Emergency Medicine Palliative Care Access

NCT03325985 | Completed Results

• 2 other identifiers: 17-01211R-1609-36306
• Study Type: interventional
• Target: 1,606
• Locations: 1 country
• Sites: 18

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 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.

Conditions

Advanced Cancer; End Stage Organ Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Number of Emergency Department (ED) Revisits

  Up to Month 12

• Number of Inpatient Days

  Up to Month 12

• Proportion of Participants Who Used Hospice

  Up to Month 12

• Change in Loneliness, as Measured by the Three-Item Loneliness Scale

  Baseline, Month 3

• Change in Loneliness, as Measured by the Three-Item Loneliness Scale

  Baseline, Month 6

Study Arms (2)

Nurse-led telephonic case management

EXPERIMENTAL

* 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

Facilitated, outpatient specialty palliative care

ACTIVE COMPARATOR

* 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

Interventions

Nurse-led telephonic case management BEHAVIORAL

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.

Nurse-led telephonic case management

Facilitated,outpatient specialty palliative care BEHAVIORAL

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.

Facilitated, outpatient specialty palliative care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Beaumont Health: collaborator
• Dana-Farber/Brigham and Women's Cancer Center: collaborator
• Ohio State University: collaborator
• University of Florida: collaborator
• Yale University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Hackensack Meridian Health: collaborator
• Atlantic Health System: collaborator
• University of California, Irvine: collaborator
• University of California, San Diego: collaborator
• University of California, Los Angeles: collaborator
• Northwestern University: collaborator
• Rush University: collaborator
• Henry Ford Health System: collaborator

Study Sites (18)

University of California, Los Angeles Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

University of California San Diego Medical Center

San Diego, California, 92103, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

University of Florida (UF)

Gainesville, Florida, 32611, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Brigham and Women's Hospital/Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital, Troy

Troy, Michigan, 48085, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Atlantic Health System, Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

NYU Langone Hospital- Brooklyn

Brooklyn, New York, 11220, United States

Location

NYU Langone Health Hospital Long Island

Mineola, New York, 11501, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

New York University Langone Tisch Hospital

New York, New York, 10016, United States

Location

Ohio State University (OSU)

Columbus, Ohio, 43210, United States

Location

Related Publications (14)

• 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.

  PMID: 38263088 BACKGROUND

• 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.

  PMID: 38188534 BACKGROUND

• 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.

  PMID: 37672598 BACKGROUND

• 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.

  PMID: 37190238 BACKGROUND

• 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.

  PMID: 35168622 BACKGROUND

• 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.

  PMID: 35149656 BACKGROUND

• 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.

  PMID: 34247588 BACKGROUND

• 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.

  PMID: 34228019 BACKGROUND

• 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.

  PMID: 33485590 BACKGROUND

• 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.

  PMID: 31486726 BACKGROUND

• 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.

  PMID: 30813112 BACKGROUND

• Grudzen CR, Flannery M, Van Allen K, Cuthel A, Liddicoat Yamarik R, Tan A, Cohen SE, Comstock Barker P, Brody AA, Herchek C, Siman N, Goldfeld KS; EMPallA Group. Nurse led telephonic palliative care versus specialty outpatient palliative care: pragmatic, randomised clinical trial. BMJ Med. 2025 Nov 12;4(1):e001392. doi: 10.1136/bmjmed-2025-001392. eCollection 2025.

  PMID: 41245582 DERIVED

• Maloney B, Flannery M, Bischof JJ, Van Allen K, Adeyemi O, Goldfeld KS, Cuthel AM, Chang A, Grudzen CR. Factors impacting loneliness in patients with serious life-limiting illness in the Emergency Medicine Palliative Care Access (EMPallA) study. BMC Palliat Care. 2025 Mar 8;24(1):58. doi: 10.1186/s12904-025-01699-1.

  PMID: 40055670 DERIVED

• Barker PC, Yamarik RL, Adeyemi O, Cuthel AM, Flannery M, Siman N, Goldfeld KS, Grudzen CR; EMPallA Investigators. Predictors of Specialty Outpatient Palliative Care Utilization Among Persons With Serious Illness. J Pain Symptom Manage. 2024 Dec;68(6):583-593. doi: 10.1016/j.jpainsymman.2024.08.004. Epub 2024 Aug 22.

  PMID: 39179000 DERIVED

Results Point of Contact

• Title: Keith Goldfeld
• Organization: NYU Langone Health

Keith.Goldfeld@nyulangone.org

(212) 263-5550

Study Officials

• Corita R. Grudzen, MD, MSHS, FACEP

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Keith S. Goldfeld, DrPH, MS, MPA

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 30, 2017
• Study Start: March 28, 2018
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Upon reasonable request.

Locations

US (18)