Terminal Conditions, End of Life
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Presence of an Active Opioid Order at Time of Death | at time of death for veterans who died in the 9 months following the intervention period | presence of an active opioid order at time of death in Veteran's medical record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of a Nasogastric Tube | in the 9 months following the intervention period | presence of a nasogastric tube at time of death |
| Presence of an Intravenous Line | in the 9 months following the intervention period | presence of an intravenous line at time of death |
| Presence of Restraints | in the 9 months following the intervention period | presence of restraints at time of death |
| Location of Death | in the 9 months following the intervention period | death in intensive care unit |
| Presence of a Do-not-resuscitate Order | last 7 days of life for veterans who died in the 9 months following the intervention period | presence of a do-not-resuscitate order in the last 7 days of life |
| Presence of a Palliative Care Consult Order | last 7 days of life for veterans who died in the 9 months following the intervention period | presence of a palliative care consult order in the last 7 days of life |
| Presence of a Pastoral Care Visit | last 7 days of life for veterans who died in the 9 months following the intervention period | presence of a pastoral care visit in the last 7 days of life |
| Presence of an Order for Benzodiazepine Medication | last 7 days of life for veterans who died in the 9 months following the intervention period | presence 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
| Arm | Count |
|---|---|
| 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 |
| Total | 6,491 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Palliative Care Team withdrew | 0 | 2 |
Baseline characteristics
| Characteristic | Enhanced Implementation Approach | Total | Basic Implementation Approach |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2855 Participants | 5288 Participants | 2433 Participants |
| Age, Categorical Between 18 and 65 years | 557 Participants | 1202 Participants | 645 Participants |
| Age, Continuous | 75.6 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 Participants | 31 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 29 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 751 Participants | 1410 Participants | 659 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 16 Participants | 49 Participants | 33 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 197 Participants | 461 Participants | 264 Participants |
| Race (NIH/OMB) White | 2415 Participants | 4511 Participants | 2096 Participants |
| Region of Enrollment United States | 3413 Participants | 6491 Participants | 3078 Participants |
| Sex: Female, Male Female | 88 Participants | 165 Participants | 77 Participants |
| Sex: Female, Male Male | 3325 Participants | 6326 Participants | 3001 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of an Active Opioid Order at Time of Death | 1330 Participants |
| Enhanced Implementation Approach | Presence of an Active Opioid Order at Time of Death | 1543 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Location of Death | 436 Participants |
| Enhanced Implementation Approach | Location of Death | 408 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of a Do-not-resuscitate Order | 1336 Participants |
| Enhanced Implementation Approach | Presence of a Do-not-resuscitate Order | 1504 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of a Nasogastric Tube | 161 Participants |
| Enhanced Implementation Approach | Presence of a Nasogastric Tube | 141 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of an Intravenous Line | 141 Participants |
| Enhanced Implementation Approach | Presence of an Intravenous Line | 184 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of an Order for Benzodiazepine Medication | 1025 Participants |
| Enhanced Implementation Approach | Presence of an Order for Benzodiazepine Medication | 1117 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of a Palliative Care Consult Order | 1208 Participants |
| Enhanced Implementation Approach | Presence of a Palliative Care Consult Order | 1426 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of a Pastoral Care Visit | 1060 Participants |
| Enhanced Implementation Approach | Presence of a Pastoral Care Visit | 1271 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Approach | Presence of Restraints | 86 Participants |
| Enhanced Implementation Approach | Presence of Restraints | 73 Participants |