Randomized Trial of Care Management to Improve End of Life Care
Kenneth E. Rosenfeld MD
VA Greater Los Angeles Health Care System
West Los Angeles, CA
Funding Period: January 2004 - December 2008

BACKGROUND/RATIONALE:
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.

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 will take place at the VA Greater Los Angeles Healthcare System. All patients admitted to the inpatient medical service during the enrollment period will be screened for survival prognosis by their admitting resident physician. Patients estimated to have at least a 25 percent risk of dying over the following year and meeting other eligibility criteria will be consented and then randomized to the study intervention or usual care; target enrollment is 200 patients in each group. The study intervention will be organized around a chronic illness model incorporating explicit plans and protocols, reorganization of care delivery centered on a nurse care manager (NCM), patient education and involvement in care, specialist support, and supportive information systems to promote coordination of care. Intervention patients will receive an inpatient palliative screening evaluation by the NCM followed by needs-based consultation by the palliative consultation team. Continuing after hospital discharge, the NCM will provide ongoing patient education, symptom management support, and coordination of medical care services through protocol-driven telephone monitoring. Patients assigned to the control group will receive current usual care practices, which includes inpatient palliative consultation only if requested by the inpatient medical team but no case management component. Data collection and analysis will permit comparisons of relevant end-of-life processes and outcomes. Data collection activities will include patient and caregiver surveys, chart reviews, and reviews of administrative databases. Patients will be interviewed at study entry (baseline), and at months 1 and 6 following study entry (if the patient is alive), while caregivers will be interviewed at study entry (baseline) and at month 1. For living patients unable to participate in follow-up interviews, caregivers will provide surrogate responses for patients. For patients who die prior to the completion of data collection, an afterdeath interview will be conducted with the primary caregiver. Chart reviews will be used to assess processes of care; administrative data will be used to assess resource use and costs. 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.

FINDINGS/RESULTS:
The study began enrollment of patients on 08/04/04. As of 01/17/05, 24 weeks into enrollment, we have screened 1,053 patients and identified 321 eligible subjects based on prognostication scores. Of these 321, 181 (58%) were excluded based on pre-determined eligibility criteria. Ninety-seven patients (30%) have agreed to participate. Of the 97 enrolled patients, 48 are intervention and 49 are control. Sixty-nine caregivers have also been enrolled. We have completed 66 1-month follow up interviews with patients. Six-month follow up interviews will begin February 2005. Twenty-two patients have expired since the beginning of the trial, five after-death interviews have been conducted with caregivers.

IMPACT:
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. 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 dissemination studies that will inform models of end-of-life care delivery both within and outside of the VA.

PUBLICATIONS:
None at this time.

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DRA: Aging and Age-Related Changes, Chronic Diseases, Health Services and Systems
DRE: Quality of Care
Keywords: Advance directives, End-of-life, Managed care
MeSH Terms: