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Focused Palliative Care Intervention in Advanced Heart Failure

Primary Purpose

Heart Failure, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verbal Information and Discussion
Control
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Palliative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Verbal Information and Discussion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
Assessment tool: Patient Preferences Questionnaire.

Secondary Outcome Measures

Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
Chart review of Advanced Care Planning documents and written notes by members of clinical team.
Is there an impact on symptom burden through a palliative care intervention?
Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Is there an impact on perceived level of illness through a palliative care intervention?
Assessment tool: EQ visual analogue scale (EQ-VAS)
Is there an impact on overall patient well being through a palliative care intervention?
Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
Is there an impact on depression through a palliative care intervention?
Assessment tool: Patient Health Questionnaire (PHQ-8)
Is there an impact on anxiety through a palliative care intervention?
Assessment tool: General Anxiety Disorder (GAD-7)
Is there an impact on cost of treatment through a palliative care intervention?
Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.

Full Information

First Posted
May 20, 2016
Last Updated
July 19, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02805712
Brief Title
Focused Palliative Care Intervention in Advanced Heart Failure
Official Title
Pilot Study of a Focused Palliative Care Intervention for Recently Hospitalized High-Risk Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Quality of Life
Keywords
Heart Failure, Palliative Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Verbal Information and Discussion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Verbal Information and Discussion
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control group will receive usual written care material and a palliative care consult if ordered by physician.
Primary Outcome Measure Information:
Title
Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?
Description
Assessment tool: Patient Preferences Questionnaire.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?
Description
Chart review of Advanced Care Planning documents and written notes by members of clinical team.
Time Frame
6 months
Title
Is there an impact on symptom burden through a palliative care intervention?
Description
Assessment tool: : The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame
Three months
Title
Is there an impact on perceived level of illness through a palliative care intervention?
Description
Assessment tool: EQ visual analogue scale (EQ-VAS)
Time Frame
6 months
Title
Is there an impact on overall patient well being through a palliative care intervention?
Description
Assessment tool: The Functional Assessment of Chronic Illness Therapy ( FACIT-Sp)
Time Frame
Three months
Title
Is there an impact on depression through a palliative care intervention?
Description
Assessment tool: Patient Health Questionnaire (PHQ-8)
Time Frame
6 months
Title
Is there an impact on anxiety through a palliative care intervention?
Description
Assessment tool: General Anxiety Disorder (GAD-7)
Time Frame
6 months
Title
Is there an impact on cost of treatment through a palliative care intervention?
Description
Focus will be on cost through health care utilization as aggregated by number of hospital days, days in ICU and 30 day re-admissions.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akshay S Desai, MPH, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29641819
Citation
O'Donnell AE, Schaefer KG, Stevenson LW, DeVoe K, Walsh K, Mehra MR, Desai AS. Social Worker-Aided Palliative Care Intervention in High-risk Patients With Heart Failure (SWAP-HF): A Pilot Randomized Clinical Trial. JAMA Cardiol. 2018 Jun 1;3(6):516-519. doi: 10.1001/jamacardio.2018.0589.
Results Reference
derived

Learn more about this trial

Focused Palliative Care Intervention in Advanced Heart Failure

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