Trial Outcomes & Findings for Emergency Medicine Palliative Care Access (NCT NCT03325985)
NCT ID: NCT03325985
Last Updated: 2025-01-13
Results Overview
* Measured by change from enrollment to 6 months * Used to measure a person's quality of life * 27 questions total * 5-point Likert scale * Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
COMPLETED
NA
1606 participants
Baseline, Month 6
2025-01-13
Participant Flow
Participant milestones
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Nurse-led Telephonic Case Management (Caregivers Only)
Caregivers of patients enrolled in the nurse-led telephonic case management arm.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Caregivers Only)
Caregivers of patients in the facilitated, outpatient specialty palliative care arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
639
|
155
|
644
|
168
|
|
Overall Study
COMPLETED
|
418
|
93
|
409
|
108
|
|
Overall Study
NOT COMPLETED
|
221
|
62
|
235
|
60
|
Reasons for withdrawal
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Nurse-led Telephonic Case Management (Caregivers Only)
Caregivers of patients enrolled in the nurse-led telephonic case management arm.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Caregivers Only)
Caregivers of patients in the facilitated, outpatient specialty palliative care arm.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
122
|
26
|
141
|
28
|
|
Overall Study
Death
|
99
|
36
|
94
|
32
|
Baseline Characteristics
Emergency Medicine Palliative Care Access
Baseline characteristics by cohort
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=541 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Nurse-led Telephonic Case Management (Caregiver Only)
n=119 Participants
Caregivers of patients enrolled in the nurse-led telephonic case management arm.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=549 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Caregivers Only)
n=136 Participants
Caregivers of patients enrolled in the facilitated, outpatient specialty palliative care arm.
|
Total
n=1345 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 10 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 15.7 • n=107 Participants
|
66.6 years
STANDARD_DEVIATION 10.2 • n=206 Participants
|
56.8 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 12.4 • n=31 Participants
|
|
Sex/Gender, Customized
Female
|
303 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
89 Participants
n=7 Participants
|
757 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Male
|
238 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
265 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
586 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Unknown/Missing
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
152 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
482 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
469 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
1174 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
189 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
426 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
288 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
307 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
752 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other race
|
38 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
101 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Missing
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
541 participants
n=99 Participants
|
119 participants
n=107 Participants
|
549 participants
n=206 Participants
|
136 participants
n=7 Participants
|
1345 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Caregivers were not assessed for this outcome measure.
* Measured by change from enrollment to 6 months * Used to measure a person's quality of life * 27 questions total * 5-point Likert scale * Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=416 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=408 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
|
3.7 score on a scale
Standard Deviation 14.6
|
3.1 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Caregivers were not assessed for this outcome measure.
Measured from enrollment to 12 months as a count of ED revisits, via self-report and EHR abstraction.
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=639 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=644 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Number of Emergency Department (ED) Revisits
|
2.5 Revisits
Standard Deviation 3.5
|
2.7 Revisits
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Caregivers were not assessed for this outcome measure.
Measured from enrollment to 12 months as the number of inpatient days, via self-report and EHR extraction.
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=639 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=644 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Number of Inpatient Days
|
8.1 Days
Standard Deviation 15.3
|
8.6 Days
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Caregivers were not assessed for this outcome measure.
Measured from enrollment to 12 months as the proportion of participants who used hospice, via self-report and EHR abstraction.
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=635 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=641 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Proportion of Participants Who Used Hospice
|
0.16 Proportion of participants
|
0.18 Proportion of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Caregivers were not assessed for this outcome measure.
* Used to measure how often a person feels disconnected from others * Three questions total * 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often) * Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness. * measured by change from enrollment to 3 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=466 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=442 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
|
0 score on a scale
Interval -1.0 to 1.0
|
0 score on a scale
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Caregivers were not assessed for this outcome measure.
* Used to measure how often a person feels disconnected from others * Three questions total * 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often) * Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness. * measured by change from enrollment to 6 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=410 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=405 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
|
0 score on a scale
Interval -1.0 to 1.0
|
0 score on a scale
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Caregivers were not assessed for this outcome measure.
* Used to measure how often a person feels disconnected from others * Three questions total * 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often) * Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness. * measured by change from enrollment to 12 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=334 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=321 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
|
0 score on a scale
Interval -1.0 to 1.0
|
0 score on a scale
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Caregivers were not assessed for this outcome measure.
* Used to measure severity of symptoms * 10 questions * Each item is rated on a 0-10 scale (0= none to 10 worst possible) * Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms. * measured by change from enrollment to 3 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=471 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=447 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
|
-3.8 score on a scale
Standard Deviation 12.1
|
-3.3 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Caregivers were not assessed for this outcome measure.
* Used to measure severity of symptoms * 10 questions * Each item is rated on a 0-10 scale (0= none to 10 worst possible) * Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms. * measured by change from enrollment to 6 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=413 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=407 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
|
-3 score on a scale
Standard Deviation 12.7
|
-2.5 score on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Caregivers were not assessed for this outcome measure.
* Used to measure severity of symptoms * 10 questions * Each item is rated on a 0-10 scale (0= none to 10 worst possible) * Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms. * measured by change from enrollment to 12 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=339 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=323 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
|
-3.3 score on a scale
Standard Deviation 13
|
-1.9 score on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale. * Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning. * measured by change from enrollment to 3 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=106 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=119 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
|
-0.3 score on a scale
Standard Deviation 5.2
|
-0.6 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale. * Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning. * measured by change from enrollment to 6 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=93 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=107 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
|
0.1 score on a scale
Standard Deviation 5.2
|
-0.3 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale. * Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning. * measured by change from enrollment to 12 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=77 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=77 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
|
-0.8 score on a scale
Standard Deviation 5.6
|
-0.2 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 3 Months Post-Patient DeathPopulation: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Measured at 3 months post-patient death * Used to measure a caregiver's bereavement * 19 items; each rated on a 5-point scale from 0 (never) to 4 (always) * Total score is the sum of responses and ranges from 0 to 76; higher scores indicate greater levels of grief
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=34 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=29 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Caregiver Bereavement, as Measured by the Texas Inventory of Grief
|
31.2 score on a scale
Standard Deviation 9.8
|
29.3 score on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Measured as change from enrollment to Month 3 * Used to measure a caregiver's strain * 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no) * Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=108 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=120 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
|
-0.5 score on a scale
Standard Deviation 6.9
|
-0.6 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Measured as change from enrollment to Month 6 * Used to measure a caregiver's strain * 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no) * Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=93 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=108 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
|
-0.6 score on a scale
Standard Deviation 7.3
|
1.3 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Measured as change from enrollment to Month 12 * Used to measure a caregiver's strain * 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no) * Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=75 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=78 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
|
-0.9 score on a scale
Standard Deviation 6.5
|
1 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Caregivers were not assessed for this outcome measure.
* Measured by change from enrollment to 3 months * Used to measure a person's quality of life * 27 questions total * 5-point Likert scale * Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=470 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=452 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Quality of Life for Patients, as Measured by the FACT-G
|
3.4 score on a scale
Standard Deviation 14.2
|
3.6 score on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Caregivers were not assessed for this outcome measure.
* Measured by change from enrollment to 12 months * Used to measure a person's quality of life * 27 questions total * 5-point Likert scale * Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=337 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=328 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Quality of Life for Patients, as Measured by the FACT-G
|
4 score on a scale
Standard Deviation 17.2
|
3.7 score on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale. * Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning. * Measured by change from enrollment to 3 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=106 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=118 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
|
0.2 score on a scale
Standard Deviation 7.9
|
0.3 score on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale. * Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning. * Measured by change from enrollment to 6 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=93 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=106 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
|
1.6 score on a scale
Standard Deviation 7.4
|
-0.1 score on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
* Quality of life for informal caregivers will be measured using the 10-item Patient-Reported Outcome Measurement Information System (PROMIS-10), an instrument designed to measure perceptions of health using global health items. It contains a global physical health scale and a global mental health scale. * Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning. * Measured by change from enrollment to 6 months
Outcome measures
| Measure |
Nurse-led Telephonic Case Management (Patients Only)
n=75 Participants
* Telephonic nurses will contact patients within 72 hours of enrollment
* Patients will speak with the telephonic nurse over the phone once a week (or as often as needed) for a duration of 6 months.
Nurse-led telephonic case management: Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
n=76 Participants
* Patients will be scheduled for their first in-person palliative care visit within two weeks of enrollment and then once a month for 6 months.
* Clinic visits will be scheduled the same day as other specialty appointments if possible
Facilitated,outpatient specialty palliative care: In-person or telehealth palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
|
|---|---|---|
|
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
|
-0.5 score on a scale
Standard Deviation 6.9
|
0.8 score on a scale
Standard Deviation 7.9
|
Adverse Events
Nurse-led Telephonic Case Management (Patients Only)
Nurse-led Telephonic Case Management (Caregivers Only)
Facilitated, Outpatient Specialty Palliative Care (Patients Only)
Facilitated, Outpatient Specialty Palliative Care (Caregivers Only)
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