Intervention to Improve Care at Life's End (BEACON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00234286
First received: October 4, 2005
Last updated: April 23, 2015
Last verified: April 2015
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Death
Pain
Dyspnea
Intervention: Behavioral: Comfort care education intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The BEACON trial implemented an intervention to improve quality of care at end of life. Six Veterans Administration Hospitals received the intervention in a pre-post design. Outcomes were abstracted for 6066 individuals who died either pre or post intervention. 78 next-of-kin were enrolled under protocol to conduct qualitative interviews.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The BEACON trial implemented an intervention to improve quality of care at end of life. Six Veterans Administration Hospitals received the intervention in a pre-post design. Outcomes were abstracted for 6066 individuals who died either pre or post intervention. 78 next-of-kin were enrolled under protocol to conduct qualitative interviews.

Reporting Groups
  Description
BEACON Intervention

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

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


Participant Flow:   Overall Study
    BEACON Intervention  
STARTED     6066 [1]
COMPLETED     6066 [1]
NOT COMPLETED     0  
[1] We reviewed eletronic health records for 6066 deceased individuals within 6 VA Hospitals



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Deceased veterans

Reporting Groups
  Description
Arm 1

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

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


Baseline Measures
    Arm 1  
Number of Participants  
[units: participants]
  6066  
Age  
[units: years]
Mean (Standard Deviation)
  71.2  (12.0)  
Gender [1]
[units: participants]
 
Female     109  
Male     5812  
Race/Ethnicity, Customized [2]
[units: participants]
 
White     3528  
Black     1876  
Hispanic white     8  
Hispanic black     2  
Native American     4  
Asian     1  
Native Hawaiian/Pacific Islander     4  
[1] The total numbers of participants with gender reported is 5921 which differs from the 6066 participant total previously reported. All outcomes and demogaphics for participants were collected by examination of VA electronic records. Gender could not not identified for 145 participants.
[2] The total numbers of participants with race/ethnicity reported is 5423 which differs from the 6066 participant total previously reported. All outcomes and demogaphics for participants were collected by examination of VA electronic records. Race/ethnicity could not be identified from electronic records for 643 participants.



  Outcome Measures
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1.  Primary:   Presence of Order for Opioid Pain Medication   [ Time Frame: Pre and Post Intervention ]

2.  Secondary:   Do Not Resuscitate Order   [ Time Frame: Pre and Post Intervention ]

3.  Secondary:   Number of Patients Who Died in ICU   [ Time Frame: Pre and Post Intervention ]

4.  Secondary:   Individuals With a Nasogastric Tube   [ Time Frame: Pre and Post Intervention ]

5.  Secondary:   Individuals With an Intravenous Line   [ Time Frame: Pre and Post Intervention ]

6.  Secondary:   Number of Individuals Who Died in Restraints   [ Time Frame: Pre and Post Intervention ]

7.  Secondary:   Individuals Administered of Opioid Medication   [ Time Frame: Pre and Post Intervention ]

8.  Secondary:   Individuals With an Order for Antipsychotic Medication   [ Time Frame: Pre and Post Intervention ]

9.  Secondary:   Individuals Administered Antipsychotic Medication   [ Time Frame: Pre and Post Intervention ]

10.  Secondary:   Individuals With an Order for Benzodiazepine Medication   [ Time Frame: Pre and Post Intervention ]

11.  Secondary:   Individuals Who Received Benzodiazepine Medication   [ Time Frame: Pre and Post Intervention ]

12.  Secondary:   Individuals Who Received Scopolamine   [ Time Frame: Pre and Post Intervention ]

13.  Secondary:   Sublingual Administration   [ Time Frame: Pre and Post Intervention ]

14.  Secondary:   Individuals With Pastoral Care Visit   [ Time Frame: Pre and Post Intervention ]

15.  Secondary:   Individuals With an Advance Directive   [ Time Frame: Pre and Post Intervention ]

16.  Secondary:   Individuals With a Palliative Care Consultation   [ Time Frame: Pre and Post Intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kathryn L. Burgio, PhD
Organization: Birmingham VA Medical Center
phone: 205-558-7064
e-mail: kburgio@uabmc.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00234286     History of Changes
Other Study ID Numbers: IIR 03-126
Study First Received: October 4, 2005
Results First Received: January 13, 2015
Last Updated: April 23, 2015
Health Authority: United States: Federal Government