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

ConditionsAdvanced Heart FailureMechanical Circulatory SupportLeft Ventricular Assist DevicePalliative Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Palliative care intervention

    Behavioral

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: Palliative care interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Trial enrollment

Number of individuals consenting to enroll in the trial.

Time frame
From enrollment to end of intervention at 6 months
2

Intervention retention

Number of patients completing the 6 month intervention

Time frame
From enrollment to end of intervention at 6 months
3

Palliative care services - medications

Number of supportive medications prescribed per patient

Time frame
From enrollment to end of intervention at 6 months
4

Palliative care services - referrals

Number of referrals placed per patient to members of the palliative care interdisciplinary team, psychiatry/behavioral health, or cardiac rehab services. Rates of follow up to each referral placed.

Time frame
From enrollment to end of intervention at 6 months

Secondary outcomes

1

Readmission rates

Readmission rates per 6 month period of intervention.

Time frame
From enrollment to end of intervention at 6 months
2

Inpatient utilization

Days spent admitted to hospital, rehabilitation facility or nursing facility

Time frame
From enrollment to end of intervention at 6 months
3

KCCQ-12

Change in KCCQ-12 score from baseline to 6 months

Time frame
From enrollment to end of intervention at 6 months
4

FACIT-Pal

Change in FACIT-Pal score from baseline to 6 months

Time frame
From enrollment to end of intervention at 6 months

Other outcomes

1

EQ-5D-5L

Change in EQ-5D-5L score from baseline to 6 months

Time frame
From enrollment to end of intervention at 6 months
2

MCS A-QOL

Change in MCS A-QOL from baseline to 6 months

Time frame
From enrollment to end of intervention at 6 months
3

HADS

Change in HADS from baseline to 6 months

Time frame
From enrollment to end of intervention at 6 months
4

IES-6

Change in IES-6 score from baseline to 6 months

Time frame
From enrollment to end of intervention at 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

Inova Schar Heart and Vascular

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: