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

NCT01427634 | Completed

• 2 other identifiers: GCO 11-0152P30AG028741-01A2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; End-stage Disease

Keywords

Heart Failure; Ventricular Assist Device; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Pain Assessment - change at 1 year from baseline

  change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale

  baseline (within 2 weeks of enrollment) and at 1 year after implantment

Secondary Outcomes (3)

• Satisfaction with care - change at 1 year from baseline

  at baseline (within 2 weeks of enrollment) and at 1 year after implantment

• PROMIS anxiety scale - change at 1 year from baseline

  at baseline (within 2 weeks of enrollment) and at 1 year after implantment

• PROMIS depression scale - change at 1 year from baseline

  at baseline (within 2 weeks of enrollment) and at 1 year after implantment

Study Arms (2)

Palliative Care

ACTIVE COMPARATOR

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

Behavioral: Palliative Care

Control

OTHER

Usual Care

Other: Usual Care

Interventions

Palliative Care BEHAVIORAL

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

Palliative Care

Usual Care OTHER

Receive usual care as provided by the VAD clinical team.

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• non English-speaking

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator
• The Greenwall Foundation: collaborator
• Emily Davie and Joseph S. Kornfeld Foundation: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

• 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. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available.

  PMID: 20019324 BACKGROUND

• 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. doi: 10.1016/j.healun.2009.10.009. No abstract available.

  PMID: 20123242 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nathan E. Goldstein, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: September 1, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

US (1)