Clinical trial NCT03325985: Emergency Medicine Palliative Care Access
Official title: Emergency Medicine Palliative Care Access (EMPallA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
End Stage Organ Failure
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Beaumont Health
name: Dana-Farber/Brigham and Women's Cancer Center
name: Ohio State University
name: University of Florida
name: Yale University
name: Patient-Centered Outcomes Research Institute
name: Hackensack Meridian Health
name: Atlantic Health System
name: University of California, Irvine
name: University of California, San Diego
name: University of California, Los Angeles
name: Northwestern University
name: Rush University
name: Henry Ford Health System
First posted: 2017-10-30
Enrollment: 1606
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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 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.

Primary outcomes:
measure: Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Number of Emergency Department (ED) Revisits
timeFrame: Up to Month 12
measure: Number of Inpatient Days
timeFrame: Up to Month 12
measure: Proportion of Participants Who Used Hospice
timeFrame: Up to Month 12
measure: Change in Loneliness, as Measured by the Three-Item Loneliness Scale
timeFrame: Baseline, Month 3
measure: Change in Loneliness, as Measured by the Three-Item Loneliness Scale
timeFrame: Baseline, Month 6
measure: Change in Loneliness, as Measured by the Three-Item Loneliness Scale
timeFrame: Baseline, Month 12
measure: Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
timeFrame: Baseline, Month 3
measure: Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
timeFrame: Baseline, Month 6
measure: Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
timeFrame: Baseline, Month 12
measure: Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
timeFrame: Baseline, Month 3
measure: Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
timeFrame: Baseline, Month 6
measure: Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
timeFrame: Baseline, Month 12
measure: Caregiver Bereavement, as Measured by the Texas Inventory of Grief
timeFrame: 3 Months Post-Patient Death
measure: Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
timeFrame: Baseline, Month 3
measure: Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
timeFrame: Baseline, Month 6
measure: Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
timeFrame: Baseline, Month 12
measure: Change in Quality of Life for Patients, as Measured by the FACT-G
timeFrame: Baseline, Month 3
measure: Change in Quality of Life for Patients, as Measured by the FACT-G
timeFrame: Baseline, Month 12
measure: Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
timeFrame: Baseline, Month 3
measure: Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
timeFrame: Baseline, Month 6
measure: Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles Ronald Reagan Medical Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: San Diego
country: United States
facility: University of California San Diego Medical Center
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida (UF)
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital/Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital, Troy
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System, Morristown Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: NYU Langone Hospital- Brooklyn
state: New York
city: Mineola
country: United States
facility: NYU Langone Health Hospital Long Island
state: New York
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: New York
country: United States
facility: New York University Langone Tisch Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University (OSU)
state: Ohio
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Corita R. Grudzen, MD, MSHS, FACEP
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Keith S. Goldfeld, DrPH, MS, MPA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
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.