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Palliative Care in Heart Failure (PAL-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01589601
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Heart Failure
Heart Diseases
Cardiovascular Diseases
Interventions Behavioral: Usual heart failure care
Behavioral: Interdisciplinary palliative care
Enrollment 150

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.
Pre-assignment Details  
Arm/Group Title Usual Care + Palliative Care Usual Heart Failure Care
Hide 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
Arm/Group Title Usual Care + Palliative Care Usual Heart Failure Care Total
Hide 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 Number of Baseline Participants 75 75 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  28.0%
25
  33.3%
46
  30.7%
>=65 years
54
  72.0%
50
  66.7%
104
  69.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants 75 participants 150 participants
71.9  (12.41) 69.8  (13.43) 70.8  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 75 participants 150 participants
Female
33
  44.0%
38
  50.7%
71
  47.3%
Male
42
  56.0%
37
  49.3%
79
  52.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 75 participants 75 participants 150 participants
75 75 150
1.Primary Outcome
Title Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants that completed the baseline and 6 month KCCQ
Arm/Group Title Usual Care + Palliative Care Usual Heart Failure Care
Hide 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.
Overall Number of Participants Analyzed 73 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
KCCQ at Baseline Number Analyzed 73 participants 74 participants
36.1  (19.80) 31.4  (16.37)
KCCQ at 6 Months Number Analyzed 41 participants 40 participants
63.1  (20.43) 52.1  (25.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1641
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments 6 Months
Statistical Test of Hypothesis P-Value 0.0299
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.4938
Confidence Interval (2-Sided) 95%
0.9406 to 18.0470
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the baseline and 6 month FACIT-Pal.
Arm/Group Title Usual Care + Palliative Care Usual Heart Failure Care
Hide 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.
Overall Number of Participants Analyzed 74 74
Mean (Standard Deviation)
Unit of Measure: units on a scale
FACIT-Pal at Baseline Number Analyzed 74 participants 74 participants
120.6  (27.03) 118.0  (25.12)
FACIT-Pal at 6 months Number Analyzed 41 participants 40 participants
136.5  (28.64) 125.8  (30.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5531
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0350
Comments [Not Specified]
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
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 59 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
HADS Anxiety at 2 weeks Number Analyzed 59 participants 54 participants
5.7  (4.85) 7.2  (4.36)
HADS Anxiety at 3 months Number Analyzed 46 participants 43 participants
5.0  (4.7) 6.0  (4.16)
HADS Anxiety at 6 months Number Analyzed 41 participants 39 participants
3.7  (3.96) 6.2  (4.75)
HADS Depression at 2 weeks Number Analyzed 59 participants 54 participants
6.0  (3.90) 7.3  (4.34)
HADS Depression at 3 months Number Analyzed 46 participants 43 participants
5.6  (4.12) 6.3  (4.23)
HADS Depression at 6 months Number Analyzed 41 participants 39 participants
4.6  (3.63) 6.4  (4.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments HADS Anxiety 2 weeks
Statistical Test of Hypothesis P-Value 0.1592
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2436
Confidence Interval (2-Sided) 95%
-2.9817 to 0.4945
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments HADS Anxiety 3 months
Statistical Test of Hypothesis P-Value 0.3657
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7946
Confidence Interval (2-Sided) 95%
-2.5285 to 0.9393
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments HADS Anxiety 6 months
Statistical Test of Hypothesis P-Value 0.0480
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.8269
Confidence Interval (2-Sided) 95%
-3.6375 to -0.0164
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments HADS Depression at 2 weeks
Statistical Test of Hypothesis P-Value 0.2372
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9097
Confidence Interval (2-Sided) 95%
-2.4253 to 0.6058
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments HADS Depression 3 months
Statistical Test of Hypothesis P-Value 0.4237
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6592
Confidence Interval (2-Sided) 95%
-2.2862 to 0.9678
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments HADS Depression at 6 months
Statistical Test of Hypothesis P-Value 0.0202
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9379
Confidence Interval (2-Sided) 95%
-3.5672 to -0.3085
Estimation Comments [Not Specified]
4.Secondary Outcome
Title After-Death Bereaved Family Member Interview - Hospice Version
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Overall rating scale 6 weeks after patient's death.
Arm/Group Title Usual Care + Palliative Care Usual Heart Failure Care
Hide 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.
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.50  (0.548) 8.87  (2.078)
5.Secondary Outcome
Title Change in FACIT-Sp
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
FACIT-Sp at 2 weeks Number Analyzed 57 participants 55 participants
36.4  (9.62) 35.3  (8.75)
FACIT-Sp at 3 months Number Analyzed 46 participants 43 participants
37.1  (9.98) 35.9  (9.77)
FACIT-Sp at 6 months Number Analyzed 41 participants 38 participants
39.6  (8.08) 35.5  (10.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments FACIT-Sp at 2 weeks
Statistical Test of Hypothesis P-Value 0.5857
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9413
Confidence Interval (2-Sided) 95%
-2.4666 to 4.3493
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments FACIT-Sp at 3 months
Statistical Test of Hypothesis P-Value 0.5655
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.1174
Confidence Interval (2-Sided) 95%
-2.7246 to 4.9594
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
Type of Statistical Test Superiority
Comments FACIT-Sp at 6 months
Statistical Test of Hypothesis P-Value 0.0271
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.9809
Confidence Interval (2-Sided) 95%
0.4581 to 7.5036
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Utilization and Cost Measured by the Aggregate Cost of Care
Hide Description

We 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 Not Reported
7.Secondary Outcome
Title Utilization and Cost Measured by Hospital Readmissions
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care + Palliative Care Usual Heart Failure Care
Hide 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.
Overall Number of Participants Analyzed 75 75
Measure Type: Number
Unit of Measure: Number of readmissions
All-cause readmissions 61 69
Cardiosvascular readmissions 50 47
Heart failure readmissions 36 35
Non-Cardiovascular readmissions 11 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
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 [Not Specified]
Method Poisson regression
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
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 [Not Specified]
Method Poisson regression
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
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 [Not Specified]
Method Poisson regression
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Usual Care + Palliative Care, Usual Heart Failure Care
Comments [Not Specified]
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 [Not Specified]
Method Poisson regression
Comments [Not Specified]
Time Frame [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   40/75 (53.33%)   38/75 (50.67%) 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care + Palliative Care Usual Heart Failure Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care + Palliative Care Usual Heart Failure Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/75 (0.00%)   0/75 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Joseph G. Rogers, MD
Organization: Duke University Medical Center
Phone: 919-681-1370
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01589601     History of Changes
Other Study ID Numbers: Pro00032443
R01NR013428 ( U.S. NIH Grant/Contract )
First Submitted: April 24, 2012
First Posted: May 2, 2012
Results First Submitted: February 27, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017