Palliative Care in Heart Failure (PAL-HF)
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| ClinicalTrials.gov Identifier: NCT01589601 |
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Recruitment Status :
Completed
First Posted : May 2, 2012
Results First Posted : July 24, 2017
Last Update Posted : August 28, 2019
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| 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 |
|---|---|---|
 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 | |
|---|---|---|---|---|
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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 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 75 participants | 75 participants | 150 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
21 28.0%
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25 33.3%
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46 30.7%
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| >=65 years |
54 72.0%
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50 66.7%
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104 69.3%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 75 participants | 75 participants | 150 participants | |
| 71.9 (12.41) | 69.8 (13.43) | 70.8 (12.93) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 75 participants | 75 participants | 150 participants | |
| Female |
33 44.0%
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38 50.7%
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71 47.3%
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| Male |
42 56.0%
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37 49.3%
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79 52.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 75 participants | 75 participants | 150 participants |
| 75 | 75 | 150 | ||
| Name/Title: | Joseph G. Rogers, MD |
| Organization: | Duke University Medical Center |
| Phone: | 919-681-1370 |
| EMail: | joseph.rogers@duke.edu |
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01589601 |
| 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: | August 28, 2019 |