Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families

• Pain Assessment [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
  change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale
• Pain Assessment [ Time Frame: 1 year after implantment ] [ Designated as safety issue: No ]
  change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale

• Satisfaction with care - change at 1 year from baseline [ Time Frame: at baseline (within 2 weeks of enrollment) and at 1 year after implantment ] [ Designated as safety issue: No ]
  changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
• PROMIS anxiety scale - change at 1 year from baseline [ Time Frame: at baseline (within 2 weeks of enrollment) and at 1 year after implantment ] [ Designated as safety issue: No ]
  changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
• PROMIS depression scale - change at 1 year from baseline [ Time Frame: at baseline (within 2 weeks of enrollment) and at 1 year after implantment ] [ Designated as safety issue: No ]
  changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale

• Satisfaction with care [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
  changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
• Satisfaction with care [ Time Frame: 1 year after implantation ] [ Designated as safety issue: No ]
  changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.
• PROMIS anxiety scale [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
  changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
• PROMIS anxiety scale [ Time Frame: 1 year after implantation ] [ Designated as safety issue: No ]
  changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
• PROMIS depression scale [ Time Frame: within 2 weeks of enrollment ] [ Designated as safety issue: No ]
  changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale
• PROMIS depression scale [ Time Frame: 1 year after implantation ] [ Designated as safety issue: No ]
  changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale

The primary aim of the study is to provide "proof of concept" to demonstrate that patients with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible. Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers. The investigators will also examine differences in utilization of healthcare services, mortality, and completion of advance directives between intervention and control patients.

A ventricular assist device is an implanted mechanical device which augments the pumping function of the heart's ventricles. The number of patients with VADs is expected to increase in an exponential manner in the years to come as device technology improves and continues to show a survival benefit. The investigators propose a randomized controlled trial of a proactive palliative care intervention for patients with VADs and their caregivers. Patients randomized to palliative care will receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study. The intervention is delivered primarily in the outpatient setting by a palliative care nurse practitioner. Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed. Control patients will receive usual care as provided by the VAD clinical team. Data collection will be performed by a research assistant at Mount Sinai (blinded to randomization) who conducts baseline assessments in person, and then follow-up assessments over the phone. The primary aim of the study is to provide "proof of concept" to demonstrate that patients and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a study is feasible. Secondary aims include demonstrating improvement in symptoms (physical and psychological) for intervention patients and their caregivers as compared to control patients and caregivers.

• Heart Failure
• End-stage Disease

• Behavioral: Palliative Care
  Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study. Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
• Other: Usual Care
  Receive usual care as provided by the VAD clinical team.

• Active Comparator: Palliative Care
  Intervention: Behavioral: Palliative Care
• Control
  Usual Care
  Intervention: Other: Usual Care

• WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. Epub 2009 Dec 17. No abstract available. Erratum in: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Veronique L].
• Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, Ulisney KL, Baldwin JT, Young JB. Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants. J Heart Lung Transplant. 2010 Jan;29(1):1-10. No abstract available.

Inclusion Criteria:

• age >21 years
• fluent in English
• have a caregiver/family member who is willing to be enrolled and who is also fluent in English
• consistent and reliable access to a phone

Exclusion Criteria:

• non English-speaking

• National Institute on Aging (NIA)
• The Greenwall Foundation
• Emily Davie and Joseph S. Kornfeld Foundation