An interventional study of Primary Palliative Care in Heart Failure, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 30 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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).
Also known as: Supportive care
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.
Time frame: One year
Intervention Acceptability
We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.
Time frame: 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.
Time frame: Two years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pittsburgh