Trial Outcomes & Findings for A Culturally-Based Palliative Care Tele-consult Program for Rural Southern Elders (NCT NCT03767517)

NCT ID: NCT03767517

Last Updated: 2025-05-23

Results Overview

Change from baseline in patient-reported symptom burden measured using the Edmonton Symptom Assessment Scale (ESAS) at baseline; change from baseline measured using the ESAS at 7 days post-baseline. Each item is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90. A higher value represents the worse possible outcome. Higher score indicates higher symptom burden.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

209 participants

Primary outcome timeframe

baseline and 7 days post-baseline and 30 days post-baseline

Results posted on

2025-05-23

Participant Flow

Patient and Caregivers were considered enrolled. The patients were not enrolled without an active caregiver. They were only given one study Identification number.

Participant milestones

Participant milestones
Measure
Active Intervention
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Overall Study
STARTED
105
104
Overall Study
Patient/Caregiver Breakdown
105
104
Overall Study
COMPLETED
87
91
Overall Study
NOT COMPLETED
18
13

Reasons for withdrawal

Reasons for withdrawal
Measure
Active Intervention
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Overall Study
Lost to Follow-up
16
10
Overall Study
Death
2
3

Baseline Characteristics

There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active Intervention
n=210 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=208 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Total
n=418 Participants
Total of all reporting groups
Age, Continuous
Patients
72.9 years
STANDARD_DEVIATION 8.7 • n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
73.7 years
STANDARD_DEVIATION 7.7 • n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
73.3 years
STANDARD_DEVIATION 8.2 • n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Age, Continuous
Caregivers
61.5 years
STANDARD_DEVIATION 14.6 • n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
58.6 years
STANDARD_DEVIATION 15.5 • n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
60.1 years
STANDARD_DEVIATION 15.1 • n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Sex: Female, Male
Patients · Female
53 Participants
n=105 Participants • \# of caregivers in USUAL CARE were lost to f/u
67 Participants
n=104 Participants • \# of caregivers in USUAL CARE were lost to f/u
120 Participants
n=209 Participants • \# of caregivers in USUAL CARE were lost to f/u
Sex: Female, Male
Patients · Male
52 Participants
n=105 Participants • \# of caregivers in USUAL CARE were lost to f/u
37 Participants
n=104 Participants • \# of caregivers in USUAL CARE were lost to f/u
89 Participants
n=209 Participants • \# of caregivers in USUAL CARE were lost to f/u
Sex: Female, Male
Caregivers · Female
83 Participants
n=105 Participants • \# of caregivers in USUAL CARE were lost to f/u
72 Participants
n=101 Participants • \# of caregivers in USUAL CARE were lost to f/u
155 Participants
n=206 Participants • \# of caregivers in USUAL CARE were lost to f/u
Sex: Female, Male
Caregivers · Male
22 Participants
n=105 Participants • \# of caregivers in USUAL CARE were lost to f/u
29 Participants
n=101 Participants • \# of caregivers in USUAL CARE were lost to f/u
51 Participants
n=206 Participants • \# of caregivers in USUAL CARE were lost to f/u
Ethnicity (NIH/OMB)
Patient · Hispanic or Latino
0 Participants
n=105 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
0 Participants
n=104 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
0 Participants
n=209 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
Ethnicity (NIH/OMB)
Patient · Not Hispanic or Latino
105 Participants
n=105 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
104 Participants
n=104 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
209 Participants
n=209 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
Ethnicity (NIH/OMB)
Patient · Unknown or Not Reported
0 Participants
n=105 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
0 Participants
n=104 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
0 Participants
n=209 Participants • There are 105 patient participants in the active intervention and There are 104 patient participants in usual care.
Race (NIH/OMB)
Patients · American Indian or Alaska Native
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Patients · Asian
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Patients · Native Hawaiian or Other Pacific Islander
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Patients · Black or African American
30.0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
28.0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
58 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Patients · White
75.0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
76.0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
151 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Patients · More than one race
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Patients · Unknown or Not Reported
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Caregivers · Asian
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Caregivers · Black or African American
29.0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
27.0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
56 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Caregivers · White
76.0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
73.0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
149 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Caregivers · More than one race
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
0 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
0 Participants
n=105 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
4.0 Participants
n=104 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
4 Participants
n=209 Participants • There are 105 patient participants and 105 caregiver participants in the active intervention and the participants were analyzed in their respective groups. There are 104 patient participants and 104 caregiver participants and the participants were analyzed in their respective groups.
Region of Enrollment
United States
210 participants
n=210 Participants
208 participants
n=208 Participants
418 participants
n=418 Participants

PRIMARY outcome

Timeframe: baseline and 7 days post-baseline and 30 days post-baseline

Change from baseline in patient-reported symptom burden measured using the Edmonton Symptom Assessment Scale (ESAS) at baseline; change from baseline measured using the ESAS at 7 days post-baseline. Each item is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90. A higher value represents the worse possible outcome. Higher score indicates higher symptom burden.

Outcome measures

Outcome measures
Measure
Active Intervention
n=105 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
baseline
35.1 score on a scale
Standard Error 0.9
34.6 score on a scale
Standard Error 0.9
Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
Day 7
38.6 score on a scale
Standard Error 0.9
38 score on a scale
Standard Error 0.9
Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
Day 30
40.5 score on a scale
Standard Error 0.9
39.4 score on a scale
Standard Error 0.9

SECONDARY outcome

Timeframe: baseline and 7 days post-baseline and 30 days post baseline

Population: The participants number analyzed in one or more rows differ from the overall number analyzed due to participants choosing not to answer certain questions from baseline to day 30.

Change from baseline measured using FAMCARE-2 at 7 days post-baseline. Each item was scored on a Likert scale of VS (very satisfied), S (satisfied), U (undecided), D (dissatisfied), VD (very dissatisfied), or NA (not applicable), which was then dichotomized into very satisfied/satisfied and undecided/dissatisfied/very dissatisfied. The mean percentages in these dichotomized categories was calculated along with the standard error of the mean. A repeated measures generalized linear mixed model was used to calculate the estimated marginal means (least squares means) and associated standard errors at each time point for the intervention and usual care groups. The higher mean percentage of the population that responded very satisfied/ satisfied equals a better outcome.

Outcome measures

Outcome measures
Measure
Active Intervention
n=105 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Patient Comfort-Very satisfied/ Satisfied
76.2 percentage of participants
78.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Patient Comfort Undecided/dissatisfied/very dissatisfied
23.8 percentage of participants
21.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Patient Comfort-Very satisfied/ Satisfied
85.7 percentage of participants
84.8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Patient Comfort-Undecided/Dissatisfied/very dissatisfied
14.3 percentage of participants
15.2 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Patient Comfort Very satisfied/Satisfied
94.3 percentage of participants
90 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Patient Comfort Undecided/Dissatisfied/Very Dissatisfied
5.7 percentage of participants
10 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline-Conditions and progress explained-Very Satisfied/Satisfied
70.8 percentage of participants
71.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Condition and Progress explained-Undecided/Dissatisfied/Very Dissatisfied
29.2 percentage of participants
28.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Conditions and Progress explained-Very Satisfied/Satisfied
80.6 percentage of participants
85.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Conditions and Progress explained- Undecided/Dissatisfied/Very Dissatisfied
19.4 percentage of participants
14.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30-Conditions and Progress Explained- Very Satisfied/Satisfied
90.6 percentage of participants
92.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Conditions and Progress Explained-Undecided/Dissatisfied/Very Dissatisfied
9.4 percentage of participants
7.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline-Information on Side Effects Very Satisfied/Satisfied
77 percentage of participants
72.8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline-Information on Side Effects/ Undecided/Dissatisfied/Very Dissatisfied
23 percentage of participants
27.2 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Information on Side Effects Very Satisfied/Satisfied
87.2 percentage of participants
78.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Information on Side Effects/ Undecided/Dissatisfied/Very Dissatisfied
12.8 percentage of participants
21.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Information on Side Effects/Very Satisfied/Satisfied
91.3 percentage of participants
86.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Information on Side Effects/ Undecided/Dissatisfied/Very Dissatisfied
8.7 percentage of participants
13.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline-Respect for Dignity/ Very Satisfied/Satisfied
88.1 percentage of participants
87.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline-Respect for Dignity/ Undecided/Dissatisfied/Very Dissatisfied
11.9 percentage of participants
12.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7-Respect for Dignity/ Very Satisfied/Satisfied
84.3 percentage of participants
88.8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7-Respect for Dignity/Undecided/Dissatisfied/Very Dissatisfied
15.7 percentage of participants
11.2 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Respect for Dignity/Very Satisfied/Satisfied
91.9 percentage of participants
93.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Respect for Dignity/ Undecided/Dissatisfied/Very Dissatisfied
8.1 percentage of participants
6.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Meetings with Care Team/ Very Satisfied/ Satisfied
64.4 percentage of participants
68.2 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Meetings with Care Team/ Undecided/Dissatisfied/Very Dissatisfied
35.6 percentage of participants
31.8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Meetings with Care Team/Very Satisfied/Satisfied
85.7 percentage of participants
83 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Meeting with Care Team/ Undecided/Dissatisfied/ Very Dissatisfied
14.3 percentage of participants
17 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30-Meetings with Care Team/Satisfied/Very Satisfied
87.2 percentage of participants
89.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Meetings with Care Team/Undecided/ Dissatisfied/Very Dissatisfied
12.8 percentage of participants
10.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Speed of Treatment/Very Satisfied/Satisfied
71 percentage of participants
62.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Speed of Treatment/ Undecided/ Dissatisfied/Very Dissatisfied
29 percentage of participants
37.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Availability of Care Team/ Undecided/ Dissatisfied/ Very Dissatisfied
14.6 percentage of participants
12.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Speed of Treatment/ Very Satisfied/Satisfied
78.8 percentage of participants
81.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Speed of Treatment/ Undecided/ Dissatisfied/ Very Dissatisfied
21.2 percentage of participants
18.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Speed of Treatment/ Very Satisfied/Satisfied
91.6 percentage of participants
87.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Speed of Treatment/ Undecided/ Dissatisfied/ Very Dissatisfied
8.4 percentage of participants
12.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Attention to Symptom description/ Very satisfied/Satisfied
80.6 percentage of participants
74.8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Attentions to Symptom description/ Undecided/ Dissatisfied/Very Dissatisfied
19.4 percentage of participants
25.2 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Attention to Symptom description/ Very Satisfied/ Satisfied
82.4 percentage of participants
84.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Attention to Symptom Description/ Undecided/ Dissatisfied/ Very Dissatisfied
17.6 percentage of participants
15.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Attention to Symptom Description/ Very Satisfied/ Satisfied
92.8 percentage of participants
94.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Attention to Symptom Description/ Undecided/ Dissatisfied/ Very Dissatisfied
7.2 percentage of participants
5.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Physical Needs Met/ Very Satisfied/ Satisfied
84.8 percentage of participants
83.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Physical Needs Met/ Undecided/ Dissatisfied/ Very Dissatisfied
15.2 percentage of participants
16.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Physical Needs Met/ Very Satisfied/ Satisfied
85.1 percentage of participants
85.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Physical Needs Met/ Undecided/ Dissatisfied/ Very Dissatisfied
14.9 percentage of participants
14.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Physical Needs Met/ Very Satisfied/ Satisfied
92.8 percentage of participants
93.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Physical Needs Met/ Undecided/ Dissatisfied/ Very Dissatisfied
7.2 percentage of participants
6.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Availability of Care Team/ Very Satisfied/ Satisfied
75.5 percentage of participants
73.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Availability of Care Team Undecided/Dissatisfied/ Very Dissatisfied
24.5 percentage of participants
26.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Availability of Care Team/Very Satisfied/ Satisfied
85.4 percentage of participants
87.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Availability of Care Team/ Very Satisfied/ Satisfied
90.8 percentage of participants
94.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Availability of Care Team/ Undecided/ Dissatisfied/ Very Dissatisfied
9.2 percentage of participants
5.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Emotional Support to Family/Very Satisfied/Satisfied
76 percentage of participants
79.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Emotional Support to Family Undecided/ Dissatisfied/ Very Dissatisfied
24 percentage of participants
20.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Emotional Support of Family/Very Satisfied/ Satisfied
81.2 percentage of participants
85 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Emotional Support to Family/ Undecided/ Dissatisfied/ Very Dissatisfied
18.8 percentage of participants
15 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Emotional Support to Family/ Very Satisfied/ Satisfied
90.9 percentage of participants
91.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Emotional Support to Family Undecided/Dissatisfied/ Very Dissatisfied
9.1 percentage of participants
8.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Practical Assistance/Very Satisfied/ Satisfied
86.2 percentage of participants
78.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Practical Assistance/ Undecided/ Dissatisfied/ Very Dissatisfied
13.8 percentage of participants
21.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Practical Assistance/Very Satisfied/ Satisdfied
80 percentage of participants
85.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Practical Assistance/Undecided/Dissatisfied/Very Dissatisfied
20 percentage of participants
14.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Practical Assistance Very Satisfied/ Satisfied
84.5 percentage of participants
85.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Practical Assistance Undecided/ Dissatisfied/Very Dissatisfied
15.5 percentage of participants
14.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Doctors Attention to Symptoms/Very Satisfied/Satisfied
80.2 percentage of participants
80.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Doctors Attention to Symptoms/ Undecided/Dissatisfied/ Very Dissatisfied
19.8 percentage of participants
19.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Doctors Attention to Symptoms/ Very Satisfied/Satisfied
84.3 percentage of participants
85.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Doctors Attention to Symptoms/ Undecided/Dissatisfied/Very Dissatisfied
15.7 percentage of participants
14.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Doctors Attention to Symptoms/Very Satisfied/Satisfied
92.9 percentage of participants
88.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Doctors Attention to Symptoms/Undecided/Dissatisfied/Very Dissatisfied
7.1 percentage of participants
11.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Family Included/Very Satisfied/Satisfied
81.2 percentage of participants
75.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Family Included/ Undecided/Dissatisfied/Very Dissatisfied
18.8 percentage of participants
24.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Family Included/ Very Satisfied/Satisfied
85.4 percentage of participants
86.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Family Included/ Undecided/Dissatisfied/Very Dissatisfied
14.6 percentage of participants
13.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Family Included/ Very Satisfied/Satisfied
89.2 percentage of participants
92 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Family Included/ Undecided/ Dissatisfied/ Very Dissatisfied
10.8 percentage of participants
8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Info about managing symptoms/ Very Satisfied/ Satisfied
68.6 percentage of participants
69.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Info about managing symptoms/ Undecided/ Dissatisfied/Very Dissatisfied
31.4 percentage of participants
30.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Info about managing symptoms/Very Satisfied/Satisfied
83.8 percentage of participants
81.2 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Info about managing symptoms/ Undecided/Dissatisfied/Very Dissatisfied
16.2 percentage of participants
18.8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Info about managing symptoms/ Very Satisfied/Satisfied
84.9 percentage of participants
92 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Info about managing symptoms/ Undecided/ Dissatisfied/Very Dissatisfied
15.1 percentage of participants
8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Effectiveness of Care Team/ Very Satisfied/Satisfied
81.4 percentage of participants
78.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Effectiveness of Care Team/ Undecided/ Dissatisfied/ Very Dissatisfied
18.6 percentage of participants
21.1 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Effectiveness of Care Team/Very Satisfied/Satisfied
83.6 percentage of participants
90.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Effectiveness of Care Team/ Undecided/ Dissatisfied/Very Dissatisfied
16.4 percentage of participants
9.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Effectiveness of Care Team/Very Satisfied/Satisfied
91.7 percentage of participants
92.4 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Effectiveness of Care Team/Undecided/Dissatisfied/Very Dissatisfied
8.3 percentage of participants
7.6 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Response to Changes/Very Satisfied/Satisfied
77 percentage of participants
77.7 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Response to Changes/Undecided/Dissatisfied/Very Dissatisfied
23 percentage of participants
22.3 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Response to Changes/Very Satisfied/ Satisfied
83.9 percentage of participants
89.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Response to Changes/ Undecided/ Dissatisfied/Very Dissatisfied
16.1 percentage of participants
10.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Response to Changes/Very Satisfied/ Satisfied
92.8 percentage of participants
92 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Response to Changes/ Undecided/Dissatisfied/ Very Dissatisfied
7.2 percentage of participants
8 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Emotional Support to Patient/Very Satisfied/Satisfied
79.8 percentage of participants
80 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Baseline Emotional Support to Patient/Undecided/Dissatisfied/Very Dissatisfied
20.2 percentage of participants
20 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Emotional Support to Patient/Very Satisfied/Satisfied
89.7 percentage of participants
87.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 7 Emotional Support to Patient/Undecided/Dissatisfied/Very Dissatisfied
10.3 percentage of participants
12.5 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Emotional Support to Patient/Very Satisfied/Satisfied
89.2 percentage of participants
90.9 percentage of participants
The Mean Percentage of Caregivers Who Responded Very Satisfied/Satisfied to the Family Satisfaction With Care (FAMCARE-2) Survey.
Day 30 Emotional Support to Patient/Undecided Dissatisfied/Very Dissatisfied
10.8 percentage of participants
9.1 percentage of participants

SECONDARY outcome

Timeframe: baseline and 7 days post-baseline

Population: The number of patients changed because of not completing the study.

Change from baseline in patient-reported quality of life using the Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS Global Health-10) at baseline; change from baseline measured using the PROMIS Health-10 at 7 days post-baseline. Items 1-6 are scored using: 1-5 (1=poor; 5=excellent). Item 7 is scored using 1-5 (1= not at all; 5= completely). Item 8 is scored using 1-5 (1= always; 5=never). Item 9 is scored using 1-5 (1=very severe; 5=none). Item 10 is scored using 0-10 (0=no pain; 10=worst pain imaginable).Items were summed , then scaled to T-scores (which would have a mean of 50 and standard deviation of 10 in the general adult population) using published procedures from Health Measures, with higher scores representing better health. As the PROMIS Global Health is scaled relative to the referent general population, there are no minimum and maximum values published.

Outcome measures

Outcome measures
Measure
Active Intervention
n=105 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Patient Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Baseline Physical Health
35.1 scaled to T-Scores
Standard Error 0.9
34.6 scaled to T-Scores
Standard Error 0.9
Patient Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Day 7 Physical Health
38.6 scaled to T-Scores
Standard Error 0.9
38 scaled to T-Scores
Standard Error 0.9
Patient Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Baseline Mental Health
45.5 scaled to T-Scores
Standard Error 0.8
43.7 scaled to T-Scores
Standard Error 0.8
Patient Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Day 7 Mental Health
45.7 scaled to T-Scores
Standard Error 0.8
44 scaled to T-Scores
Standard Error 0.8

SECONDARY outcome

Timeframe: Baseline and 7 days post-Baseline

Population: The number of Caregivers changed at Day 7.

Change from baseline in caregiver-reported quality of life using the Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS Global Health-10) at baseline; change from baseline measured using the PROMIS Global Health-10 at 7 days post-baseline. Items 1-6 are scored using: 1-5 (1=poor; 5=excellent). Item 7 is scored using 1-5 (1= not at all; 5= completely). Item 8 is scored using 1-5 (1= always; 5=never). Item 9 is scored using 1-5 (1=very severe; 5=none). Item 10 is scored using 0-10 (0=no pain; 10=worst pain imaginable).Items were summed , then scaled to T-scores (which would have a mean of 50 and standard deviation of 10 in the general adult population) using published procedures from Health Measures, with higher scores representing better health. As the PROMIS Global Health is scaled relative to the referent general population, there are no minimum and maximum values published.

Outcome measures

Outcome measures
Measure
Active Intervention
n=104 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=101 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Caregiver Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Baseline Physical Health
48.5 score on a scale
Standard Error 0.9
47.6 score on a scale
Standard Error 0.9
Caregiver Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Day 7 Physical Health
50.9 score on a scale
Standard Error 0.9
49.4 score on a scale
Standard Error 0.9
Caregiver Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Baseline Mental Health
50 score on a scale
Standard Error 0.7
47.7 score on a scale
Standard Error 0.7
Caregiver Quality of Life (Patient-Reported Outcomes Measurement Information System Global Health-10 [PROMIS Global Health-10])
Day 7 Mental Health
49.6 score on a scale
Standard Error 0.7
48.3 score on a scale
Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline and 7 days post-Baseline

Population: The number analyzed in one or more rows differ from the overall number analyzed because some of the participants failed to answer questions during data collection.

Change from baseline in caregiver-reported burden using the Montgomery Borgatta Caregiver Burden Scale (MBCB) at baseline; change from baseline measured using the MBCB at 7 days post-baseline. This scale contains a total of 14 questions and 5 Likert scale responses (a lot less, a little less, the same, a little more, or a lot more). Caregiver burden will be quantified by three subscales; objective, subjective and demand burdens. Objective burden is measured by 6 questions (total score between 0-30), subjective burden is measured by 4 questions (total score between 4-20), and demand burden is measured by 4 questions (total score between 4-20).

Outcome measures

Outcome measures
Measure
Active Intervention
n=105 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
Baseline Objective Burden
19.5 score on a scale
Standard Error 0.3
19.9 score on a scale
Standard Error 0.3
Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
Day 7 Objective Burden
19.1 score on a scale
Standard Error 0.3
19.4 score on a scale
Standard Error 0.3
Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
Baseline Subjective Burden
13.4 score on a scale
Standard Error 0.3
13.1 score on a scale
Standard Error 0.3
Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
Day 7 Subjective Burden
11.9 score on a scale
Standard Error 0.3
11.6 score on a scale
Standard Error 0.3
Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
Baseline Demand Burden
12.1 score on a scale
Standard Error 0.3
11.8 score on a scale
Standard Error 0.3
Caregiver Burden Scale (Montgomery Borgatta Caregiver Burden Scale [MBCB])
Day 7 Demand Burden
11 score on a scale
Standard Error 0.3
10.8 score on a scale
Standard Error 0.3

SECONDARY outcome

Timeframe: 30 days post-Baseline

Population: Some participants reported that they were not sure which was considered missing data for analysis.

Patient resource use (e.g., number of hospital readmissions, and number of Emergency Department \[ED\] visits) within 30 days after enrollment.

Outcome measures

Outcome measures
Measure
Active Intervention
n=90 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=91 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Resource Use
Number of ER visits
0.19 count the number of visits
Standard Error 0.06
0.16 count the number of visits
Standard Error 0.05
Resource Use
Number of Hospital Re-admissions
0.2 count the number of visits
Standard Error 0.06
0.14 count the number of visits
Standard Error 0.04

SECONDARY outcome

Timeframe: Baseline and 7 days post-Baseline

Population: Nine of the participants dropped out of the study by Day 7.

Change from baseline in patient-reported satisfaction with care using the Feeling Heard and Understood questionnaire at baseline; change from baseline using the Feeling Heard and Understood questionnaire at 7 days post-baseline. Likert scale using: completely, quite a bit, moderately, slightly, not at all. Which was then dichotomized into completely/quite-a-bit and moderately/slightly/not at all. The mean percentage of participants in these dichotomized categories were calculated along with the standard error of the mean. The higher mean percentage of the population that responded completely/ quite a bit equals a better outcome.

Outcome measures

Outcome measures
Measure
Active Intervention
n=104 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
The Mean Percentage of Caregivers Who Responded Completely/Quite a Bit to the Patient Satisfaction With Care (Feeling Heard and Understood) Survey.
Day 7 Moderately/Slightly/Not at all
11.6 percentage of participants
Standard Error 3.3
9.5 percentage of participants
Standard Error 3
The Mean Percentage of Caregivers Who Responded Completely/Quite a Bit to the Patient Satisfaction With Care (Feeling Heard and Understood) Survey.
Baseline Completely/Quite a bit
76.9 percentage of participants
Standard Error 4.1
76.9 percentage of participants
Standard Error 4.1
The Mean Percentage of Caregivers Who Responded Completely/Quite a Bit to the Patient Satisfaction With Care (Feeling Heard and Understood) Survey.
Day 7 Completely/ Quite a Bit
88.4 percentage of participants
Standard Error 3.3
90.5 percentage of participants
Standard Error 3
The Mean Percentage of Caregivers Who Responded Completely/Quite a Bit to the Patient Satisfaction With Care (Feeling Heard and Understood) Survey.
Baseline Moderately/Slightly/Not at all
23.1 percentage of participants
Standard Error 4.1
23.1 percentage of participants
Standard Error 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7

Patient symptom burden measured by Edmonton Symptom Assessment Scale \[ESAS\] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record \[eHR\] documentation of recommendations by hospitalist/clinician at Day 7. Each item in the ESAS is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90.

Outcome measures

Outcome measures
Measure
Active Intervention
n=94 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=91 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Exploratory Aim 1a. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
28.7 score on a scale
Standard Error 1.5
24.9 score on a scale
Standard Error 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7

Patient symptom burden measured by Edmonton Symptom Assessment Scale \[ESAS\] mediated and/or moderated by patient/caregiver implementation of palliative care recommendations. Patient/caregiver implementation of palliative care recommendations are measured using patient/caregiver report at Day 7. Each item in the Edmonton Symptom Assessment Scale \[ESAS\] is scored using: 0-10 (0= no pain; 10= worst possible pain), yielding a total score between 0 and 90.

Outcome measures

Outcome measures
Measure
Active Intervention
n=105 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Exploratory Aim 1b. Patient Symptom Burden (Edmonton Symptom Assessment Scale [ESAS])
24.9 score on a scale
Standard Error 1.5
28.7 score on a scale
Standard Error 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 7

Population: Some participants did not answer which resulted in missing data

Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale \[MBCB\] mediated and/or moderated by hospitalist/clinician implementation of palliative care recommendations. Implementation of palliative care recommendations are measured using Electronic Health Record \[eHR\] documentation of recommendations by hospitalist/clinician at Day 7. This scale contains a total of 14 questions and 5 Likert scale responses (a lot less, a little less, the same, a little more, or a lot more) with higher scores indicating greater burden. Caregiver burden will be quantified by three subscales; objective, subjective and demand burdens. Objective burden is measured by 6 questions (total score between 0-30), subjective burden is measured by 4 questions (total score between 4-20), and demand burden is measured by 4 questions (total score between 4-20).

Outcome measures

Outcome measures
Measure
Active Intervention
n=105 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Exploratory Aim 1c. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
Objective Subscale
19.1 score on a scale
Standard Error 0.3
19.4 score on a scale
Standard Error 0.3
Exploratory Aim 1c. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
Subjective Subscale
11.9 score on a scale
Standard Error 0.3
11.6 score on a scale
Standard Error 0.3
Exploratory Aim 1c. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
Demand Burden
11 score on a scale
Standard Error 0.3
10.8 score on a scale
Standard Error 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 30

Population: Some participants did not answer which resulted in missing data

Caregiver burden measured by Montgomery Borgatta Caregiver Burden Scale \[MBCB\] mediated and/or moderated by caregiver/patient implementation of palliative care recommendations. Caregiver/patient implementation of palliative care recommendations are measured using caregiver/patient report at Day 7. This scale contains a total of 14 questions and 5 Likert scale responses (a lot less, a little less, the same, a little more, or a lot more). Caregiver burden will be quantified by three subscales; objective, subjective and demand burdens. Objective burden is measured by 6 questions (total score between 0-30), subjective burden is measured by 4 questions (total score between 4-20), and demand burden is measured by 4 questions (total score between 4-20). Higher scores indicates greater burden.

Outcome measures

Outcome measures
Measure
Active Intervention
n=105 Participants
Usual Care + Tele-consult Intervention Active Intervention: Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Usual Care
n=104 Participants
Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted. Usual Care: Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
Exploratory Aim 1d. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
Objective burden
19.4 score on a scale
Standard Error 0.3
19.1 score on a scale
Standard Error 0.3
Exploratory Aim 1d. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
Subjective Burden
11.8 score on a scale
Standard Error 0.3
12.2 score on a scale
Standard Error 0.3
Exploratory Aim 1d. Caregiver Burden (Montgomery Borgatta Caregiver Burden Scale [MBCB]).
Demand Burden
11.3 score on a scale
Standard Error 0.3
11.3 score on a scale
Standard Error 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-3 Months after death of patient, if applicable

Population: This data was not collected.

Caregiver evaluation of end-of-life care quality measured by Caregiver Evaluation of Quality of End-of-Life Care \[CEQUEL\]

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 2-3 Months after death of patient, if applicable

Population: This was not collected.

Caregiver bereavement measured by Caregiver Bereavement Items (\[CBI\]

Outcome measures

Outcome data not reported

Adverse Events

Active Intervention/Patients Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Usual Care/Patients Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ronit Elk

University of Alabama at Birmingham

Phone: 205-996-1702

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place