The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Behavioral
  Palliative care intervention

  The palliative care arm mirrors the intervention described in a cohort of patients with HF in the PAL-HF trial. The intervention will be conducted by a palliative care specialist nurse clinician with standardized training in administering the intervention. The palliative care clinician will conduct visits within 2 weeks of randomization/enrollment and subsequently approximately every 4-6 weeks with the patient for 6 months total duration. The patient will be referred for interdisciplinary supportive care from the palliative care chaplain, social worker, and/or pharmacist based on NP evaluation. Additionally, based on baseline clinical assessment scales and symptoms, patients will be offered supportive medications or referrals for cardiac rehabilitation and behavioral health/psychiatry.

Locations (2)