Study to Improve Care for Veterans During Serious Illness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00106041
First received: March 18, 2005
Last updated: February 6, 2014
Last verified: September 2012
  Purpose

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.


Condition Intervention
Palliative Care
Behavioral: Veterans Integrated Palliative Care Nurse Case Manager

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Care Management to Improve End of Life Care

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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. [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: This will be assessed during the first year of enrollment. ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: August 2004
Study Completion Date: September 2012
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Palliative Care Nurse Case Management
Behavioral: Veterans Integrated Palliative Care Nurse Case Manager
Palliative Care nurse case management

Detailed Description:

Background / Rationale: Improving end-of-life care is of critical importance to the VA as it faces an increasingly aging and dying veteran population. 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. Previous work within and outside of the VA has identified serious deficiencies in the quality of care delivered near the end of life. A pilot program of a collaborative care intervention in patients with advanced illness suggests that palliative care management may lead to improvements in processes and outcomes of care at reduced costs.

Objective(s): The purpose of this project is to test the effectiveness of a chronic illness model-based palliative care intervention that utilizes prognosis-based palliative care evaluation and longitudinal nurse care management on the processes and outcomes of end-of-life care at one VA medical center.

Methods: The study uses a randomized, controlled design. All patients admitted to the inpatient medical service during the enrollment period are screened for survival prognosis by their admitting resident physician. Patients estimated to have at least a 25% risk of dying over the following year and who meet other basic inclusion criteria are invited to participate. Consenting patients are randomized to intervention or usual care. The intervention entails initial palliative evaluation followed by nurse care management designed to promote informed goal-setting, symptom management, psycho/socio/spiritual support, and family support. Data collection activities include patient and caregiver surveys, chart reviews, and reviews of administrative databases. Primary study outcomes include caregiver-rated quality of death and dying, hospital-based resource use, and costs; secondary outcomes include patient quality of life, satisfaction with care, continuity and coordination of care, and patient self-determination

Status: Enrollment and follow up of veterans/patients in the study is complete. Follow up with the caregivers of patients who died is ongoing and projected to end in February 2008. Subject enrollment began on 08/04/04 and target enrollment of 400 patients was reached in November 2006. Of the 1354 non-duplicated patients admitted to the hospital and prognostically eligible for the study, 795 (59%) were excluded; 400 (30%) were enrolled; 142(10%) refused; and 17 (1%) were missed or did not respond to recruitment efforts. To date, 257 of 400 enrolled veterans (64%) have died and 152 after-death interviews have been conducted with caregivers.

Impact: If shown to be effective, the palliative care program tested in this study will be the first of its type to demonstrate success in a controlled trial, and it will be ready for larger-scale implementation studies that will inform models of end-of-life care delivery both within and outside of the VA. Administrators at VAs nationwide, including chiefs of service, chiefs of staff, hospital directors, and VISN directors will be able to use the plans and protocols developed in this project to develop programs at their own institutions. Nurses, generalist physicians, and specialists can gain important insights about the special needs of seriously ill patients and the role of care systems in delivering high-quality end of life care. Finally, the project has immediate relevance to the healthcare system at large, as it struggles to find effective end-of-life care delivery models.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106041

Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
Investigators
Principal Investigator: Kenneth E. Rosenfeld, MD VA Greater Los Angeles Health Care System
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00106041     History of Changes
Other Study ID Numbers: IIR 02-294
Study First Received: March 18, 2005
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
end of life care
evaluation studies
quality of death and dying
palliative care
coordination of care
satisfaction with care
healthcare cost
utilization of healthcare resources
caregivers
veterans

ClinicalTrials.gov processed this record on October 29, 2014