Intervention to Improve Care at Life's End (BEACON)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00234286
First received: October 4, 2005
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

The primary aim was to evaluate a multi-component education-based 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: 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. [ 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 ]

Enrollment: 78
Study Start Date: August 2005
Estimated Study Completion Date: September 2013
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 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:

At life's end, most people experience physical suffering, as well as significant emotional, spiritual, and social distress. Often, patients are not recognized as actively dying. Suffering may be exacerbated by usual medical care, in which aggressive, futile, or iatrogenically harmful treatments frequently are continued. During this time, palliative care treatment plans have the potential to improve quality of end-of-life care and reduce hospital costs. Despite the benefits of palliative care, it is not routinely available in inpatient settings without designated hospice units. Most individuals are likely to die in a hospital or nursing home, creating a compelling need to address processes of care for actively dying patients in inpatient settings. The "Best Practices for End-of-Life Care for Our Nations' Veterans" (BEACON) trial, was a multi-center implementation-facilitation trial of an intervention to improve the quality of end-of-life care in VA Medical Centers (VAMCs).

Objectives:

The primary aim of this study was to evaluate the effectiveness of a multi-component intervention for improving processes of care provided in the last days of life in VAMCs.

The second aim was to conduct after-death interviews with next-of-kin and qualitative analysis of their perceptions of the care provided to the veteran and family.

Methods:

The BEACON study was a real-world, pre-post implementation trial in six VAMCs. The 4-month, multi-modal intervention targeted VAMC inpatient providers, including physician, nursing, and ancillary staff. It consisted of preparatory site visits, a staff training program, a newly developed Comfort Care Order et decision support tool built into the CPRS, and follow-up consultation. The intervention team travelled to each site to conduct two weeks of comprehensive in-service training. Staff were trained to identify actively-dying patients and implement a set of best practices of traditionally home-based hospice care for dying patients. The team provided assistance with policies, procedures, and skill training needed to implement comfort care interventions.

To control for secular trends, introduction of the intervention at each VAMC was staggered across time at six-month intervals using a multiple-baseline, stepped wedge design. Data on processes of end-of-life care (last 7 days) were abstracted from the CPRS medical records of all veterans who died before, during, and after the intervention (January 2005-February 2011).

A priori, five processes of care were identified as primary endpoints to indicate quality of end-of-life care: 1) presence of an order for opioid pain medication at time of death; 2) a do-not- resuscitate (DNR) order in place at time of death; 3) location of death; 4) presence of enteral feeding tube or intravenous line at time of death; and 5) physical restraints in place at or near time of death.

Status:

The results of the trial were presented at the European Association for Palliative Care. The primary analyses have been completed and the main manuscript will be submitted in December 2012 for publication. Interviews have been conducted with key informants to describe uptake of the intervention and a formative analysis is underway. The team will continue to analyze both quantitative and qualitative data for future publication.

  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
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: April 24, 2013
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 May 16, 2013