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Primary Palliative Care in Heart Failure: A Pilot Trial

Primary Palliative Care in Heart Failure: A Pilot Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03170466
Enrollment
30
Registered
2017-05-31
Start date
2017-10-23
Completion date
2020-08-01
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Palliative care

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.

Interventions

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).

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of enrolling 30 patients via attempting to enroll 30 patientsOne yearWe will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.

Secondary

MeasureTime frameDescription
Intervention AcceptabilityTwo yearsWe will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.
Intervention Fidelity via the Intervention Fidelity Monitoring ReportTwo yearsWe will assess intervention fidelity by audio-recording the interventions and having independent reviewers listen to them and complete our Intervention Fidelity Monitoring Report.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026