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GrudzenCR, etal. BMJ Open 2019;9:e025692. doi:10.1136/bmjopen-2018-025692
Open access
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
Corita R Grudzen,1 Deborah J Shim,2 Abigail M Schmucker,3 Jeanne Cho,1
Keith S Goldfeld,4 The EMPallA Investigators
To cite: GrudzenCR,
ShimDJ, SchmuckerAM,
etal. 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;9:e025692. doi:10.1136/
bmjopen-2018-025692
►Prepublication history and
additional material for this
paper are available online. To
view these les, please visit
the journal online (http:// dx. doi.
org/ 10. 1136/ bmjopen- 2018-
025692).
Received 8 August 2018
Revised 16 October 2018
Accepted 18 October 2018
For numbered afliations see
end of article.
Correspondence to
JeanneCho;
jeanne. cho@ nyulangone. org
Protocol
© Author(s) (or their
employer(s)) 2019. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Introduction Emergency department (ED)-initiated
palliative care has been shown to improve patient-
centred outcomes in older adults with serious, life-limiting
illnesses. However, the optimal modality for providing such
interventions is unknown. This study aims to compare
nurse-led telephonic case management to specialty
outpatient palliative care for older adults with serious,
life-limiting illness on: (1) quality of life in patients; (2)
healthcare utilisation; (3) loneliness and symptom burden
and (4) caregiver strain, caregiver quality of life and
bereavement.
Methods and analysis This is a protocol for a pragmatic,
multicentre, parallel, two-arm randomised controlled
trial in ED patients comparing two established models of
palliative care: nurse-led telephonic case management
and specialty, outpatient palliative care. We will enrol
1350 patients aged 50+ years and 675 of their caregivers
across nine EDs. Eligible patients: (1) have advanced
cancer (metastatic solid tumour) or end-stage organ failure
(New York Heart Association class III or IV heart failure,
end-stage renal disease with glomerular ltration rate
<15 mL/min/m2, or global initiative for chronic obstructive
lung disease stage III, IV or oxygen-dependent chronic
obstructive pulmonary disease); (2) speak English; (3)
are scheduled for ED discharge or observation status;
(4) reside locally; (5) have a working telephone and (6)
are insured. Patients will be excluded if they: (1) have
dementia; (2) have received hospice care or two or more
palliative care visits in the last 6 months or (3) reside
in a long-term care facility. We will use patient-level
block randomisation, stratied by ED site and disease.
Effectiveness will be compared by measuring the impact of
each intervention on the specied outcomes. The primary
outcome will measure change in patient quality of life.
Ethics and dissemination Institutional Review Board
approval was obtained at all study sites. Trial results will
be submitted for publication in a peer-reviewed journal.
Trial registration number NCT03325985; Pre-results.
INTRODUCTION
Rationale
According to the World Health Organization,
palliative care is ‘an approach that improves
the quality of life of patients and their fami-
lies facing the problems associated with
life-threatening illness, through the preven-
tion and relief of suffering by means of early
identification and impeccable assessment
and treatment of pain and other problems,
physical, psychosocial, and spiritual.’ Palli-
ative care can include hospice care, but is
distinct from hospice in that it may be deliv-
ered throughout the time course of serious,
life-limiting illness alongside life-prolonging,
disease-model treatment.1
Multiple studies have shown that palliative
care services improve patients’ symptoms
Strengths and limitations of this study
►This study will be a large, randomised controlled trial
comparing the efcacy of two palliative care models;
it will provide evidence on which to base emergency
department-initiated palliative care interventions.
►Subjects are recruited from geographically and con-
textually diverse settings across public hospitals,
academic medical centres and community hospital
afliates nationwide.
►To ensure a pragmatic, patient-oriented interven-
tion, we incorporated feedback from patient and
organisational stakeholders, as well as our clinical
and research collaborators.
►The lack of blinding of patients and clinicians deliv-
ering the interventions is an inherent limitation of
the study design.
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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 patient and family satisfaction and less
prolonged grief and post-traumatic stress disorder among
bereaved family members.2–7 Palliative care also lowers
costs by reducing unnecessary hospitalisations, diagnostic
and treatment interventions, and avoidable intensive and
emergency department (ED) care.8–12 Randomised trials
with palliative care interventions have demonstrated: (1)
better quality of life and mood in patients with poor-prog-
nosis cancer who received palliative care in addition to
standard care and (2) improved symptom management
and patient satisfaction.9 13 Patients with late-stage chronic
obstructive pulmonary disease (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.14
The ED serves as the healthcare safety net for the most
vulnerable, including older adults, non-Hispanic blacks,
the poor and those with Medicaid coverage.15 Notably,
half of older Americans visit the ED in the last month of
life, and patients with serious illness frequently visit the
ED, making the ED a key decision point where providers
establish the subsequent care trajectory.16–18 Palliative
care interventions in the ED can both capture high-risk
patients at a time of crisis and dramatically improve
patient-centred outcomes.19 20
Case management palliative care programmes have
been used in older adults with multiple chronic condi-
tions and have demonstrated reductions in end of life
healthcare utilisation and increased hospice utilisa-
tion.21–23 Many of these programmes have used nurse-led
telephonic contact, which is less expensive and more
accessible to seriously ill patients than outpatient palli-
ative care encounters. However, there is little to no
research comparing the effectiveness of the telephonic
case management model to the more costly model of
specialty, outpatient palliative care.
Therefore, this is a protocol for a large, multicentre,
parallel, two-arm randomised controlled trial in ED
patients comparing two established models of pallia-
tive care: nurse-led telephonic case management and
specialty, outpatient palliative care. The current evidence
base has critical gaps, notably failing to achieve statistical
power in order to ‘report conclusive results’, ‘account for
clustering’, ‘quantify the effects’ of palliative care and
‘address the generalisability of insights across settings’.24 25
We address these evidence gaps in our trial by evaluating
palliative care in a variety of ED settings, using validated
tools to quantify changes in our outcomes of interest, and
performing rigorous power calculations based on our
prior randomised controlled trial of palliative care in the
ED.
Objectives
The aims of this study are to compare nurse-led telephonic
case management to facilitated, outpatient specialty
palliative care for older adults with serious, life-limiting
illness on: (1) quality of life in patients, as measured by
the Functional Assessment of Cancer Therapy-General
(FACT-G)26 from enrolment to 6 months; (2) healthcare
utilisation (eg, ED revisits, hospital admissions, hospice
use)27–30 at 12 months; (3) loneliness, as measured by the
Three-Item Loneliness Scale31 32 and symptom burden,
as measured by Edmonton Symptom Assessment Scale
Revised (ESAS-r)33 from enrolment to 6 months and (4)
caregiver strain, as measured by the 12-item Zarit Burden
Interview (ZBI-12),34 caregiver quality of life, as measured
by the 10-item Patient-Reported Outcome Measurement
Information System (PROMIS-10)35 and bereavement,
as measured by the Texas Revised Inventory of Grief
(TRIG)36 3 months after patient death.
METHODS AND ANALYSIS
Trial design
This is a pragmatic, two-arm, multisite randomised
controlled trial of 1350 older adults (50+ years) with
either poor-prognosis cancer or end-stage organ failure
who will be recruited during an ED visit, along with
675 of their informal caregivers, to compare nurse-led
telephonic case management to facilitated, outpatient
specialty palliative care. Recruitment began in April 2018
and will continue through July 2021. All follow-up data
collection is expected to be completed by August 2022.
Randomisation will be at the patient level and will be strat-
ified by ED site and disease (advanced cancer vs end-stage
organ failure) to ensure a balance of patients randomised
to each intervention at each site. We will use block rando-
misation with random block sizes of two, four and six at
a ratio of 1:1 assignment to each group. A biostatistician
will randomly preassign the expected number of study
subjects to either intervention group at each site (150
patients at each of nine sites for a total of 1350 patients).
Setting
This trial will be conducted in the EDs of nine diverse
sites, including large public hospitals, academic medical
centres and smaller community hospitals in different
regions across the country (see table 1).
Prior to the start of patient recruitment, the principal
investigator (PI) at each site notified all primary care
providers and haematologists/oncologists in the health
system via email of the study parameters in order to
allow physicians to opt-out of routine participation by
their patients. The site PI assumed that any primary care
providers or haematologists/oncologists who did not opt
out of participation were willing to have their eligible
patients enrol.
Eligibility criteria
Inclusion criteria
Patients eligible for participation are English-speaking
adults aged 50+ years with a serious, life-limiting condi-
tion. Qualifying conditions include advanced cancer
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(defined as a solid metastatic tumour meeting advanced
cancer criteria; see online supplementary 1) and poor
prognosis, end-stage organ failure (defined as New
York Heart Association class III and IV heart failure,37 38
end-stage renal disease defined as glomerular filtration
rate <15 mL/min/m2 or global initiative for chronic
obstructive lung disease stage III and IV or oxygen-de-
pendent COPD defined as forced expiratory volume in
1 s <50% predicted or the modified Medical Research
Council dyspnoea scale).39 Patients must be scheduled
for ED discharge or observation status. Patients who are
placed in observation overnight will still be eligible to
participate the following morning. For sites with no obser-
vation unit, patients with an expected admission of two
nights or less will be eligible. Patients must have health
insurance, reside within the geographical area and have a
working telephone. These inclusion criteria are designed
to ensure that patient participants are able to engage in
the intervention and follow-up procedures.
Exclusion criteria
We will exclude those patients with dementia identified
in the electronic health records (EHRs), received hospice
services or two or more palliative care visits in the last 6
months, or reside in a skilled nursing or assisted living
facility or chronic care hospital. These exclusion criteria
are in place to ensure effective engagement with the inter-
vention and follow-up protocols. No specific genders or
racial or ethnic origins will be excluded from this study.
Children, pregnant patients and prisoners will not be
recruited.
Caregiver criteria
English-speaking primary caregivers aged 18+ years who
accompany eligible, enrolled patients will be eligible to
participate. The caregiver must fulfil one of the following
categories: (1) immediate or extended family member
or (2) close friend who lives with the eligible patient
full time. Caregivers must possess a working telephone
and cannot be currently compensated for providing care
to a patient if not a family member. The caregiver sample
will exclude individuals <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 from this study.
Table 1 ED characteristics and eligible adult patients with serious illness, by year
Site Location
Inpatient
beds Admissions ED visits
Eligible*,
no (% of ED
visits)
Discharged or
Observed†, no
(% of eligible)
New York University
(NYU)School of Medicine
Perelman ED/Tisch Hospital New YorkCity, New
York, USA
718 38 045 60 096 9014 (15) 2704 (30)
Bellevue Hospital Center ED New YorkCity, New
York, USA
827 29 793 122389 11 015 (9) 2203 (20)
NYU Hospital Brooklyn ED Brooklyn, New York,
USA
450 24 748 68 060 8167 (12) 2041 (25)
Brigham and Women’s/Dana
Farber Cancer Institute
Brigham and Women’s ED Boston,
Massachusetts,USA 757 19 091 62 000 9300 (15) 2511 (27)
Beaumont
Royal Oak Royal Oak,
Michigan,USA
1070 58 539 120 000 25 666 (21) 3853 (15)
Tro y Troy, Michigan,USA 520 33 759 79 000 17 434 (22) 2151 (12)
Ohio State University
Wexner Medical Center Columbus, Ohio,USA 962 45 927 120 156 17 801 (15) 8393 (47)
University of Florida(UF)
UF Shands Gainesville,
Florida,USA
973 41 669 75 537 15 561 (21) 5176 (33)
Yale University
Yale New Haven New Haven,
Connecticut,USA
1576 54 412 141 422 11 828 (8) 4408 (37)
*ED-admissions by patients with ICD-9 or ICD-10 codes consistent with advanced cancer or end-stage organ failure.
†Patients who met criteria based on ICD-9 and ICD-10 codes who were discharged home from the ED or the observation unit.
ED,emergency department.
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Recruitment
Research assistants (RAs) will check the ED and obser-
vation unit electronic track boards at each site at least
two to three times a day to identify patients with previ-
ously defined qualifying conditions. The RAs will review
patients’ EHRs to confirm inclusion criteria are met. This
recruitment method will ensure the RAs only approach
patients who are potentially eligible for the study.
RAs will then approach patients and conduct face-to-
face interviews to confirm that patients meet all eligibility
criteria. Once eligibility is established, RAs will discuss
with patients the purpose, requirements and timeline
of the study. For patients interested in enrolling for the
study, RAs will then review the consent form with partic-
ipants and obtain signed, informed consent (see online
supplementaries 2 and 3).
After informed consent is signed, a baseline face-to-face
survey will be conducted at bedside to document partic-
ipants’ demographics and quality of life, loneliness and
symptom burden.
After patient enrolment, RAs will assess accompanying
caregivers and discuss their participation in the study. With
each caregiver agreeing to participate, RAs will review the
caregiver consent form, obtain signed, informed consent
and conduct a baseline face-to-face survey.
Each patient and caregiver will be offered a US$40
gift card to participate with a repeated compensation
of a US$20 gift card for completing each subsequent
follow-up survey over the phone. Patients randomised to
the outpatient arm will receive a US$25 gift card for each
appointment attended during study enrolment.
Randomisation and blinding
After a patient has enrolled in the study and completed
the baseline interview, an automated notification will
be sent to the project manager, who will initiate patient
randomisation based on the previously generated allo-
cation sequence. Depending on patient assignment, the
project manager will relay the patient’s contact informa-
tion to the telephonic nurses or outpatient palliative care
clinic so that they can initiate the appropriate interven-
tion. A list linking the patient name and group assign-
ment will only be accessible to the project manager and
data analyst; RAs and other staff involved in recruitment,
follow-up and analysis will remain blinded to patient
assignment. It is not feasible to blind study subjects or
care providers to patient assignment. The unit of anal-
ysis will be the patient, and a blinded outcome assessment
will occur for all patient and caregiver participants at 12
weeks, 6 months and 12 months. Please refer to figure 1
for the study overview diagram.
Treatment arms
Both treatment arms will include standardised assess-
ments and referral for patients randomised to either
group, as well as criteria for the timing and frequency
of follow-up visits and phone calls. All care will
address ongoing concerns within the eight domains of
palliative care1: (1) structure and processes of care (eg,
goals of care); (2) physical aspects of care (eg, pain);
(3) psychological aspects of care (eg, depression); (4)
social aspects of care (eg, caregiver burden); (5) spiri-
tual aspects of care (eg, hopes and fears); (6) cultural
aspects of care (eg, ritual); (7) care of the imminently
dying (eg, prognosis) and (8) ethical and legal aspects
of care (eg, advance directives).
Nurse-led telephonic case management arm
Nurse-led telephonic case management will be conducted
at a central site located at the primary site, New York
University School of Medicine (NYUSoM). A registered
nurse with a Certified Hospice and Palliative Nurse certi-
fication will interact with patients via telephone and
deliver quality care according to the eight domains of
palliative care as described above. The nurse will contact
the patient once a week, or more frequently according to
patient needs, for a duration of 6 months.
Facilitated, outpatient care arm
Facilitated, outpatient specialty palliative care visits will
take place face to face in the outpatient facilities at each
participating clinical site. A physician or nurse practi-
tioner board eligible or board certified in hospice and
palliative medicine will also deliver care according to the
eight domains of palliative care as outlined above. The
patient will be scheduled to meet with the outpatient
team once a month for a duration of 6 months.
Follow-up assessments
While receiving either intervention, all enrolled patients
and caregivers will participate in follow-up assessments
using the same questionnaires that were completed at
baseline (FACT-G, Three-Item Loneliness Scale, ESAS-r,
ZBI-12, PROMIS-10). RAs will complete follow-up assess-
ments over the phone. For both caregivers and patients,
follow-ups will take place 12 weeks, 6 months and 12
months after enrolment.
If patient death occurs during the course of the study,
the caregiver will be asked additional questions about
bereavement using the TRIG survey. This bereavement
instrument is completed 3 months after patient death.
Outcome measures
Outcomes were specified ahead of time. Dependent and
independent variables are collected by blinded RAs via
face-to-face bedside interview or EHR at baseline prior to
randomisation and over the phone at 12 weeks, 6 months
and 12 months. Healthcare utilisation data, including ED
revisits, inpatient days and hospice use, will be abstracted
from the EHR and administrative data at 12 months.
Independent and dependent variables are listed in online
supplementaries 4 and 5, respectively.
The primary outcome is change in patient quality
of life from enrolment to 6 months, as measured by
the FACT-G. The FACT-G is a 27-item questionnaire
assessing quality of life domains in physical, social,
emotional and functional well-being.26 While it has been
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used extensively in oncology, it is validated and used as
an assessment of chronic illness therapy in many other
serious illnesses.40
Secondary outcomes in patients include healthcare util-
isation (ED visits, hospital admissions and hospice use)
from enrolment to 12 months; loneliness, as measured by
change in the Three-Item Loneliness Scale from enrol-
ment to 6 months; symptom burden, as measured by
change in the ESAS-r from enrolment to 6 months and
quality of life, as measured by the FACT-G, at 12 weeks
and 12 months. Secondary outcomes in caregivers include
caregiver physical and psychosocial distress, as measured
by change in the ZBI-12 from enrolment to 6 months;
caregiver quality of life, as measured by change in the
PROMIS-10 from enrolment to 6 months and bereave-
ment as measured by the TRIG at 3 months after patient
death.
Adverse events
Numerous important medical events, such as hospi-
talisation and death, are expected due to the stage of
patients’ illnesses and will be unrelated to the study. We
do not expect any study-related serious adverse events.
Data collection and management
Data collection is performed by trained RAs at each
study site, and data entry into a Research Electronic
Data Capture (REDCap) database is completed in a stan-
dardised fashion on tablets and computers. REDCap is a
secure, web-based application designed to support data
capture for research studies.41
Statistical analysis
The primary effect of interest is the change in quality
of life of patients with serious, life-limiting illness from
Figure 1 Study overview diagram.ED,emergency department.
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baseline to 6 months as measured by the FACT-G. The
effect size parameter will be estimated by comparing
patients who receive telephonic palliative care with
those who receive outpatient palliative care. Randomi-
sation will be done at the site level and stratified by
primary diagnosis. This ensures that each of the nine
sites will have patients in both intervention arms, and
patients with cancer will be randomised separately
from those who have an organ failure diagnosis. To
account for nesting in the data structure (patients
nested in hospitals), we will use mixed effect multilevel
linear model to estimate effect sizes. We anticipate
two sources of variation. First, there will be regional
(site) variation in the outcomes independent of the
intervention; although the telephonic arm is centrally
delivered, there may still be clustering at the site level.
Second, there will be variation in how specialty, palli-
ative care outpatient clinics deliver the clinic inter-
vention arm, which will add an additional source of
variation for this arm alone. We will adjust for cancer
status to account for differences in outcomes for the
patients with cancer and non-cancer in the study. If
we conclude there is enough evidence that suggests
there is an intervention effect (based on a t-test using
α=0.05), we will use a second model to assess whether
the treatment effect differs for patients with cancer
and organ failure.
We will analyse the secondary outcomes using similar
multilevel models. In one set of analyses, we will be inves-
tigating whether the intervention affects healthcare
utilisation following the initial ED visit. These outcomes—
subsequent ED visits (counts), inpatient days (counts)
and hospice use (binary)—will require generalised linear
mixed effect models; for the count models we will consider
Poisson or negative binomial distributions, and for the
binary outcome we will use logistic regression. In a second
set of analyses, we will be measuring the intervention
effects on additional quality of life measures—loneliness,
symptom burden, caregiver strain, caregiver quality of life
and bereavement—which are all continuous measures. For
these analyses, we will use linear mixed effect models.
Sample size calculation
Simulation methods were used to estimate power
based on the primary outcome, a change in quality of
life from enrolment to 6 months as measured by the
FACT-G. In the simulations, we incorporated the two
sources of variability at the site level, as described in
the statistical plan. We further assumed a drop-out rate
of 15% due to death or drop-out, as we will recruit
patients earlier in the course of their advanced illness
when they are still well enough to be discharged
home. With an effective sample size of 287 subjects in
each comparison arm, we will achieve 100% power to
detect an effect of nurse-led telephonic care given an
overall effect of 4 points on the FACT-G, a clinically
meaningful difference in quality of life. Moreover, this
sample size will provide about 80% power to detect a
difference in effect sizes between the groups given that
the true difference is only 2 points.
Patient and public involvement
A study advisory committee was assembled of (1)
patients with serious, life-limiting illness and their
caregivers; (2) the chief medical executive of a large
Medicare Advantage Plan; (3) community faculty from
Charles R. Drew University of Medicine and Science,
Division of Community Engagement; (4) patient
advocates from stakeholder organisations (eg, Amer-
ican Heart Association, American Cancer Society,
Equity Healthcare, Cambia Health); (5) representa-
tives from Emergency Medicine and Palliative Care
organisations (eg, Society for Academic Emergency
Medicine, Hospice and Palliative Nurses Associa-
tion, Emergency Nurses Association) and (6) other
content experts. These key stakeholders, who have a
history of cofunding, copublication and collaboration,
are involved in all stages of the research, including
the development of appropriate comparators and
outcomes of interest, the conduct and oversight of the
study, and analysis and dissemination of the results.
Monitoring
The PI, in cooperation with the coinvestigators and the
NYUSoM Institutional Review Board (IRB), will monitor
the safety of the proposed project. We have created a
data safety and monitoring plan and established formal
monitoring procedures at each site to closely monitor
participant safety, data quality and study progress. A data
monitoring committee is not needed since the study is
minimal risk.
Monitoring for protocol adherence will be performed
monthly to ensure early identification of poor perfor-
mance at individual sites and in the trial overall. Specific
parameters to be monitored will include randomisation
of ineligible subjects and treatment allocation errors. Our
study protocol will continue to be informed by our patient
and organisational stakeholders throughout its initiation.
ETHICS AND DISSEMINATION
Safety considerations
IRB approval was first obtained at NYUSoM, followed by
approval from the other study sites (see online supple-
mentary 6). To minimise research-associated risk and
protect the confidentiality of participant data, all inves-
tigators and staff involved in this project have completed
extensive courses and passed certifying examinations on
the protection of human subjects in research through
Collaborative Institutional Training Initiative training
and Health Insurance Portability and Accountability Act
certification.
Dissemination plan
Patient and organisational stakeholders will significantly
contribute to the translation of the research findings into
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lay language. Additionally, our group has long-standing
relationships with large, disease-based not-for-profit
organisations and will work closely with these stakeholders
to develop and activate their communications infrastruc-
ture to disseminate our results through social media,
community-based outreach and local academic partners.
Furthermore, the results of this study will be submitted
to ClinicalTrials. gov, and peer-review publications will be
coauthored by the research team.
Author afliations
1Ronald O Perelman Department of Emergency Medicine, New York University
School of Medicine, New York, NY
2Augusta University Medical College of Georgia, Augusta, Georgia, USA
3Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia,
Pennsylvania, USA
4Department of Population Health, New York University School of Medicine, New
York City, New York, USA
Acknowledgements We would like to thank the members of the EMPallA Study
Advisory Committee for their contributions to the development of our protocol.
Collaborators The EMPallA Investigators: Ada L Rubin, Caroline Blaum, Lauren
Southerland, Jeffrey M Caterino, Kei Ouchi, Marie-Carmelle Elie, Robert Swor,
Karen Jubanyik, Susan E Cohen, Arum Kim, Joseph Lowy, Jennifer S Scherer,
Nancy E Bael, Ellin Gafford, Joshua Lakin, Paige Barker, Angela Chmielewski,
Jennifer Kapo, Audrey Tan, Abraham Brody, Rebecca Yamarik, Susan Salz, Stephen
Ryan, Anne Kim, Mara Flannery, Isabel Castro, Nicole Tang, Michael Hill, Amelia
Hargrove, Richard Tamirian, Rebecca Murray, Laura Stuecher, Nora Daut, Pamela
Marsack, Jennifer Bonito, Marie Bakitas, Romilla Batra, Juanita Booker-Vaughns,
Donna C Sadasivan, Garrett K Chan, J Nicholas Dionne-Odom, Patrick Dunn, Robert
Galvin, Ernest A Hopkins III, Eric David Isaacs, Constance L Kizzie-Gillett, Margaret
M Maguire, Neha Reddy Pidatala, Dawn Rosini, William K Vaughan, Sally Welsh,
Pluscedia G Williams, Angela Young-Brinn
Contributors CRG: conception and design of study, drafting and critically revising
the manuscript. DJS: acquisition of study data, drafting and critically revising
the manuscript. AMS: acquisition of study data, drafting and critically revising
the manuscript. JC: acquisition of study data, drafting and critically revising the
manuscript. KSG: conception and design of study, drafting the manuscript. 'The
EMPallA Investigators' development of the protocol and manuscript review. All
authors approved of the nal version of the manuscript.
Funding This work was (partially) supported through a Patient-Centered Outcomes
Research Institute (PCORI) Award (PLC-1609-36306) and a Medical Student
Training in Aging Research (MSTAR) grant (1T35AG050998-01) from the National
Institute on Aging (Abigail Schmucker).
Disclaimer All statements in this report, including its ndings and conclusions,
are solely those of the authors and do not necessarily represent the views of the
Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or
Methodology Committee.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval New York University School of Medicine.
Provenance and peer review Not commissioned; peer reviewed for ethical and
funding approval prior to submission.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
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