Advanced Cancer, End Stage Organ Failure
Conditions
Brief summary
This is a two-arm, multi-site randomized controlled trial of 1,350 older adults (50+ years) with either advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure (New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) \< 15 ml/min/m2 or dialysis ; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher, or oxygen-dependent chronic obstructive pulmonary disease (COPD) who present to the Emergency Department (ED), along with 675 of their informal caregivers. Investigators will compare the effectiveness of two distinct palliative care models: a) nurse-led telephonic case management; and b) facilitated, outpatient specialty palliative care.
Interventions
BEHAVIORALNurse-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.
BEHAVIORALFacilitated,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.
Sponsors
Beaumont Health
Dana-Farber/Brigham and Women's Cancer Center
Ohio State University
University of Florida
Yale University
Patient-Centered Outcomes Research Institute
Hackensack Meridian Health
Atlantic Health System
University of California, Irvine
University of California, San Diego
University of California, Los Angeles
Northwestern University
Rush University
Henry Ford Health System
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients: * English or Spanish-speaking patients ages 50 years and older * Qualifying serious, life-limiting conditions and who are scheduled for ED discharge, observation status, or admission for two midnights or less. * Qualifying conditions include: advanced cancer (defined as metastatic solid tumor) or poor prognosis end-stage organ failure New York Heart Association (NYHA) Class III or IV Congestive Heart Failure (CHF), End-Stage Renal Disease (ESRD), defined as Glomerular Filtration Rate (GFR) \< 15 ml/min/m2 or dialysis; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or stage III or IV, or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD) * Patients must have health insurance, reside within the geographical area, and have a working telephone. Informal Caregivers: * English or Spanish-speaking primary caregivers (relative or friend who has contact with the patient at least two times per week) ages 18 years and older.
Exclusion criteria
* Patients with dementia identified in the EHR, who received hospice services in the last six months, who have received 2 or more palliative care visits in the last 6 months, and those who reside in a skilled nursing or assisted living facility, or chronic care hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G) | Baseline, Month 6 | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Inpatient Days | Up to Month 12 | Measured from enrollment to 12 months as the number of inpatient days, via self-report and EHR extraction. |
| Proportion of Participants Who Used Hospice | Up to Month 12 | Measured from enrollment to 12 months as the proportion of participants who used hospice, via self-report and EHR abstraction. |
| Change in Loneliness, as Measured by the Three-Item Loneliness Scale | Baseline, Month 3 | * 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 |
| Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | Baseline, Month 3 | * 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 |
| Number of Emergency Department (ED) Revisits | Up to Month 12 | Measured from enrollment to 12 months as a count of ED revisits, via self-report and EHR abstraction. |
| Caregiver Bereavement, as Measured by the Texas Inventory of Grief | 3 Months Post-Patient Death | * 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 |
| Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12) | Baseline, Month 3 | * 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 |
| Change in Quality of Life for Patients, as Measured by the FACT-G | Baseline, Month 3 | * 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. |
| Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10) | Baseline, Month 3 | * 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 |
| Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10) | Baseline, Month 3 | * 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 541 |
| Nurse-led Telephonic Case Management (Caregiver Only) Caregivers of patients enrolled in the nurse-led telephonic case management arm. | 119 |
| 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. | 549 |
| Facilitated, Outpatient Specialty Palliative Care (Caregivers Only) Caregivers of patients enrolled in the facilitated, outpatient specialty palliative care arm. | 136 |
| Total | 1,345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 99 | 36 | 94 | 32 |
| Overall Study | Lost to Follow-up | 122 | 26 | 141 | 28 |
Baseline characteristics
| Characteristic | Nurse-led Telephonic Case Management (Patients Only) | Nurse-led Telephonic Case Management (Caregiver Only) | Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Facilitated, Outpatient Specialty Palliative Care (Caregivers Only) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 10 | 55.8 years STANDARD_DEVIATION 15.7 | 66.6 years STANDARD_DEVIATION 10.2 | 56.8 years STANDARD_DEVIATION 13.7 | 61.4 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 9 Participants | 73 Participants | 20 Participants | 152 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 482 Participants | 108 Participants | 469 Participants | 115 Participants | 1174 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 2 Participants | 7 Participants | 1 Participants | 19 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 2 Participants | 4 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 2 Participants | 3 Participants | 1 Participants | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 189 Participants | 34 Participants | 170 Participants | 33 Participants | 426 Participants |
| Race/Ethnicity, Customized Missing | 5 Participants | 1 Participants | 9 Participants | 2 Participants | 17 Participants |
| Race/Ethnicity, Customized More than one race | 7 Participants | 0 Participants | 11 Participants | 0 Participants | 18 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 3 Participants | 1 Participants | 4 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Other race | 38 Participants | 8 Participants | 41 Participants | 14 Participants | 101 Participants |
| Race/Ethnicity, Customized White | 288 Participants | 71 Participants | 307 Participants | 86 Participants | 752 Participants |
| Region of Enrollment United States | 541 participants | 119 participants | 549 participants | 136 participants | 1345 participants |
| Sex/Gender, Customized Female | 303 Participants | 81 Participants | 284 Participants | 89 Participants | 757 Participants |
| Sex/Gender, Customized Male | 238 Participants | 36 Participants | 265 Participants | 47 Participants | 586 Participants |
| Sex/Gender, Customized Unknown/Missing | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 99 / 639 | 36 / 155 | 94 / 644 | 32 / 168 |
| other Total, other adverse events | 0 / 639 | 0 / 155 | 0 / 644 | 0 / 168 |
| serious Total, serious adverse events | 0 / 639 | 0 / 155 | 0 / 644 | 0 / 168 |
Outcome results
Primary
Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
* 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.
Time frame: Baseline, Month 6
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | 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 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G) | 3.1 score on a scale | Standard Deviation 15 |
Secondary
Caregiver Bereavement, as Measured by the Texas Inventory of Grief
* 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
Time frame: 3 Months Post-Patient Death
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Caregiver Bereavement, as Measured by the Texas Inventory of Grief | 31.2 score on a scale | Standard Deviation 9.8 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Caregiver Bereavement, as Measured by the Texas Inventory of Grief | 29.3 score on a scale | Standard Deviation 8.7 |
Secondary
Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
* 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
Time frame: Baseline, Month 3
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | 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 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10) | 0.3 score on a scale | Standard Deviation 7.9 |
Secondary
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
* 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
Time frame: Baseline, Month 12
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | 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 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | 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 7.9 |
Secondary
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
* 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
Time frame: Baseline, Month 3
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | 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 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10) | -0.6 score on a scale | Standard Deviation 4.4 |
Secondary
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
* 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
Time frame: Baseline, Month 6
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | 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 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | 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 4.4 |
Secondary
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
* 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
Time frame: Baseline, Month 12
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | 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 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10) | -0.2 score on a scale | Standard Deviation 5.1 |
Secondary
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
* 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
Time frame: Baseline, Month 6
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | 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 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | 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 6.6 |
Secondary
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
* 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
Time frame: Baseline, Month 12
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12) | -0.9 score on a scale | Standard Deviation 6.5 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12) | 1 score on a scale | Standard Deviation 7.7 |
Secondary
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
* 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
Time frame: Baseline, Month 3
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12) | -0.5 score on a scale | Standard Deviation 6.9 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12) | -0.6 score on a scale | Standard Deviation 6.3 |
Secondary
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
* 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
Time frame: Baseline, Month 6
Population: Patient participants were not assessed for this outcome measure; only Caregiver participants were assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12) | -0.6 score on a scale | Standard Deviation 7.3 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12) | 1.3 score on a scale | Standard Deviation 5.9 |
Secondary
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
* 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
Time frame: Baseline, Month 12
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Loneliness, as Measured by the Three-Item Loneliness Scale | 0 score on a scale |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Loneliness, as Measured by the Three-Item Loneliness Scale | 0 score on a scale |
Secondary
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
* 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
Time frame: Baseline, Month 6
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Loneliness, as Measured by the Three-Item Loneliness Scale | 0 score on a scale |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Loneliness, as Measured by the Three-Item Loneliness Scale | 0 score on a scale |
Secondary
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
* 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
Time frame: Baseline, Month 3
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Loneliness, as Measured by the Three-Item Loneliness Scale | 0 score on a scale |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Loneliness, as Measured by the Three-Item Loneliness Scale | 0 score on a scale |
Secondary
Change in Quality of Life for Patients, as Measured by the FACT-G
* 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.
Time frame: Baseline, Month 3
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Quality of Life for Patients, as Measured by the FACT-G | 3.4 score on a scale | Standard Deviation 14.2 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Quality of Life for Patients, as Measured by the FACT-G | 3.6 score on a scale | Standard Deviation 14.6 |
Secondary
Change in Quality of Life for Patients, as Measured by the FACT-G
* 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.
Time frame: Baseline, Month 12
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Quality of Life for Patients, as Measured by the FACT-G | 4 score on a scale | Standard Deviation 17.2 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Quality of Life for Patients, as Measured by the FACT-G | 3.7 score on a scale | Standard Deviation 15.5 |
Secondary
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
* 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
Time frame: Baseline, Month 3
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | -3.8 score on a scale | Standard Deviation 12.1 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | -3.3 score on a scale | Standard Deviation 12.2 |
Secondary
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
* 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
Time frame: Baseline, Month 12
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | -3.3 score on a scale | Standard Deviation 13 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | -1.9 score on a scale | Standard Deviation 13.4 |
Secondary
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
* 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
Time frame: Baseline, Month 6
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | -3 score on a scale | Standard Deviation 12.7 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) | -2.5 score on a scale | Standard Deviation 12.9 |
Secondary
Number of Emergency Department (ED) Revisits
Measured from enrollment to 12 months as a count of ED revisits, via self-report and EHR abstraction.
Time frame: Up to Month 12
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Number of Emergency Department (ED) Revisits | 2.5 Revisits | Standard Deviation 3.5 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Number of Emergency Department (ED) Revisits | 2.7 Revisits | Standard Deviation 3.8 |
Secondary
Number of Inpatient Days
Measured from enrollment to 12 months as the number of inpatient days, via self-report and EHR extraction.
Time frame: Up to Month 12
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Number of Inpatient Days | 8.1 Days | Standard Deviation 15.3 |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Number of Inpatient Days | 8.6 Days | Standard Deviation 18.6 |
Secondary
Proportion of Participants Who Used Hospice
Measured from enrollment to 12 months as the proportion of participants who used hospice, via self-report and EHR abstraction.
Time frame: Up to Month 12
Population: Caregivers were not assessed for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nurse-led Telephonic Case Management (Patients Only) | Proportion of Participants Who Used Hospice | 0.16 Proportion of participants |
| Facilitated, Outpatient Specialty Palliative Care (Patients Only) | Proportion of Participants Who Used Hospice | 0.18 Proportion of participants |