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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1606 participants

Primary outcome timeframe

Baseline, Month 6

Results posted on

2025-01-13

Participant Flow

Participant milestones

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

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

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 6

Population: 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

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 12

Population: 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

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 12

Population: 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

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 12

Population: 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

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 3

Population: 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

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 6

Population: 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

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 12

Population: 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

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 3

Population: 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

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 6

Population: 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

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 12

Population: 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

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 3

Population: 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

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 6

Population: 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

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 12

Population: 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

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 Death

Population: 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

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 3

Population: 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

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 6

Population: 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

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 12

Population: 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

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 3

Population: 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

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 12

Population: 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

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 3

Population: 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

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 6

Population: 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

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 12

Population: 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

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)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 99 deaths

Nurse-led Telephonic Case Management (Caregivers Only)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 36 deaths

Facilitated, Outpatient Specialty Palliative Care (Patients Only)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 94 deaths

Facilitated, Outpatient Specialty Palliative Care (Caregivers Only)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 32 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Keith Goldfeld

NYU Langone Health

Phone: (212) 263-5550

Results disclosure agreements

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