We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00234286
Recruitment Status : Completed
First Posted : October 6, 2005
Results First Posted : April 27, 2015
Last Update Posted : April 27, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Death Pain Dyspnea Behavioral: Comfort care education intervention

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Intervention to Improve Care at Life's End in VA Medical Centers
Study Start Date : August 2005
Primary Completion Date : March 2011
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Presence of Order for Opioid Pain Medication [ Time Frame: Pre and Post Intervention ]
    Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record


Secondary Outcome Measures :
  1. Do Not Resuscitate Order [ Time Frame: Pre and Post Intervention ]
    Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record

  2. Number of Patients Who Died in ICU [ Time Frame: Pre and Post Intervention ]
    Location of death (ICU vs. other) based on abstraction of electronic medical record

  3. Individuals With a Nasogastric Tube [ Time Frame: Pre and Post Intervention ]
    Presence of nasogastric tube based on abstraction of electronic medical record

  4. Individuals With an Intravenous Line [ Time Frame: Pre and Post Intervention ]
    Presence of intravenous line infusing at time of death based on abstraction of electronic medical record

  5. Number of Individuals Who Died in Restraints [ Time Frame: Pre and Post Intervention ]
    Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record

  6. Individuals Administered of Opioid Medication [ Time Frame: Pre and Post Intervention ]
    Administration of opioid medication based on abstraction of medical record

  7. Individuals With an Order for Antipsychotic Medication [ Time Frame: Pre and Post Intervention ]
    Order for antipsychotic medication based on abstraction of medical record

  8. Individuals Administered Antipsychotic Medication [ Time Frame: Pre and Post Intervention ]
    Administration of antipsychotic medication based on abstraction of medical record

  9. Individuals With an Order for Benzodiazepine Medication [ Time Frame: Pre and Post Intervention ]
    Order for benzodiazepine medication based on abstraction of medical record

  10. Individuals Who Received Benzodiazepine Medication [ Time Frame: Pre and Post Intervention ]
    Administration of benzodiazepine medication based on abstraction of medical record

  11. Individuals Who Received Scopolamine [ Time Frame: Pre and Post Intervention ]
    Administration of scopolamine (for death rattle) based on abstraction of medical record

  12. Sublingual Administration [ Time Frame: Pre and Post Intervention ]
    Sublingual administration of medication based on abstraction of medical record

  13. Individuals With Pastoral Care Visit [ Time Frame: Pre and Post Intervention ]
    Pastoral Care Visit based on abstraction of medical record

  14. Individuals With an Advance Directive [ Time Frame: Pre and Post Intervention ]
    Presence of advance directive based on abstraction of medical record

  15. Individuals With a Palliative Care Consultation [ Time Frame: Pre and Post Intervention ]
    Palliative Care Consultation based on abstraction of medical record


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00234286


Locations
United States, Alabama
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Kathryn L Burgio, PhD MA BA VA Office of Research and Development
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00234286     History of Changes
Other Study ID Numbers: IIR 03-126
First Posted: October 6, 2005    Key Record Dates
Results First Posted: April 27, 2015
Last Update Posted: April 27, 2015
Last Verified: April 2015

Keywords provided by VA Office of Research and Development:
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