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Intervention to Improve Care at Life's End

This study has been suspended.
( VA investigation of unrelated data loss in Birmingham )

Sponsored by: Department of Veterans Affairs
Information provided by: 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 Intervention

MedlinePlus related topics:   Breathing Problems    Hospice Care    Palliative Care   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:   Intervention to Improve Care at Life's End in VA Medical Centers

Further study details as provided by Department of Veterans Affairs:

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

Secondary Outcome Measures:
  • Symptoms/care plans, advance directives, resuscitations, hospice care, palliative consults, presence of family, pastoral services, info on hospital stay, locations of care. After-death interviews of family on attitudes, perceptions & satisfaction w/care [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   August 2005
Estimated Study Completion Date:   October 2009

Arms Assigned Interventions
1 Behavioral: Comfort Care Intervention

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 5 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 ICUs to medical units, and elimination of instrumentation and restraints. Through intensive on-site staff training and follow-up consultation, staff will be 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 will be 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 will be used to elicit family members' attitudes, beliefs and feelings about the care received at the end of life. They will 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 initiated at Sites #1, #2, and #3. Preparation for intervention at Site #4 is underway and planned for September 2008.

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

Criteria

Inclusion Criteria:

Aim 1: Not applicable. Patients are deceased. Aim 2: 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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234286

Locations
United States, Alabama
Birmingham, AL    
      Birmingham, Alabama, United States, 35233

Sponsors and Collaborators

Investigators
Principal Investigator:     Kathryn L. Burgio, BA MA PhD     Department of Veterans Affairs    
  More Information

Department of Veterans Affairs website for information and materials related to hospice and palliative care  This link exits the ClinicalTrials.gov site
 
Growthhouse website MegaSearch, an international clearing house for high quality educational materials related to hospice and palliative care  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Department of Veterans Affairs ( Burgio, Kathryn - Principal Investigator )
Study ID Numbers:   IIR 03-126
First Received:   October 4, 2005
Last Updated:   August 14, 2008
ClinicalTrials.gov Identifier:   NCT00234286
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Palliative Care  
Terminal Care  
Hospice Care  
Patient Care Planning  
Nursing Care Plans  
Quality of Health Care
Inpatients
Professional education
Resuscitiation orders
Pastoral Care

Study placed in the following topic categories:
Death
Pain
Dyspnea

ClinicalTrials.gov processed this record on September 04, 2008




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