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

March 18, 2005
February 6, 2014
August 2004
November 2007   (final data collection date for primary outcome measure)
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 ]
  • Caregiver-rated quality of death and dying
  • Hospital-based resource use
  • Costs
Complete list of historical versions of study NCT00106041 on ClinicalTrials.gov Archive Site
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 ]
  • Patient quality of life
  • Satisfaction with care
  • Continuity and coordination of care
  • Patient self-determination
Not Provided
Not Provided
 
Study to Improve Care for Veterans During Serious Illness
Randomized Trial of Care Management to Improve End of Life Care

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Palliative Care
Behavioral: Veterans Integrated Palliative Care Nurse Case Manager
Palliative Care nurse case management
Arm 1
Palliative Care Nurse Case Management
Intervention: Behavioral: Veterans Integrated Palliative Care Nurse Case Manager

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
September 2012
November 2007   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106041
IIR 02-294
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Kenneth E. Rosenfeld, MD VA Greater Los Angeles Health Care System
Department of Veterans Affairs
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP