Trial Outcomes & Findings for Translating Data Science to Palliative Care (NCT NCT05942040)
NCT ID: NCT05942040
Last Updated: 2025-11-18
Results Overview
The investigators will assess refusal rate using the MA plan's electronic health records. Refusal rate will be calculated as # of eligible individuals refusing palliative care / total # of individuals eligible for palliative care
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
301 participants
Primary outcome timeframe
Baseline through 10 months. Pre (control group) test for 5 months prior to intervention. Post (intervention group) for 5 months during intervention.
Results posted on
2025-11-18
Participant Flow
301 individuals enrolled in the study. 294 participants enrolled via a waiver of consent to retrospectively analyze electronic records (primary outcome only). Of these, 111 were in intervention; 182 in control. 7 participants were palliative care team members who provided satisfaction data (secondary outcome only). Of these 7, 1 individual dropped out of the study after consent and prior to providing any data. Reported results are based on 300 participants for whom data were provided.
Participant milestones
| Measure |
Intervention Group
Intervention group will consist of all MA plan members eligible for community-based palliative care and of those who refused it (to calculate refusal rate) during the six month period following the introduction of tailored informational materials developed on CBPC.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Control Group
Control group will be a retrospective review of individuals who were eligible for community-based palliative care and of those who refused it, for the 6-month period prior to introducing the tailored informational materials. All of these individuals will have received usual care/information regarding community-based palliative care.
Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Community Based Palliative Care Team Members
Tailored Palliative Care Information: This study test feasibility and acceptability of implementing tailored informational materials into clinician's discussions about CBPC with MA plan members who are eligible for the service.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
182
|
7
|
|
Overall Study
COMPLETED
|
111
|
182
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Intervention Group
Intervention group will consist of all MA plan members eligible for community-based palliative care and of those who refused it (to calculate refusal rate) during the six month period following the introduction of tailored informational materials developed on CBPC.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Control Group
Control group will be a retrospective review of individuals who were eligible for community-based palliative care and of those who refused it, for the 6-month period prior to introducing the tailored informational materials. All of these individuals will have received usual care/information regarding community-based palliative care.
Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Community Based Palliative Care Team Members
Tailored Palliative Care Information: This study test feasibility and acceptability of implementing tailored informational materials into clinician's discussions about CBPC with MA plan members who are eligible for the service.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
|---|---|---|---|
|
Overall Study
No longer employed at study site.
|
0
|
0
|
3
|
Baseline Characteristics
This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=111 Participants
Intervention group will consist of all MA plan members eligible for community-based palliative care and of those who refused it (to calculate refusal rate) during the six month period following the introduction of tailored informational materials developed on CBPC.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Control Group
n=182 Participants
Control group will be a retrospective review of individuals who were eligible for community-based palliative care and of those who refused it, for the 6-month period prior to introducing the tailored informational materials. All of these individuals will have received usual care/information regarding community-based palliative care.
Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Community Based Palliative Care Team Members
n=7 Participants
Tailored Palliative Care Information: This study test feasibility and acceptability of implementing tailored informational materials into clinician's discussions about CBPC with MA plan members who are eligible for the service.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
84.7 years
STANDARD_DEVIATION 10.7 • n=111 Participants
|
86.5 years
STANDARD_DEVIATION 11.1 • n=182 Participants
|
50.1 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
84.0 years
STANDARD_DEVIATION 11.0 • n=300 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=111 Participants
|
130 Participants
n=182 Participants
|
7 Participants
n=7 Participants
|
226 Participants
n=300 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=111 Participants
|
52 Participants
n=182 Participants
|
0 Participants
n=7 Participants
|
74 Participants
n=300 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=111 Participants
|
79 Participants
n=182 Participants
|
1 Participants
n=7 Participants
|
118 Participants
n=300 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=111 Participants
|
0 Participants
n=182 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=300 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
73 Participants
n=111 Participants
|
103 Participants
n=182 Participants
|
0 Participants
n=7 Participants
|
176 Participants
n=300 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=111 Participants
|
4 Participants
n=182 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=300 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=111 Participants
|
13 Participants
n=182 Participants
|
0 Participants
n=7 Participants
|
27 Participants
n=300 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=111 Participants
|
0 Participants
n=182 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=300 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=111 Participants
|
58 Participants
n=182 Participants
|
4 Participants
n=7 Participants
|
95 Participants
n=300 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=111 Participants
|
80 Participants
n=182 Participants
|
2 Participants
n=7 Participants
|
118 Participants
n=300 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=111 Participants
|
8 Participants
n=182 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=300 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=111 Participants
|
19 Participants
n=182 Participants
|
1 Participants
n=7 Participants
|
41 Participants
n=300 Participants
|
|
Region of Enrollment
United States
|
111 Participants
n=111 Participants
|
182 Participants
n=182 Participants
|
7 Participants
n=7 Participants
|
300 Participants
n=300 Participants
|
|
Palliative care refusal rate
Enrolled in Palliative Care
|
50 Participants
n=111 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
69 Participants
n=182 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
—
|
119 Participants
n=293 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
|
Palliative care refusal rate
Declined Palliative Care
|
61 Participants
n=111 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
113 Participants
n=182 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
—
|
174 Participants
n=293 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
|
Palliative care refusal rate
Did not contribute data
|
0 Participants
n=111 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
0 Participants
n=182 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
—
|
0 Participants
n=293 Participants • This measure was assessed for intervention and control group participants only. community palliative care team members did not complete it.
|
|
End-User Satisfaction Survey
|
—
|
—
|
35.4 units on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants • This feasibility and acceptability measure was only assessed for community based palliative care team members. It was not assessed for intervention and control group participants.
|
35.4 units on a scale
STANDARD_DEVIATION 5.7 • n=7 Participants • This feasibility and acceptability measure was only assessed for community based palliative care team members. It was not assessed for intervention and control group participants.
|
PRIMARY outcome
Timeframe: Baseline through 10 months. Pre (control group) test for 5 months prior to intervention. Post (intervention group) for 5 months during intervention.Population: All participants who were eligible for the VNS Health Total Medicare Advantage plan's community-based palliative care program in the 5 months pre-intervention or 5-months post-intervention.
The investigators will assess refusal rate using the MA plan's electronic health records. Refusal rate will be calculated as # of eligible individuals refusing palliative care / total # of individuals eligible for palliative care
Outcome measures
| Measure |
Intervention Group
n=111 Participants
Intervention group will consist of all MA plan members eligible for community-based palliative care and of those who refused it (to calculate refusal rate) during the six month period following the introduction of tailored informational materials developed on CBPC.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Control Group
n=182 Participants
Control group will be a retrospective review of individuals who were eligible for community-based palliative care and of those who refused it, for the 6-month period prior to introducing the tailored informational materials. All of these individuals will have received usual care/information regarding community-based palliative care.
Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
|---|---|---|
|
Palliative Care Refusal Rate
Enrolled in Palliative Care
|
50 Participants
|
69 Participants
|
|
Palliative Care Refusal Rate
Declined Palliative Care
|
61 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: Baseline, 2.5 and 5 months into intervention delivery.Population: All CBPC Team Member participants who provided survey responses to the End-User Satisfaction survey at 2.5 and 5 months
Investigators will assess intervention feasibility and acceptability using the end-user satisfaction survey. End-User Satisfaction ratings for each concept are scored as 1 (almost never); 2 (some of the time); 3 (about half the time); 4 (most of the time); 5 (almost always). Minimum score is 12; maximum 60, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
Intervention Group
n=4 Participants
Intervention group will consist of all MA plan members eligible for community-based palliative care and of those who refused it (to calculate refusal rate) during the six month period following the introduction of tailored informational materials developed on CBPC.
Note: Post-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
Control Group
Control group will be a retrospective review of individuals who were eligible for community-based palliative care and of those who refused it, for the 6-month period prior to introducing the tailored informational materials. All of these individuals will have received usual care/information regarding community-based palliative care.
Note: Pre-intervention planned to be 6 months, in implementation was 5-months due to delayed initiation of intervention.
|
|---|---|---|
|
CBPC Team Members Satisfaction
2.5 months
|
47.5 score on a scale
Standard Deviation 9.7
|
—
|
|
CBPC Team Members Satisfaction
5 months
|
52 score on a scale
Standard Deviation 11.8
|
—
|
|
CBPC Team Members Satisfaction
Baseline
|
35 score on a scale
Standard Deviation 5.7
|
—
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Based Pallaitve Care Team Members
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
Dr. Elizabeth Luth, Principal Investigator
Rutgers University
Phone: 6465120670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place