Trial Outcomes & Findings for Palliative Care in Heart Failure (NCT NCT01589601)
NCT ID: NCT01589601
Last Updated: 2019-08-28
Results Overview
The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2019-08-28
Participant Flow
The duration of the intervention in PAL-HF is 6 months but patients in both groups were followed until death or until the end of the study (approximately 3.5 years). Please see the numbers "completed" in the "Overall Study" section.
Participant milestones
| Measure |
Usual Care + Palliative Care
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
47
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Palliative Care in Heart Failure
Baseline characteristics by cohort
| Measure |
Usual Care + Palliative Care
n=75 Participants
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
n=75 Participants
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 12.41 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 13.43 • n=7 Participants
|
70.8 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
75 participants
n=7 Participants
|
150 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: Participants that completed the baseline and 6 month KCCQ
The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status.
Outcome measures
| Measure |
Usual Care + Palliative Care
n=73 Participants
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
n=74 Participants
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ at Baseline
|
36.1 units on a scale
Standard Deviation 19.80
|
31.4 units on a scale
Standard Deviation 16.37
|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
KCCQ at 6 Months
|
63.1 units on a scale
Standard Deviation 20.43
|
52.1 units on a scale
Standard Deviation 25.02
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: Participants who completed the baseline and 6 month FACIT-Pal.
The primary endpoint is health-related quality of life as measured by the FACIT-Pal. The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better.
Outcome measures
| Measure |
Usual Care + Palliative Care
n=74 Participants
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
n=74 Participants
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
|---|---|---|
|
Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)
FACIT-Pal at Baseline
|
120.6 units on a scale
Standard Deviation 27.03
|
118.0 units on a scale
Standard Deviation 25.12
|
|
Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)
FACIT-Pal at 6 months
|
136.5 units on a scale
Standard Deviation 28.64
|
125.8 units on a scale
Standard Deviation 30.69
|
SECONDARY outcome
Timeframe: Baseline (2 weeks post hospital discharge), 3 months, 6 monthsPopulation: Participants that completed the baseline, 3 month, and 6 month HADS.
Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months. Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status.
Outcome measures
| Measure |
Usual Care + Palliative Care
n=59 Participants
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
n=54 Participants
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
HADS Anxiety at 2 weeks
|
5.7 units on a scale
Standard Deviation 4.85
|
7.2 units on a scale
Standard Deviation 4.36
|
|
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
HADS Anxiety at 3 months
|
5.0 units on a scale
Standard Deviation 4.7
|
6.0 units on a scale
Standard Deviation 4.16
|
|
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
HADS Anxiety at 6 months
|
3.7 units on a scale
Standard Deviation 3.96
|
6.2 units on a scale
Standard Deviation 4.75
|
|
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
HADS Depression at 2 weeks
|
6.0 units on a scale
Standard Deviation 3.90
|
7.3 units on a scale
Standard Deviation 4.34
|
|
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
HADS Depression at 3 months
|
5.6 units on a scale
Standard Deviation 4.12
|
6.3 units on a scale
Standard Deviation 4.23
|
|
Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
HADS Depression at 6 months
|
4.6 units on a scale
Standard Deviation 3.63
|
6.4 units on a scale
Standard Deviation 4.29
|
SECONDARY outcome
Timeframe: 6 weeks after patient's deathPopulation: Overall rating scale 6 weeks after patient's death.
A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care).
Outcome measures
| Measure |
Usual Care + Palliative Care
n=21 Participants
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
n=26 Participants
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
|---|---|---|
|
After-Death Bereaved Family Member Interview - Hospice Version
|
9.50 units on a scale
Standard Deviation 0.548
|
8.87 units on a scale
Standard Deviation 2.078
|
SECONDARY outcome
Timeframe: Baseline (2 weeks post hospital discharge), 3 months, 6 monthsPopulation: Participants that completed the baseline, 3 month, and 6 month FACIT-Sp.
Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions.
Outcome measures
| Measure |
Usual Care + Palliative Care
n=57 Participants
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
n=55 Participants
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
|---|---|---|
|
Change in FACIT-Sp
FACIT-Sp at 2 weeks
|
36.4 units on a scale
Standard Deviation 9.62
|
35.3 units on a scale
Standard Deviation 8.75
|
|
Change in FACIT-Sp
FACIT-Sp at 3 months
|
37.1 units on a scale
Standard Deviation 9.98
|
35.9 units on a scale
Standard Deviation 9.77
|
|
Change in FACIT-Sp
FACIT-Sp at 6 months
|
39.6 units on a scale
Standard Deviation 8.08
|
35.5 units on a scale
Standard Deviation 10.27
|
SECONDARY outcome
Timeframe: time of randomization until end of follow-up, approximately 3.5 yearsPopulation: Data not collected.
The investigators will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study. Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (2 weeks post hospital discharge), 6 monthsWe evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.
Outcome measures
| Measure |
Usual Care + Palliative Care
n=75 Participants
Patients will receive an interdisciplinary, multicomponent palliative care intervention combined with state of the art heart failure management designed to assess and manage the multiple domains of quality of life at the end of life for patients with advanced heart failure, including physical symptoms, psychosocial concerns, and spiritual concerns, and to facilitate advance care planning.
Usual heart failure care + interdisciplinary palliative care: Usual heart failure care + interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
|
Usual Heart Failure Care
n=75 Participants
Patients will be managed by a cardiologist-directed team with expertise in the diagnosis and treatment of heart failure. Until discharge, inpatient care will focus on symptom relief and initiation of evidence-based therapies. Additional goals of care will include treatment of co-morbidities and patient education designed to assist with self-management techniques. However, after discharge, which is where the study actually takes place, patients will only receive outpatient follow-up with a heart failure cardiologist or nurse practitioner who will focus on medication titration to evidence-based dosing, titration of diuretic therapy, assessment of compliance with medical and dietary regimens, and serial monitoring of end-organ function.
|
|---|---|---|
|
Utilization and Cost Measured by Hospital Readmissions
All-cause readmissions
|
61 Number of readmissions
|
69 Number of readmissions
|
|
Utilization and Cost Measured by Hospital Readmissions
Cardiosvascular readmissions
|
50 Number of readmissions
|
47 Number of readmissions
|
|
Utilization and Cost Measured by Hospital Readmissions
Heart failure readmissions
|
36 Number of readmissions
|
35 Number of readmissions
|
|
Utilization and Cost Measured by Hospital Readmissions
Non-Cardiovascular readmissions
|
11 Number of readmissions
|
22 Number of readmissions
|
Adverse Events
Usual Care + Palliative Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 40 deaths
Usual Heart Failure Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 38 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place