N/A N=1,606 Randomized Single-blind Supportive Care

Emergency Medicine Palliative Care Access

Advanced Cancer · End Stage Organ Failure

Bottom Line

View on ClinicalTrials.gov: NCT03325985 ↗

Enrolled (actual)

1,606

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G) — 3.7; 3.1 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nurse-led telephonic case management (Behavioral); Facilitated,outpatient specialty palliative care (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)	3.7; 3.1	—
SECONDARY Number of Emergency Department (ED) Revisits	2.5; 2.7	—
SECONDARY Number of Inpatient Days	8.1; 8.6	—
SECONDARY Proportion of Participants Who Used Hospice	0.16; 0.18	—
SECONDARY Change in Loneliness, as Measured by the Three-Item Loneliness Scale	0; 0	—
SECONDARY Change in Loneliness, as Measured by the Three-Item Loneliness Scale	0; 0	—
SECONDARY Change in Loneliness, as Measured by the Three-Item Loneliness Scale	0; 0	—
SECONDARY Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)	-3.3; -1.9	—
SECONDARY Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)	-3.3; -1.9	—
SECONDARY Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)	-3.3; -1.9	—
SECONDARY Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	-0.5; 0.8	—
SECONDARY Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	-0.5; 0.8	—
SECONDARY Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	-0.5; 0.8	—
SECONDARY Caregiver Bereavement, as Measured by the Texas Inventory of Grief	31.2; 29.3	—
SECONDARY Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)	-0.9; 1	—
SECONDARY Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)	-0.9; 1	—
SECONDARY Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)	-0.9; 1	—
SECONDARY Change in Quality of Life for Patients, as Measured by the FACT-G	4; 3.7	—
SECONDARY Change in Quality of Life for Patients, as Measured by the FACT-G	4; 3.7	—
SECONDARY Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	0.2; 0.3	—
SECONDARY Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	-0.5; 0.8	—
SECONDARY Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	-0.5; 0.8	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03325985). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.