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DeathBEACONNCT00234286

Intervention to Improve Care at Life's End

A study testing Comfort care education intervention in people with Death and Pain, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Death, Pain, Dyspnea
What is being tested?
Comfort care education intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited States
Study dates
Aug 2005to Sep 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Birmingham VA Medical Center

    Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: Intervention to Improve Care at Life's End in VA Medical Centers

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.

Read the 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.

Conditions
Death, Pain, Dyspnea
Being tested
Comfort care education intervention
Keywords
Palliative Care, Terminal Care, Hospice Care, Patient Care Planning, Nursing Care Plans, Quality of Health Care, Inpatients, Professional education, Resuscitation orders, Pastoral Care
Medical subject headings
Death, Pain, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Comfort care education interventionBehavioural

    Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials

Study groups in NCT00234286
Study groupRoleWhat they receive
Arm 1ExperimentalComfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
Receives: Behavioral: Comfort care education intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Pre and Post Intervention

Secondary outcomes (15)

  1. Do Not Resuscitate Order

    Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record

    Measured: Pre and Post Intervention

  2. Number of Patients Who Died in ICU

    Location of death (ICU vs. other) based on abstraction of electronic medical record

    Measured: Pre and Post Intervention

  3. Individuals With a Nasogastric Tube

    Presence of nasogastric tube based on abstraction of electronic medical record

    Measured: Pre and Post Intervention

  4. Individuals With an Intravenous Line

    Presence of intravenous line infusing at time of death based on abstraction of electronic medical record

    Measured: Pre and Post Intervention

  5. 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

    Measured: Pre and Post Intervention

  6. Individuals Administered of Opioid Medication

    Administration of opioid medication based on abstraction of medical record

    Measured: Pre and Post Intervention

  7. Individuals With an Order for Antipsychotic Medication

    Order for antipsychotic medication based on abstraction of medical record

    Measured: Pre and Post Intervention

  8. Individuals Administered Antipsychotic Medication

    Administration of antipsychotic medication based on abstraction of medical record

    Measured: Pre and Post Intervention

  9. Individuals With an Order for Benzodiazepine Medication

    Order for benzodiazepine medication based on abstraction of medical record

    Measured: Pre and Post Intervention

  10. Individuals Who Received Benzodiazepine Medication

    Administration of benzodiazepine medication based on abstraction of medical record

    Measured: Pre and Post Intervention

  11. Individuals Who Received Scopolamine

    Administration of scopolamine (for death rattle) based on abstraction of medical record

    Measured: Pre and Post Intervention

  12. Sublingual Administration

    Sublingual administration of medication based on abstraction of medical record

    Measured: Pre and Post Intervention

  13. Individuals With Pastoral Care Visit

    Pastoral Care Visit based on abstraction of medical record

    Measured: Pre and Post Intervention

  14. Individuals With an Advance Directive

    Presence of advance directive based on abstraction of medical record

    Measured: Pre and Post Intervention

  15. Individuals With a Palliative Care Consultation

    Palliative Care Consultation based on abstraction of medical record

    Measured: Pre and Post Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionMar 2011
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00234286
Sponsor's protocol ID
IIR 03-126
Acronym
BEACON
Status last verified
Apr 2015
First submitted
4 Oct 2005
Last updated
27 Apr 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 18705168

  • 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.

    PubMed 21393618

  • 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.

    PubMed 22765968

  • 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.

    PubMed 22536938

  • 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.

    PubMed 31792872

  • 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.

    PubMed 24655157

  • 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.

    PubMed 24449032

Questions about this trial

What is this clinical trial studying?

A study testing Comfort care education intervention in people with Death and Pain, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Order for Opioid Pain Medication (time frame: Pre and Post Intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00234286, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.

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