Trial Outcomes & Findings for Intervention to Improve Care at Life's End (NCT NCT00234286)

NCT ID: NCT00234286

Last Updated: 2015-04-27

Results Overview

Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: Pre and Post Intervention
• Results posted on: 2015-04-27

Participant Flow

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.

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.

Participant milestones

Measure	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
Overall Study STARTED	6066
Overall Study COMPLETED	6066
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intervention to Improve Care at Life's End

Baseline characteristics by cohort

Measure	Arm 1 n=6066 Participants 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
Age, Continuous	71.2 years STANDARD_DEVIATION 12.0 • n=5 Participants
Gender Female	109 participants n=5 Participants
Gender Male	5812 participants n=5 Participants
Race/Ethnicity, Customized White	3528 participants n=5 Participants
Race/Ethnicity, Customized Black	1876 participants n=5 Participants
Race/Ethnicity, Customized Hispanic white	8 participants n=5 Participants
Race/Ethnicity, Customized Hispanic black	2 participants n=5 Participants
Race/Ethnicity, Customized Native American	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre and Post Intervention

Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Presence of Order for Opioid Pain Medication	2004 participants	2056 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

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

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Do Not Resuscitate Order	2282 participants	2127 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

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

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Number of Patients Who Died in ICU	1312 participants	1046 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Presence of nasogastric tube based on abstraction of electronic medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals With a Nasogastric Tube	1293 participants	922 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

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

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals With an Intravenous Line	2004 participants	2056 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Number of Individuals Who Died in Restraints	531 participants	362 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Administration of opioid medication based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals Administered of Opioid Medication	1569 participants	1662 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Order for antipsychotic medication based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals With an Order for Antipsychotic Medication	336 participants	661 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Administration of antipsychotic medication based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals Administered Antipsychotic Medication	224 participants	280 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Order for benzodiazepine medication based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals With an Order for Benzodiazepine Medication	1102 participants	1185 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Administration of benzodiazepine medication based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals Who Received Benzodiazepine Medication	710 participants	675 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

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

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals Who Received Scopolamine	113 participants	633 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Sublingual administration of medication based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Sublingual Administration	122 participants	322 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Pastoral Care Visit based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals With Pastoral Care Visit	1630 participants	1765 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Presence of advance directive based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals With an Advance Directive	1194 participants	1306 participants

SECONDARY outcome

Timeframe: Pre and Post Intervention

Palliative Care Consultation based on abstraction of medical record

Outcome measures

Measure	Pre-Intervention n=3243 Participants 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	Post-Intervention n=2823 Participants 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
Individuals With a Palliative Care Consultation	184 participants	885 participants

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathryn L. Burgio, PhD

Birmingham VA Medical Center

Phone: 205-558-7064

Email: kburgio@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place