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Palliative Care for Heart Failure Patients

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Palliative Care Consultation
Control
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Congestive Heart Failure, Heart Failure, Palliative Care, Palliative Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abbott Northwestern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Palliative Care Consultation

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Differential use of medical services- 30 day readmission
*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
Assessment tool: *Symptom Severity - Edmonton Symptom Assessment scale (ESAS)
Is there an impact on depression with the addition of palliative care intervention?
Assessment Tool: *Depression- Patient Health Questionnaire (PHQ-9)

Full Information

First Posted
January 19, 2012
Last Updated
March 15, 2019
Sponsor
Allina Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01519479
Brief Title
Palliative Care for Heart Failure Patients
Official Title
An Examination of Palliative Care as Standard Practice for Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Congestive Heart Failure, Heart Failure, Palliative Care, Palliative Medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palliative Care Consultation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual care for HF patient which may include a palliative care consult if ordered by treating physician.
Intervention Type
Other
Intervention Name(s)
Palliative Care Consultation
Other Intervention Name(s)
palliative care consults, palliative care medicine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
palliative care consult, palliative care medicine
Intervention Description
The control group would receive usual care and could receive a palliative consult if ordered by the treating provider
Primary Outcome Measure Information:
Title
Is there an impact on quality of life with the addition of palliative care intervention?
Description
Assessment Tools: *Quality of Life-Minnesota Living with Heart Failure questionnaire (MLHF)
Time Frame
Change from baseline in quality of life score at 3 months
Secondary Outcome Measure Information:
Title
Differential use of medical services- 30 day readmission
Description
*Number of readmissions in 30 days of discharge from initial enrollment hospitalization.
Time Frame
30 Days
Title
Is there an impact on Symptom Severity with the addition of palliative care
Description
Assessment tool: *Symptom Severity - Edmonton Symptom Assessment scale (ESAS)
Time Frame
Change from baseline in symptom severity score at 3 months
Title
Is there an impact on depression with the addition of palliative care intervention?
Description
Assessment Tool: *Depression- Patient Health Questionnaire (PHQ-9)
Time Frame
Change from baseline in depression score at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Kirven, MD
Organizational Affiliation
Allina Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19690306
Citation
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.
Results Reference
background
PubMed Identifier
20818875
Citation
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.
Results Reference
background
PubMed Identifier
12420047
Citation
Smith ER. Heart failure--are we making progress? Can J Cardiol. 2002 Oct;18(10):1124-5. No abstract available.
Results Reference
background
PubMed Identifier
21383364
Citation
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.
Results Reference
background
PubMed Identifier
17081306
Citation
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.
Results Reference
background
PubMed Identifier
11773934
Citation
Wilson E. Congestive heart failure: A national priority. Can J Cardiol. 2001 Dec;17(12):1243-4. No abstract available. English, French.
Results Reference
background
PubMed Identifier
9338529
Citation
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.
Results Reference
background
PubMed Identifier
15265849
Citation
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.
Results Reference
background
PubMed Identifier
17298270
Citation
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.
Results Reference
background
PubMed Identifier
19628112
Citation
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.
Results Reference
background
PubMed Identifier
11378002
Citation
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.
Results Reference
background
PubMed Identifier
17387068
Citation
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.
Results Reference
background
PubMed Identifier
14718327
Citation
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.
Results Reference
background
PubMed Identifier
12445531
Citation
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.
Results Reference
background
PubMed Identifier
15120810
Citation
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.
Results Reference
background
PubMed Identifier
15120809
Citation
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.
Results Reference
background
PubMed Identifier
19332232
Citation
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.
Results Reference
background
PubMed Identifier
1529875
Citation
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.
Results Reference
background
PubMed Identifier
8475878
Citation
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.
Results Reference
background
Citation
Rector, T.S., Overview of The Minnesota Living with Heart Failure Questionnaire. 2005, University of Minnesota.
Results Reference
background
PubMed Identifier
10813730
Citation
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.
Results Reference
background
PubMed Identifier
18372376
Citation
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.
Results Reference
background
PubMed Identifier
11556941
Citation
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.
Results Reference
background
PubMed Identifier
19678944
Citation
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.
Results Reference
background
PubMed Identifier
20831837
Citation
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.
Results Reference
background
PubMed Identifier
8875378
Citation
McCarthy M, Lay M, Addington-Hall J. Dying from heart disease. J R Coll Physicians Lond. 1996 Jul-Aug;30(4):325-8.
Results Reference
background
PubMed Identifier
25479182
Citation
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.
Results Reference
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Palliative Care for Heart Failure Patients

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