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

NCT07445932 | Not Yet Recruiting

• 2 other identifiers: STUDY00010236#5363
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Heart Failure; Mechanical Circulatory Support; Left Ventricular Assist Device; Palliative Care

Keywords

advanced heart failure; left ventricular assist device; palliative care

Outcome Measures

Primary Outcomes (8)

• Trial enrollment

  Number of individuals consenting to enroll in the trial.

  From enrollment to end of intervention at 6 months

• Intervention retention

  Number of patients completing the 6 month intervention

  From enrollment to end of intervention at 6 months

• Palliative care services - medications

  Number of supportive medications prescribed per patient

  From enrollment to end of intervention at 6 months

• 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.

  From enrollment to end of intervention at 6 months

• Advance care planning

  We will track number of patients that have completed advance care planning

  From enrollment to end of intervention at 6 months

• Patient satisfaction with intervention

  Survey scores (Likert scale)

  From enrollment to end of intervention at 6 months

• Patient perspectives of intervention

  Themes/codes will be identified out of semi-structured interviews conducted with patients examining perspectives on and barriers/facilitators of the intervention. These will be quantified.

  From enrollment to end of intervention at 6 months

• Provider perspectives of intervention

  Themes/codes will be identified out of semi-structured interviews conducted with providers examining perspectives on and barriers/facilitators of the intervention. These will be quantified.

  From enrollment to end of intervention at 6 months

Secondary Outcomes (4)

• Readmission rates

  From enrollment to end of intervention at 6 months

• Inpatient utilization

  From enrollment to end of intervention at 6 months

• KCCQ-12

  From enrollment to end of intervention at 6 months

• FACIT-Pal

  From enrollment to end of intervention at 6 months

Other Outcomes (6)

• EQ-5D-5L

  From enrollment to end of intervention at 6 months

• MCS A-QOL

  From enrollment to end of intervention at 6 months

• HADS

  From enrollment to end of intervention at 6 months

Study Arms (2)

Usual care

NO INTERVENTION

The usual care arm will consist of routine LVAD care with clinician-triggered referral for palliative care specialist evaluation.

Palliative care intervention

ACTIVE COMPARATOR

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.

Behavioral: Palliative care intervention

Interventions

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.

Also known as: PC intervention

Palliative care intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LVAD patients \>= 18 years of age
• \>= 1 year post-LVAD implantation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Inova Schar Heart and Vascular: collaborator

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Inova Schar Heart and Vascular Institute

Fairfax, Virginia, 22042, United States

Location

Related Publications (21)

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Study Officials

• Richa Gupta, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richa Gupta, MD MPH

CONTACT

202-877-4698; richa.gupta@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)