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 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.

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): 1606
• 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 University
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida (UF)
  • 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/Dana-Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Health
    • 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 (OSU)

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 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.

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 or telehealth 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 Functional Assessment of Cancer Therapy - General (FACT-G)	Measured by change from enrollment to 6 months; Used to measure a person's quality of life; 27 questions total; 5-point Likert scale; Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Emergency Department (ED) Revisits	Measured from enrollment to 12 months as a count of ED revisits, via self-report and EHR abstraction.	Up to Month 12
Number of Inpatient Days	Measured from enrollment to 12 months as the number of inpatient days, via self-report and EHR extraction.	Up to Month 12
Proportion of Participants Who Used Hospice	Measured from enrollment to 12 months as the proportion of participants who used hospice, via self-report and EHR abstraction.	Up to Month 12
Change in Loneliness, as Measured by the Three-Item Loneliness Scale	Used to measure how often a person feels disconnected from others; Three questions total; 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often); Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.; measured by change from enrollment to 3 months	Baseline, Month 3
Change in Loneliness, as Measured by the Three-Item Loneliness Scale	Used to measure how often a person feels disconnected from others; Three questions total; 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often); Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.; measured by change from enrollment to 6 months	Baseline, Month 6
Change in Loneliness, as Measured by the Three-Item Loneliness Scale	Used to measure how often a person feels disconnected from others; Three questions total; 3-point rating scale (1 = Hardly ever, 2 = Some of the time, 3 = Often); Total score is the sum of responses and ranges from 3 to 9; higher scores indicate greater loneliness.; measured by change from enrollment to 12 months	Baseline, Month 12
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)	Used to measure severity of symptoms; 10 questions; Each item is rated on a 0-10 scale (0= none to 10 worst possible); Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.; measured by change from enrollment to 3 months	Baseline, Month 3
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)	Used to measure severity of symptoms; 10 questions; Each item is rated on a 0-10 scale (0= none to 10 worst possible); Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.; measured by change from enrollment to 6 months	Baseline, Month 6
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)	Used to measure severity of symptoms; 10 questions; Each item is rated on a 0-10 scale (0= none to 10 worst possible); Total score ranges from 0 to 100; higher scores indicate greater severity of symptoms.; measured by change from enrollment to 12 months	Baseline, Month 12
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	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 a global mental health scale.; Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.; measured by change from enrollment to 3 months	Baseline, Month 3
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	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 a global mental health scale.; Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.measured by change from enrollment to 6 months	Baseline, Month 6
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	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 a global mental health scale.; Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.measured by change from enrollment to 12 months	Baseline, Month 12
Caregiver Bereavement, as Measured by the Texas Inventory of Grief	Measured at 3 months post-patient death; Used to measure a caregiver's bereavement; 19 items; each rated on a 5-point scale from 0 (never) to 4 (always); Total score is the sum of responses and ranges from 0 to 76; higher scores indicate greater levels of grief	3 Months Post-Patient Death
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)	Measured as change from enrollment to Month 3; Used to measure a caregiver's strain; 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no); Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden	Baseline, Month 3
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)	Measured as change from enrollment to Month 6; Used to measure a caregiver's strain; 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no); Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden	Baseline, Month 6
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)	Measured as change from enrollment to Month 12; Used to measure a caregiver's strain; 12 items; each rated on a 3-point scale from 0 (yes, on a regular basis) to 3 (no); Total score is the sum of responses and ranges from 0 to 48; higher scores indicate greater burden	Baseline, Month 12
Change in Quality of Life for Patients, as Measured by the FACT-G	Measured by change from enrollment to 3 months; Used to measure a person's quality of life; 27 questions total; 5-point Likert scale; Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.	Baseline, Month 3
Change in Quality of Life for Patients, as Measured by the FACT-G	Measured by change from enrollment to 12 months; Used to measure a person's quality of life; 27 questions total; 5-point Likert scale; Reverse code select items per scoring guidelines at facit.org, then calculate a summary score for each respondent. The total score ranges from 0-108 points; higher scores indicate greater quality of life.	Baseline, Month 12
Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	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 a global mental health scale.; Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.; Measured by change from enrollment to 3 months	Baseline, Month 3
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	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 a global mental health scale.; Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.; Measured by change from enrollment to 6 months	Baseline, Month 6
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)	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 a global mental health scale.; Scored by reverse coding with a raw score ranging from 0-20; 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health. Scales are scored using the raw sum to T-score tables for physical health and mental health. T-scores range from 0-100; higher scores reflect better functioning.; Measured by change from enrollment to 6 months	Baseline, Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Patient-Centered Outcomes Research Institute; University of California, San Diego; University of California, Los Angeles; Northwestern University; Yale University; University of Florida; Ohio State University; University of California, Irvine; Henry Ford Health System; Hackensack Meridian Health; Rush University; Atlantic Health System; Dana-Farber/Brigham and Women's Cancer Center; Beaumont Health
• Investigators: Principal Investigator: Corita R. Grudzen, MD, MSHS, FACEP, Memorial Sloan Kettering Cancer Center; Principal Investigator: Keith S. Goldfeld, DrPH, MS, MPA, NYU Langone Health

Publications and helpful links

General Publications

• Zhao N, Cuthel AM, Storms O, Zhang R, Yamarik RL, Hill J, Kaur R, Van Allen K, Flannery M, Chang A, Chung F, Randhawa S, Alvarez IC, Young-Brinn A, Kizzie-Gillett CL, Rosini D, Isaacs ED, Hopkins E 3rd, Chan GK, Booker-Vaughns J, Maguire M, Navarro M, Pidatala NR, Dunn P, Williams P, Galvin R, Batra R, Welsh S, Vaughan W, Bouillon-Minois JB, Grudzen CR. Advancing patient-centered research practices in a pragmatic patient-level randomized clinical trial: A thematic analysis of stakeholder engagement in Emergency Medicine Palliative Care Access (EMPallA). Res Involv Engagem. 2024 Jan 23;10(1):10. doi: 10.1186/s40900-023-00539-x.
• Booker-Vaughns J, Rosini D, Batra R, Chan GK, Dunn P, Galvin R, Hopkins E 3rd, Isaacs E, Kizzie-Gillett CL, Maguire M, Navarro M, Reddy Pidatala N, Vaughan W, Welsh S, Williams P, Young-Brinn A, Van Allen K, Cuthel AM, Liddicoat Yamarik R, Flannery M, Goldfeld KS, Grudzen CR. What's in This For You? What's in This For Me?: A Win-Win Perspective of Involving Study Advisory Committee Members in Palliative Care Research. J Patient Exp. 2024 Jan 2;11:23743735231224562. doi: 10.1177/23743735231224562. eCollection 2024.
• Yusufov M, Adeyemi O, Flannery M, Bouillon-Minois JB, Van Allen K, Cuthel AM, Goldfeld KS, Ouchi K, Grudzen CR. Psychometric Properties of the Functional Assessment of Cancer Therapy-General for Evaluating Quality of Life in Patients With Life-Limiting Illness in the Emergency Department. J Palliat Med. 2024 Jan;27(1):63-74. doi: 10.1089/jpm.2022.0270. Epub 2023 Sep 6.
• Liddicoat Yamarik R, Chiu LA, Flannery M, Van Allen K, Adeyemi O, Cuthel AM, Brody AA, Goldfeld KS, Schrag D, Grudzen CR, On Behalf Of The EMPallA Investigators. Engagement, Advance Care Planning, and Hospice Use in a Telephonic Nurse-Led Palliative Care Program for Persons Living with Advanced Cancer. Cancers (Basel). 2023 Apr 15;15(8):2310. doi: 10.3390/cancers15082310.
• 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.
• de Forcrand C, Flannery M, Cho J, Reddy Pidatala N, Batra R, Booker-Vaughns J, Chan GK, Dunn P, Galvin R, Hopkins E, Isaacs ED, Kizzie-Gillett CL, Maguire M, Navarro M, Rosini D, Vaughan W, Welsh S, Williams P, Young-Brinn A, Grudzen CR. Pragmatic Considerations in Incorporating Stakeholder Engagement Into a Palliative Care Transitions Study. Med Care. 2021 Aug 1;59(Suppl 4):S370-S378. doi: 10.1097/MLR.0000000000001583.
• Tan AJ, Yamarik R, Brody AA, Chung FR, Grudzen C; EMPallA Telephonic Working Group. Development and protocol for a nurse-led telephonic palliative care program. Nurs Outlook. 2021 Jul-Aug;69(4):626-631. doi: 10.1016/j.outlook.2020.12.011. Epub 2021 Jan 21.
• Grudzen CR, Schmucker AM, Shim DJ, Ibikunle A, Cho J, Chung FR, Cohen SE; EMPallA Outpatient Investigators. Development of an Outpatient Palliative Care Protocol to Monitor Fidelity in the Emergency Medicine Palliative Care Access Trial. J Palliat Med. 2019 Sep;22(S1):66-71. doi: 10.1089/jpm.2019.0115.
• 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): August 24, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

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)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Keith.Goldfeld@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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