NCT01519479

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

January 19, 2012

Last Update Submit

March 15, 2019

Conditions

Heart Failure

Keywords

Congestive Heart FailureHeart FailurePalliative CarePalliative Medicine

Outcome Measures

Primary Outcomes (1)

  • Is there an impact on quality of life with the addition of palliative care intervention?

    Assessment Tools: \*Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)

    Change from baseline in quality of life score at 3 months

Secondary Outcomes (3)

  • Differential use of medical services- 30 day readmission

    30 Days

  • Is there an impact on Symptom Severity with the addition of palliative care

    Change from baseline in symptom severity score at 3 months

  • Is there an impact on depression with the addition of palliative care intervention?

    Change from baseline in depression score at 3 months

Study Arms (2)

Palliative Care Consultation

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Usual care for HF patient which may include a palliative care consult if ordered by treating physician.

Other: Control

Interventions

Palliative Care ConsultationOTHER

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.

Also known as: palliative care consults, palliative care medicine
Palliative Care Consultation
ControlOTHER

The control group would receive usual care and could receive a palliative consult if ordered by the treating provider

Also known as: palliative care consult, palliative care medicine
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (27)

  • 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. doi: 10.1001/jama.2009.1198.

    PMID: 19690306BACKGROUND

  • 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. doi: 10.1056/NEJMoa1000678.

    PMID: 20818875BACKGROUND

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

    PMID: 12420047BACKGROUND

  • 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. doi: 10.1377/hlthaff.2010.0929.

    PMID: 21383364BACKGROUND

  • 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. doi: 10.1186/1471-2261-6-43.

    PMID: 17081306BACKGROUND

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

    PMID: 11773934BACKGROUND

  • 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. doi: 10.1097/00005650-199710000-00005.

    PMID: 9338529BACKGROUND

  • 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. doi: 10.1001/jama.292.3.344.

    PMID: 15265849BACKGROUND

  • Stuart B. Palliative care and hospice in advanced heart failure. J Palliat Med. 2007 Feb;10(1):210-28. doi: 10.1089/jpm.2006.9988.

    PMID: 17298270BACKGROUND

  • Goodlin SJ. Palliative care in congestive heart failure. J Am Coll Cardiol. 2009 Jul 28;54(5):386-96. doi: 10.1016/j.jacc.2009.02.078.

    PMID: 19628112BACKGROUND

  • 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. doi: 10.1016/s1388-9842(00)00141-0.

    PMID: 11378002BACKGROUND

  • 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. doi: 10.1300/J457v01n03_04.

    PMID: 17387068BACKGROUND

  • 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. doi: 10.1001/archinte.164.1.83.

    PMID: 14718327BACKGROUND

  • 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. doi: 10.1053/euhj.2002.3309. No abstract available.

    PMID: 12445531BACKGROUND

  • 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. doi: 10.1016/j.jacc.2004.02.003. No abstract available.

    PMID: 15120810BACKGROUND

  • 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. doi: 10.1016/j.jacc.2003.10.064.

    PMID: 15120809BACKGROUND

  • 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. doi: 10.1016/j.amjmed.2008.09.046.

    PMID: 19332232BACKGROUND

  • 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. doi: 10.1016/0002-8703(92)90986-6.

    PMID: 1529875BACKGROUND

  • 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. doi: 10.1016/0002-9149(93)90582-w. No abstract available.

    PMID: 8475878BACKGROUND

  • Rector, T.S., Overview of The Minnesota Living with Heart Failure Questionnaire. 2005, University of Minnesota.

    BACKGROUND

  • Chang VT, Hwang SS, Feuerman M. Validation of the Edmonton Symptom Assessment Scale. Cancer. 2000 May 1;88(9):2164-71. doi: 10.1002/(sici)1097-0142(20000501)88:93.0.co;2-5.

    PMID: 10813730BACKGROUND

  • 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. doi: 10.1177/0269216307087659.

    PMID: 18372376BACKGROUND

  • 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. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND

  • Peters-Klimm F, Campbell S, Muller-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. doi: 10.1186/1745-6215-10-68.

    PMID: 19678944BACKGROUND

  • Peters-Klimm F, Kunz CU, Laux G, Szecsenyi J, Muller-Tasch T. Patient- and provider-related determinants of generic and specific health-related quality of life of patients with chronic systolic heart failure in primary care: a cross-sectional study. Health Qual Life Outcomes. 2010 Sep 13;8:98. doi: 10.1186/1477-7525-8-98.

    PMID: 20831837BACKGROUND

  • McCarthy M, Lay M, Addington-Hall J. Dying from heart disease. J R Coll Physicians Lond. 1996 Jul-Aug;30(4):325-8.

    PMID: 8875378BACKGROUND

  • Sidebottom AC, Jorgenson A, Richards H, Kirven J, Sillah A. Inpatient palliative care for patients with acute heart failure: outcomes from a randomized trial. J Palliat Med. 2015 Feb;18(2):134-42. doi: 10.1089/jpm.2014.0192. Epub 2014 Dec 5.

    PMID: 25479182RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Justin Kirven, MD

    Allina Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 27, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

US(1)