Trial Outcomes & Findings for Evaluation of Methods for Implementation of a Comfort Care Order Set (NCT NCT02383173)
NCT ID: NCT02383173
Last Updated: 2023-07-27
Results Overview
presence of an active opioid order at time of death in Veteran's medical record
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
at time of death for veterans who died in the 9 months following the intervention period
Results posted on
2023-07-27
Participant Flow
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.
Eligibility of VAMCs and Palliative Care Consult Team members were determined before enrollment. All those enrolled teams were randomized.
Unit of analysis: Palliative Care Consult Teams
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
88 23
|
46 24
|
|
Overall Study
COMPLETED
|
88 23
|
44 23
|
|
Overall Study
NOT COMPLETED
|
0 0
|
2 1
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Palliative Care Team withdrew
|
0
|
2
|
Baseline Characteristics
1 participant is missing age data
Baseline characteristics by cohort
| Measure |
Basic Implementation Approach
n=3078 Participants
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.
|
Enhanced Implementation Approach
n=3413 Participants
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
|
Total
n=6491 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3078 Participants • 1 participant is missing age data
|
0 Participants
n=3412 Participants • 1 participant is missing age data
|
0 Participants
n=6490 Participants • 1 participant is missing age data
|
|
Age, Categorical
Between 18 and 65 years
|
645 Participants
n=3078 Participants • 1 participant is missing age data
|
557 Participants
n=3412 Participants • 1 participant is missing age data
|
1202 Participants
n=6490 Participants • 1 participant is missing age data
|
|
Age, Categorical
>=65 years
|
2433 Participants
n=3078 Participants • 1 participant is missing age data
|
2855 Participants
n=3412 Participants • 1 participant is missing age data
|
5288 Participants
n=6490 Participants • 1 participant is missing age data
|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 11.6 • n=3078 Participants • 1 participant was missing age data
|
75.6 years
STANDARD_DEVIATION 11.4 • n=3412 Participants • 1 participant was missing age data
|
75.0 years
STANDARD_DEVIATION 11.5 • n=6490 Participants • 1 participant was missing age data
|
|
Sex: Female, Male
Female
|
77 Participants
n=3078 Participants
|
88 Participants
n=3413 Participants
|
165 Participants
n=6491 Participants
|
|
Sex: Female, Male
Male
|
3001 Participants
n=3078 Participants
|
3325 Participants
n=3413 Participants
|
6326 Participants
n=6491 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=3078 Participants
|
20 Participants
n=3413 Participants
|
31 Participants
n=6491 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=3078 Participants
|
14 Participants
n=3413 Participants
|
29 Participants
n=6491 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
33 Participants
n=3078 Participants
|
16 Participants
n=3413 Participants
|
49 Participants
n=6491 Participants
|
|
Race (NIH/OMB)
Black or African American
|
659 Participants
n=3078 Participants
|
751 Participants
n=3413 Participants
|
1410 Participants
n=6491 Participants
|
|
Race (NIH/OMB)
White
|
2096 Participants
n=3078 Participants
|
2415 Participants
n=3413 Participants
|
4511 Participants
n=6491 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3078 Participants
|
0 Participants
n=3413 Participants
|
0 Participants
n=6491 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
264 Participants
n=3078 Participants
|
197 Participants
n=3413 Participants
|
461 Participants
n=6491 Participants
|
|
Region of Enrollment
United States
|
3078 Participants
n=3078 Participants
|
3413 Participants
n=3413 Participants
|
6491 Participants
n=6491 Participants
|
PRIMARY outcome
Timeframe: at time of death for veterans who died in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
presence of an active opioid order at time of death in Veteran's medical record
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of an Active Opioid Order at Time of Death
|
1330 Participants
|
1543 Participants
|
SECONDARY outcome
Timeframe: last 7 days of life for veterans who died in the 9 months following the intervention periodPopulation: 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
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of an Order for Benzodiazepine Medication
|
1025 Participants
|
1117 Participants
|
SECONDARY outcome
Timeframe: last 7 days of life for veterans who died in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
presence of a do-not-resuscitate order in the last 7 days of life
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of a Do-not-resuscitate Order
|
1336 Participants
|
1504 Participants
|
SECONDARY outcome
Timeframe: last 7 days of life for veterans who died in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
presence of a palliative care consult order in the last 7 days of life
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of a Palliative Care Consult Order
|
1208 Participants
|
1426 Participants
|
SECONDARY outcome
Timeframe: in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
death in intensive care unit
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Location of Death
|
436 Participants
|
408 Participants
|
SECONDARY outcome
Timeframe: in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
presence of a nasogastric tube at time of death
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of a Nasogastric Tube
|
161 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
presence of an intravenous line at time of death
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of an Intravenous Line
|
141 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
presence of restraints at time of death
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of Restraints
|
86 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: last 7 days of life for veterans who died in the 9 months following the intervention periodPopulation: Veterans who died as inpatients in acute care units of VA Medical Centers
presence of a pastoral care visit in the last 7 days of life
Outcome measures
| Measure |
Basic Implementation Approach
n=1519 Participants
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.
|
Enhanced Implementation Approach
n=1687 Participants
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
|
|---|---|---|
|
Presence of a Pastoral Care Visit
|
1060 Participants
|
1271 Participants
|
Adverse Events
Basic Implementation Approach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Implementation Approach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place