Emergency Medicine Palliative Care Access (EMPallA)
Phase: NA
Conditions: Advanced Cancer, End Stage Organ Failure
Sponsor: NYU Langone Health

Official Title:
Emergency Medicine Palliative Care Access (EMPallA)  
NCT Number: 
NCT03325985 
Study Number:
17-01211
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
November 30, 2023

 
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Protocol Name 
Emergency Medicine Palliative Care Access (EMPallA)
Principal Investigator:
Keith Goldfeld, DrPH Department of Population Health
NYU Grossman School of Medicine 
180 Madison Avenue 
New York, NY 10016 
Keith.Goldfeld@nyulangone.org 
(646) 501-3650
Primary Contact 
Name/Info: 
Kaitlyn Van Allen, MPH
Project Manager 
(212) 263-8631 
Kaitlyn.Vanallen@nyulangone.org
NYULMC Study Number: 
s17-01211
Funding Sponsor:
Patient-Centered Outcomes Research Institute (PCORI)
1828 L Street, NW, Suite 900 
Washington, DC 20036 
Phone: (202) 827-7700 
Initial Version Date: 08-24-2017 
Version 2: 01-02-2018 
Version 3: 02-13-2018 
Version 4: 04-30-2018 
Version 5: 05-30-2018 
Version 6: 12-18-2018 
Version 7: 04-02-2019 
Version 8: 07-26-2019 
Version 9: 11-15-2019 
Version 10: 03-13-2020 
Version 11: 11-05-2020 
Version 12: 1-25-2021 
Version 13: 4-6-2021 
Version 14: 7-30-2021 
Version 15: 8-26-2022 
Version 16: 10-25-2023 
 
1. Objectives 
We will perform a pragmatic, two-arm, multi-site randomized controlled trial of 1,350 older adults 
(50 years and older) with either 1) advanced cancer (defined as metastatic solid tumor) or 2) 
end-stage organ failure defined as New York Heart Association (NYHA) Class III or IV Heart 
Failure; End Stage Renal Disease defined as GFR < 15 ml/min/m2 or on dialysis; or chronic 
obstructive pulmonary disease (COPD) defined as oxygen-dependent or FEV1 < 50%  
who present to the Emergency Department (ED), along with 675 of their primary caregivers, to 
compare nurse-led telephonic case management to facilitated, outpatient specialty palliative 
care. We will compare the effectiveness of two distinct palliative care models that vary by 
provider type (nurse versus physician-led) and mode of delivery (telephonic versus in-person or 
telehealth): a) nurse-led telephonic case management; and b) facilitated, outpatient specialty 
palliative care. Both models of care provide supportive care services to the older adult within 
their current home environment. Both approaches are standard of care and the main difference 

 
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is the delivery of care by provider type. The telephonic nurse intervention arm provides palliative 
care services to older adults over the phone and is delivered by licensed nurses. The outpatient 
arm provides palliative care services to older adults and the patients have the option to receive 
care by attending in-person clinic visits or telehealth visits. The outpatient arm is delivered by 
physicians. The primary objective to be addressed is to compare both interventions on quality of 
life in patients with serious, life-limiting illness. Secondary objectives for this proposal include 
evaluating the effectiveness of both interventions on healthcare use in the 12 months following 
enrollment, loneliness, and symptom burden in patients. Furthermore, we will compare the 
impact of the interventions on several caregiver outcomes, including caregiver strain, caregiver 
quality of life, and bereavement. Randomization will be at the patient level and will be stratified 
by site and disease (cancer versus end-stage organ failure). 
Overall, we seek to discover when caring for older adults with serious, life-limiting illness 
discharged home after an ED visit, how effectively does nurse-led telephonic case management 
enhance quality of life in patients and primary caregivers and reduce healthcare utilization, 
loneliness, symptom burden, caregiver strain, and bereavement when compared with facilitated, 
outpatient specialty palliative care? We hypothesize that patients randomized to nurse-led 
telephonic case management will have greater improvements in quality of life and lower 
healthcare utilization, loneliness, and symptom burden than those referred to outpatient 
specialty palliative care. We also hypothesize that caregivers will experience greater quality of 
life and less psychosocial and physical strain and bereavement in the nurse-led telephonic 
group. 
2. Background
Most persons with a serious, life-limiting illness do not receive the care they prefer at the end of 
life.1-3 The vast majority of Medicare beneficiaries (86%) prefer to spend as much time as 
possible at home, and to optimize control of pain and other burdensome symptoms.1 While 
some are able to achieve these goals, many individuals, especially those who belong to 
vulnerable populations—including racial and ethnic minorities—spend their final days in and out 
of the ED and the hospital. This group often receives intensive, life-sustaining therapies (e.g., 
cardiopulmonary resuscitation) that are unlikely to prolong life or enhance quality of life, and 
many die in the hospital or intensive care unit (ICU).4 While this may sometimes reflect an 
informed patient choice, more often it does not.5,6 Over three-quarters of patients with serious 
illness would not choose a treatment if it resulted in severe functional or cognitive impairment.7
Patients’ main concerns at the end of life include maintaining control, relieving burdens, and 
strengthening family relationships.8 
According to the World Health Organization, palliative care is “an approach that improves the 
quality of life of patients and their families facing the problems associated with life-threatening 
illness, through the prevention and relief of suffering by means of early identification and 
impeccable assessment and treatment of pain and other problems, physical, psychosocial and 
spiritual”. Multiple studies have shown that palliative care services improve patients’ symptoms 
and the quality of end-of-life care across a broad range of illnesses. Patients receiving palliative 
care services are often able to remain cared for and supported at home, leading to greater 

 
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patient and family satisfaction, and less prolonged grief and posttraumatic stress disorder 
among bereaved family members.9-14 Palliative care also lowers costs by reducing unnecessary 
hospitalizations, diagnostic and treatment interventions, and avoidable intensive and ED care.15-
19 The ENABLE II trial demonstrated higher scores for quality of life and mood in patients with 
life-limiting cancer and a prognosis of one year who received a psycho-educational palliative 
intervention in addition to standard care.16 Another randomized trial demonstrated that 
comprehensive outpatient palliative care improves symptom management and patient 
satisfaction.20 Patients with late-stage COPD and heart failure who were randomly assigned to 
in-home palliative care, as compared with usual care, reported greater satisfaction with care and 
were more likely to die at home.21 Given these benefits, there is a need to change the paradigm 
for management of patients with serious, life-limiting illness and extend it beyond specialty 
palliative care in patients with advanced cancer to enable more individual patients and 
populations to benefit. 
3. Setting of the Human Research
This study will be conducted in the Emergency Departments and observation units at the 
following sites: 
- 
NYU Langone Tisch Hospital, New York, NY 
- 
Bellevue Hospital Center, New York, NY 
- 
NYU Langone Hospital – Brooklyn, Brooklyn, NY 
- 
NYU Langone Hospital-Long Island – Mineola, NY  
- 
Beaumont Hospital – Royal Oak, Royal Oak, MI 
- 
Beaumont Hospital – Troy, Troy, MI 
- 
Brigham and Women’s Hospital, Boston, MA 
- 
The Ohio State University Wexner Medical Center, Columbus, OH 
- 
University of Florida Shands Hospital, Gainesville, FL 
- 
Yale New Haven Hospital, New Haven, CT 
- 
University of California Los Angeles, Los Angeles, CA 
- 
University of California San Diego, San Diego, CA 
- 
University of California Irvine, Irvine, CA 
- 
Weill Cornell Medicine, New York, NY 
- 
Hackensack University Health, Hackensack, NJ 
- 
Atlantic Health, Morristown, NJ 
- 
Northwestern University, Chicago, IL 
- 
Rush University, Chicago, IL 
- 
Henry Ford Health System, Detroit, MI 
In a leadership transition, this research will be overseen by a multiple PI format. Dr. Corita 
Grudzen, will serve as Multiple PI (mPI) from Memorial Sloan Kettering Cancer Center 
(MSKCC) via subcontract, and Dr. Keith Goldfeld will serve as Contact PI and mPI from NYU 
Langone Health. In this, MSKCC will be added as a project site solely for data analysis, and will 
not be actively recruiting additional subjects. 

 
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4. Subject Identification, Recruitment, and Consent
 
a) Methods and Procedures 
This is a pragmatic, two-arm, multi-site randomized controlled trial with patient-level 
randomization and stratification by site and disease (cancer versus end-stage organ failure) to 
compare nurse-led telephonic case management to facilitated, outpatient specialty palliative 
care for older adults with serious, life-limiting illness and their primary caregivers. Prior to the 
start of patient enrollment, the PI at each site will notify all treating physicians at their clinical site 
via email of the study parameters in order to allow physicians to opt out of routine participation 
by their patients. If the site PI does not hear from the primary care physician and/or oncologist 
that s/he wishes to opt out of routine participation, the site PI will assume they are willing to 
have their patients enroll should they meet the inclusion criteria. 
Patients 
Patients will be screened in the ED or observation unit at each site. For sites with no 
observation unit, patients who are admitted as inpatient for two midnights or less will also still be 
eligible to participate. Patients will also be screened from a generated report capturing all 
patients over age 50, visiting the ED, admitted or discharged, within 24 hours. Patient MRN will 
be collected from the 24-hour report and ED Trackboard and stored in REDCap if patients meet 
all initial qualifying criteria. The MRN will be expunged from REDCap once a patient either 
declines participation or reaches the disqualification state from the study after 48 hours. Patient 
MRN will not be recorded for subjects who opt out of research participation listed in their EHR. 
Research coordinators will be responsible for collecting, logging, and expunging MRN from 
REDCap. The data analyst will run a quarterly report to ensure data expungement. Qualifying 
conditions include 1) advanced cancer (defined as metastatic solid tumor) or 2) end-stage organ 
failure defined as New York Heart Association (NYHA) Class III or IV Heart Failure; End Stage 
Renal Disease defined as GFR < 15 ml/min/m2 or on dialysis; or chronic obstructive pulmonary 
disease (COPD) defined as oxygen-dependent or FEV1 < 50%. Only patients discharged or 
likely to be discharged per provider from the ED home will be approached. 
 
The RA will then approach the patient and ask face-to-face questions or call the patient over the 
phone to ensure that the patient meets all eligibility criteria that could not be obtained in the 
electronic health record. The recruitment process can thus be either in-person or telephonically 
depending on if the patient has been already discharged from the ED or not. Only patients who 
are discharged or likely to be discharged home are eligible to participate.  
Once eligibility is confirmed, the RA will discuss with the patient what active participation in this 
study means (review verbal consent, randomization to an intervention, potential benefits, risks 
of participation), the purpose and limitations of the study (what will and will not be tested, 
confidentiality, what will be done with the results), and requirements of the study (duration of 
participant involvement, follow-up data collection 3 months, 6 months, and 12 months post-
enrollment). If the patient agrees to participate, the patient’s primary care physician and/or 
oncologist will also be notified that the patient is being enrolled in a study of palliative care and 
that they should expect a follow-up phone call from a palliative care provider or nurse. For 
patients and caregivers that will be consented in person, verbal consent will be obtained, but 

 
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subjects will be asked to sign the standalone HIPAA authorization form. The verbal consent 
process is an accommodation due to the COVID-19 environment making it difficult for this 
specific study population to process paperwork including signing and mailing back documents. 
Since the intervention is occurring in the environment available to each study subject and all 
subjects will receive a standard of care palliative care intervention, verbal consent is ethical. 
 
For patients and caregivers that will be consented over the phone, the study team has 
requested a waiver of signed HIPAA authorization and all information will be presented verbally.  
The RA will review the consent form with the participant, either in-person or over the phone, and 
obtain verbal consent using the provided key information sheet, HIPAA authorization form and 
consent document; the subject will verbalize comprehension of the consent form and study 
enrollment. For subjects that choose to participate, a copy of the informed consent form, HIPAA 
form, and the key study information sheet will be mailed to the subject. 
 
After informed verbal consent is obtained, a baseline survey to assess demographics and 
patients’ quality of life, loneliness, and symptom burden will be conducted at bedside. Patients 
may also opt to complete the baseline surveys over the phone, email, or postal mail after 
informed verbal consent is obtained if they do not wish to complete it in the ED. Patients will be 
randomized to either telephonic nurse-led case management or facilitated, outpatient specialty 
palliative care after the baseline survey is administered. The baseline surveys will not interfere 
with emergency care and the interviews will be paused or stopped if the patient requires a 
diagnostic test or other medical intervention, or needs to speak with a nurse, physician, or other 
provider. The interview will continue when it will not interfere with any medical care. Patients will 
receive a $40 gift card upon completion of the baseline survey and a $20 gift card for every 
follow-up survey completed via phone, email, or postal mail after 12 weeks, 6 months, and 12 
months following enrollment. Multiple phone numbers (e.g., mobile, home, and work) along with 
email addresses and emergency contacts will be collected in order to secure various ways to 
keep in contact with the patient. Follow-up surveys can also be completed by the patient's 
caregiver or emergency contact collected at the time of consent, at patient’s discretion. 
Reimbursement for up to $25 per visit to offset the costs of copay or travel, for either in-person 
and telehealth visits, will also be given in the form of a gift card to those randomized into the 
facilitated, outpatient palliative care clinic arm of the study. Patients randomized to the 
facilitated, outpatient palliative care arm are expected to attend monthly visits for up to 6 
months.  
 
Primary caregivers 
RAs will approach primary caregivers of all eligible enrolled patients. RAs will engage in the 
same conversation as patients with primary caregivers regarding the scope of the study, their 
role in the study, and their rights as a participating subject in human subjects research. If the 
caregiver is present with the patient at bedside, the RA will obtain verbal informed consent and 
signed HIPAA authorization, and a copy of the informed consent will be provided to the 
caregiver. If the caregiver is not present at bedside, the RA will call the caregiver to obtain 
verbal consent and all information will be presented verbally using the key information sheet, 
HIPAA form, and informed consent document. A patient does not need to have a primary 

 
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caregiver in order to participate in the study and all primary caregivers have the opportunity to 
decline participation if they do not want to participate. 
Following study enrollment, a baseline survey will be administered. If they are enrolled in-
person, caregivers will also have the option to complete the baseline surveys over the phone, 
email or postal mail after informed consent is obtained, if they do not wish to complete it in the 
ED. Baseline surveys will collect information pertaining to caregiver strain, caregiver quality of 
life, and demographics. Caregivers will receive a $40 gift card after completing the baseline 
survey and will receive a $20 gift card for each completed subsequent survey at 3 months, 6 
months, and 12 months after enrollment.  
b) Inclusion and Exclusion Criteria 
Patients 
English or Spanish-speaking older adults ages 50 years and older who have one or more
qualifying serious, life-limiting conditions and who are scheduled for ED discharge, observation 
status, or inpatient stay for two midnights or less will be eligible to participate. The patient 
sample will only include older adults 50 years and over, as the comorbidity scoring tools that 
predict short- and long-term mortality were derived and validated in this population.22-26 Older 
adults’ disease progression and physical functioning differ from those of children and younger 
adults with serious, life-limiting illness, making comparisons regarding patient-oriented 
outcomes across the life span problematic. Qualifying conditions include: 1) advanced cancer 
(defined as metastatic solid tumor) or 2) end-stage organ failure defined as New York Heart 
Association (NYHA) Class III or IV Heart Failure; End Stage Renal Disease defined as GFR < 
15 ml/min/m2 or on dialysis; or chronic obstructive pulmonary disease (COPD) defined as 
oxygen-dependent or FEV1 < 50%. Patients must have health insurance, reside within the 
geographical area, and have a working telephone. We will exclude those who have dementia 
listed in the EHR problem list, received hospice services in the last six months, have received 2 
or more palliative care consults or visits in the last 6 months, and those who reside in or are 
being discharged to a skilled nursing or assisted living facility or chronic care hospital. No 
specific genders and racial and ethnic origins will be excluded from this study. Children, 
pregnant women, prisoners, and other vulnerable populations will not be recruited. 
Primary Caregivers 
English or Spanish-speaking primary caregivers (relative OR friend who has contact with the 
patient at least two times per week (not home health aide)) ages 18 years and older will be 
eligible to participate. Primary caregivers can provide verbal informed consent either in-person 
or telephonically. Caregivers must possess a working telephone. The caregiver sample will 
exclude individuals less than 18 years old because the unique stresses a child caregiver 
experiences are outside of the scope of this study. No specific genders and racial and ethnic 
origins will be excluded. Children, pregnant women, prisoners, and other vulnerable populations 
will not be recruited. 
c) Number of Subjects 

 
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We will recruit a total of 1,350 patients with serious, life-limiting illness and 675 of their primary 
caregivers in eighteen EDs across the country. Sample size for patients was based on 
simulation methods to estimate power based on the primary outcome, a change in quality of life 
for patients, as measured by FACT-G from enrollment to 6 months. The change in quality of life 
between enrollment and 6 months is our primary outcome, though additional data points at 3 
months will be collected as we found in our prior palliative care clinical trial that patients often 
died prior to 6 month follow-up. Power analyses were also performed to estimate the number of 
caregivers needed to detect a difference in caregiver strain measured by the Modified Caregiver 
Strain Index between the two groups. 
d) Study Timelines 
The total duration of patient and caregiver participation in this study will be 12 months. Baseline 
surveys will be performed at enrollment, and follow-up surveys will occur at 3 months, 6 months, 
and 12 months post enrollment. Follow up surveys will include measuring outcomes of quality of 
life, loneliness, and symptom burden in patients, and caregiver strain, caregiver quality of life, 
and bereavement (if patient death occurs) in caregivers. 
e) Endpoints 
The primary outcome is to compare both interventions on quality of life in patients. The 
secondary outcomes are to compare the effectiveness of both interventions on healthcare 
utilization, loneliness, and symptom burden in patients, and caregiver strain, caregiver quality of 
life, and bereavement in caregivers. These outcomes were selected from input by our clinical 
and research collaborators, PCORI program staff, and our Study Advisory Committee, including 
patient representatives, clinicians, researchers, and stakeholder representatives from a large 
Medicare Advantage Plan, the American Cancer Society, the American Society of Nephrology, 
and the American Heart Association. 
f) Specimen Banking 
N/A 
g) Data Management and Confidentiality 
We will use a centrally managed REDCap database to collect and house study data for patients 
and caregivers at all sites.  Study data will be entered directly into REDCap in real-time via 
iPads or laptop computers which are password-protected, secured and managed by the study 
site. Paper surveys will be used if unavoidable (Spanish-speaking patient surveys, Wi-Fi 
connectivity issues in ED) and will be transposed into REDCap at study sites at earliest 
convenience and stored in a locked cabinet. The Senior Research Coordinator will conduct all 
data management and data quality assurance activities required by the survey data, as well as 
de-identify the data for analyses.   
 
Patient and caregiver name, mailing address, date of birth, telephone number, MRN, and email 
address will be entered into REDCap and assigned a non-identifiable study ID number. No other 
PHI will be collected in the survey nor assigned to this study ID. Contact information and MRN 

 
Page 8 
will only be used for the purpose of facilitating clinical care or locating participants to complete 
surveys or receive study compensation.
Data collection, secure data transfer, and storage have been designed to minimize the risk of a 
patient or caregiver participant’s breach of confidentiality. All patients and caregivers will be 
assigned a unique study ID number and only one master list correlating to subject identifiers will 
be maintained at each site. RAs at each site will retain access to the list for intervention 
assignment, follow-up interviews, and chart abstractions. All lists linking participant IDs to 
subject identifiers will be stored in double-locked locations (e.g., locked filing cabinet in a locked 
office, or encrypted electronic file on a secure server). The ID numbers will be used for data 
collection, data tracking, and data entry, so the secure aggregated database will not contain any 
patient identifiers. Data use agreements will be established between the host institution (NYU 
School of Medicine) and the other sites to ensure that only the minimally necessary data is 
shared with the primary institution and nurse case managers. Secure data transfer from each 
site to NYUSoM research team will occur using encrypted electronic files via a secure 
connection, as delineated in the data use agreements. 
To minimize research-associated risk and protect the confidentiality of participant data, all 
investigators and staff involved in this project will complete extensive courses and pass 
certifying exams on the protection of human subjects in research through CITI training and 
HIPAA certification. 
As a result of a contract modification with PCORI, data will be stored long term with University of 
Michigan’s Patient-Centered Outcomes Data Repository (PCODR) via the Inter-university 
Consortium for Political and Social Research (ICPSR) platform. Data repositories are best 
practices for advancing research and the sole purpose of this storage will be as such.  
All data is currently housed at NYU, and NYU will be responsible for submitting the secure 
transfer, as approved by NYU legal entities via an appropriate data use agreement. This dataset 
will include de-identified full dataset, study protocol, metadata, data dictionary, full statistical 
analysis plan and analytic code. This data package will be de-identified in accordance with the 
HIPAA Privacy Rule or comparable applicable regulations prior to the transfer to ensure 
participant privacy and safety. PI, Dr. Goldfeld will be overseeing the transfer process. There is 
a vetting process in place that other researchers who want to use this dataset will need to abide 
by. Dr. Goldfeld will be consulted when requests to use the de-identified dataset come in and 
will be closely involved in the approval process.  
This dataset will not include participants’ name, any personal information (telephone number, 
address, e-mail address), health related information (including disease and insurance status), or 
individual responses to any surveys completed. 
Subjects will be notified of the data transfer via mail, and will be provided the opportunity to opt 
out. If subjects contact our team and do not want their de-identified data transferred, the data 
analyst will remove them from the dataset for transferring purposes.  
h) Provisions to Monitor the Data to Ensure the Safety of Subjects 

 
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The mPIs, in cooperation with Co-Is, and the NYUSoM IRB will monitor the safety of the 
proposed project. A Data Safety Monitoring Plan (DSMP) will be created for this study. The data 
analyst will be responsible for the oversight of all data and producing an interim analysis report 
midway through participant enrollment. The project manager will inform the mPIs immediately of 
any harmful, unexpected serious adverse events (SAEs) related to the research—these will also 
be reported to the IRB within 24 hours in a full written report. Other SAEs will be reported 
annually in the IRB application for continuation or termination of the research. All expected 
SAEs, non-serious adverse events that occur at a greater frequency or severity than 
anticipated, and all unexpected non-serious adverse events will be reported to the NYU PI 
within 15 working days and summarized annually in the IRB application for continuation or 
termination of the research. The mPIs and Co-Is will be versed in these reporting procedures, 
as they are currently required for all research conducted at each respective site.   
i) 
Data Analysis 
The analytic plan accounts for the nested structure of the data, assesses normality assumptions 
of dependent variables, and addresses issues related to missing data, study participation bias, 
and baseline covariate balance. We address each of these in turn. All analyses will be 
conducted by the biostatistician in R 4.3.1 (R Foundation for Statistical Computing, Vienna). 
Prior to conducting the outcome analyses, we will compare patients in each intervention arm 
(nurse-led telephonic care and specialty, outpatient palliative care clinic) with respect to 
baseline socio-demographic characteristics (age, gender, race, education, etc.) and functional 
status. We will assess whether any adjustments will need to be made in the final statistical 
models based on whether the differences are clinically meaningful. 
To account for nesting in the data structure (patients nested in hospitals), we will use mixed 
effect multi-level models to estimate effect sizes. We anticipate two sources of variation. First, 
there will be regional (site) variation in the outcomes independent of the intervention. This 
means that even though the telephonic arm is centrally delivered, there may still be clustering at 
the site level. Second, there will be variation in how specialty, palliative care outpatient clinics 
deliver the clinic intervention arm, which will add an additional source of variation for this arm 
alone. As a result, we expect variation in the effect of the telephonic intervention across sites 
due to these sources of variation. 
Various models will be created to estimate these effects. For the primary analysis, a linear 
mixed effect model will be made, as quality of life for patients will be a continuous variable. For 
secondary analysis, linear mixed effect models will be created for loneliness, symptoms burden, 
caregiver strain, caregiver quality of life, and bereavement, as these outcomes are continuous 
as well. Test Poisson and negative binomial mixed effects models will be generated for analysis 
of healthcare utilization since this outcome will be a count variable. All analysis will be tested 
-level of 0.05. 
In all models, we will conduct an Intent-to-Treat (ITT) analyses. We also plan to perform 
sensitivity analyses with group assignments per protocol (in addition to a traditional intention to 
treat) to test whether receipt of nurse-led telephonic care or a visit to the palliative care 

 
Page 10 
outpatient clinic impacts our outcomes. We will interpret the results and evaluate the 
performance of different statistical data analysis plans from both statistical and clinical 
perspectives. These more advanced statistical methods are able to rigorously capture the 
complex data structure, efficiently borrow information across different patient subgroups, 
significantly boost power in the statistical inference, and fully explore the rich information in the 
collected patient cohort. 
j) 
Withdrawal of Subjects 
 
Patient and caregiver participants may withdraw from participation in the study at any time upon 
verbal or written request. An investigator may terminate participation if s/he decides it would be 
in the best interest of the participant to no longer proceed in the study. 
 
5. Risks to Subjects 
Risks 
The study involves obtaining demographic and other survey data from patients and caregivers 
to determine the effectiveness of the interventions on quality of life, loneliness, healthcare 
utilization, and symptom burden in patients, and caregiver strain, caregiver quality of life, and 
bereavement in caregivers. The survey instruments pose no physical, financial, or legal risk to 
patients or caregivers. Answering some of the questions may be psychologically difficult for 
patients and families because they involve discussing the potential for worsening health and the 
possible death of the patient. Past studies of patients near the end of life demonstrate that 
enrolling patients in research studies similar to this project do not harm patients or caregivers, 
and many studies report that patients are actually helped by participating in these types of 
projects. The risks of discussing death, dying, and bereavement with terminally ill patients is 
minimally stressful and often helpful. The study team has substantial expertise in assessing 
patients who become upset during the survey, and an established protocol will be used should 
this situation occur. All RAs will be trained on recruitment and interview/communication 
techniques to be used in the ED and during telephone follow-up. Should a patient experience 
emotional distress as a result of study participation, the RA will immediately inform the physician 
(when in the ED) or study mPI (when conducting telephone surveys). We have carefully 
considered the respondent burden in designing our project and all surveys will last less than 20 
minutes. Our surveys are similar in number and content to that used in previous studies of 
patients with advanced illness. 
Protection Against Risks 
This proposed study contains minimal risk for the patients and caregivers involved. A breach of 
confidentiality and the psychological discomfort in discussing serious illness constitute the 
primary risks to the enrolled patients and caregivers. Patients and caregivers will be informed 
that information collected during interviews will be kept confidential and only be available to the 
research team. Additionally, participants will be advised that they can refuse to answer any 
question or stop the interview at any point. All RAs will be trained on recruitment and interview 

 
Page 11 
techniques to be used in the ED and during telephone follow-up. Should a patient experience 
emotional distress as a result of study participation, the RA will immediately inform the physician 
(when in the ED) or study mPI (when conducting telephone interviews). The interview will 
conclude if the patient or caregiver appears emotionally distressed. If, at any time, a participant 
expresses verbal or nonverbal reluctance to participate, the interview will be terminated and the 
participant will be withdrawn from the study. Of note, these extreme emotional reactions are 
very rare and the literature supports that conversations with patients tend to be helpful and not 
harmful. Throughout the course of the study, the mPI will monitor the safety of all study 
participants. A DSMP will also be established for this study for the protection of subjects. A 
DSMP will replace a Data Safety Monitoring Board (DSMB), as this study is minimal risk. Death 
is already expected in patients with advanced disease, and there are also no known potential 
Serious Adverse Events. 
Data collection, secure data transfer, and storage have been designed to minimize the risk of a 
patient or caregiver participant’s breach of confidentiality. All patients and caregivers will be 
assigned a unique study ID number and only one master list correlating to subject identifiers will 
be maintained at each site. RAs at each site will retain access to the list for follow-up interviews 
and chart abstractions. All lists linking participant IDs to subject identifiers will be stored in 
double-locked locations (e.g., locked filing cabinet in a locked office, or encrypted electronic file 
on a secure server). The ID numbers will be used for data collection, data tracking, and data 
entry, so the secure aggregated database will not contain any patient identifiers. Data use 
agreements will be established between the host institution (NYUSoM) and the other sites to 
ensure that only the minimally necessary data is shared with the primary institution and nurse 
case managers. Secure data transfer from each site to the NYUSoM research team will occur 
using encrypted electronic files via a secure connection, as delineated in the data use 
agreements. 
To minimize research-associated risk and protect the confidentiality of participant data, all 
investigators and staff involved in this project will complete extensive courses and pass 
certifying exams on the protection of human subjects in research through CITI training and 
HIPAA certification. 
6. Potential Benefits to Subjects
The proposed study is designed to compare two methods of palliative care delivery for patients 
with serious, life-limiting illness—nurse-led telephonic case management and facilitated, 
outpatient specialty palliative care. These interventions may improve patient-centered outcomes 
including quality of life, loneliness, and symptom burden, and may reduce caregiver strain and 
bereavement and improve caregiver quality of life in primary caregivers. These interventions 
may also decrease future healthcare utilization (e.g., ED visits and hospital admissions) and 
increase hospice use in patient participants. For patients with serious, life-limiting illness, visits 
to the ED are common. For these patients, the ED often represents a place of last resort to 
address both physical and/or psychosocial crises. As a result, emergency care has not adapted 
to the needs or goals of this patient population; seriously ill patients who prefer to have care 
delivered at home are often admitted because of inadequate care coordination or providers’ fear 

 
Page 12 
of ED revisits. This study will help align discussions for patients and providers regarding goals of 
care, end-of-life wishes, advance directives, pain and symptom management, and community 
resources. We hypothesize that patients randomized to nurse-led telephonic case management 
will demonstrate greater improvements in quality of life and reduced healthcare utilization and 
loneliness than those referred to outpatient specialty palliative care. We hypothesize that 
caregivers may also experience improved caregiver quality of life and less psychosocial and 
physical strain and bereavement. We hope to demonstrate the comparative effectiveness of a 
palliative care model so that payers and medical centers can incorporate such services into their 
institutions. 
As PCORI asks investigators to make every reasonable effort to return aggregate results to 
study participants, participants will be mailed a document summarizing study findings.  
7. Economic Impact to Subjects
There is no expected economic impact to patient and caregiver participants. As part of the 
inclusion criteria, all patient participants are required to possess health insurance in order to 
receive outpatient palliative care services. 
8. Payments to Subjects 
Patient and caregiver participants will receive a $40 gift card upon completion of the baseline 
interview at enrollment. Patient and caregiver participants will receive a $20 gift card for every 
follow-up survey milestone completed at 3 months, 6 months, and 12 months. Patient 
participants randomized to the outpatient palliative care group will be reimbursed up to $25 in 
the form a gift card to cover the cost of travel for each monthly palliative care visit for 6 months 
from enrollment. Patient participants who are randomized into the outpatient palliative care 
group and choose to attend the appointments via telehealth will not receive the $25 travel 
reimbursement as there is no cost of travel to cover. 
 
 
9. Vulnerable Populations 
Include
Exclude
Vulnerable Population Type
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g., infants, 
children, teenagers 
 
X 
Wards of the State (e.g., foster children)
 
X 
Pregnant women 
 
X 
Prisoners 
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Page 13 
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