PAL-HF: Palliative Care in Heart Failure

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01589601
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

The primary aim of the PAL-HF trial is to assess the impact of an interdisciplinary palliative care intervention combined with usual heart failure management on health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Heart Diseases; Cardiovascular Diseases	Behavioral: Usual heart failure care; Behavioral: Interdisciplinary palliative care	N/A

Detailed Description

Heart failure currently affects over 5 million Americans. Symptomatic patients have a median life expectancy of less than 5 years and those with late-stage disease have 1-year mortality rates approaching 90%. Despite recent therapeutic advances that reduce morbidity and mortality, heart failure continues to cause enormous suffering. Patients with advanced disease suffer not only from the physical effects of the illness, but also from psychosocial and spiritual distress. In addition, heart failure costs more than $34 billion annually to the healthcare system and a disproportionate amount is spent on patients in the last 6 months of life when some of the treatments may be either ineffective or undesired. Selected patients are candidates for aggressive treatments such as cardiac transplantation or mechanical circulatory support, but the application of these therapies to the broader heart failure population is limited by resource scarcity and their untested usefulness in older patients with significant co-morbidities.

The progressive nature of heart failure coupled with high mortality rates and poor quality of life mandates greater attention to palliative care as a routine component of heart failure management. Patients with advanced heart failure, particularly the elderly and those with significant co-morbidities, ought to be ideal candidates for palliative care that aims to relieve suffering and improve quality of life. Yet, several challenges have limited the use of palliative care approaches in heart failure:

1. Determination of Prognosis. Several validated multivariable models have been developed to predict survival, yet considerable uncertainty remains and physicians are frequently unsure whether they are caring for a patient near or far from the end of life. Patients have an even harder time and are typically overly optimistic about their survival relative to that observed or predicted by multivariable models.

2. Timing of Implementation. This prognostic uncertainty and the highly variable disease trajectories of individual patients with heart failure pose a challenge as to when palliative care interventions ought to be implemented. The most appropriate time to introduce palliative care concepts, particularly with regard to end-of-life planning, remains undefined and is linked to patient prognosis and preferences.

3. Untested Interventions. There is limited evidence from randomized controlled trials of palliative care interventions in heart failure and the majority focus on resuscitation preferences. Further, practice guidelines from major cardiovascular societies are limited on this subject.

4. Lack of Palliative Care Training of Cardiovascular Specialists . The education of cardiovascular specialists typically excludes formalized training in the principles and practice of palliative care.

Given these limitations, a properly designed and powered study is required to determine whether a multidimensional palliative care intervention in addition to usual care improves health-related outcomes relative to usual care alone in advanced heart failure patients with a highly probable short-term mortality.

PAL-HF is prospective, controlled, unblinded, 2-arm, single-center clinical trial of approximately 200 advanced heart failure patients with >50% predicted 6-month mortality randomized to usual, state of the art heart failure care or usual care combined with the PAL-HF intervention.

Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:

• Usual advanced HF care

• Usual advanced HF 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.

The primary endpoint will be health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Functional Assessment of Chronic Illness Therapy with Palliative Care Subscale (FACIT-Pal) score at 6 months

The duration of the intervention in PAL-HF is 6 months, but patients in both groups will be followed until death, or the end of the study.

The study will be completed in both arms of the trial with a post-death interview with the caregiver.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Palliative Care in Heart Failure (PAL-HF)
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No 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.
Active Comparator: 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.	Behavioral: Usual heart failure care; Usual heart failure 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.; Other Names: Palliative Care Palliative Medicine Supportive Care ; Behavioral: Interdisciplinary palliative 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.

Outcome Measures

Primary Outcome Measures

1. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) [Baseline, 6 months]

   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.

2. Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal) [Baseline, 6 months]

   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.

Secondary Outcome Measures

1. Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety [Baseline (2 weeks post hospital discharge), 3 months, 6 months]

   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.

2. After-Death Bereaved Family Member Interview - Hospice Version [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).

3. Change in FACIT-Sp [Baseline (2 weeks post hospital discharge), 3 months, 6 months]

   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.

4. Utilization and Cost Measured by the Aggregate Cost of Care [time of randomization until end of follow-up, approximately 3.5 years]

   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.

5. Utilization and Cost Measured by Hospital Readmissions [Baseline (2 weeks post hospital discharge), 6 months]

   We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Duke University Hospital inpatient adults

• Hospitalization for acute decompensated heart failure

• Dyspnea (shortness of breath) at rest or minimal exertion plus at least 1 sign of volume overload

• Previous heart failure hospitalization within the past 1 year

• At significant risk of dying from heart failure in the next 6 months

• Anticipated discharge from hospital with anticipated ability to return to outpatient follow-up appointments

Exclusion Criteria:

• Are not an inpatient at Duke University Hospital

• Acute coronary syndrome within 30 days

• Cardiac resynchronization therapy (CRT) within the past 3 months or current plan to implant CRT device

• Active myocarditis, constrictive pericarditis

• Severe stenotic valvular disease amenable to surgical intervention

• Anticipated heart transplant or ventricular assist device within 6 months

• Renal replacement therapy

• Non-cardiac terminal illness

• Women who are pregnant or planning to become pregnant

• Inability to comply with study protocol

• Are not proficient in the English language

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Hospital	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Joseph G. Rogers, MD, Duke University Medical Center - DCRI

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hayden D, Pauler DK, Schoenfeld D. An estimator for treatment comparisons among survivors in randomized trials. Biometrics. 2005 Mar;61(1):305-10.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01589601
• Other Study ID Numbers: Pro00032443; R01NR013428
• First Posted: May 2, 2012
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Duke University: Congestive Heart Failure; Heart Failure; Palliative Care; Palliative Medicine
• Additional relevant MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	75	75
COMPLETED	28	26
NOT COMPLETED	47	49

Baseline Characteristics

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	75	75	150
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 28%	25 33.3%	46 30.7%
>=65 years	54 72%	50 66.7%	104 69.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.9 (12.41)	69.8 (13.43)	70.8 (12.93)
Sex: Female, Male (Count of Participants)
Female	33 44%	38 50.7%	71 47.3%
Male	42 56%	37 49.3%	79 52.7%
Region of Enrollment (participants) [Number]
United States	75 100%	75 100%	150 100%

Outcome Measures

1. Primary Outcome

Title	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description	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.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Participants that completed the baseline and 6 month KCCQ

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Measure Participants	73	74
KCCQ at Baseline	36.1 (19.80)	31.4 (16.37)
KCCQ at 6 Months	63.1 (20.43)	52.1 (25.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1641
	Comments
	Method	Mixed Models Analysis
	Comments	Baseline
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.8719
	Confidence Interval	(2-Sided) 95%; -2.0289 to 11.7728
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	6 Months
Statistical Test of Hypothesis	p-Value	0.0299
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.4938
	Confidence Interval	(2-Sided) 95%; 0.9406 to 18.0470
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)
Description	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.
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

Participants who completed the baseline and 6 month FACIT-Pal.

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Measure Participants	74	74
FACIT-Pal at Baseline	120.6 (27.03)	118.0 (25.12)
FACIT-Pal at 6 months	136.5 (28.64)	125.8 (30.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5531
	Comments
	Method	Mixed Models Analysis
	Comments	Baseline
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.7157
	Confidence Interval	(2-Sided) 95%; -6.3054 to 11.7368
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0350
	Comments
	Method	Mixed Models Analysis
	Comments	6 Months
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	11.7730
	Confidence Interval	(2-Sided) 95%; 0.8409 to 22.7052
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
Description	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.
Time Frame	Baseline (2 weeks post hospital discharge), 3 months, 6 months

Outcome Measure Data

Analysis Population Description

Participants that completed the baseline, 3 month, and 6 month HADS.

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Measure Participants	59	54
HADS Anxiety at 2 weeks	5.7 (4.85)	7.2 (4.36)
HADS Anxiety at 3 months	5.0 (4.7)	6.0 (4.16)
HADS Anxiety at 6 months	3.7 (3.96)	6.2 (4.75)
HADS Depression at 2 weeks	6.0 (3.90)	7.3 (4.34)
HADS Depression at 3 months	5.6 (4.12)	6.3 (4.23)
HADS Depression at 6 months	4.6 (3.63)	6.4 (4.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	HADS Anxiety 2 weeks
Statistical Test of Hypothesis	p-Value	0.1592
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.2436
	Confidence Interval	(2-Sided) 95%; -2.9817 to 0.4945
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	HADS Anxiety 3 months
Statistical Test of Hypothesis	p-Value	0.3657
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7946
	Confidence Interval	(2-Sided) 95%; -2.5285 to 0.9393
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	HADS Anxiety 6 months
Statistical Test of Hypothesis	p-Value	0.0480
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.8269
	Confidence Interval	(2-Sided) 95%; -3.6375 to -0.0164
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	HADS Depression at 2 weeks
Statistical Test of Hypothesis	p-Value	0.2372
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.9097
	Confidence Interval	(2-Sided) 95%; -2.4253 to 0.6058
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	HADS Depression 3 months
Statistical Test of Hypothesis	p-Value	0.4237
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6592
	Confidence Interval	(2-Sided) 95%; -2.2862 to 0.9678
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	HADS Depression at 6 months
Statistical Test of Hypothesis	p-Value	0.0202
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.9379
	Confidence Interval	(2-Sided) 95%; -3.5672 to -0.3085
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	After-Death Bereaved Family Member Interview - Hospice Version
Description	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).
Time Frame	6 weeks after patient's death

Outcome Measure Data

Analysis Population Description

Overall rating scale 6 weeks after patient's death.

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Measure Participants	21	26
Mean (Standard Deviation) [units on a scale]	9.50 (0.548)	8.87 (2.078)

5. Secondary Outcome

Title	Change in FACIT-Sp
Description	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.
Time Frame	Baseline (2 weeks post hospital discharge), 3 months, 6 months

Outcome Measure Data

Analysis Population Description

Participants that completed the baseline, 3 month, and 6 month FACIT-Sp.

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Measure Participants	57	55
FACIT-Sp at 2 weeks	36.4 (9.62)	35.3 (8.75)
FACIT-Sp at 3 months	37.1 (9.98)	35.9 (9.77)
FACIT-Sp at 6 months	39.6 (8.08)	35.5 (10.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	FACIT-Sp at 2 weeks
Statistical Test of Hypothesis	p-Value	0.5857
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.9413
	Confidence Interval	(2-Sided) 95%; -2.4666 to 4.3493
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	FACIT-Sp at 3 months
Statistical Test of Hypothesis	p-Value	0.5655
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.1174
	Confidence Interval	(2-Sided) 95%; -2.7246 to 4.9594
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	FACIT-Sp at 6 months
Statistical Test of Hypothesis	p-Value	0.0271
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.9809
	Confidence Interval	(2-Sided) 95%; 0.4581 to 7.5036
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Utilization and Cost Measured by the Aggregate Cost of Care
Description	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.
Time Frame	time of randomization until end of follow-up, approximately 3.5 years

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Measure Participants	0	0

7. Secondary Outcome

Title	Utilization and Cost Measured by Hospital Readmissions
Description	We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.
Time Frame	Baseline (2 weeks post hospital discharge), 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care + Palliative Care	Usual Heart Failure Care
Arm/Group Description	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.	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.
Measure Participants	75	75
All-cause readmissions	61	69
Cardiosvascular readmissions	50	47
Heart failure readmissions	36	35
Non-Cardiovascular readmissions	11	22

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	All-cause readmissions, Poisson regression with log link and Pearson scale
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	Poisson regression
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	Cardiovascular readmissions, Poisson regression with log link and Pearson scale
Statistical Test of Hypothesis	p-Value	0.80
	Comments
	Method	Poisson regression
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	Heart failure readmissions, Poisson regression with log link and Pearson scale
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Poisson regression
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Usual Care + Palliative Care, Usual Heart Failure Care
	Comments
	Type of Statistical Test	Superiority
	Comments	Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Poisson regression
	Comments

Adverse Events

Adverse Event Reporting Description	Per IRB approved protocol adverse events that required MedWatch reporting were the only adverse events collected.
Arm/Group Title	Usual Care + Palliative Care		Usual Heart Failure Care
Arm/Group Description	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.		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.
All Cause Mortality
	Usual Care + Palliative Care		Usual Heart Failure Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/75 (53.3%)		38/75 (50.7%)
Serious Adverse Events
	Usual Care + Palliative Care		Usual Heart Failure Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care + Palliative Care		Usual Heart Failure Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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