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Evaluation of Methods for Implementation of a Comfort Care Order Set (BEACON II)

Primary Purpose

Terminal Conditions, End of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Basic Implementation Approach
Enhanced Implementation Approach
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Terminal Conditions, End of Life focused on measuring end of life, palliative care, implementation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

To be eligible, each provider had to be a member of a VA palliative care consult team (PCCT)

Exclusion Criteria:

VAMCs were excluded if the facility scored in the top 10th percentile or lowest 10th percentile on PROMISE after-death survey; if they had no prescribing provider on the PCCT team; or if there were fewer than 30 deaths in VAMC during the reporting period

Sites / Locations

  • Birmingham VA Medical Center, Birmingham, AL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Basic Implementation Approach

Enhanced Implementation Approach

Arm Description

Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams

Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams

Outcomes

Primary Outcome Measures

Presence of an Active Opioid Order at Time of Death
presence of an active opioid order at time of death in Veteran's medical record

Secondary Outcome Measures

Presence of an Order for Benzodiazepine Medication
presence of an order for benzodiazepine medication in the last 7 days of life
Presence of a Do-not-resuscitate Order
presence of a do-not-resuscitate order in the last 7 days of life
Presence of a Palliative Care Consult Order
presence of a palliative care consult order in the last 7 days of life
Location of Death
death in intensive care unit
Presence of a Nasogastric Tube
presence of a nasogastric tube at time of death
Presence of an Intravenous Line
presence of an intravenous line at time of death
Presence of Restraints
presence of restraints at time of death
Presence of a Pastoral Care Visit
presence of a pastoral care visit in the last 7 days of life

Full Information

First Posted
December 23, 2014
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02383173
Brief Title
Evaluation of Methods for Implementation of a Comfort Care Order Set
Acronym
BEACON II
Official Title
Evaluation of Methods for Implementation of a Comfort Care Order Set
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overarching goal of this research program is to improve the quality of end-of-life care provided to Veterans dying in VA Medical Centers (VAMCs), by transferring the best practices of home hospice and palliative care for the last days and hours of life into the inpatient setting. This trial will examine two methods of delivering a Comfort Care Education Intervention utilizing the established infrastructure of VA Palliative Care Consult Teams (PCCT): a Basic Implementation Approach using a teleconference to review educational materials and activate PCCTs to educate other providers, and an Enhanced Implementation Approach utilizing in-person, train-the-"champion" workshops to prepare PCCT members to be leaders and trainers at their home sites. Findings will provide a robust evaluation of the implementation process, and will be used to refine the Comfort Care Education Intervention and implementation strategies in preparation for nationwide dissemination of best practices for end-of-life care within the VA Healthcare System.
Detailed Description
Anticipated Impacts on Veterans' Healthcare: The overarching goal of this research program is to improve the quality of end-of-life care provided to Veterans dying in VA Medical Centers (VAMCs), by transferring the best practices of home hospice and palliative care for the last days and hours of life into the inpatient setting. Project Background: Often, patients who are near the end of life are not recognized as actively dying. As a result, their suffering may not be appreciated or managed properly, and may even be exacerbated by usual medical care when aggressive, futile, or iatrogenically harmful treatments are continued. During this time, supportive and comfort care treatment plans can be implemented to reduce suffering and improve the quality of care provided to these patients. The investigative team has developed and evaluated an education-based intervention to teach providers how to identify patients who are actively dying and to implement care plans appropriate for the last days or hours of life. To facilitate use of these interventions, an electronic Comfort Care Order Set (CCOS) was designed and integrated into the Computerized Patient Record System (CPRS) to support and guide the selection of comfort care treatments. The effectiveness of the Comfort Care Education Intervention has been demonstrated in 7 VAMCs and it is ready for implementation on a broader scale. Project Objectives: This trial will extend this line of research by examining two methods of delivering this Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams (PCCT): a Basic Implementation Approach using a teleconference to review educational materials and activate PCCTs to educate other providers, and an Enhanced Implementation Approach utilizing in-person, train-the-"champion" workshops to prepare PCCT members to be leaders and trainers at their home sites. The aims of this study are 1) to compare the effectiveness of the two approaches for changing provider behavior, as reflected in documented processes of end-of-life care, 2) to formatively evaluate PCCT members' experiences with and perceptions of the two approaches, and 3) to quantitatively evaluate PCCT members' perceptions of the training received and its impact on attitudes, skills, and perceived efficacy to care for patients and teach other providers. Project Methods: PCCTs at 47 VA Medical Centers will be recruited to participate in the trial and randomized to receive the Comfort Care Education Intervention using the Basic or the Enhanced Implementation Approach. Data on processes of end-of-life care will be abstracted from the CPRS medical records of Veterans who die before and after the interventions, including presence of an active opioid order at time of death (primary endpoint), other medication orders and administration, do-not-resuscitate orders, palliative care consult orders, location of death, presence of nasogastric tubes/intravenous lines, restraints, and pastoral care. Semi-structured telephone interviews will be conducted with all participating PCCT members to explore their perceptions of training, the process of teaching other providers at each site, barriers and facilitators they encountered, how prepared they felt to overcome these barriers, and specific needs and preferences regarding the implementation approach. Findings will provide a robust evaluation of the implementation process, and will be used to refine the Comfort Care Education Intervention and implementation strategies in preparation for nationwide dissemination of best practices for end-of-life care within the VA Healthcare System.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Terminal Conditions, End of Life
Keywords
end of life, palliative care, implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basic Implementation Approach
Arm Type
Active Comparator
Arm Description
Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams
Arm Title
Enhanced Implementation Approach
Arm Type
Experimental
Arm Description
Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams
Intervention Type
Other
Intervention Name(s)
Basic Implementation Approach
Intervention Description
Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers.
Intervention Type
Other
Intervention Name(s)
Enhanced Implementation Approach
Intervention Description
Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-"champion" workshops to prepare PCCT members to be leaders and trainers at their home sites
Primary Outcome Measure Information:
Title
Presence of an Active Opioid Order at Time of Death
Description
presence of an active opioid order at time of death in Veteran's medical record
Time Frame
at time of death for veterans who died in the 9 months following the intervention period
Secondary Outcome Measure Information:
Title
Presence of an Order for Benzodiazepine Medication
Description
presence of an order for benzodiazepine medication in the last 7 days of life
Time Frame
last 7 days of life for veterans who died in the 9 months following the intervention period
Title
Presence of a Do-not-resuscitate Order
Description
presence of a do-not-resuscitate order in the last 7 days of life
Time Frame
last 7 days of life for veterans who died in the 9 months following the intervention period
Title
Presence of a Palliative Care Consult Order
Description
presence of a palliative care consult order in the last 7 days of life
Time Frame
last 7 days of life for veterans who died in the 9 months following the intervention period
Title
Location of Death
Description
death in intensive care unit
Time Frame
in the 9 months following the intervention period
Title
Presence of a Nasogastric Tube
Description
presence of a nasogastric tube at time of death
Time Frame
in the 9 months following the intervention period
Title
Presence of an Intravenous Line
Description
presence of an intravenous line at time of death
Time Frame
in the 9 months following the intervention period
Title
Presence of Restraints
Description
presence of restraints at time of death
Time Frame
in the 9 months following the intervention period
Title
Presence of a Pastoral Care Visit
Description
presence of a pastoral care visit in the last 7 days of life
Time Frame
last 7 days of life for veterans who died in the 9 months following the intervention period

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be eligible, each provider had to be a member of a VA palliative care consult team (PCCT) Exclusion Criteria: VAMCs were excluded if the facility scored in the top 10th percentile or lowest 10th percentile on PROMISE after-death survey; if they had no prescribing provider on the PCCT team; or if there were fewer than 30 deaths in VAMC during the reporting period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn L Burgio, PhD MA BA
Organizational Affiliation
Birmingham VA Medical Center, Birmingham, AL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham VA Medical Center, Birmingham, AL
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-1927
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33547573
Citation
Bailey FA, Williams BR, Goode PS, Kennedy RE, Redden DT, Kvale E, Bakitas M, Dionne-Odom JN, Burgio KL. Comparison of Two Methods for Implementing Comfort Care Order Sets in the Inpatient Setting: a Cluster Randomized Trial. J Gen Intern Med. 2021 Jul;36(7):1928-1936. doi: 10.1007/s11606-020-06482-x. Epub 2021 Feb 5.
Results Reference
derived

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Evaluation of Methods for Implementation of a Comfort Care Order Set

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