Primary Palliative Care in Heart Failure: A Pilot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Primary Palliative Care in Heart Failure: A Pilot Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Primary Palliative Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Palliative Care<br>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<br>* 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).<br>* Other names: Supportive care;|
| No Intervention: Usual Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care