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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00234286
First received: October 4, 2005
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site implementation study to evaluate a multi-component, education-based intervention 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:
  • Presence of order for opioid pain medication [ Time Frame: at time of death ] [ Designated as safety issue: No ]
    Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record


Secondary Outcome Measures:
  • Do Not Resuscitate order [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record

  • Location of death [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Location of death (ICU vs. other) based on abstraction of electronic medical record

  • Presence of nasogastric tube [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Presence of nasogastric tube based on abstraction of electronic medical record

  • Presence of intravenous line [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Presence of intravenous line infusing at time of death based on abstraction of electronic medical record

  • Presence of restraints [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record

  • Administration of opioid medication [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Administration of opioid medication based on abstraction of medical record

  • Order for antipsychotic medication [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Order for antipsychotic medication based on abstraction of medical record

  • Administration of antipsychotic medication [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Administration of antipsychotic medication based on abstraction of medical record

  • Order for benzodiazepine medication [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Order for benzodiazepine medication based on abstraction of medical record

  • Administration of benzodiazepine medication [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Administration of benzodiazepine medication based on abstraction of medical record

  • Administration of scopolamine [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Administration of scopolamine (for death rattle) based on abstraction of medical record

  • Sublingual administration [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Sublingual administration of medication based on abstraction of medical record

  • Palliative care consultation [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Palliative care consultation based on abstraction of medical record

  • Presence of advance directive [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Presence of advance directive based on abstraction of medical record

  • Pastoral care visit [ Time Frame: before and after intervention ] [ Designated as safety issue: No ]
    Pastoral care visit based on abstraction of medical record


Enrollment: 78
Study Start Date: August 2005
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 and educational materials
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 and educational materials

Detailed Description:

The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site, real-world implementation trial of a multi-component, education-based intervention to improve the quality of end-of-life care conducted in VA Medical Centers (VAMCs).

The primary aim 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.

The multi-component 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 set 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. 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.

In addition, in-depth, face-to-face interviews were conducted with 78 bereaved next-of-kin.

  Eligibility

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

Inclusion Criteria:

  • Aim 1: Not applicable. Patients were 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 15, 2014
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

ClinicalTrials.gov processed this record on September 22, 2014