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Intervention to Improve Care at Life's End

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00234286
Acronym
BEACON
Enrollment
78
Registered
2005-10-06
Start date
2005-08-31
Completion date
2013-09-30
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Dyspnea, Pain

Keywords

Palliative Care, Terminal Care, Hospice Care, Patient Care Planning, Nursing Care Plans, Quality of Health Care, Inpatients, Professional education, Resuscitation orders, Pastoral Care

Brief 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.

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.

Interventions

BEHAVIORALComfort 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

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Presence of Order for Opioid Pain MedicationPre and Post InterventionPresence of order for opioid pain medication at time of death based on abstraction of electronic medical record

Secondary

MeasureTime frameDescription
Do Not Resuscitate OrderPre and Post InterventionPresence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record
Number of Patients Who Died in ICUPre and Post InterventionLocation of death (ICU vs. other) based on abstraction of electronic medical record
Individuals With a Nasogastric TubePre and Post InterventionPresence of nasogastric tube based on abstraction of electronic medical record
Number of Individuals Who Died in RestraintsPre and Post InterventionPresence of restraints at or near time of death at time of death based on abstraction of electronic medical record
Individuals Administered of Opioid MedicationPre and Post InterventionAdministration of opioid medication based on abstraction of medical record
Individuals With an Order for Antipsychotic MedicationPre and Post InterventionOrder for antipsychotic medication based on abstraction of medical record
Individuals Administered Antipsychotic MedicationPre and Post InterventionAdministration of antipsychotic medication based on abstraction of medical record
Individuals With an Intravenous LinePre and Post InterventionPresence of intravenous line infusing at time of death based on abstraction of electronic medical record
Individuals Who Received Benzodiazepine MedicationPre and Post InterventionAdministration of benzodiazepine medication based on abstraction of medical record
Individuals Who Received ScopolaminePre and Post InterventionAdministration of scopolamine (for death rattle) based on abstraction of medical record
Sublingual AdministrationPre and Post InterventionSublingual administration of medication based on abstraction of medical record
Individuals With Pastoral Care VisitPre and Post InterventionPastoral Care Visit based on abstraction of medical record
Individuals With an Advance DirectivePre and Post InterventionPresence of advance directive based on abstraction of medical record
Individuals With a Palliative Care ConsultationPre and Post InterventionPalliative Care Consultation based on abstraction of medical record
Individuals With an Order for Benzodiazepine MedicationPre and Post InterventionOrder for benzodiazepine medication based on abstraction of medical record

Countries

United States

Participant flow

Recruitment details

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

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.

Participants by arm

ArmCount
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
6,066
Total6,066

Baseline characteristics

CharacteristicArm 1
Age, Continuous71.2 years
STANDARD_DEVIATION 12
Gender
Female
109 participants
Gender
Male
5812 participants
Race/Ethnicity, Customized
Asian
1 participants
Race/Ethnicity, Customized
Black
1876 participants
Race/Ethnicity, Customized
Hispanic black
2 participants
Race/Ethnicity, Customized
Hispanic white
8 participants
Race/Ethnicity, Customized
Native American
4 participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
4 participants
Race/Ethnicity, Customized
White
3528 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionPresence of Order for Opioid Pain Medication2004 participants
Post-InterventionPresence of Order for Opioid Pain Medication2056 participants
p-value: 0.00995% CI: [1.09, 1.76]Generalized Estimating Equation
Secondary

Do Not Resuscitate Order

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

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionDo Not Resuscitate Order2282 participants
Post-InterventionDo Not Resuscitate Order2127 participants
p-value: 0.0995% CI: [0.95, 1.96]Generalized Estimating Equation
Secondary

Individuals Administered Antipsychotic Medication

Administration of antipsychotic medication based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals Administered Antipsychotic Medication224 participants
Post-InterventionIndividuals Administered Antipsychotic Medication280 participants
p-value: 0.3695% CI: [0.73, 2.35]Generalized Estimating Equation
Secondary

Individuals Administered of Opioid Medication

Administration of opioid medication based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals Administered of Opioid Medication1569 participants
Post-InterventionIndividuals Administered of Opioid Medication1662 participants
p-value: 0.0995% CI: [0.95, 1.96]Generalized Estimating Equation
Secondary

Individuals Who Received Benzodiazepine Medication

Administration of benzodiazepine medication based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals Who Received Benzodiazepine Medication710 participants
Post-InterventionIndividuals Who Received Benzodiazepine Medication675 participants
p-value: 0.7695% CI: [0.7, 1.3]Generalized Estimating Equation
Secondary

Individuals Who Received Scopolamine

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

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals Who Received Scopolamine113 participants
Post-InterventionIndividuals Who Received Scopolamine633 participants
p-value: 0.00495% CI: [1.41, 5.44]Generalized Estimating Equation
Secondary

Individuals With an Advance Directive

Presence of advance directive based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals With an Advance Directive1194 participants
Post-InterventionIndividuals With an Advance Directive1306 participants
p-value: 0.00395% CI: [1.15, 1.88]Generalized Estimating Equation
Secondary

Individuals With a Nasogastric Tube

Presence of nasogastric tube based on abstraction of electronic medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals With a Nasogastric Tube1293 participants
Post-InterventionIndividuals With a Nasogastric Tube922 participants
p-value: 0.0395% CI: [0.53, 0.96]Generalized Estimating Equations
Secondary

Individuals With an Intravenous Line

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

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals With an Intravenous Line2004 participants
Post-InterventionIndividuals With an Intravenous Line2056 participants
p-value: 0.1595% CI: [0.38, 1.16]Generalized Estimating Equation
Secondary

Individuals With an Order for Antipsychotic Medication

Order for antipsychotic medication based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals With an Order for Antipsychotic Medication336 participants
Post-InterventionIndividuals With an Order for Antipsychotic Medication661 participants
p-value: 0.0195% CI: [1.17, 3.36]Generalized Estimating Equation
Secondary

Individuals With an Order for Benzodiazepine Medication

Order for benzodiazepine medication based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals With an Order for Benzodiazepine Medication1102 participants
Post-InterventionIndividuals With an Order for Benzodiazepine Medication1185 participants
p-value: 0.0195% CI: [1.08, 1.77]Generalized Estimating Equation
Secondary

Individuals With a Palliative Care Consultation

Palliative Care Consultation based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals With a Palliative Care Consultation184 participants
Post-InterventionIndividuals With a Palliative Care Consultation885 participants
p-value: 0.1995% CI: [0.62, 9.7]Generalized Estimation Equations
Secondary

Individuals With Pastoral Care Visit

Pastoral Care Visit based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionIndividuals With Pastoral Care Visit1630 participants
Post-InterventionIndividuals With Pastoral Care Visit1765 participants
p-value: 0.1495% CI: [0.84, 3.2]Generalized Estimating Equations
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

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionNumber of Individuals Who Died in Restraints531 participants
Post-InterventionNumber of Individuals Who Died in Restraints362 participants
p-value: 0.8695% CI: [0.67, 1.62]Generalized Estimating Equation
Secondary

Number of Patients Who Died in ICU

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

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionNumber of Patients Who Died in ICU1312 participants
Post-InterventionNumber of Patients Who Died in ICU1046 participants
p-value: 0.6995% CI: [0.59, 1.42]Generalized Estimating Equation
Secondary

Sublingual Administration

Sublingual administration of medication based on abstraction of medical record

Time frame: Pre and Post Intervention

ArmMeasureValue (NUMBER)
Pre-InterventionSublingual Administration122 participants
Post-InterventionSublingual Administration322 participants
p-value: 0.00795% CI: [1.51, 11.28]Generalized Estimating Equations

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026