Primary Palliative Care in Heart Failure: A Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Primary Palliative Care

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • White Oak, Pennsylvania, United States, 15131
      • UPMC Heart Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Primary Palliative Care; 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; 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).; Other Names: Supportive care
NO_INTERVENTION: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability	We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.	Two years
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.	Two years

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Dio Kavalieratos, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2017
• Primary Completion (ACTUAL): May 28, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Palliative care
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: PRO16090248; K01HL133466-01 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No