Primary Palliative Care in Heart Failure: A Pilot Trial
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|ClinicalTrials.gov Identifier: NCT03170466|
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Primary Palliative Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
|Actual Primary Completion Date :||May 28, 2020|
|Actual Study Completion Date :||August 1, 2020|
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.
- 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.
- Intervention Acceptability [ Time Frame: Two years ]We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.
- 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.
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
|United States, Pennsylvania|
|UPMC Heart Vascular Institute|
|White Oak, Pennsylvania, United States, 15131|
|Principal Investigator:||Dio Kavalieratos, PhD||University of Pittsburgh|