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

Heart Failure Clinical Trial

Official title:

Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427634
• Other study ID #: GCO 11-0152
• Secondary ID: P30AG028741-01A2
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: September 5, 2013
• Start date: July 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End-stage Disease
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Emily Davie and Joseph S. Kornfeld Foundation, National Institute on Aging (NIA), The Greenwall Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Erratum in: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Véronique L]. Circulation. 2011 Oct 18;124(16):e425. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Satisfaction with care - change at 1 year from baseline	changes in satisfaction with care from baseline to 1 year as measured with validated scales for satisfaction with care.	at baseline (within 2 weeks of enrollment) and at 1 year after implantment	No
Secondary	PROMIS anxiety scale - change at 1 year from baseline	changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale	at baseline (within 2 weeks of enrollment) and at 1 year after implantment	No
Secondary	PROMIS depression scale - change at 1 year from baseline	changes in depression measured from baseline to 1 year as measured by the PROMIS depression scale	at baseline (within 2 weeks of enrollment) and at 1 year after implantment	No