Emergency Medicine Palliative Care Access (EMPallA)

NYU Langone Health

Status: Completed

Conditions: Advanced Cancer; End Stage Organ Failure

Treatments: Behavioral: Nurse-led telephonic case management; Behavioral: Facilitated,outpatient specialty palliative care

Study type: Interventional

Funder types: Other

Identifiers

NCT03325985

R-1609-36306 (Other Grant/Funding Number)

17-01211

Details and patient eligibility

About

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.

Enrollment: 1,606 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,606 participants in 2 patient groups

Nurse-led telephonic case management

Experimental group

Description:

* 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.

Treatment:

Behavioral: Nurse-led telephonic case management

Facilitated, outpatient specialty palliative care

Active Comparator group

Description:

* 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

Treatment:

Behavioral: Facilitated,outpatient specialty palliative care