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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00234286 |
Purpose
The primary aim is to evaluate an intervention designed to improve the quality of end-of-life care provided in VA Medical Centers.
| Condition | Intervention |
|---|---|
|
Death Pain Dyspnea |
Behavioral: Comfort care education intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Intervention to Improve Care at Life's End in VA Medical Centers |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | June 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care
|
Behavioral: Comfort care education intervention
Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care
|
Background:
Currently 28,000 veterans die each year within VA Medical Centers. In acute care units, patients near the end of life are frequently not identified, and as a result, their suffering may not be properly appreciated or managed, and may even be exacerbated by standard medical care. The primary goal of this study is to evaluate an intervention designed to improve the quality of end-of-life care provided in VA Medical Centers.
Objectives:
The objective of this study is to transfer the best practices of traditionally home-based hospice and palliative care into the VA inpatient setting. Specific aims are: (1) to evaluate the effectiveness of a Comfort Care intervention for improving processes of care at life's end, and (2) conduct qualitative analyses of after-death interviews with families and caregivers.
Methods:
The study is a pre-post intervention trial in 6 VA Medical Centers. The Comfort Care intervention targets physician, nursing, and ancillary staff, training them to identify veterans who are dying and to implement care plans appropriate for the last days or hours of life. Applying Comfort Care to dying patients in the acute care setting involves altering the trajectory of care to treatment pathways oriented more toward meeting the needs of dying patients, including pain control, DNR planning, transfer from intensive care units to medical units, and elimination of instrumentation and restraints. Through intensive on-site staff training and follow-up consultation, staff are trained to identify patients who are near the end of life and implement Comfort Care interventions. To facilitate the use of these interventions, an electronic Comfort Care Order Set is integrated into the Computerized Patient Record System (CPRS).
Data extracted from the CPRS records of veterans who have died during a 12-month period before and after intervention will be used to determine the impact of the intervention on 5 process of care indicators: presence of an order for opioid pain medication at the time of death, DNR orders, location of death, nasogastric tubes/intravenous lines, and restraints. Analyses will account for clustering of patients within facilities and staggered implementation of intervention across facilities will allow for examination of secular trends.
Semi-structured after-death interviews are used to elicit family members' attitudes, beliefs and feelings about the care received at the end of life. They also complete questionnaires assessing their perceptions of the intensity and frequency of the loved one's pain at the end of life, satisfaction with care, and impact of the death on the family/caregiver. Data from qualitative analyses will be compared with quantitative measures of processes of care to help in developing concurrency between the issues of importance to families and patients and those of the medical system.
Status:
Intervention and next-of-kin interviews have been completed at all sites. Data collection (chart abstractions) will continue for all sites to the end of the last post-intervention phase (approximately March 2012).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Birmingham VA Medical Center | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Massachusetts | |
| Edith Nourse Rogers Memorial Veterans Hospital, Bedford | |
| Bedford, Massachusetts, United States, 01730 | |
| Principal Investigator: | Kathryn L. Burgio, PhD MA BA | Department of Veterans Affairs |
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00234286 History of Changes |
| Other Study ID Numbers: | IIR 03-126 |
| Study First Received: | October 4, 2005 |
| Last Updated: | October 19, 2011 |
| Health Authority: | United States: Federal Government |
|
Palliative Care Terminal Care Hospice Care Patient Care Planning Nursing Care Plans |
Quality of Health Care Inpatients Professional education Resuscitation orders Pastoral Care |
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