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Focused Palliative Care Intervention in Advanced Heart Failure

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: NCT02805712
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Akshay Desai, MD, Brigham and Women's Hospital

Brief Summary:
This small pilot study will be assessing the the impact of a standardized, social-worker led, longitudinal palliative care intervention on alignment of patient and physician understanding of prognosis and goals of care. Secondary objectives include assessing the impact of this intervention on documentation of advanced care planning and end of life preferences, symptom burden, quality of life and health care utilization.

Condition or disease Intervention/treatment Phase
Heart Failure Quality of Life Other: Verbal Information and Discussion Other: Control Not Applicable

Detailed Description:

Patients will be assigned to one of two groups a) longitudinal goals of care discussion led by a palliative care-trained social worker or b) usual care + written information regarding advanced directives. The intervention group will be enrolled in the hospital and then be followed longitudinally for 3 months by a palliative care-trained social worker who will shepherd a conversation around prognosis, expectations, and goals of care. The results of these conversations will be documented in the electronic medical record and shared with the clinical team. Clinical symptoms that are identified during these conversations will be evaluated by a Palliative Care Physician who will relay suggestions regarding management to the primary treating clinician. Baseline surveys will assess prognostic awareness, symptom burden, anxiety, depression, and quality of life for both groups. At the conclusion of the study, an individualized follow-up plan will be devised for each patient based on a needs assessment by the study social worker.

Patients assigned to the control/usual care arm will complete the same series of questionnaires as those assigned to the intervention group and will undergo usual in hospital and post-discharge treatment as directed by their care team. All control subjects will receive written Advanced Care planning and Heart Failure education materials as provided routinely to inpatients at Brigham and Women's Hospital. At the 6 month visit following hospitalization, these patients will be asked to complete follow up questionnaires and then will be given the option to participate in the above verbal intervention and guided "Goals and Values" conversation that was provided to the intervention group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Participant will receive usual care for Heart Failure patients, which include standard written material on Advanced Care planning and supportive cardiology/palliative care consult if ordered by attending.
Other: Control
The control group will receive usual written care material and a palliative care consult if ordered by physician.

Experimental: Verbal Information and Discussion
Participants will participate in a guided goals of care conversation and the support of a Palliative Care Social Worker who is working closely with the patients' primary cardiology team. Social worker has ongoing clinical review of participants with a Palliative Care physician who will provide a full medical consult if appropriate.
Other: Verbal Information and Discussion
Intervention patient will receive a outpatient session with a palliative care social worker in the heart failure clinic two weeks post discharge consent focusing on goals of care.




Primary Outcome Measures :
  1. Is there a change in patient understanding of prognosis with the addition of a palliative care intervention? [ Time Frame: 6 months ]
    Assessment tool: Patient Preferences Questionnaire.


Secondary Outcome Measures :
  1. Is there an impact on documentation of advanced care planning documentation with a palliative care intervention? [ Time Frame: 6 months ]
    Chart review of Advanced Care Planning documents and written notes by members of clinical team.

  2. Is there an impact on symptom burden through a palliative care intervention? [ Time Frame: Three months ]
    Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  3. Is there an impact on perceived level of illness through a palliative care intervention? [ Time Frame: 6 months ]
    Assessment tool: EQ visual analogue scale (EQ-VAS)

  4. Is there an impact on overall patient well being through a palliative care intervention? [ Time Frame: Three months ]
    Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)

  5. Is there an impact on depression through a palliative care intervention? [ Time Frame: 6 months ]
    Assessment tool: Patient Health Questionnaire (PHQ-8)

  6. Is there an impact on anxiety through a palliative care intervention? [ Time Frame: 6 months ]
    Assessment tool: General Anxiety Disorder (GAD-7)

  7. Is there an impact on cost of treatment through a palliative care intervention? [ Time Frame: 6 months ]
    Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Symptomatic Heart Failure (NYHA II-IV)
  • Hospitalized or recently for acute decompensation with at least one of the following high-risk features

    • Prior hospitalization for Heart Failure (HF) within 1 year
    • Age > 80 years
    • Chronic Kidney Disease (estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/m2)
    • Systolic Blood Pressure < 100 mm Hg
    • Serum sodium < 130 meq/L
    • Cardiogenic Shock (Cardiac Index < 2.0)
    • Serious Non-Cardiovascular Illness (e.g. advanced stage cancer, Chronic Obstructive Pulmonary Disease (COPD) , or the like.
  • Ability to Provide Informed Consent
  • Permission of attending physician

Exclusion Criteria

  • Anticipated major cardiac surgery, including Ventricular Assist Device (VAD) or transplant, within 3 months of enrollment
  • Already enrolled in hospice or receiving outpatient palliative care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805712


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Akshay S Desai, MPH, MD Brigham and Women's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Akshay Desai, MD, Director, Heart Failure Disease Management Program, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02805712    
Other Study ID Numbers: 2014P001391
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Akshay Desai, MD, Brigham and Women's Hospital:
Heart Failure
Palliative Care
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases