Clinical trial NCT00234286: Intervention to Improve Care at Life's End
Official title: Intervention to Improve Care at Life's End in VA Medical Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-10-06
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Presence of Order for Opioid Pain Medication
timeFrame: Pre and Post Intervention
Secondary outcomes:
measure: Do Not Resuscitate Order
timeFrame: Pre and Post Intervention
measure: Number of Patients Who Died in ICU
timeFrame: Pre and Post Intervention
measure: Individuals With a Nasogastric Tube
timeFrame: Pre and Post Intervention
measure: Individuals With an Intravenous Line
timeFrame: Pre and Post Intervention
measure: Number of Individuals Who Died in Restraints
timeFrame: Pre and Post Intervention
measure: Individuals Administered of Opioid Medication
timeFrame: Pre and Post Intervention
measure: Individuals With an Order for Antipsychotic Medication
timeFrame: Pre and Post Intervention
measure: Individuals Administered Antipsychotic Medication
timeFrame: Pre and Post Intervention
measure: Individuals With an Order for Benzodiazepine Medication
timeFrame: Pre and Post Intervention
measure: Individuals Who Received Benzodiazepine Medication
timeFrame: Pre and Post Intervention
measure: Individuals Who Received Scopolamine
timeFrame: Pre and Post Intervention
measure: Sublingual Administration
timeFrame: Pre and Post Intervention
measure: Individuals With Pastoral Care Visit
timeFrame: Pre and Post Intervention
measure: Individuals With an Advance Directive
timeFrame: Pre and Post Intervention
measure: Individuals With a Palliative Care Consultation
timeFrame: Pre and Post Intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
Study officials:
affiliation: Birmingham, Alabama VA Medical Center
name: Kathryn L Burgio, PhD MA BA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.