Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00234286
Other study ID # IIR 03-126
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care