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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basic Implementation Approach | Active Comparator | Basic approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams |
|
| Enhanced Implementation Approach | Experimental | Enhanced approach to implementing a Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basic Implementation Approach | Other | 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. |
| 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 |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn L Burgio, PhD MA BA | Birmingham VA Medical Center, Birmingham, AL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233-1927 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33547573 | Derived | 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. |
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Eligibility of VAMCs and Palliative Care Consult Team members were determined before enrollment. All those enrolled teams were randomized.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Overall Number of Baseline Participants is greater than the number Started in the Participant Flow. The participant flow numbers describe the study participants, VA providers who participated in the education intervention. Data in Baseline Characteristics describe the patients whose medical records were abstracted to measure outcomes.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 1 participant is missing age data |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | at time of death for veterans who died in the 9 months following the intervention period |
|
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All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed. All patients were already deceased and outcomes were based on review of their medical records.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Analyses limited by baseline values on some key endpoints
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn L. Burgio, PhD | Birmingham VA Medical Center | 205-558-7064 | kburgio@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2017 | Jul 7, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Enhanced Implementation Approach | Other | 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 |
|
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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 1 participant was missing age data | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
|
|
| Secondary | Presence of an Order for Benzodiazepine Medication | presence of an order for benzodiazepine medication in the last 7 days of life | Veterans who died in the 9 months following the intervention period | Posted | Count of Participants | Participants | last 7 days of life for veterans who died in the 9 months following the intervention period |
|
|
|
| Secondary | Presence of a Do-not-resuscitate Order | presence of a do-not-resuscitate order in the last 7 days of life | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | last 7 days of life for veterans who died in the 9 months following the intervention period |
|
|
|
| Secondary | Presence of a Palliative Care Consult Order | presence of a palliative care consult order in the last 7 days of life | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | last 7 days of life for veterans who died in the 9 months following the intervention period |
|
|
|
| Secondary | Location of Death | death in intensive care unit | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | in the 9 months following the intervention period |
|
|
|
| Secondary | Presence of a Nasogastric Tube | presence of a nasogastric tube at time of death | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | in the 9 months following the intervention period |
|
|
|
| Secondary | Presence of an Intravenous Line | presence of an intravenous line at time of death | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | in the 9 months following the intervention period |
|
|
|
| Secondary | Presence of Restraints | presence of restraints at time of death | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | in the 9 months following the intervention period |
|
|
|
| Secondary | Presence of a Pastoral Care Visit | presence of a pastoral care visit in the last 7 days of life | Veterans who died as inpatients in acute care units of VA Medical Centers | Posted | Count of Participants | Participants | last 7 days of life for veterans who died in the 9 months following the intervention period |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|