NCT02805712

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

May 20, 2016

Last Update Submit

July 19, 2017

Conditions

Heart FailureQuality of Life

Keywords

Heart FailurePalliative Care

Outcome Measures

Primary Outcomes (1)

  • Is there a change in patient understanding of prognosis with the addition of a palliative care intervention?

    Assessment tool: Patient Preferences Questionnaire.

    6 months

Secondary Outcomes (7)

  • Is there an impact on documentation of advanced care planning documentation with a palliative care intervention?

    6 months

  • Is there an impact on symptom burden through a palliative care intervention?

    Three months

  • Is there an impact on perceived level of illness through a palliative care intervention?

    6 months

  • Is there an impact on overall patient well being through a palliative care intervention?

    Three months

  • Is there an impact on depression through a palliative care intervention?

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Verbal Information and Discussion

EXPERIMENTAL

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

Interventions

Verbal Information and DiscussionOTHER

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.

Verbal Information and Discussion
ControlOTHER

The control group will receive usual written care material and a palliative care consult if ordered by physician.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 29641819DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Akshay S Desai, MPH, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Heart Failure Disease Management Program

Study Record Dates

First Submitted

May 20, 2016

First Posted

June 20, 2016

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)