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Primary Palliative Care in Heart Failure: A Pilot Trial

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ClinicalTrials.gov Identifier: NCT03170466
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dio Kavalieratos, PhD, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Primary Palliative Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Primary Palliative Care in Heart Failure: A Pilot Trial
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Primary Palliative Care
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 Name: Supportive care

No Intervention: Usual Care
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170466


Contacts
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Contact: Dio Kavalieratos, PhD 412-246-6929 diok@pitt.edu
Contact: Zachariah Hoydich, BS 412-692-2747 hoydichzp@upmc.edu

Locations
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United States, Pennsylvania
UPMC Heart Vascular Institute Recruiting
White Oak, Pennsylvania, United States, 15131
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Dio Kavalieratos, PhD University of Pittsburgh

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Responsible Party: Dio Kavalieratos, PhD, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03170466     History of Changes
Other Study ID Numbers: PRO16090248
K01HL133466-01 ( U.S. NIH Grant/Contract )
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dio Kavalieratos, PhD, University of Pittsburgh:
Palliative care

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases