Clinical trial NCT03170466: Primary Palliative Care in Heart Failure: A Pilot Trial
Official title: Primary Palliative Care in Heart Failure: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Palliative care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility of enrolling 30 patients via attempting to enroll 30 patients
timeFrame: One year
Secondary outcomes:
measure: Intervention Acceptability
timeFrame: Two years
measure: Intervention Fidelity via the Intervention Fidelity Monitoring Report
timeFrame: Two years
Other outcomes:
Locations:
city: White Oak
country: United States
facility: UPMC Heart Vascular Institute
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dio Kavalieratos, PhD
role: PRINCIPAL_INVESTIGATOR
References: