Advanced CancerEMPallANCT03325985
Emergency Medicine Palliative Care Access
A study testing Nurse-led telephonic case management and Facilitated,outpatient specialty palliative care in people with Advanced Cancer and End Stage Organ Failure, run by NYU Langone Health at 18 sites in United States.
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)… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Advanced Cancer, End Stage Organ Failure
- What is being tested?
- Nurse-led telephonic case management and Facilitated,outpatient specialty palliative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,606 participants
- Where
- 18 sitesUnited States
- Study dates
- 28 Mar 2018to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Brigham and Women's Hospital/Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
NYU Langone Hospital- Brooklyn
Brooklyn, New York, 11220
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Ohio State University (OSU)
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
University of Florida (UF)
Gainesville, Florida, 32611
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of California, Los Angeles Ronald Reagan Medical Center
Los Angeles, California, 90095
NYU Langone Health Hospital Long Island
Mineola, New York, 11501
Atlantic Health System, Morristown Medical Center
Morristown, New Jersey, 07960
Yale University
New Haven, Connecticut, 06510
Bellevue Hospital
New York, New York, 10016
New York University Langone Tisch Hospital
New York, New York, 10016
University of California Irvine Medical Center
Orange, California, 92868
Beaumont Health
Royal Oak, Michigan, 48073
University of California San Diego Medical Center
San Diego, California, 92103
William Beaumont Hospital, Troy
Troy, Michigan, 48085
About this study
Official title: 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.
- Conditions
- Advanced Cancer, End Stage Organ Failure
- Being tested
- Nurse-led telephonic case management, Facilitated,outpatient specialty palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led telephonic case managementBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Facilitated,outpatient specialty palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 6
Secondary outcomes (21)
Number of Emergency Department (ED) Revisits
Measured from enrollment to 12 months as a count of ED revisits, via self-report and EHR abstraction.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start28 Mar 2018
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,606 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Beaumont Health, Dana-Farber/Brigham and Women's Cancer Center, Ohio State University, University of Florida, Yale University, Patient-Centered Outcomes Research Institute, Hackensack Meridian Health, Atlantic Health System, University of California, Irvine, University of California, San Diego, University of California, Los Angeles, Northwestern University, Rush University, Henry Ford Health System
- Responsible party
- Sponsor
- Investigators
- Corita R. Grudzen, MD, MSHS, FACEP, Principal investigator, Memorial Sloan Kettering Cancer CenterKeith S. Goldfeld, DrPH, MS, MPA, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325985
- Sponsor's protocol ID
- 17-01211
- Other IDs
- R-1609-36306
- Acronym
- EMPallA
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2017
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 38263088Booker-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.
PubMed 38188534Yusufov 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.
PubMed 37672598Liddicoat 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.
PubMed 37190238Brickey 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.
PubMed 35168622Yamarik 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.
PubMed 35149656Schmucker 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.
PubMed 34247588de 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.
PubMed 34228019Tan 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.
PubMed 33485590Grudzen 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.
PubMed 31486726Grudzen 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.
PubMed 30813112Cooper RJ, de la Rosa O, Flannery M, Cuthel A, Liddicoat Yamarik R, Goldfeld KS, Grudzen CR; EMPallA Group. Caregiver outcomes in nurse-led telephonic versus specialty palliative care for the seriously ill. BMJ Support Palliat Care. 2026 Sep 16:spcare-2026-006291. doi: 10.1136/spcare-2026-006291. Online ahead of print.
PubMed 42749467Grudzen 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.
PubMed 41245582Maloney 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.
PubMed 40055670Barker 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.
PubMed 39179000
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Medicine Palliative Care Access (EMPallA)
- ClinicalTrials.gov ID
- NCT03325985
- Acronym / sponsor ID
- EMPallA / 17-01211
- Conditions
- Advanced Cancer, End Stage Organ Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,606 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Beaumont Health, Dana-Farber/Brigham and Women's Cancer Center, Ohio State University, University of Florida, Yale University, Patient-Centered Outcomes Research Institute, Hackensack Meridian Health, Atlantic Health System, University of California, Irvine, University of California, San Diego, University of California, Los Angeles, Northwestern University, Rush University, Henry Ford Health System
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led telephonic case management | Experimental | Behavioral: 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. |
| Facilitated, outpatient specialty palliative care | Active comparator | Behavioral: 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led telephonic case managementTelephonic 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. | Behavioural | Nurse-led telephonic case management |
| Facilitated,outpatient specialty palliative careIn-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. | Behavioural | Facilitated, outpatient specialty palliative care |
Primary outcome
Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G)
Time frame: Baseline, Month 6
* 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.
21 secondary outcomes
Number of Emergency Department (ED) Revisits
Time frame: Up to Month 12
Number of Inpatient Days
Time frame: Up to Month 12
Proportion of Participants Who Used Hospice
Time frame: Up to Month 12
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
Time frame: Baseline, Month 3
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
Time frame: Baseline, Month 6
Change in Loneliness, as Measured by the Three-Item Loneliness Scale
Time frame: Baseline, Month 12
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
Time frame: Baseline, Month 3
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
Time frame: Baseline, Month 6
Change in Symptom Burden, as Measured by Edmonton Symptom Assessment Scale Revised (ESAS-r)
Time frame: Baseline, Month 12
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time frame: Baseline, Month 3
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time frame: Baseline, Month 6
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time frame: Baseline, Month 12
Caregiver Bereavement, as Measured by the Texas Inventory of Grief
Time frame: 3 Months Post-Patient Death
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
Time frame: Baseline, Month 3
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
Time frame: Baseline, Month 6
Change in Caregiver Strain, as Measured by the Zarit Burden Interview (ZBI-12)
Time frame: Baseline, Month 12
Change in Quality of Life for Patients, as Measured by the FACT-G
Time frame: Baseline, Month 3
Change in Quality of Life for Patients, as Measured by the FACT-G
Time frame: Baseline, Month 12
Change in Caregiver Mental Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time frame: Baseline, Month 3
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time frame: Baseline, Month 6
Change in Caregiver Physical Health Quality of Life, as Measured by the Patient-Reported Outcome Measurement Information System (PROMIS-10)
Time frame: Baseline, Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38263088Zhao 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.
- Background: PubMed 38188534Booker-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.
- Background: PubMed 37672598Yusufov 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.
- Background: PubMed 37190238Liddicoat 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.
- Background: PubMed 35168622Brickey 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.
- Background: PubMed 35149656Yamarik 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.
- Background: PubMed 34247588Schmucker 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.
- Background: PubMed 34228019de 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.
- Background: PubMed 33485590Tan 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.
- Background: PubMed 31486726Grudzen 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.
- Background: PubMed 30813112Grudzen 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.
- Derived from this study: PubMed 42749467Cooper RJ, de la Rosa O, Flannery M, Cuthel A, Liddicoat Yamarik R, Goldfeld KS, Grudzen CR; EMPallA Group. Caregiver outcomes in nurse-led telephonic versus specialty palliative care for the seriously ill. BMJ Support Palliat Care. 2026 Sep 16:spcare-2026-006291. doi: 10.1136/spcare-2026-006291. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corita R. Grudzen, MD, MSHS, FACEP principal investigator
Memorial Sloan Kettering Cancer Center
Keith S. Goldfeld, DrPH, MS, MPA principal investigator
NYU Langone Health
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led telephonic case management and Facilitated,outpatient specialty palliative care in people with Advanced Cancer and End Stage Organ Failure, run by NYU Langone Health at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life for Patients, as Measured by the Functional Assessment of Cancer Therapy - General (FACT-G) (time frame: Baseline, Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325985, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.