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Evaluation of Methods for Implementation of a Comfort Care Order Set

Evaluation of Methods for Implementation of a Comfort Care Order Set

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02383173
Acronym
BEACON II
Enrollment
134
Registered
2015-03-09
Start date
2015-03-01
Completion date
2020-01-31
Last updated
2023-07-27

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

Conditions

Terminal Conditions, End of Life

Keywords

end of life, palliative care, implementation

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.

Interventions

OTHERBasic 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.

OTHEREnhanced 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

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of an Active Opioid Order at Time of Deathat time of death for veterans who died in the 9 months following the intervention periodpresence of an active opioid order at time of death in Veteran's medical record

Secondary

MeasureTime frameDescription
Presence of a Nasogastric Tubein the 9 months following the intervention periodpresence of a nasogastric tube at time of death
Presence of an Intravenous Linein the 9 months following the intervention periodpresence of an intravenous line at time of death
Presence of Restraintsin the 9 months following the intervention periodpresence of restraints at time of death
Location of Deathin the 9 months following the intervention perioddeath in intensive care unit
Presence of a Do-not-resuscitate Orderlast 7 days of life for veterans who died in the 9 months following the intervention periodpresence of a do-not-resuscitate order in the last 7 days of life
Presence of a Palliative Care Consult Orderlast 7 days of life for veterans who died in the 9 months following the intervention periodpresence of a palliative care consult order in the last 7 days of life
Presence of a Pastoral Care Visitlast 7 days of life for veterans who died in the 9 months following the intervention periodpresence of a pastoral care visit in the last 7 days of life
Presence of an Order for Benzodiazepine Medicationlast 7 days of life for veterans who died in the 9 months following the intervention periodpresence of an order for benzodiazepine medication in the last 7 days of life

Countries

United States

Participant flow

Recruitment details

Palliative Care Consult Teams (PCCT) from eligible VA Medical Centers were recruited to participate in the education interventions. Demographic characteristics were not collected on providers.

Pre-assignment details

Eligibility of VAMCs and Palliative Care Consult Team members were determined before enrollment. All those enrolled teams were randomized.

Participants by arm

ArmCount
Basic Implementation Approach
Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams 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.
3,078
Enhanced Implementation Approach
Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams 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
3,413
Total6,491

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPalliative Care Team withdrew02

Baseline characteristics

CharacteristicEnhanced Implementation ApproachTotalBasic Implementation Approach
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2855 Participants5288 Participants2433 Participants
Age, Categorical
Between 18 and 65 years
557 Participants1202 Participants645 Participants
Age, Continuous75.6 years
STANDARD_DEVIATION 11.4
75.0 years
STANDARD_DEVIATION 11.5
74.2 years
STANDARD_DEVIATION 11.6
Race (NIH/OMB)
American Indian or Alaska Native
20 Participants31 Participants11 Participants
Race (NIH/OMB)
Asian
14 Participants29 Participants15 Participants
Race (NIH/OMB)
Black or African American
751 Participants1410 Participants659 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
16 Participants49 Participants33 Participants
Race (NIH/OMB)
Unknown or Not Reported
197 Participants461 Participants264 Participants
Race (NIH/OMB)
White
2415 Participants4511 Participants2096 Participants
Region of Enrollment
United States
3413 Participants6491 Participants3078 Participants
Sex: Female, Male
Female
88 Participants165 Participants77 Participants
Sex: Female, Male
Male
3325 Participants6326 Participants3001 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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

Time frame: at time of death for veterans who died in the 9 months following the intervention period

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of an Active Opioid Order at Time of Death1330 Participants
Enhanced Implementation ApproachPresence of an Active Opioid Order at Time of Death1543 Participants
Comparison: Generalized Estimating Equation (GEE) analyses of post-intervention data were used to account for clustering. We adjusted for age, race, cancer, length of stay and study year.p-value: 0.445Generalized Estimating Equation (GEE)
Secondary

Location of Death

death in intensive care unit

Time frame: in the 9 months following the intervention period

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachLocation of Death436 Participants
Enhanced Implementation ApproachLocation of Death408 Participants
Secondary

Presence of a Do-not-resuscitate Order

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

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of a Do-not-resuscitate Order1336 Participants
Enhanced Implementation ApproachPresence of a Do-not-resuscitate Order1504 Participants
Secondary

Presence of a Nasogastric Tube

presence of a nasogastric tube at time of death

Time frame: in the 9 months following the intervention period

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of a Nasogastric Tube161 Participants
Enhanced Implementation ApproachPresence of a Nasogastric Tube141 Participants
Secondary

Presence of an Intravenous Line

presence of an intravenous line at time of death

Time frame: in the 9 months following the intervention period

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of an Intravenous Line141 Participants
Enhanced Implementation ApproachPresence of an Intravenous Line184 Participants
Secondary

Presence of an Order for Benzodiazepine Medication

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

Population: Veterans who died in the 9 months following the intervention period

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of an Order for Benzodiazepine Medication1025 Participants
Enhanced Implementation ApproachPresence of an Order for Benzodiazepine Medication1117 Participants
Secondary

Presence of a Palliative Care Consult Order

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

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of a Palliative Care Consult Order1208 Participants
Enhanced Implementation ApproachPresence of a Palliative Care Consult Order1426 Participants
Secondary

Presence of a Pastoral Care Visit

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

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of a Pastoral Care Visit1060 Participants
Enhanced Implementation ApproachPresence of a Pastoral Care Visit1271 Participants
Secondary

Presence of Restraints

presence of restraints at time of death

Time frame: in the 9 months following the intervention period

Population: Veterans who died as inpatients in acute care units of VA Medical Centers

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Basic Implementation ApproachPresence of Restraints86 Participants
Enhanced Implementation ApproachPresence of Restraints73 Participants

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026