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Completed

NCT Number: NCT03170466

Primary Palliative Care in Heart Failure: A Pilot Trial

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Heart Vascular Institute

White Oak, Pennsylvania, 15131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary palliative care

Behavioral

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).

Other names: Supportive care

Primary outcomes

  1. Feasibility of enrolling 30 patients via attempting to enroll 30 patients

    Time frame: One year

    We will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.

Secondary outcomes

  1. Intervention Acceptability

    Time frame: Two years

    We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.

  2. Intervention Fidelity via the Intervention Fidelity Monitoring Report

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 31, 2017
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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