Emergency Medicine Palliative Care Access
- Conditions
- End Stage Organ FailureAdvanced Cancer
- Interventions
- Behavioral: Nurse-led telephonic case managementBehavioral: Facilitated,outpatient specialty palliative care
- Registration Number
- NCT03325985
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1350
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nurse-led telephonic case management Nurse-led telephonic case management * 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. Facilitated, outpatient specialty palliative care Facilitated,outpatient specialty palliative care * 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Patient Level: Healthcare Utilization, as measured by number of patients with Hospice use Up to Month 12 -Measured from enrollment to 12 months
Symptom burden, as measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) Baseline, Month 12 * 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 monthsCaregiver 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 griefChange in Caregiver strain, as measured by the Zarit Burden Interview (ZBI-12) Baseline, Month 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 burdenPatient Level: Healthcare Utilization, as measured by number of Inpatient Days Up to Month 12 -Measured from enrollment to 12 months
Change in Caregiver Quality of Life, as measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10) Baseline, Month 12 * 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.
* 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.
* measured by change from enrollment to 12 monthsLoneliness, as measured by the Three-Item Loneliness Scale Baseline, Month 12 * 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 monthsChange in quality of life for patients, as measured by the FACT-G Baseline, Month 12 * 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.Patient Level: Healthcare Utilization, as measured by number of ED revisits Up to Month 12 -Measured from enrollment to 12 months
Trial Locations
- Locations (18)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Ohio State University (OSU)
🇺🇸Columbus, Ohio, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Brigham and Women's Hospital/Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of California San Diego Medical Center
🇺🇸San Diego, California, United States
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 Florida (UF)
🇺🇸Gainesville, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Beaumont Health
🇺🇸Royal Oak, Michigan, United States
NYU Langone Health Hospital Long Island
🇺🇸Mineola, New York, United States
Atlantic Health System, Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
William Beaumont Hospital, Troy
🇺🇸Troy, Michigan, United States
NYU Langone Hospital- Brooklyn
🇺🇸Brooklyn, New York, United States
New York University Langone Tisch Hospital
🇺🇸New York, New York, United States
Bellevue Hospital
🇺🇸New York, New York, United States