About this trial

Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care.

Problem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown.

Objective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits.

Aims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population.

Significance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.

Eligibility criteria

Qualifiers

LVAD patients >= 18 years of age

>= 1 year post-LVAD implantation

Disqualifiers

Listed for heart transplantation. Undergoing evaluation for heart transplantation, however, is not an exclusion.

Non-English speaking

Receiving outpatient palliative care in the last 6 months

Renal replacement therapy

Trial design

Treatments tested in this trial

  • Palliative care intervention

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

2
MedStar Washington Hospital Center20010, Washington D.C.District of Columbia, United States
Inova Schar Heart and Vascular Institute22042, FairfaxVirginia, United States

Sponsors and collaborators

Medstar Health Research Institute

Lead sponsor

Inova Schar Heart and Vascular

Collaborator