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

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.

Study Overview

• Status: Completed
• Conditions: Terminal Conditions, End of Life
• Intervention / Treatment: Other: Basic Implementation Approach; Other: Enhanced Implementation Approach

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1927
      • Birmingham VA Medical Center, Birmingham, AL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Basic Implementation Approach; Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams	Other: Basic Implementation Approach; 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.
Experimental: Enhanced Implementation Approach; Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams	Other: Enhanced Implementation Approach; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at time of death for veterans who died in the 9 months following the intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of an Order for Benzodiazepine Medication	presence of an order for benzodiazepine medication in the last 7 days of life	last 7 days of life for veterans who died in the 9 months following the intervention period
Presence of a Do-not-resuscitate Order	presence of a do-not-resuscitate order in the last 7 days of life	last 7 days of life for veterans who died in the 9 months following the intervention period
Presence of a Palliative Care Consult Order	presence of a palliative care consult order in the last 7 days of life	last 7 days of life for veterans who died in the 9 months following the intervention period
Location of Death	death in intensive care unit	in the 9 months following the intervention period
Presence of a Nasogastric Tube	presence of a nasogastric tube at time of death	in the 9 months following the intervention period
Presence of an Intravenous Line	presence of an intravenous line at time of death	in the 9 months following the intervention period
Presence of Restraints	presence of restraints at time of death	in the 9 months following the intervention period
Presence of a Pastoral Care Visit	presence of a pastoral care visit in the last 7 days of life	last 7 days of life for veterans who died in the 9 months following the intervention period

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Kathryn L Burgio, PhD MA BA, Birmingham VA Medical Center, Birmingham, AL

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimated): March 9, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: palliative care; implementation; end of life
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: IIR 12-071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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