Palliative Care for Heart Failure Patients - Full Text View

Purpose

The purpose of this study is to assess the impact of palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital.

Condition	Intervention
Heart Failure	Other: Palliative Care Consultation Other: Control

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	An Examination of Palliative Care as Standard Practice for Heart Failure Patients

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Palliative Care

U.S. FDA Resources

Further study details as provided by Abbott Northwestern Hospital:

Primary Outcome Measures:

Is there an impact on quality of life with the addition of palliative care intervention? [ Time Frame: Change from baseline in quality of life score at 3 months ] [ Designated as safety issue: No ]
Assessment Tools:

*Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)

Secondary Outcome Measures:

Differential use of medical services- 30 day readmission [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
*Number of readmissions in 30 days of discharge from initial enrollment hospitalization.
Is there an impact on Symptom Severity with the addition of palliative care [ Time Frame: Change from baseline in symptom severity score at 3 months ] [ Designated as safety issue: No ]
Assessment tool:

*Symptom Severity - Edmonton Symptom Assessment scale (ESAS)
Is there an impact on depression with the addition of palliative care intervention? [ Time Frame: Change from baseline in depression score at 3 months ] [ Designated as safety issue: No ]
Assessment Tool:

*Depression- Patient Health Questionnaire (PHQ-9)

Enrollment:	232
Study Start Date:	April 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Palliative Care Consultation Participant will get one palliative care consultation while in the hospital. The participants desire for subsequent palliative care visits will be determined and mutually agreed upon at the initial consultation.	Other: Palliative Care Consultation Intervention patient would receive an inpatient palliative care consultation to focus on comprehensive symptom assessment, create goals of care/treatment plan which include recommendations and referrals. Other Names: palliative care consults palliative care medicine
Active Comparator: Control Usual care for HF patient which may include a palliative care consult if ordered by treating physician.	Other: Control The control group would receive usual care and could receive a palliative consult if ordered by the treating provider Other Names: palliative care consult palliative care medicine

Detailed Description:

Research questions:

Q1. Does the provision of palliative care to heart failure patients yield higher quality of life, increased symptom management, or reduced depression compared to heart failure patients not receiving palliative care?

Q2. Does the provision of palliative care to heart failure patients result in differential use of medical services (lower hospital days and readmission) compared to heart failure patients not receiving systematic palliative care?

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Abbott Northwestern Hospital inpatient adults with a diagnosis of acute heart failure

Exclusion Criteria:

Are not an inpatient at Abbott Northwestern Hospital
Are in the ICU
On a ventilator
Are pre-or post heart transplant
Have a ventricular assist device (VAD)
Determined to be actively dying
Have cognitive impairments such that informed consent would not be possible,
Are not proficient in the English language

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519479

Locations

United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407

Sponsors and Collaborators

Abbott Northwestern Hospital

Allina Hospitals and Clinics

Investigators

Principal Investigator:

Justin Kirven, MD

Abbott Northwestern Hospital

More Information

Publications:

Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9.

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42.

Smith ER. Heart failure--are we making progress? Can J Cardiol. 2002 Oct;18(10):1124-5. No abstract available.

Morrison RS, Dietrich J, Ladwig S, Quill T, Sacco J, Tangeman J, Meier DE. Palliative care consultation teams cut hospital costs for Medicaid beneficiaries. Health Aff (Millwood). 2011 Mar;30(3):454-63.

Jovicic A, Holroyd-Leduc JM, Straus SE. Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials. BMC Cardiovasc Disord. 2006 Nov 2;6:43. Review.

Wilson E. Congestive heart failure: A national priority. Can J Cardiol. 2001 Dec;17(12):1243-4. English, French. No abstract available.

Wolinsky FD, Overhage JM, Stump TE, Lubitz RM, Smith DM. The risk of hospitalization for congestive heart failure among older adults. Med Care. 1997 Oct;35(10):1031-43.

Roger VL, Weston SA, Redfield MM, Hellermann-Homan JP, Killian J, Yawn BP, Jacobsen SJ. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004 Jul 21;292(3):344-50.

Stuart B. Palliative care and hospice in advanced heart failure. J Palliat Med. 2007 Feb;10(1):210-28. Review.

Goodlin SJ. Palliative care in congestive heart failure. J Am Coll Cardiol. 2009 Jul 28;54(5):386-96. Review.

Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22.

Enguidanos SM, Cherin D, Brumley R. Home-based palliative care study: site of death, and costs of medical care for patients with congestive heart failure, chronic obstructive pulmonary disease, and cancer. J Soc Work End Life Palliat Care. 2005;1(3):37-56.

Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91.

Archana R, Gray D. The quality of life in chronic disease--heart failure is as bad as it gets. Eur Heart J. 2002 Dec;23(23):1806-8. No abstract available.

O'Connor CM, Joynt KE. Depression: are we ignoring an important comorbidity in heart failure? J Am Coll Cardiol. 2004 May 5;43(9):1550-2. No abstract available.

Gottlieb SS, Khatta M, Friedmann E, Einbinder L, Katzen S, Baker B, Marshall J, Minshall S, Robinson S, Fisher ML, Potenza M, Sigler B, Baldwin C, Thomas SA. The influence of age, gender, and race on the prevalence of depression in heart failure patients. J Am Coll Cardiol. 2004 May 5;43(9):1542-9.

Albert NM, Fonarow GC, Abraham WT, Gheorghiade M, Greenberg BH, Nunez E, O'Connor CM, Stough WG, Yancy CW, Young JB. Depression and clinical outcomes in heart failure: an OPTIMIZE-HF analysis. Am J Med. 2009 Apr;122(4):366-73.

Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. Am Heart J. 1992 Oct;124(4):1017-25.

Rector TS, Kubo SH, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol. 1993 May 1;71(12):1106-7. No abstract available.

Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71.

Nekolaichuk C, Watanabe S, Beaumont C. The Edmonton Symptom Assessment System: a 15-year retrospective review of validation studies (1991--2006). Palliat Med. 2008 Mar;22(2):111-22. Review.

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.

Peters-Klimm F, Campbell S, Müller-Tasch T, Schellberg D, Gelbrich G, Herzog W, Szecsenyi J. Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial. Trials. 2009 Aug 13;10:68.

Responsible Party:	Justin Kirven, Principle Investigator, Abbott Northwestern Hospital
ClinicalTrials.gov Identifier:	NCT01519479 History of Changes
Other Study ID Numbers:	3601-2
Study First Received:	January 19, 2012
Last Updated:	March 21, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Abbott Northwestern Hospital:

Congestive Heart Failure
Heart Failure
Palliative Care
Palliative Medicine

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013