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Palliative Care in Heart Failure (PAL-HF)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01589601
First received: April 24, 2012
Last updated: April 28, 2017
Last verified: April 2017
Results First Received: February 27, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Usual Care + Palliative Care   Usual Heart Failure Care
STARTED   75   75 
COMPLETED   28   26 
NOT COMPLETED   47   49 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Usual Care + Palliative Care   Usual Heart Failure Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 75   75   150 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 71.9  (12.41)   69.8  (13.43)   70.8  (12.93) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      33  44.0%      38  50.7%      71  47.3% 
Male      42  56.0%      37  49.3%      79  52.7% 
Region of Enrollment 
[Units: Participants]
     
United States   75   75   150 


  Outcome Measures
  Show All Outcome Measures

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

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

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

4.  Secondary:   After-Death Bereaved Family Member Interview - Hospice Version   [ Time Frame: 6 weeks after patient's death ]

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

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

7.  Secondary:   Utilization and Cost Measured by the Aggregate Cost of Care   [ Time Frame: time of randomization until end of follow-up, approximately 3.5 years ]
Results not yet reported.   Anticipated Reporting Date:   07/2017  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: joseph.rogers@duke.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01589601     History of Changes
Other Study ID Numbers: Pro00032443
R01NR013428 ( U.S. NIH Grant/Contract )
Study First Received: April 24, 2012
Results First Received: February 27, 2017
Last Updated: April 28, 2017