of 4 clinical domains: symptoms - frequency & severity; Physical Limitation; Quality of Life and Social Limitation and captures the patient's perspective of heart failure. Clinical summary scores range from 0 to 100. Higher KCCQ scores indicate better perceived health status. KCCQ clinical summary scores greater than or equal to 50 indicate good QOL.

    3. Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) [Baseline]

      Baseline patient-reported Quality of Life (QOL) was measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14). Scores range from 0 to 56; higher scores indicate better quality of life.

    4. Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) [16 weeks]

      Patient-reported Quality of Life (QOL) was measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) at 16 weeks. Scores range from 0 to 56; higher scores indicate better quality of life.

    5. Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) [Baseline]

      Baseline patient & caregiver-reported mood - Anxiety - was measured on the Hospital Anxiety and Depression Scale (HADS). 7 items measure anxiety symptoms.Scores range from 0 to 21; higher scores indicate more severe symptoms.

    6. Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS) [16 weeks]

      Change from baseline in patient & caregiver-reported mood - Anxiety was measured on the HADS. 7 items measure anxiety symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.

    7. Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) [Baseline]

      Baseline patient and caregiver-reported depression was measured on the Hospital Anxiety and Depression Scale (HADS). 7 items measure depression symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.

    8. Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS) [16 weeks]

      Patient and caregiver-reported depression was measured on the Hospital Anxiety and Depression Scale (HADS) at 16 weeks. 7 items measure depression symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.

    9. Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) [Baseline]

      Baseline caregiver-reported quality of life (QOL) was measured on the Bakas Caregiving Outcomes Scale (BCOS). Score range: 15-105; higher scores indicate higher quality of life.

    10. Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS) [16 weeks]

      Caregiver-reported quality of life (QOL) was measured on the Bakas Caregiving Outcomes Scale (BCOS) at 16 weeks. Score range: 15-105; higher scores indicate higher quality of life.

    11. Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) [Baseline]

      Baseline caregiver-reported Objective burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). This subscale measures the object burden, interference with the caregiver's day-to-day activities given caregiving demands. Score range: 6-30, Greater than 23 indicates high burden.

    12. Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) [16 weeks]

      Caregiver-reported Objective burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale measures the object burden, interference with the caregiver's day-to-day activities given caregiving demands.Score range: 6-30, Greater than 23 indicates high burden.

    13. Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) [Baseline]

      Baseline caregiver-reported Demand burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). This subscale measures the demand burden or the strain among caregivers from meeting the needs of the care recipient. Score range: 6-30, Greater than 23 indicates high burden.

    14. Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) [16 weeks]

      Caregiver-reported Demand burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale measures the demand burden or the strain among caregivers from meeting the needs of the care recipient. Score range: 6-30, Greater than 23 indicates high burden.

    15. Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) [Baseline]

      Baseline caregiver-reported Stress burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). his subscale indicates the stress burden or emotional stress from the demands of caregiving. Score range: 6-30, Greater than 23 indicates high burden.

    16. Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) [16 weeks]

      Caregiver-reported Stress burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale indicates the stress burden or emotional stress from the demands of caregiving. Score range: 6-30, Greater than 23 indicates high burden.

    Secondary Outcome Measures

    1. Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 [Baseline]

      Baseline patient- and caregiver-reported PHYSICAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

    2. Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 [16 weeks]

      Patient- and caregiver-reported PHYSICAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health at 16 weeks. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

    3. Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 [Baseline]

      Baseline patient- and caregiver-reported MENTAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

    4. Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10 [16 weeks]

      Patient- and caregiver-reported MENTAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health at 16 weeks. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.

    5. Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items [Baseline]

      Baseline patient-reported symptom burden was measured on symptom-based items from the Kansas City Cardiomyopathy Questionnaire (KCCQ). Higher KCCQ scores indicate better perceived health status. The KCCQ Symptom burden domain consists of 8 items and quantifies the frequency, severity and change over time with clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ symptom domain scores range from 0 to 100; A score of 50 is the threshold between unstable heart failure symptoms (<50) or stable heart failure symptoms (>=50).

    6. Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items. [16 weeks]

      Patient-reported symptom burden was measured on symptom-based items from the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 16 weeks. Higher KCCQ scores indicate better perceived health status. The KCCQ Symptom burden domain consists of 8 items and quantifies the frequency, severity and change over time for clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ symptom domain scores range from 0 to 100; A score of 50 is the threshold between unstable heart failure symptoms (<50) or stable heart failure symptoms (>=50).

    7. Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale [Baseline]

      Baseline patient-reported PAIN INTENSITY was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale. Higher pain scores indicate more pain. Score range: 0-100; Scores greater than 50 indicate high pain.

    8. Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale [16 weeks]

      Patient-reported PAIN INTENSITY was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale at 16 weeks. Higher pain scores indicate more pain. Score range: 0-100; Scores greater than 50 indicate high pain.

    9. Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale [Baseline]

      Baseline patient-reported PAIN INTERFERENCE was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale. Higher pain interference scores indicate more interference in daily life. Score range: 0-100; Scores greater than 50 indicate high pain.

    10. Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale [16 weeks]

      Patient-reported PAIN INTERFERENCE was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale at 16 weeks. Higher pain interference scores indicate more interference in daily life. Score range: 0-100; Scores greater than 50 indicate high pain.

    11. Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument [Baseline]

      Baseline patient-reported health care utilization - Number of Days in Hospital, last two months - was measured on the Resource Use Questionnaire. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Days in Hospital is 0 Days to 60 Days (last/previous two months prior to this measure).

    12. Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument [16 weeks]

      Patient-reported health care utilization - Number of Days in Hospital, last two months - was measured on the Resource Use Questionnaire at 16 weeks. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Days in Hospital is 0 Days to 60 Days (last/previous two months prior to this measure).

    13. Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument [Baseline]

      Baseline patient-reported health care utilization - Number of Emergency Department Visits, last two months - was measured on the Resource Use Questionnaire. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Visits to ED is 0 Visits to 60 Visits (in the last/previous two months prior to this measure).

    14. Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument [16 weeks]

      Patient-reported health care utilization - Number of Emergency Department Visits, last two months - was measured on the Resource Use Questionnaire at 16 weeks. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Visits to ED is 0 Visits to 60 Visits (in the last/previous two months prior to this measure).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Veterans Affairs Medical Center (BVAMC) Birmingham Alabama United States 35233
    2 University of Alabama at Birmingham, School of Nursing, Dept. Acute, Chronic and Continuing Care Birmingham Alabama United States 35233

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • US Department of Veterans Affairs

    Investigators

    • Principal Investigator: Marie Bakitas, DNSc, University of Alabama at Birmimgham, School of Nursing, Dept. Acute, Chronic & Continuing Care

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Marie Anne Bakitas, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT02505425
    Other Study ID Numbers:
    • X140813007
    First Posted:
    Jul 22, 2015
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details The study recruitment period was from October 2015 thru October 2018. Recruitment occurred at two sites: the University of Alabama at Birmingham (UAB) and the Birmingham Veterans Affairs Medical Center (BVAMC).
    Pre-assignment Detail
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Period Title: Overall Study
    STARTED 208 207 82 76
    COMPLETED 120 125 32 50
    NOT COMPLETED 88 82 50 26

    Baseline Characteristics

    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers Total
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Total of all reporting groups
    Overall Participants 208 207 82 76 573
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    63.5
    (8.0)
    64.1
    (9.1)
    58.2
    (12.4)
    57.6
    (10.8)
    60.85
    (10.1)
    Sex: Female, Male (Count of Participants)
    Female
    97
    46.6%
    97
    46.9%
    73
    89%
    62
    81.6%
    329
    57.4%
    Male
    111
    53.4%
    110
    53.1%
    9
    11%
    14
    18.4%
    244
    42.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    113
    54.3%
    113
    54.6%
    46
    56.1%
    36
    47.4%
    308
    53.8%
    White
    92
    44.2%
    92
    44.4%
    32
    39%
    38
    50%
    254
    44.3%
    More than one race
    3
    1.4%
    2
    1%
    3
    3.7%
    2
    2.6%
    10
    1.7%
    Unknown or Not Reported
    0
    0%
    0
    0%
    1
    1.2%
    0
    0%
    1
    0.2%
    Region of Enrollment (Count of Participants)
    United States
    208
    100%
    207
    100%
    82
    100%
    76
    100%
    573
    100%

    Outcome Measures

    1. Primary Outcome
    Title Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
    Description Baseline patient-reported Quality of Life (QOL) was measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score, a heart failure-specific 23-item instrument. The KCCQ consists of 4 clinical domains: symptoms - frequency & severity; Physical Limitation; Quality of Life and Social Limitation and captures the patient's perspective of heart failure. Clinical summary scores range from 0 to 100. Higher KCCQ scores indicate better perceived health status. KCCQ clinical summary scores greater than or equal to 50 indicate good QOL.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 0 0
    Mean (Standard Deviation) [score on a scale]
    54.2
    (20.5)
    51.1
    (21.5)
    2. Primary Outcome
    Title Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
    Description Patient-reported Quality of Life (QOL) was measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 16 weeks. The KCCQ consists of 4 clinical domains: symptoms - frequency & severity; Physical Limitation; Quality of Life and Social Limitation and captures the patient's perspective of heart failure. Clinical summary scores range from 0 to 100. Higher KCCQ scores indicate better perceived health status. KCCQ clinical summary scores greater than or equal to 50 indicate good QOL.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient Quality of Life (QOL) using the KCCQ. Caregiver QOL was analyzed using a different measure.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 120 125 0 0
    Mean (Standard Error) [score on a scale]
    59.7
    (1.8)
    54.8
    (1.8)
    3. Primary Outcome
    Title Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
    Description Baseline patient-reported Quality of Life (QOL) was measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14). Scores range from 0 to 56; higher scores indicate better quality of life.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 0 0
    Mean (Standard Deviation) [score on a scale]
    36.8
    (9.3)
    36.1
    (9.7)
    4. Primary Outcome
    Title Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
    Description Patient-reported Quality of Life (QOL) was measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14) at 16 weeks. Scores range from 0 to 56; higher scores indicate better quality of life.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure. One intervention participant and two usual care participants did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 123 0 0
    Mean (Standard Error) [score on a scale]
    38.5
    (0.8)
    36.8
    (0.8)
    5. Primary Outcome
    Title Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
    Description Baseline patient & caregiver-reported mood - Anxiety - was measured on the Hospital Anxiety and Depression Scale (HADS). 7 items measure anxiety symptoms.Scores range from 0 to 21; higher scores indicate more severe symptoms.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient & Caregiver Mood - Anxiety HADS
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 82 76
    Mean (Standard Deviation) [score on a scale]
    6.6
    (3.5)
    6.8
    (3.7)
    3.9
    (3.1)
    3.7
    (2.9)
    6. Primary Outcome
    Title Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
    Description Change from baseline in patient & caregiver-reported mood - Anxiety was measured on the HADS. 7 items measure anxiety symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient & Caregiver Mood - Anxiety HADS. One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 122 32 50
    Mean (Standard Error) [score on a scale]
    6.6
    (0.3)
    7.1
    (0.3)
    3.8
    (0.5)
    4.2
    (0.4)
    7. Primary Outcome
    Title Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
    Description Baseline patient and caregiver-reported depression was measured on the Hospital Anxiety and Depression Scale (HADS). 7 items measure depression symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient and Caregiver Mood - Depression Scale.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 82 76
    Mean (Standard Deviation) [score on a scale]
    5.7
    (4.3)
    5.8
    (4.2)
    4.7
    (3.1)
    4.8
    (3.3)
    8. Primary Outcome
    Title Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
    Description Patient and caregiver-reported depression was measured on the Hospital Anxiety and Depression Scale (HADS) at 16 weeks. 7 items measure depression symptoms. Scores range from 0 to 21; higher scores indicate more severe symptoms.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    This measure pertains to Patient and Caregiver Mood - Depression Scale. One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 122 32 50
    Mean (Standard Error) [score on a scale]
    4.9
    (0.3)
    5.6
    (0.3)
    4.5
    (0.5)
    4.4
    (0.4)
    9. Primary Outcome
    Title Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
    Description Baseline caregiver-reported quality of life (QOL) was measured on the Bakas Caregiving Outcomes Scale (BCOS). Score range: 15-105; higher scores indicate higher quality of life.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This measure was conducted among Caregiver participants only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 82 76
    Mean (Standard Deviation) [score on a scale]
    65.0
    (12.9)
    60.7
    (10.4)
    10. Primary Outcome
    Title Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
    Description Caregiver-reported quality of life (QOL) was measured on the Bakas Caregiving Outcomes Scale (BCOS) at 16 weeks. Score range: 15-105; higher scores indicate higher quality of life.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    This measure conducted among Caregiver participants only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 32 50
    Mean (Standard Error) [score on a scale]
    66.9
    (2.1)
    63.9
    (1.7)
    11. Primary Outcome
    Title Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
    Description Baseline caregiver-reported Objective burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). This subscale measures the object burden, interference with the caregiver's day-to-day activities given caregiving demands. Score range: 6-30, Greater than 23 indicates high burden.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 82 76
    Mean (Standard Error) [score on a scale]
    20.1
    (2.8)
    20.0
    (2.9)
    12. Primary Outcome
    Title Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
    Description Caregiver-reported Objective burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale measures the object burden, interference with the caregiver's day-to-day activities given caregiving demands.Score range: 6-30, Greater than 23 indicates high burden.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 32 50
    Mean (Standard Error) [score on a scale]
    20.2
    (0.5)
    19.7
    (0.4)
    13. Primary Outcome
    Title Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
    Description Baseline caregiver-reported Demand burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). This subscale measures the demand burden or the strain among caregivers from meeting the needs of the care recipient. Score range: 6-30, Greater than 23 indicates high burden.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 82 76
    Mean (Standard Deviation) [score on a scale]
    11.6
    (2.5)
    11.6
    (1.8)
    14. Primary Outcome
    Title Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
    Description Caregiver-reported Demand burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale measures the demand burden or the strain among caregivers from meeting the needs of the care recipient. Score range: 6-30, Greater than 23 indicates high burden.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 32 50
    Mean (Standard Error) [score on a scale]
    11.1
    (0.4)
    11.6
    (0.3)
    15. Primary Outcome
    Title Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
    Description Baseline caregiver-reported Stress burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB). his subscale indicates the stress burden or emotional stress from the demands of caregiving. Score range: 6-30, Greater than 23 indicates high burden.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Montgomery Borgatta Caregiver Burden Scale (MBCB) was conducted among Caregivers only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 82 76
    Mean (Standard Deviation) [score on a scale]
    12.3
    (2.4)
    12.3
    (2.2)
    16. Primary Outcome
    Title Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
    Description Caregiver-reported Stress burden was measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB) at 16 weeks. This subscale indicates the stress burden or emotional stress from the demands of caregiving. Score range: 6-30, Greater than 23 indicates high burden.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 0 0 32 50
    Mean (Standard Error) [score on a scale]
    11.7
    (0.4)
    12.2
    (0.3)
    17. Secondary Outcome
    Title Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
    Description Baseline patient- and caregiver-reported PHYSICAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 82 76
    Mean (Standard Deviation) [score on a scale]
    38.6
    (8.0)
    38.1
    (8.0)
    46.9
    (8.9)
    48.0
    (8.6)
    18. Secondary Outcome
    Title Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
    Description Patient- and caregiver-reported PHYSICAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health at 16 weeks. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    One intervention and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks. One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 122 32 50
    Mean (Standard Error) [score on a scale]
    39.4
    (0.7)
    38.8
    (0.7)
    46.9
    (8.9)
    48.0
    (8.6)
    19. Secondary Outcome
    Title Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
    Description Baseline patient- and caregiver-reported MENTAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 82 76
    Mean (Standard Deviation) [score on a scale]
    45.8
    (8.6)
    44.9
    (8.7)
    48.5
    (7.1)
    48.1
    (7.9)
    20. Secondary Outcome
    Title Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
    Description Patient- and caregiver-reported MENTAL health status was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health at 16 weeks. The PROMIS SF Global Health-10 measures general domains of health including physical, mental, and social health, symptoms, overall quality of life. Summed scores for PROMIS measures are converted to T scores with a mean of 50 and standard deviation of 10 in the general US population; higher scores indicate better functioning.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 122 32 50
    Mean (Standard Error) [score on a scale]
    45.9
    (0.7)
    44.7
    (0.7)
    47.7
    (1.0)
    48.2
    (0.9)
    21. Secondary Outcome
    Title Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items
    Description Baseline patient-reported symptom burden was measured on symptom-based items from the Kansas City Cardiomyopathy Questionnaire (KCCQ). Higher KCCQ scores indicate better perceived health status. The KCCQ Symptom burden domain consists of 8 items and quantifies the frequency, severity and change over time with clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ symptom domain scores range from 0 to 100; A score of 50 is the threshold between unstable heart failure symptoms (<50) or stable heart failure symptoms (>=50).
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This outcomes measure pertains to patient-reported symptom burden.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 0 0
    Mean (Standard Deviation) [score on a scale]
    52.2
    (22.1)
    50.9
    (24.2)
    22. Secondary Outcome
    Title Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items.
    Description Patient-reported symptom burden was measured on symptom-based items from the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 16 weeks. Higher KCCQ scores indicate better perceived health status. The KCCQ Symptom burden domain consists of 8 items and quantifies the frequency, severity and change over time for clinical symptoms in heart failure, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea and patients' edema/swelling. KCCQ symptom domain scores range from 0 to 100; A score of 50 is the threshold between unstable heart failure symptoms (<50) or stable heart failure symptoms (>=50).
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    This outcomes measure pertains to patient-reported symptom burden.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 120 125 0 0
    Mean (Standard Error) [score on a scale]
    59.6
    (2.0)
    55.3
    (1.9)
    23. Secondary Outcome
    Title Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
    Description Baseline patient-reported PAIN INTENSITY was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale. Higher pain scores indicate more pain. Score range: 0-100; Scores greater than 50 indicate high pain.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Measure conducted among patients only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 0 0
    Mean (Standard Deviation) [score on a scale]
    46.8
    (10.8)
    45.1
    (10.5)
    24. Secondary Outcome
    Title Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
    Description Patient-reported PAIN INTENSITY was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale at 16 weeks. Higher pain scores indicate more pain. Score range: 0-100; Scores greater than 50 indicate high pain.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Measure conducted among patients only. One intervention participant and three usual care participants did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 122 0 0
    Mean (Standard Error) [score on a scale]
    45.8
    (0.9)
    47.4
    (0.9)
    25. Secondary Outcome
    Title Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
    Description Baseline patient-reported PAIN INTERFERENCE was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale. Higher pain interference scores indicate more interference in daily life. Score range: 0-100; Scores greater than 50 indicate high pain.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    This measure was conducted among patients only.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 207 0 0
    Mean (Standard Deviation) [score on a scale]
    55.4
    (10.9)
    54.5
    (10.7)
    26. Secondary Outcome
    Title Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
    Description Patient-reported PAIN INTERFERENCE was measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale at 16 weeks. Higher pain interference scores indicate more interference in daily life. Score range: 0-100; Scores greater than 50 indicate high pain.
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Conducted among patients only. One intervention participant and three usual care participants did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 122 0 0
    Mean (Standard Error) [score on a scale]
    54.3
    (0.9)
    57.7
    (0.9)
    27. Secondary Outcome
    Title Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
    Description Baseline patient-reported health care utilization - Number of Days in Hospital, last two months - was measured on the Resource Use Questionnaire. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Days in Hospital is 0 Days to 60 Days (last/previous two months prior to this measure).
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Patient resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 206 0 0
    Mean (95% Confidence Interval) [days]
    2.59
    2.75
    28. Secondary Outcome
    Title Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
    Description Patient-reported health care utilization - Number of Days in Hospital, last two months - was measured on the Resource Use Questionnaire at 16 weeks. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Days in Hospital is 0 Days to 60 Days (last/previous two months prior to this measure).
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Patient resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients. One intervention participant and one usual care participant did not provide sufficient responses to contribute to this outcomes measure at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 124 0 0
    Mean (95% Confidence Interval) [days]
    1.51
    1.29
    29. Secondary Outcome
    Title Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
    Description Baseline patient-reported health care utilization - Number of Emergency Department Visits, last two months - was measured on the Resource Use Questionnaire. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Visits to ED is 0 Visits to 60 Visits (in the last/previous two months prior to this measure).
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    Patient resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients. One participant in the Usual Care group did not respond to this survey item.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 208 206 0 0
    Mean (95% Confidence Interval) [visits]
    0.3
    0.28
    30. Secondary Outcome
    Title Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
    Description Patient-reported health care utilization - Number of Emergency Department Visits, last two months - was measured on the Resource Use Questionnaire at 16 weeks. This measure is an investigator-developed instrument to capture number of Inpatient days, ICU days, ED visits, hospice use, palliative care provider visits, AD completion, and DNR orders. The possible range of Visits to ED is 0 Visits to 60 Visits (in the last/previous two months prior to this measure).
    Time Frame 16 weeks

    Outcome Measure Data

    Analysis Population Description
    Patient resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients. One intervention participant did not provide sufficient responses to contribute to this outcomes measure score at 16 weeks.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    Measure Participants 119 125 0 0
    Mean (95% Confidence Interval) [visits]
    0.17
    0.19

    Adverse Events

    Time Frame Baseline through 41 months
    Adverse Event Reporting Description All cause mortality: Patients - 41 were lost to follow-up & 39 withdrew among 208 patients enrolled and allocated to the intervention group; 61 were lost to follow-up & 9 withdrew of the 207 patients enrolled and allocated to the usual care group. Caregivers - 31 were lost to follow-up & 19 withdrew of the 82 caregivers enrolled and allocated to the intervention group; 19 were lost to follow-up & 7 withdrew of the 76 caregivers enrolled and allocated to the usual care group.
    Arm/Group Title Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Arm/Group Description Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death. The PNC uses the manualized curriculum: "Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families". Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines. Usual HF Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
    All Cause Mortality
    Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/208 (3.8%) 12/207 (5.8%) 0/82 (0%) 0/76 (0%)
    Serious Adverse Events
    Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/208 (0%) 0/207 (0%) 0/82 (0%) 0/76 (0%)
    Other (Not Including Serious) Adverse Events
    Active Intervention for Patients Usual HF Care for Patients Active Intervention for Caregivers Usual HF Care for Caregivers
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/208 (0%) 0/207 (0%) 0/82 (0%) 0/76 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Marie A. Bakitas, DNSc, NP-C, FAAN
    Organization The University of Alabama at Birmingham, School of Nursing
    Phone (205) 934-5277
    Email mbakitas@uab.edu
    Responsible Party:
    Marie Anne Bakitas, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT02505425
    Other Study ID Numbers:
    • X140813007
    First Posted:
    Jul 22, 2015
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022