EMPallA: Emergency Medicine Palliative Care Access

Sponsor

NYU Langone Health (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03325985

Collaborator

William Beaumont Hospitals (Other), Brigham and Women's Hospital (Other), Ohio State University (Other), University of Florida Health (Other), Yale New Haven Health System Center for Healthcare Solutions (Other), Patient-Centered Outcomes Research Institute (Other)

2,025

Enrollment

Locations

Arms

65.1

Anticipated Duration (Months)

112.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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 end-stage organ failure (New York Heart Association (NYHA) Class III or IV Heart Failure, End Stage Renal Disease defined as GFR < 15 ml/min/m2; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% or the mMRC dyspnea scale) 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer End Stage Organ Failure	Behavioral: Nurse-led telephonic case management Behavioral: Facilitated,outpatient specialty palliative care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2025 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Estimated Enrollment (1350 patients, 675 caregivers)

Primary Purpose:

Supportive Care

Official Title:

Emergency Medicine Palliative Care Access (EMPallA)

Actual Study Start Date :

Mar 28, 2018

Anticipated Primary Completion Date :

Feb 16, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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	Behavioral: Facilitated,outpatient specialty palliative care In-person 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: 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.

Active Comparator: 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

Behavioral: Facilitated,outpatient specialty palliative care

In-person 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.

Outcome Measures

Primary Outcome Measures

Change in quality of life for patients, as measured by the FACT-G [6 Months]
Measured by change from enrollment to 6 months

Secondary Outcome Measures

Patient Level: Healthcare Utilization, as measured by self-report and EHR abstraction [12 Months]
Measured by change from enrollment to 12 months (e.g., ED revisits, hospital admissions, hospice use)
Loneliness, as measured by the Three-Item Loneliness Scale [6 Months]
Used to measure how often a person feels disconnected from others Three questions total 4-point rating scale (1 = never; 2 = rarely; 3 = sometimes; 4 = always). Reverse-code the positively worded items so that high values mean more loneliness, and then calculate a score for each respondent by averaging their ratings.
Symptom burden, as measured by Edmonton Symptom Assessment Scale Revised (ESAS-r) [6 Months]
Used to measure severity of symptoms 10 questions 0-10 scale (0= none to 10 worst possible) Total score
Caregiver-Level: Quality of Life, as measured by the Patient-Reported Outcome Measurement Information System [6 Months]
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 global mental health scale. Both scales had internal consistency scores of α=0.81 and α=0.86, respectively. Scored by reverse coding with a raw score totaling up to 20
Caregiver Bereavement, as measured by the Texas Inventory of Grief [3 Months]
Measured by 3 months post-patient death

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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 end-stage organ failure (New York Heart Association (NYHA) Class III or IV Heart Failure, End Stage Renal Disease defined as GFR < 15 ml/min/m2; or Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III or higher or oxygen-dependent chronic obstructive pulmonary disease (COPD) defined as FEV1 < 50% or the mMRC dyspnea scale)
Patients must have health insurance, reside within the geographical area, and have a working telephone.

Informal Caregivers:

English or Spanish-speaking caregivers ages 18 years and older who care for and accompany an enrolled patient. Informal caregivers must possess a working telephone.

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 and chronic care hospital.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles Ronald Reagan Medical Center	Los Angeles	California	United States	90095
2	University of California Irvine Medical Center	Orange	California	United States	92868
3	University of California San Diego Medical Center	San Diego	California	United States	92103
4	Yale New Haven Hospital	New Haven	Connecticut	United States	06510
5	University of Florida Health	Gainesville	Florida	United States	32611
6	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
7	Rush University Medical Center	Chicago	Illinois	United States	60612
8	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
9	Henry Ford Health System	Detroit	Michigan	United States	48202
10	William Beaumont Hospital, Royal Oak	Royal Oak	Michigan	United States	48073
11	William Beaumont Hospital, Troy	Troy	Michigan	United States	48085
12	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
13	Atlantic Health System, Morristown Medical Center	Morristown	New Jersey	United States	07960
14	NYU Langone Hospital- Brooklyn	Brooklyn	New York	United States	11220
15	NYU Langone Health Hospital Long Island	Mineola	New York	United States	11501
16	Bellevue Hospital	New York	New York	United States	10016
17	New York University Langone Tisch Hospital	New York	New York	United States	10016
18	Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

NYU Langone Health
William Beaumont Hospitals
Brigham and Women's Hospital
Ohio State University
University of Florida Health
Yale New Haven Health System Center for Healthcare Solutions
Patient-Centered Outcomes Research Institute

Investigators

Principal Investigator: Corita Grudzen, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03325985

Other Study ID Numbers:

17-01211
R-1609-36306

First Posted:

Oct 30, 2017

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Aug 17, 2022