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Emergency Medicine Palliative Care Access (EMPallA)

Primary Purpose

Advanced Cancer, End Stage Organ Failure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse-led telephonic case management
Facilitated,outpatient specialty palliative care
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of California, Los Angeles Ronald Reagan Medical Center
  • University of California Irvine Medical Center
  • University of California San Diego Medical Center
  • Yale New Haven Hospital
  • University of Florida Health
  • Northwestern Memorial Hospital
  • Rush University Medical Center
  • Brigham and Women's Hospital
  • Henry Ford Health System
  • William Beaumont Hospital, Royal Oak
  • William Beaumont Hospital, Troy
  • Hackensack University Medical Center
  • Atlantic Health System, Morristown Medical Center
  • NYU Langone Hospital- Brooklyn
  • NYU Langone Health Hospital Long Island
  • Bellevue Hospital
  • New York University Langone Tisch Hospital
  • Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse-led telephonic case management

Facilitated, outpatient specialty palliative care

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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.
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
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
Caregiver Bereavement, as measured by the Texas Inventory of Grief
Measured by 3 months post-patient death

Full Information

First Posted
October 26, 2017
Last Updated
March 2, 2023
Sponsor
NYU Langone Health
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03325985
Brief Title
Emergency Medicine Palliative Care Access
Acronym
EMPallA
Official Title
Emergency Medicine Palliative Care Access (EMPallA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2018 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, End Stage Organ Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Estimated Enrollment (1350 patients, 675 caregivers)
Allocation
Randomized
Enrollment
2025 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse-led telephonic case management
Arm Type
Experimental
Arm 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.
Arm Title
Facilitated, outpatient specialty palliative care
Arm Type
Active Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Nurse-led telephonic case management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated,outpatient specialty palliative care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality of life for patients, as measured by the FACT-G
Description
Measured by change from enrollment to 6 months
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Patient Level: Healthcare Utilization, as measured by self-report and EHR abstraction
Description
Measured by change from enrollment to 12 months (e.g., ED revisits, hospital admissions, hospice use)
Time Frame
12 Months
Title
Loneliness, as measured by the Three-Item Loneliness Scale
Description
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.
Time Frame
6 Months
Title
Symptom burden, as measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
Description
Used to measure severity of symptoms 10 questions 0-10 scale (0= none to 10 worst possible) Total score
Time Frame
6 Months
Title
Caregiver-Level: Quality of Life, as measured by the Patient-Reported Outcome Measurement Information System
Description
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
Time Frame
6 Months
Title
Caregiver Bereavement, as measured by the Texas Inventory of Grief
Description
Measured by 3 months post-patient death
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corita Grudzen, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospital, Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital, Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Atlantic Health System, Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
NYU Langone Hospital- Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
NYU Langone Health Hospital Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York University Langone Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35168622
Citation
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.
Results Reference
derived
PubMed Identifier
35149656
Citation
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.
Results Reference
derived
PubMed Identifier
34247588
Citation
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.
Results Reference
derived
PubMed Identifier
30813112
Citation
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.
Results Reference
derived

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Emergency Medicine Palliative Care Access

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