NCT03170466

Brief Summary

Patients with advanced heart failure (HF) typically experience significant burdens that negatively impact their quality of life. Although palliative care has been shown to improve patient outcomes in other serious illnesses, insufficient data exist to support its use in HF. Furthermore, the demand for palliative care in serious illness outstrips the available supply of certified palliative care clinicians. This pilot trial will assess the feasibility and acceptability of training cardiology nurses in basic palliative care skills and their ability to deliver this care alongside usual HF management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable heart-failure

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

May 22, 2017

Last Update Submit

September 1, 2020

Conditions

Heart Failure

Keywords

Palliative care

Outcome Measures

Primary Outcomes (1)

  • Feasibility of enrolling 30 patients via attempting to enroll 30 patients

    We will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.

    One year

Secondary Outcomes (2)

  • Intervention Acceptability

    Two years

  • Intervention Fidelity via the Intervention Fidelity Monitoring Report

    Two years

Study Arms (2)

Primary Palliative Care

EXPERIMENTAL

The intervention will be delivered through four primary mechanisms. First, an existing HF nurse will deliver the intervention to patients during regularly scheduled visits. Second, telephone calls will reinforce topics. Third, patients will regularly report symptoms through the MyUPMC patient portal. Fourth, the nurse will act as a liaison to communicate concerns to the patient's cardiologist and primary care physician, as well as facilitating other resources (e.g., home health). In addition, follow-up assessments will be completed via phone or email at least 2 weeks post-intervention delivery. Caregivers will complete surveys during the first in-person visit and then during the follow-up assessments.

Behavioral: Primary Palliative Care

Usual Care

NO INTERVENTION

Patients randomized to the control arm of this study will continue to receive the standard of high-quality HF care provided to all patients. Control patients may still receive palliative care outside of the study.

Interventions

Primary Palliative CareBEHAVIORAL

The intervention will span 4 domains: symptom management (e.g., dyspnea), psychosocial support (e.g., anxiety), advance care planning (e.g., understanding prognosis and electing a proxy) and care coordination (e.g., communication across providers).

Also known as: Supportive care
Primary Palliative Care

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New York Heart Association Class III or IV Heart Failure
  • or more hospitalizations in the past year due to Heart Failure

You may not qualify if:

  • Less than 40 years old
  • Currently awaiting a transplant
  • Received outpatient palliative care within the past 12 months
  • Pregnant or intends to be within the next 12 months
  • No regular phone access
  • Not fluent in English
  • Failed the Callahan 6-item Screener
  • Does not intent to regularly attend clinic for the next 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Heart Vascular Institute

White Oak, Pennsylvania, 15131, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Dio Kavalieratos, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 31, 2017

Study Start

October 23, 2017

Primary Completion

May 28, 2020

Study Completion

August 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)