Heart FailureNCT01427634
Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families
A study testing Palliative Care in people with Heart Failure and End-stage Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure, End-stage Disease
- What is being tested?
- Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jul 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Randomized Controlled Trial of Proactive Palliative Care for Patients With Ventricular Assist Devices and Their Families
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.
Read the detailed 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.
- Conditions
- Heart Failure, End-stage Disease
- Being tested
- Palliative Care, Usual Care
- Keywords
- Heart Failure, Ventricular Assist Device, Palliative Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareBehavioural
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
Usual CareOther
Receive usual care as provided by the VAD clinical team.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Palliative Care |
| Control | Other | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment - change at 1 year from baseline
change in pain from baseline to 1 year, using the Memorial Symptom Assessment Scale
Measured: baseline (within 2 weeks of enrollment) and at 1 year after implantment
Secondary outcomes (3)
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.
Measured: at baseline (within 2 weeks of enrollment) and at 1 year after implantment
PROMIS anxiety scale - change at 1 year from baseline
changes in anxiety from baseline to 1 year as measured by the PROMIS anxiety scale
Measured: at baseline (within 2 weeks of enrollment) and at 1 year after implantment
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
Measured: at baseline (within 2 weeks of enrollment) and at 1 year after implantment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), The Greenwall Foundation, Emily Davie and Joseph S. Kornfeld Foundation
- Responsible party
- Sponsor
- Investigators
- Nathan E. Goldstein, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427634
- Sponsor's protocol ID
- GCO 11-0152
- Other IDs
- P30AG028741-01A2
- Status last verified
- Sep 2013
- First submitted
- 15 Aug 2011
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20019324Kirklin 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.
PubMed 20123242