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Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "For this, the investigators will conduct a mixed-methods analysis using quantitative surveys and qualitative interviews."
  • "To study acceptability, the investigators will conduct surveys with patients examining their perspectives on the intervention."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ongoing palliative care is practical and helpful for people with a long-term LVAD, a pump that helps the heart move blood. Palliative care supports comfort and well-being. The study is for adults who have had an LVAD for at least 1 year and are not on a heart transplant waiting list.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have had an LVAD heart pump for at least 1 year.

Who can't join

  • You are on a heart transplant waiting list. Being tested for a possible transplant does not rule you out.
  • You do not speak English.
  • You have received palliative care outside the hospital in the past 6 months.
  • You receive treatment that replaces kidney function, such as dialysis.
  • You have a terminal illness, or an illness expected to end your life, that is not related to your heart.
  • You are pregnant or plan to become pregnant.
  • You cannot give consent or follow the study rules and follow-up schedule.
  • You have problems with thinking or an intellectual disability that prevents you from completing quality-of-life surveys or following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * LVAD patients \>= 18 years of age * \>= 1 year post-LVAD implantation Exclusion Criteria: * 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 * Non-cardiac terminal illness * Women who are pregnant or planning to become pregnant * Inability to comply with study protocol and follow up * Inabilty to provide consent. * Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.

Study sites (2)

DC

VA