NCT00106041

Brief Summary

Improving end-of-life care is of critical importance to the VA as it faces an increasingly aging and dying veteran population. Previous work within and outside of the VA has demonstrated serious deficiencies in the quality of care delivered near the end of life. Moreover, veterans in the VA system suffer from a higher rate of chronic and life-limiting illnesses and decrements in health-related quality of life compared with the age-matched controls. In FY2000 approximately 104,000 enrolled veterans died in the U.S. including 27,200 that died as inpatients in VA acute or chronic care medical wards. The care model on which the proposed study is based is theoretically sound and has been piloted in a study that suggested its use can help the VA achieve substantial quality improvement at reduced costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

August 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 7, 2015

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

March 18, 2005

Last Update Submit

April 6, 2015

Conditions

Keywords

end of life careevaluation studiesquality of death and dyingpalliative carecoordination of caresatisfaction with carehealthcare costutilization of healthcare resourcescaregiversveterans

Outcome Measures

Primary Outcomes (1)

  • Healthcare expenditures including inpatient, ICU, outpatient, pharmacy and total costs; utilization of healthcare resources; and quality of death and dying experience. Includes expenditures time of study enrollment until patient's death.

    We will be tracking resource use until the death of the patient or the conclusion of the study, whichever comes first. Quality of the death and dying experience will be assessed within 90 days of death

Secondary Outcomes (1)

  • Satisfaction with care, quality of care, symptom management, understanding of illness, continuity and coordination of care, end-of-life care preferences, advance care planning, and treatments.

    This will be assessed during the first year of enrollment.

Study Arms (1)

Arm 1

OTHER

Palliative Care Nurse Case Management

Behavioral: Veterans Integrated Palliative Care Nurse Case Manager

Interventions

Palliative Care nurse case management

Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to the hospital's general medicine service and estimated to have at least a 25% risk of dying over the following year.

You may not qualify if:

  • Inability to pass cognitive screen
  • Homelessness
  • No telephone
  • Admission from or discharge to a nursing home or hospice care
  • Enrollment in another healthcare program or study that duplicates services of this study
  • Receives most healthcare/primary healthcare services outside the VA GLA catchment area
  • Does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (9)

  • Wagner GJ, Riopelle D, Steckart J, Lorenz KA, Rosenfeld KE. Provider communication and patient understanding of life-limiting illness and their relationship to patient communication of treatment preferences. J Pain Symptom Manage. 2010 Mar;39(3):527-34. doi: 10.1016/j.jpainsymman.2009.07.012. Epub 2010 Feb 19.

  • Seow H, Snyder CF, Shugarman LR, Mularski RA, Kutner JS, Lorenz KA, Wu AW, Dy SM. Developing quality indicators for cancer end-of-life care: proceedings from a national symposium. Cancer. 2009 Sep 1;115(17):3820-9. doi: 10.1002/cncr.24439.

  • Goebel JR, Doering LV, Lorenz KA, Maliski SL, Nyamathi AM, Evangelista LS. Caring for special populations: total pain theory in advanced heart failure: applications to research and practice. Nurs Forum. 2009 Jul-Sep;44(3):175-85. doi: 10.1111/j.1744-6198.2009.00140.x.

  • Fromme EK, Hughes MT, Brokaw FC, Rosenfeld KE, Arnold RM. Update in palliative medicine 2008. Journal of palliative medicine. 2008 Jun 1; 11(5):769-75.

    RESULT
  • Casarett D, Pickard A, Amos Bailey F, Ritchie C, Furman C, Rosenfeld K, Shreve S, Shea JA. Important aspects of end-of-life care among veterans: implications for measurement and quality improvement. J Pain Symptom Manage. 2008 Feb;35(2):115-25. doi: 10.1016/j.jpainsymman.2007.03.008. Epub 2007 Nov 28.

  • Lorenz KA, Lynn J, Dy SM, Shugarman LR, Wilkinson A, Mularski RA, Morton SC, Hughes RG, Hilton LK, Maglione M, Rhodes SL, Rolon C, Sun VC, Shekelle PG. Evidence for improving palliative care at the end of life: a systematic review. Ann Intern Med. 2008 Jan 15;148(2):147-59. doi: 10.7326/0003-4819-148-2-200801150-00010.

  • Lorenz KA, Rosenfeld K, Wenger N. Quality indicators for palliative and end-of-life care in vulnerable elders. J Am Geriatr Soc. 2007 Oct;55 Suppl 2:S318-26. doi: 10.1111/j.1532-5415.2007.01338.x. No abstract available.

  • Chang VT, Sorger B, Rosenfeld KE, Lorenz KA, Bailey AF, Bui T, Weinberger L, Montagnini M. Pain and palliative medicine. J Rehabil Res Dev. 2007;44(2):279-94. doi: 10.1682/jrrd.2006.06.0067.

  • Krouse RS, Mohler MJ, Wendel CS, Grant M, Baldwin CM, Rawl SM, McCorkle R, Rosenfeld KE, Ko CY, Schmidt CM, Coons SJ. The VA Ostomy Health-Related Quality of Life Study: objectives, methods, and patient sample. Curr Med Res Opin. 2006 Apr;22(4):781-91. doi: 10.1185/030079906X96380.

Study Officials

  • Kenneth E. Rosenfeld, MD

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2005

First Posted

March 21, 2005

Study Start

August 1, 2004

Primary Completion

November 1, 2007

Study Completion

September 1, 2012

Last Updated

April 7, 2015

Record last verified: 2012-09

Locations