Emergency Medicine Palliative Care Access

Advanced Cancer Clinical Trial

— EMPallA  

Official title:

Emergency Medicine Palliative Care Access (EMPallA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325985
• Other study ID #: 17-01211
• Secondary ID: R-1609-36306
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: August 24, 2023

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1350
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Emergencies
• End Stage Organ Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital/Dana-Farber Cancer Institute	Boston	Massachusetts
United States	NYU Langone Hospital- Brooklyn	Brooklyn	New York
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Ohio State University (OSU)	Columbus	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Florida (UF)	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	University of California, Los Angeles Ronald Reagan Medical Center	Los Angeles	California
United States	NYU Langone Health Hospital Long Island	Mineola	New York
United States	Atlantic Health System, Morristown Medical Center	Morristown	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Bellevue Hospital	New York	New York
United States	New York University Langone Tisch Hospital	New York	New York
United States	University of California Irvine Medical Center	Orange	California
United States	Beaumont Health	Royal Oak	Michigan
United States	University of California San Diego Medical Center	San Diego	California
United States	William Beaumont Hospital, Troy	Troy	Michigan

Sponsors (15)

Lead Sponsor

Collaborator

NYU Langone Health

Atlantic Health, Beaumont Health, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Hackensack Meridian Health, Henry Ford Health System, Northwestern University, Ohio State University (OSU), Patient-Centered Outcomes Research Institute, Rush University, University of California Irvine (UCI), University of California Los Angeles (UCLA), University of California San Diego (UCSD), University of Florida (UF), Yale University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Level: Healthcare Utilization, as measured by number of ED revisits	-Measured from enrollment to 12 months	Up to Month 12
Secondary	Patient Level: Healthcare Utilization, as measured by number of Inpatient Days	-Measured from enrollment to 12 months	Up to Month 12
Secondary	Patient Level: Healthcare Utilization, as measured by number of patients with Hospice use	-Measured from enrollment to 12 months	Up to Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Caregiver 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.; 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.; measured by change from enrollment to 3 months	Baseline, Month 3
Secondary	Change in Caregiver 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.; 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.; measured by change from enrollment to 6 months	Baseline, Month 6
Secondary	Change in Caregiver 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.; 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.; measured by change from enrollment to 12 months	Baseline, Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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