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| Tracking Information | |||||
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| First Received Date ICMJE | October 4, 2005 | ||||
| Last Updated Date | July 10, 2009 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Chart review 1. Presence of order for opioid pain medication at time of death 2.Do Not Resuscitate order present 3.Location of death (ICU vs. other) 4.Presence of nasogastric tube or intravenous line 5.Presence of restraints at or near time of death [ Time Frame: For primary analysis of each outcome, 12 months before and 12 months after 6-month intervention period ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00234286 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Intervention to Improve Care at Life's End | ||||
| Official Title ICMJE | Intervention to Improve Care at Life's End in VA Medical Centers | ||||
| Brief Summary | The primary aim is to evaluate an intervention designed to improve the quality of end-of-life care provided in VA Medical Centers. |
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| Detailed Description | 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 has been completed at the first five sites. Preparation for initiating intervention at Site #6 is underway and planned for October 2009. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Health Services Research, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Comfort care education intervention | ||||
| Study Arms / Comparison Groups | Experimental: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care | ||||
| Publications * | Williams BR, Woodby LL, Bailey FA, Burgio KL. Identifying and responding to ethical and methodological issues in after-death interviews with next-of-kin. Death Stud. 2008;32(3):197-236. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Aim 1: Not applicable. Patients are deceased. Aim 2: After-death interviews with next of kin: must be willing and able to participate in after-death interview at local VA Medical Center. Exclusion Criteria: N/A |
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00234286 | ||||
| Responsible Party | Burgio, Kathryn - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | IIR 03-126 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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