NCT02398617

Brief Summary

Heart failure is a chronic and frequently terminal illness associated with poor quality of life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent guideline updates have highlighted the need for improved focus on end-of-life and palliative care of advanced heart failure patients, in whom symptom burden can be high and treatment options are often limited. The aims of this study are to evaluate the feasibility of implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive care intervention concerning multiple domains of end-of-life care not often included in regular, outpatient clinic visits.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

February 20, 2015

Last Update Submit

October 14, 2021

Conditions

Heart Failure

Keywords

Heart FailureEnd of Life CareDecision Making

Outcome Measures

Primary Outcomes (4)

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Heart failure-related quality of life

    1 month

  • Decisional Conflict Scale

    Decision-making confidence/readiness

    1 month

  • Peace, Equanimity, and Acceptance in Cancer Experience (PEACE) Scale

    Illness Acceptance

    1 month

  • Kaldjian's Goals of Care at End of Life

    Patient-ranked importance for different goals of care

    1 month

Secondary Outcomes (5)

  • Death

    6 months

  • Code Status Change

    6 months

  • Advance Directive creation

    6 months

  • Durable Power of Attorney appointment

    6 months

  • Unscheduled Healthcare Encounter

    6 months

Study Arms (1)

Decision Making Intervention

OTHER

At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.

Other: Decision Making Intervention

Interventions

Decision Making InterventionOTHER

At their regularly scheduled admission follow-up visit with seven days of discharge, participants will be asked to bring their medical decision maker and participate in a semi-structured supplemental palliative care/education session facilitated by a heart failure nurse practitioner trained in palliative care discussions. Domains included in the intervention will include disease literacy and understanding, goals of care, legal issues for patients with terminal illness, symptom management, health-related quality of life, caregiver burden, patient autonomy, healthcare utilization, and establishment of end-of-life plans.

Decision Making Intervention

Eligibility Criteria

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

You may qualify if:

  • advanced heart failure
  • ineligible for advanced therapies
  • % risk of death or continued poor heart failure-related health status at 6 months from hospital discharge, based on validated risk score

You may not qualify if:

  • Hospice enrollment
  • Previous heart transplant or left ventricular assist device placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • John A Spertus, MD, MPH

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 25, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

US(1)