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Intervention to Improve Care at Life's End (BEACON)
This study is ongoing, but not recruiting participants.

First Received on October 4, 2005.   Last Updated on October 19, 2011   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

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. [ Time Frame: For primary analysis of each outcome, 12 months before and 12 months after 6-month intervention period ] [ Designated as safety issue: No ]
  • After-death interviews of family on attitudes, perceptions & satisfaction w/care [ Time Frame: For primary analysis of each outcome, 12 months before and 12 months after 6-month intervention period ] [ Designated as safety issue: No ]

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

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 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
Criteria

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

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

Additional Information:
Publications:
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

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
Resuscitation orders
Pastoral Care

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012