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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
1,606
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.
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.
University of California, Los Angeles Ronald Reagan Medical Center
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
University of Florida (UF)
Gainesville, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Brigham and Women's Hospital/Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Beaumont Health
Royal Oak, Michigan, United States
...and 8 more locations
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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