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.
COMPLETED
NA
573 participants
Baseline
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
| 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
| 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselineBaseline 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
| 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 weeksPopulation: 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
| 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: BaselineBaseline 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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: BaselinePopulation: 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
| 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 weeksPopulation: 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
| 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
Usual HF Care for Patients
Active Intervention for Caregivers
Usual HF Care for Caregivers
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place