Trial Outcomes & Findings for ENABLE CHF-PC (Comprehensive Heartcare For Patients and Caregivers) (NCT NCT02505425)

NCT ID: NCT02505425

Last Updated: 2022-01-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

573 participants

Primary outcome timeframe

Baseline

Results posted on

2022-01-18

Participant Flow

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).

Participant milestones

Participant milestones
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Overall Study
STARTED
208
207
82
76
Overall Study
COMPLETED
120
125
32
50
Overall Study
NOT COMPLETED
88
82
50
26

Reasons for withdrawal

Reasons for withdrawal
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Overall Study
Lost to Follow-up
41
61
31
19
Overall Study
Withdrawal by Subject
39
9
19
7
Overall Study
Death
8
12
0
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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
n=573 Participants
Total of all reporting groups
Sex: Female, Male
Female
97 Participants
n=5 Participants
97 Participants
n=7 Participants
73 Participants
n=5 Participants
62 Participants
n=4 Participants
329 Participants
n=21 Participants
Age, Continuous
63.5 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
64.1 Years
STANDARD_DEVIATION 9.1 • n=7 Participants
58.2 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
57.6 Years
STANDARD_DEVIATION 10.8 • n=4 Participants
60.85 Years
STANDARD_DEVIATION 10.1 • n=21 Participants
Sex: Female, Male
Male
111 Participants
n=5 Participants
110 Participants
n=7 Participants
9 Participants
n=5 Participants
14 Participants
n=4 Participants
244 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
113 Participants
n=5 Participants
113 Participants
n=7 Participants
46 Participants
n=5 Participants
36 Participants
n=4 Participants
308 Participants
n=21 Participants
Race (NIH/OMB)
White
92 Participants
n=5 Participants
92 Participants
n=7 Participants
32 Participants
n=5 Participants
38 Participants
n=4 Participants
254 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
10 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
Region of Enrollment
United States
208 Participants
n=5 Participants
207 Participants
n=7 Participants
82 Participants
n=5 Participants
76 Participants
n=4 Participants
573 Participants
n=21 Participants

PRIMARY outcome

Timeframe: Baseline

Population: This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
54.2 score on a scale
Standard Deviation 20.5
51.1 score on a scale
Standard Deviation 21.5

PRIMARY outcome

Timeframe: 16 weeks

Population: This measure pertains to Patient Quality of Life (QOL) using the KCCQ. Caregiver QOL was analyzed using a different measure.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=120 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=125 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Quality of Life as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
59.7 score on a scale
Standard Error 1.8
54.8 score on a scale
Standard Error 1.8

PRIMARY outcome

Timeframe: Baseline

Population: This measure pertains to Patient Quality of Life (QOL). Caregiver QOL was analyzed using a different measure.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
36.8 score on a scale
Standard Deviation 9.3
36.1 score on a scale
Standard Deviation 9.7

PRIMARY outcome

Timeframe: 16 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=123 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Quality of Life as Measured on the Functional Assessment of Chronic Illness Therapy-Palliative Care Scale (FACIT-PAL-14)
38.5 score on a scale
Standard Error 0.8
36.8 score on a scale
Standard Error 0.8

PRIMARY outcome

Timeframe: Baseline

Population: This measure pertains to Patient \& Caregiver Mood - Anxiety HADS

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
6.6 score on a scale
Standard Deviation 3.5
6.8 score on a scale
Standard Deviation 3.7
3.9 score on a scale
Standard Deviation 3.1
3.7 score on a scale
Standard Deviation 2.9

PRIMARY outcome

Timeframe: 16 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=122 Participants
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Patient & Caregiver Mood - Anxiety - as Measured on the Hospital Anxiety and Depression Scale (HADS)
6.6 score on a scale
Standard Error 0.3
7.1 score on a scale
Standard Error 0.3
3.8 score on a scale
Standard Error 0.5
4.2 score on a scale
Standard Error 0.4

PRIMARY outcome

Timeframe: Baseline

Population: This measure pertains to Patient and Caregiver Mood - Depression Scale.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
5.7 score on a scale
Standard Deviation 4.3
5.8 score on a scale
Standard Deviation 4.2
4.7 score on a scale
Standard Deviation 3.1
4.8 score on a scale
Standard Deviation 3.3

PRIMARY outcome

Timeframe: 16 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=122 Participants
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Patient & Caregiver Mood - Depression - as Measured on the Hospital Anxiety and Depression Scale (HADS)
4.9 score on a scale
Standard Error 0.3
5.6 score on a scale
Standard Error 0.3
4.5 score on a scale
Standard Error 0.5
4.4 score on a scale
Standard Error 0.4

PRIMARY outcome

Timeframe: Baseline

Population: This measure was conducted among Caregiver participants only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
65.0 score on a scale
Standard Deviation 12.9
60.7 score on a scale
Standard Deviation 10.4

PRIMARY outcome

Timeframe: 16 weeks

Population: This measure conducted among Caregiver participants only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Caregiver Quality of Life as Measured on the Bakas Caregiving Outcomes Scale (BCOS)
66.9 score on a scale
Standard Error 2.1
63.9 score on a scale
Standard Error 1.7

PRIMARY outcome

Timeframe: Baseline

Population: Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
20.1 score on a scale
Standard Error 2.8
20.0 score on a scale
Standard Error 2.9

PRIMARY outcome

Timeframe: 16 weeks

Population: Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Caregiver Burden - Objective - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
20.2 score on a scale
Standard Error 0.5
19.7 score on a scale
Standard Error 0.4

PRIMARY outcome

Timeframe: Baseline

Population: Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
11.6 score on a scale
Standard Deviation 2.5
11.6 score on a scale
Standard Deviation 1.8

PRIMARY outcome

Timeframe: 16 weeks

Population: Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Caregiver Burden - Demand - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
11.1 score on a scale
Standard Error 0.4
11.6 score on a scale
Standard Error 0.3

PRIMARY outcome

Timeframe: Baseline

Population: Montgomery Borgatta Caregiver Burden Scale (MBCB) was conducted among Caregivers only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Caregiver Burden - Stress - as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
12.3 score on a scale
Standard Deviation 2.4
12.3 score on a scale
Standard Deviation 2.2

PRIMARY outcome

Timeframe: 16 weeks

Population: Montgomery Borgatta Caregiver Burden Scale (MBCB) was measured among Caregivers only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Caregiver Burden - Stress- as Measured on the Montgomery Borgatta Caregiver Burden Scale (MBCB)
11.7 score on a scale
Standard Error 0.4
12.2 score on a scale
Standard Error 0.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
38.6 score on a scale
Standard Deviation 8.0
38.1 score on a scale
Standard Deviation 8.0
46.9 score on a scale
Standard Deviation 8.9
48.0 score on a scale
Standard Deviation 8.6

SECONDARY outcome

Timeframe: 16 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=122 Participants
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Patient and Caregiver PHYSICAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
39.4 score on a scale
Standard Error 0.7
38.8 score on a scale
Standard Error 0.7
46.9 score on a scale
Standard Error 8.9
48.0 score on a scale
Standard Error 8.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
n=82 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=76 Participants
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.
Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
45.8 score on a scale
Standard Deviation 8.6
44.9 score on a scale
Standard Deviation 8.7
48.5 score on a scale
Standard Deviation 7.1
48.1 score on a scale
Standard Deviation 7.9

SECONDARY outcome

Timeframe: 16 weeks

Population: One intervention patient and three usual care patients did not provide sufficient responses to contribute to this outcomes measure score at 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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=122 Participants
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.
Active Intervention for Caregivers
n=32 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
n=50 Participants
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.
Patient and Caregiver MENTAL Health Status as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Global Health-10
45.9 score on a scale
Standard Error 0.7
44.7 score on a scale
Standard Error 0.7
47.7 score on a scale
Standard Error 1.0
48.2 score on a scale
Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline

Population: This outcomes measure pertains to patient-reported symptom burden.

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).

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Symptom Burden as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items
52.2 score on a scale
Standard Deviation 22.1
50.9 score on a scale
Standard Deviation 24.2

SECONDARY outcome

Timeframe: 16 weeks

Population: This outcomes measure pertains to patient-reported symptom burden.

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).

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=120 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=125 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Symptom Burden Items as Measured on the Kansas City Cardiomyopathy Questionnaire (KCCQ) Symptom Items.
59.6 score on a scale
Standard Error 2.0
55.3 score on a scale
Standard Error 1.9

SECONDARY outcome

Timeframe: Baseline

Population: Measure conducted among patients only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
46.8 score on a scale
Standard Deviation 10.8
45.1 score on a scale
Standard Deviation 10.5

SECONDARY outcome

Timeframe: 16 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=122 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Pain Intensity as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 3-item Pain Intensity Scale
45.8 score on a scale
Standard Error 0.9
47.4 score on a scale
Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline

Population: This measure was conducted among patients only.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=207 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
55.4 score on a scale
Standard Deviation 10.9
54.5 score on a scale
Standard Deviation 10.7

SECONDARY outcome

Timeframe: 16 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=122 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Pain Interference as Measured on the Patient-Reported Outcomes Measurement Information System (PROMIS) 2-item Pain Interference Scale
54.3 score on a scale
Standard Error 0.9
57.7 score on a scale
Standard Error 0.9

SECONDARY outcome

Timeframe: Baseline

Population: Patient resource use (e.g. hospital admissions and days, emergency visits) was only captured among patients.

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).

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=206 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
2.59 days
Interval 1.64 to 4.07
2.75 days
Interval 1.74 to 4.34

SECONDARY outcome

Timeframe: 16 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=124 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Resource Use - Days in Hospital - as Measured on the Investigator-developed Instrument
1.51 days
Interval 0.82 to 2.77
1.29 days
Interval 0.71 to 2.38

SECONDARY outcome

Timeframe: Baseline

Population: 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.

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).

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=208 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=206 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
0.3 visits
Interval 0.23 to 0.4
0.28 visits
Interval 0.21 to 0.37

SECONDARY outcome

Timeframe: 16 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure
Active Intervention for Patients
n=119 Participants
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Patients
n=125 Participants
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.
Active Intervention for Caregivers
Behavioral: behavioral support Usual HF Care + ENABLE CHF-PC Behavioral Support: ENABLE CHF-PC includes: 1. In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment. 2. 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 HF Care for Caregivers
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.
Patient Resource Use - Emergency Department Visits - as Measured on the Investigator-developed Instrument
0.17 visits
Interval 0.11 to 1.26
0.19 visits
Interval 0.13 to 0.28

Adverse Events

Active Intervention for Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths

Usual HF Care for Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths

Active Intervention for Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Usual HF Care for Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marie A. Bakitas, DNSc, NP-C, FAAN

The University of Alabama at Birmingham, School of Nursing

Phone: (205) 934-5277

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place