Intervention to Improve Care at Life's End

Pain Clinical Trial

— BEACON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234286
• Other study ID #: IIR 03-126
• Status: Completed
• Phase: N/A
• First received: October 4, 2005
• Last updated: April 23, 2015
• Start date: August 2005
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2013
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Death
• Dyspnea
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Birmingham VA Medical Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre and Post Intervention	No
Secondary	Do Not Resuscitate Order	Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record	Pre and Post Intervention	No
Secondary	Number of Patients Who Died in ICU	Location of death (ICU vs. other) based on abstraction of electronic medical record	Pre and Post Intervention	No
Secondary	Individuals With a Nasogastric Tube	Presence of nasogastric tube based on abstraction of electronic medical record	Pre and Post Intervention	No
Secondary	Individuals With an Intravenous Line	Presence of intravenous line infusing at time of death based on abstraction of electronic medical record	Pre and Post Intervention	No
Secondary	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	Pre and Post Intervention	No
Secondary	Individuals Administered of Opioid Medication	Administration of opioid medication based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals With an Order for Antipsychotic Medication	Order for antipsychotic medication based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals Administered Antipsychotic Medication	Administration of antipsychotic medication based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals With an Order for Benzodiazepine Medication	Order for benzodiazepine medication based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals Who Received Benzodiazepine Medication	Administration of benzodiazepine medication based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals Who Received Scopolamine	Administration of scopolamine (for death rattle) based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Sublingual Administration	Sublingual administration of medication based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals With Pastoral Care Visit	Pastoral Care Visit based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals With an Advance Directive	Presence of advance directive based on abstraction of medical record	Pre and Post Intervention	No
Secondary	Individuals With a Palliative Care Consultation	Palliative Care Consultation based on abstraction of medical record	Pre and Post Intervention	No

External Links

•   Growthhouse website MegaSearch, an international clearing house for high quality educational materials related to hospice and palliative care