Emergency Medicine Palliative Care Access (EMPallA)

Emergency Medicine Palliative Care Access (EMPallA)

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer; End Stage Organ Failure
• Intervention / Treatment: Behavioral: Nurse-led telephonic case management; Behavioral: Facilitated,outpatient specialty palliative care

• Study Type: Interventional
• Enrollment (Actual): 1679
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles Ronald Reagan Medical Center
    • Orange, California, United States, 92868
      • University of California Irvine Medical Center
    • San Diego, California, United States, 92103
      • University of California San Diego Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida Health
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital, Royal Oak
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital, Troy
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System, Morristown Medical Center
  • New York
    • Brooklyn, New York, United States, 11220
      • NYU Langone Hospital- Brooklyn
    • Mineola, New York, United States, 11501
      • NYU Langone Health Hospital Long Island
    • New York, New York, United States, 10016
      • Bellevue Hospital
    • New York, New York, United States, 10016
      • New York University Langone Tisch Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life for patients, as measured by the FACT-G	Measured by change from enrollment to 6 months	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Level: Healthcare Utilization, as measured by self-report and EHR abstraction	Measured by change from enrollment to 12 months (e.g., ED revisits, hospital admissions, hospice use)	12 Months
Loneliness, as measured by the Three-Item Loneliness Scale	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.	6 Months
Symptom burden, as measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)	Used to measure severity of symptoms; 10 questions; 0-10 scale (0= none to 10 worst possible); Total score	6 Months
Caregiver-Level: Quality of Life, as measured by the Patient-Reported Outcome Measurement Information System	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	6 Months
Caregiver Bereavement, as measured by the Texas Inventory of Grief	Measured by 3 months post-patient death	3 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Patient-Centered Outcomes Research Institute; Brigham and Women's Hospital; Ohio State University; William Beaumont Hospitals; University of Florida Health; Yale New Haven Health System Center for Healthcare Solutions
• Investigators: Principal Investigator: Corita Grudzen, MD, NYU Langone Health

Publications and helpful links

General Publications

• Brickey J, Flannery M, Cuthel A, Cho J, Grudzen CR; EMPallA Investigators. Barriers to recruitment into emergency department-initiated palliative care: a sub-study of a multi-site, randomized controlled trial. BMC Palliat Care. 2022 Feb 15;21(1):22. doi: 10.1186/s12904-021-00899-9.
• Yamarik RL, Tan A, Brody AA, Curtis J, Chiu L, Bouillon-Minois JB, Grudzen CR. Nurse-Led Telephonic Palliative Care: A Case-Based Series of a Novel Model of Palliative Care Delivery. J Hosp Palliat Nurs. 2022 Apr 1;24(2):E3-E9. doi: 10.1097/NJH.0000000000000850.
• Schmucker AM, Flannery M, Cho J, Goldfeld KS, Grudzen C; EMPallA Investigators. Data from emergency medicine palliative care access (EMPallA): a randomized controlled trial comparing the effectiveness of specialty outpatient versus telephonic palliative care of older adults with advanced illness presenting to the emergency department. BMC Emerg Med. 2021 Jul 12;21(1):83. doi: 10.1186/s12873-021-00478-4.
• Grudzen CR, Shim DJ, Schmucker AM, Cho J, Goldfeld KS; EMPallA Investigators. Emergency Medicine Palliative Care Access (EMPallA): protocol for a multicentre randomised controlled trial comparing the effectiveness of specialty outpatient versus nurse-led telephonic palliative care of older adults with advanced illness. BMJ Open. 2019 Jan 25;9(1):e025692. doi: 10.1136/bmjopen-2018-025692.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): January 20, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 17-01211; R-1609-36306 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No