Primary Palliative Care in Heart Failure: A Pilot Trial

University of Pittsburgh

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Primary Palliative Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03170466

K01HL133466-01 (U.S. NIH Grant/Contract)

PRO16090248

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Primary Palliative Care

Experimental group

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.

Treatment:

Behavioral: Primary Palliative Care

Usual Care

No Intervention group

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.