Intervention to Improve Care at Life's End (BEACON)
Primary Purpose
Death, Pain, Dyspnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comfort care education intervention
Sponsored by
About this trial
This is an interventional health services research trial for Death focused on measuring Palliative Care, Terminal Care, Hospice Care, Patient Care Planning, Nursing Care Plans, Quality of Health Care, Inpatients, Professional education, Resuscitation orders, Pastoral Care
Eligibility 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
Sites / Locations
- Birmingham VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Outcomes
Primary Outcome Measures
Presence of Order for Opioid Pain Medication
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
Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record
Number of Patients Who Died in ICU
Location of death (ICU vs. other) based on abstraction of electronic medical record
Individuals With a Nasogastric Tube
Presence of nasogastric tube based on abstraction of electronic medical record
Individuals With an Intravenous Line
Presence of intravenous line infusing at time of death based on abstraction of electronic medical record
Number of Individuals Who Died in Restraints
Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record
Individuals Administered of Opioid Medication
Administration of opioid medication based on abstraction of medical record
Individuals With an Order for Antipsychotic Medication
Order for antipsychotic medication based on abstraction of medical record
Individuals Administered Antipsychotic Medication
Administration of antipsychotic medication based on abstraction of medical record
Individuals With an Order for Benzodiazepine Medication
Order for benzodiazepine medication based on abstraction of medical record
Individuals Who Received Benzodiazepine Medication
Administration of benzodiazepine medication based on abstraction of medical record
Individuals Who Received Scopolamine
Administration of scopolamine (for death rattle) based on abstraction of medical record
Sublingual Administration
Sublingual administration of medication based on abstraction of medical record
Individuals With Pastoral Care Visit
Pastoral Care Visit based on abstraction of medical record
Individuals With an Advance Directive
Presence of advance directive based on abstraction of medical record
Individuals With a Palliative Care Consultation
Palliative Care Consultation based on abstraction of medical record
Full Information
NCT ID
NCT00234286
First Posted
October 4, 2005
Last Updated
April 23, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00234286
Brief Title
Intervention to Improve Care at Life's End
Acronym
BEACON
Official Title
Intervention to Improve Care at Life's End in VA Medical Centers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Death, Pain, Dyspnea
Keywords
Palliative Care, Terminal Care, Hospice Care, Patient Care Planning, Nursing Care Plans, Quality of Health Care, Inpatients, Professional education, Resuscitation orders, Pastoral Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Intervention Type
Behavioral
Intervention Name(s)
Comfort care education intervention
Intervention Description
Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Primary Outcome Measure Information:
Title
Presence of Order for Opioid Pain Medication
Description
Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record
Time Frame
Pre and Post Intervention
Secondary Outcome Measure Information:
Title
Do Not Resuscitate Order
Description
Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record
Time Frame
Pre and Post Intervention
Title
Number of Patients Who Died in ICU
Description
Location of death (ICU vs. other) based on abstraction of electronic medical record
Time Frame
Pre and Post Intervention
Title
Individuals With a Nasogastric Tube
Description
Presence of nasogastric tube based on abstraction of electronic medical record
Time Frame
Pre and Post Intervention
Title
Individuals With an Intravenous Line
Description
Presence of intravenous line infusing at time of death based on abstraction of electronic medical record
Time Frame
Pre and Post Intervention
Title
Number of Individuals Who Died in Restraints
Description
Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record
Time Frame
Pre and Post Intervention
Title
Individuals Administered of Opioid Medication
Description
Administration of opioid medication based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals With an Order for Antipsychotic Medication
Description
Order for antipsychotic medication based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals Administered Antipsychotic Medication
Description
Administration of antipsychotic medication based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals With an Order for Benzodiazepine Medication
Description
Order for benzodiazepine medication based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals Who Received Benzodiazepine Medication
Description
Administration of benzodiazepine medication based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals Who Received Scopolamine
Description
Administration of scopolamine (for death rattle) based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Sublingual Administration
Description
Sublingual administration of medication based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals With Pastoral Care Visit
Description
Pastoral Care Visit based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals With an Advance Directive
Description
Presence of advance directive based on abstraction of medical record
Time Frame
Pre and Post Intervention
Title
Individuals With a Palliative Care Consultation
Description
Palliative Care Consultation based on abstraction of medical record
Time Frame
Pre and Post Intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn L Burgio, PhD MA BA
Organizational Affiliation
Birmingham, Alabama VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18705168
Citation
Williams BR, Woodby LL, Bailey FA, Burgio KL. Identifying and responding to ethical and methodological issues in after-death interviews with next-of-kin. Death Stud. 2008;32(3):197-236. doi: 10.1080/07481180701881297.
Results Reference
background
PubMed Identifier
21393618
Citation
Woodby LL, Williams BR, Wittich AR, Burgio KL. Expanding the notion of researcher distress: the cumulative effects of coding. Qual Health Res. 2011 Jun;21(6):830-8. doi: 10.1177/1049732311402095. Epub 2011 Mar 10.
Results Reference
background
PubMed Identifier
22765968
Citation
Bailey FA, Williams BR, Goode PS, Woodby LL, Redden DT, Johnson TM 2nd, Taylor JW, Burgio KL. Opioid pain medication orders and administration in the last days of life. J Pain Symptom Manage. 2012 Nov;44(5):681-91. doi: 10.1016/j.jpainsymman.2011.11.006. Epub 2012 Jul 4.
Results Reference
result
PubMed Identifier
22536938
Citation
Bailey FA, Allen RS, Williams BR, Goode PS, Granstaff S, Redden DT, Burgio KL. Do-not-resuscitate orders in the last days of life. J Palliat Med. 2012 Jul;15(7):751-9. doi: 10.1089/jpm.2011.0321. Epub 2012 Apr 26.
Results Reference
result
PubMed Identifier
31792872
Citation
Bickel KE, Kennedy R, Levy C, Burgio KL, Bailey FA. The Relationship of Post-traumatic Stress Disorder to End-of-life Care Received by Dying Veterans: a Secondary Data Analysis. J Gen Intern Med. 2020 Feb;35(2):505-513. doi: 10.1007/s11606-019-05538-x. Epub 2019 Dec 2.
Results Reference
derived
PubMed Identifier
24655157
Citation
Riggs JS, Woodby LL, Burgio KL, Bailey FA, Williams BR. "Don't get weak in your compassion": bereaved next of kin's suggestions for improving end-of-life care in Veterans Affairs Medical Centers. J Am Geriatr Soc. 2014 Apr;62(4):642-8. doi: 10.1111/jgs.12764. Epub 2014 Mar 21.
Results Reference
derived
PubMed Identifier
24449032
Citation
Bailey FA, Williams BR, Woodby LL, Goode PS, Redden DT, Houston TK, Granstaff US, Johnson TM 2nd, Pennypacker LC, Haddock KS, Painter JM, Spencer JM, Hartney T, Burgio KL. Intervention to improve care at life's end in inpatient settings: the BEACON trial. J Gen Intern Med. 2014 Jun;29(6):836-43. doi: 10.1007/s11606-013-2724-6.
Results Reference
derived
Links:
URL
http://www.growthhouse.org
Description
Growthhouse website MegaSearch, an international clearing house for high quality educational materials related to hospice and palliative care
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Intervention to Improve Care at Life's End
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