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Primary Palliative Care in Heart Failure: A Pilot Trial

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Palliative Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Palliative care

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • UPMC Heart Vascular Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Primary Palliative Care

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intervention Acceptability
We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.
Intervention Fidelity via the Intervention Fidelity Monitoring Report
We will assess intervention fidelity by audio-recording the interventions and having independent reviewers listen to them and complete our Intervention Fidelity Monitoring Report.

Full Information

First Posted
May 22, 2017
Last Updated
September 1, 2020
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03170466
Brief Title
Primary Palliative Care in Heart Failure: A Pilot Trial
Official Title
Primary Palliative Care in Heart Failure: A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients with advanced heart failure (HF) suffer from significant pain, fatigue, difficulty breathing, anxiety, and depression. Palliative Care (PC) is a medical specialty designed to focus on relieving patient suffering by providing an extra layer of support on top of usual care. To date, there has been little research on the impact of PC in HF. We will conduct a randomized clinical trial to assess the feasibility, acceptability, and perceived effectiveness of training cardiology nurses in PC and administering PC to their patients. Patients will be randomized into either the usual care group or the intervention group. Usual care participants will receive their care with no alterations, and intervention participants will receive the PC intervention from their nurse on top of their usual care. Both groups will complete health-related surveys on tablet computers, via email, and/or via telephone. In the intervention group, these answers will be used to tailor the intervention to the specific patient's needs. Caregivers will also be recruited into the study, and will complete surveys similar to the patients via the aforementioned methods.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Palliative Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Primary Palliative Care
Other Intervention Name(s)
Supportive care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Feasibility of enrolling 30 patients via attempting to enroll 30 patients
Description
We will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Intervention Acceptability
Description
We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.
Time Frame
Two years
Title
Intervention Fidelity via the Intervention Fidelity Monitoring Report
Description
We will assess intervention fidelity by audio-recording the interventions and having independent reviewers listen to them and complete our Intervention Fidelity Monitoring Report.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: New York Heart Association Class III or IV Heart Failure 2 or more hospitalizations in the past year due to Heart Failure Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dio Kavalieratos, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Heart Vascular Institute
City
White Oak
State/Province
Pennsylvania
ZIP/Postal Code
15131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Primary Palliative Care in Heart Failure: A Pilot Trial

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