Primary Palliative Care in Heart Failure: A Pilot Trial

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Primary Palliative Care

• Registration Number: NCT03170466
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-31
• Study Start: 2017-10-23
• Primary Completion: 2020-05-28
• Study Completion: 2020-08-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Palliative Care	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of enrolling 30 patients via attempting to enroll 30 patients	One year	We will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UPMC Heart Vascular Institute; 🇺🇸 White Oak, Pennsylvania, United States