Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home
Phase: NA
Conditions: Dementia
Sponsor: Icahn School of Medicine at Mount Sinai

Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home
Dr. Nathan Goldstein
NCT03798327
Document Date: 9-7-2020

Icahn School of Medicine at Mount Sinai
Mount Sinai Beth Israel
Mount Sinai Brooklyn
The Mount Sinai Hospital
Mount Sinai Queens
New York Eye and Ear Infirmary
of Mount Sinai
Mount Sinai St. Luke's
Mount Sinai West
Program for the Protection
of Human Subjects
Institutional Review Boards
Mount Sinai Health System
One Gustave L. Levy Place, Box
 1081
New York, NY 10029-6574
T 212-824-8200
F 212-876-6789
irb@mssm.edu
icahn.mssm.edu/pphs
Initial Application
IRB-19-01975
Nathan Goldstein
Table of Contents
1. Summary - Title.....................................................................................................................................................................1
2. Summary - Setup..................................................................................................................................................................2
3. Summary - Background......................................................................................................................................................4
4. Research Personnel.............................................................................................................................................................5
5. Sites.......................................................................................................................................................................................... 7
6. Subjects - Enrollment.......................................................................................................................................................... 8
7. Subjects - Setting and Resources...................................................................................................................................9
8. Subjects - Populations......................................................................................................................................................10
9. Subjects - Participation.....................................................................................................................................................12
10. Subjects - Risk and Benefits........................................................................................................................................14
11. Subjects - Adults Without Capacity............................................................................................................................16
12. Procedures - Narrative...................................................................................................................................................17
13. Procedures - Genetic Testing......................................................................................................................................19
14. Procedures - Details....................................................................................................................................................... 20
15. Procedures - Instruments..............................................................................................................................................21
16. Procedures - Compensation.........................................................................................................................................22
17. Consent - Obtaining Consent.......................................................................................................................................23
18. Consent - Legally Authorized Representative.........................................................................................................24
19. Consent - Documents.....................................................................................................................................................26
20. Data - Collection...............................................................................................................................................................27
21. Data - HIPAA.................................................................................................................................................................... 30
22. Data - HIV/AIDS...............................................................................................................................................................31
23. Data - Storage.................................................................................................................................................................. 32
24. Data - Safety Monitoring................................................................................................................................................35
25. Funding................................................................................................................................................................................37
26. Attachments....................................................................................................................................................................... 38

IRB-19-01975
Initial Application
Nathan Goldstein
1. Summary - Title
Protocol Title
Palliative Care for Patients with Dementia 
Principal Investigator
Nathan Goldstein
When the application is complete, it will be sent to the PI for submission
When the application is complete, it will be sent to the PI for submission
Primary Department
Geriatrics and Palliative Medicine
When the application is complete, it will be sent to the PI for submission
Application Initiated By
Harriet Mather
Lay Summary
We propose a single-blinded, randomized-controlled, clinical trial to evaluate the impact of an innovative model of
 home-based palliative care on outcomes for patients with advanced dementia and their caregivers. 250 subjects
 (125 patients, 125 caregivers) will be enrolled from across the Mount Sinai Health System and randomized to
 receive the home-based palliative care program or usual care. Intervention patients will be cared for by a pyramid
 of palliative care focused providers, the core of which comprises specially trained community health workers, social
 workers, and registered nurses. These providers are supported by a palliative care advanced practice nurse and
 physician. All visits will be done by video or telephone from 3/19/20 due to the ongoing risk of transmission of
 COVID-19. Usual care patients will have the results of their baseline interview shared with their Mount Sinai provider.
 Additionally, caregivers in the usual care arm will receive training from a health coach on a health issue identified as
 important to them (e.g., smoking cessation, healthy eating). This is a kind of attention control. of this intervention on
 meaningful outcomes for patients, caregivers, and the health system. Outcomes are symptom control and quality of
 life in persons with dementia; caregiver burden; caregiver satisfaction with care; patient days in the hospital and ED
 visits. In exploratory analyses we will also determine if the intervention decreases costs of healthcare. Outcomes will
 be ascertained through interviews with caregivers, chart abstraction from the medical record, and the Mount Sinai
 Data Warehouse. 
IF Number
IF2478054
Page 1 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
2. Summary - Setup
Funding Has Been Requested /
 Obtained
Yes
Application Type
Request to Rely on Mount Sinai IRB
Research Involves
Prospective Study ONLY
Consenting Participants
Yes
Requesting Waiver or Alteration
 of Informed Consent for Any
 Procedures
No
Humanitarian Use Device (HUD)
 Used Exclusively in the Course of
 Medical Practice
No
Use of an Investigational Device to
 Evaluate Its Safety or Effectiveness
No
Banking Specimens for Future
 Research
No
Cancer Related Research that
 Requires Approval from the
 Protocol Review and Monitoring
 Committee (PRMC).
No
   Is this Cancer Related Research?  Cancer Related Research is defined as research that
 has cancer endpoints or has a cancer population as part of or all of its targeted population.
 This includes protocols studying patients with cancer or those at risk for cancer.
  
Clinical Trial
No
   
   * A prospective biomedical or behavioral research study of human subjects that is
 designed to answer specific questions about biomedical or behavioral interventions
 (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). 
   *  Used to determine whether new biomedical or behavioral interventions are safe,
 efficacious, and effective.    
  
Drugs / Biologics 
No
   
   * Drugs / Biologics That Are Not a Part of Standard Practice 
   * Controlled Substances 
   * Drugs / Biologics Supplied by the Research Sponsor or Purchased with Study Funds 
  
   Ionizing Radiation for imaging or therapy, including X-Ray, Fluoroscopy, CT, Nuclear
 Medicine, PET andor Radiation Therapy:
  
* Purely for standard of care:
No
* In frequency or intensity that
 exceeds what is necessary for
 standard of care:
No
Hazardous Materials
No
   * Recombinant DNA 
   * Viral Vectors 

   * Plasmids 
   * Bacterial Artificial Chromosomes 
   * Toxic Chemicals, Potentially Toxic Medications, Carcinogens 
   * Autologous Cell Lines 
  
Request Use of Clinical Research
 Unit Resources
No
Page 3 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
3. Summary - Background
Objectives
The objective of this study is to determine whether a new home based palliative care program for patients with
 advanced dementia: 1) Improves overall symptom control and quality of life in patients with dementia; 2) Reduces
 caregiver burden, increases caregiver satisfaction, reduces caregiver depression; and 3) Reduces healthcare
 utilization (number of hospital admissions, days in hospital, emergency department visits) and increases days at
 home.
Background
Comprehensive case management programs for people with dementia and their caregivers have traditionally
 been clinic-based. In recent years, programs have been developed for care delivery in the home for patients with
 dementia, but these models focus on patient monitoring, care coordination, and caregiver support through the use of
 clinical and/or non-clinical coordinators. Each of the programs has had some elements of a palliative care approach,
 but none have been intentionally designed to provide comprehensive home-based palliative care using a team as
 novel as we are proposing. Our model is tailored to the needs of patients with advanced dementia and focuses
 on the core palliative care concepts of symptom control, caregiver support, better aligning treatments to goals and
 preferences, and assuring appropriate care plans to keep patients at home if this is consistent with their preferences.
 In addition, there is a national shortage of physicians and nurse practitioners with specialty-level training in the
 fields of palliative care and geriatrics. Our model is particularly innovative in that it will create a cadre of community
 health workers (CHWs), social workers (SWs), and registered nurses (RNs) to work with dementia patients and their
 caregivers. The integration of the lower-cost, more community-based CHWs within a comprehensive palliative care
 team builds on their effectiveness in chronic disease management while simultaneously helping to solve issues of
 workforce shortage.
Primary and Secondary Study Endpoints
1. Patient symptoms and quality of life (co-primary endpoints). Measured using Symptom Management at the End-
of-Life in Dementia (SM-EOLD) and Quality of Life in Alzheimer's Disease (QOL-AD) respectively. Measured at
 baseline, 3 months, 6 months. 
2. Caregiver burden, satisfaction with care, and depression. Measured using Zarit Burden Inventory, FAMCARE-10,
 and Patient Health Questionnaire 9 (PHQ-9) respectively. Measured at baseline, 3 months, 6 months. We will also
 study the effect of the intervention on caregiver self-efficacy, using the revised scale for caregiving self-efficacy. 
3. Healthcare utilization: from the data warehouse as well as using the Resource Use Instrument (RUI) collected
 through interviews with patients. Healthcare cost:  measured through the Mount Sinai Data Warehouse. 
Study duration is 6 months.
Protocol Was Already Approved
 by the Icahn School of Medicine at
 Mount Sinai (ISMMS) Institutional
 Review Board (IRB) Under a
 Different Principal Investigator
No
Protocol Was Previously Submitted
 to an External(non-ISMMS) IRB
No
Page 4 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
4. Research Personnel
Name/Department
Role/Status
CC
Access
Obtaining
 Consent
Phone
Email
Nathan Goldstein /
 Geriatrics and
 Palliative Medicine
PI / 1
SIGNAUTH
212-241-1446
Harriet Mather /
 Geriatrics and
 Palliative Medicine
Study Coordinator / 
SIGNAUTHYes
Christian Espino /
 Geriatrics and
 Palliative Medicine
Study Coordinator / 
SIGNAUTHYes
Magdalena Grzebyk /
 Geriatrics and
 Palliative Medicine
Research Assistant / 
READONLYYes
Mohammed Husain /
 Geriatrics and
 Palliative Medicine
Research Assistant / 
EDIT
Meng Zhang /
 Medicine
Co-Investigator / 
READONLY
212-241-4141
Brenda Green /
 Social Work Service
Research Nurse / 
READONLY
Latoya Sealy /
 Geriatrics and
 Palliative Medicine
Research Nurse / 
READONLY
Marie Persaud /
 Geriatrics and
 Palliative Medicine
Study Coordinator / 
READONLYYes
Linda DeCherrie /
 Geriatrics and
 Palliative Medicine
Co-Investigator / 
READONLY
na
R Morrison /
 Geriatrics and
 Palliative Medicine
Co-Investigator / 
READONLY
(212)
 241-1446
Amy Kelley /
 Geriatrics and
 Palliative Medicine
Co-Investigator / 
READONLY
212-241-2631
Lihua Li / Population
 Health Science and
 Policy
Co-Investigator / 
READONLY
2126599663
Barbara Vickrey /
 Neurology
Co-Investigator / 
READONLY
Katherine Ornstein /
 Geriatrics and
 Palliative Medicine
Co-Investigator / 1
READONLY
917-518-2250
Carolyn Zhu /
 Geriatrics and
 Palliative Medicine
Co-Investigator / 
READONLY
718-584-9000
 x3810
Xiaobo Zhong /
 Population Health
 Science and Policy
Co-Investigator / 
READONLY
 

Page 6 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
5. Sites
Site Name
Icahn School of Medicine at Mount Sinai
Other External Site Name
Contact Details
Approved
Approval Document
Funded By Mount Sinai
Other IRB
Site Name
Mount Sinai Beth Israel
Other External Site Name
Contact Details
Approved
0
Approval Document
Funded By Mount Sinai
1
Reviewed By
Mount Sinai IRB
Other IRB
Site Name
The Mount Sinai Hospital
Other External Site Name
Contact Details
Approved
Approval Document
Funded By Mount Sinai
Other IRB
Site Name
Mount Sinai St. Luke's
Other External Site Name
Contact Details
Approved
0
Approval Document
Funded By Mount Sinai
1
Reviewed By
Mount Sinai IRB
Other IRB
Site Name
Mount Sinai West
Other External Site Name
Contact Details
Approved
0
Approval Document
Funded By Mount Sinai
1
Reviewed By
Mount Sinai IRB
Other IRB
Page 7 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
6. Subjects - Enrollment
Site Name
Icahn School of Medicine at Mount Sinai
Subjects To Be Enrolled
60
Site Name
Mount Sinai Beth Israel
Subjects To Be Enrolled
40
Site Name
The Mount Sinai Hospital
Subjects To Be Enrolled
90
Site Name
Mount Sinai St. Luke's
Subjects To Be Enrolled
40
Site Name
Mount Sinai West
Subjects To Be Enrolled
20
Total Number of Subjects to be
 Enrolled Across All Listed Sites
 Above (Auto Populated)
250
Page 8 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
7. Subjects - Setting and Resources
Setting of Human Research
Faculty Practice Associates, Emergency
 Department, Internal Medicine Associates,
 Other
Specify Other Setting of Human Research
Patient home - we enroll subjects in their home as well as conducting follow up interviews in their home. This has
 been specified elsewhere in the previously approved protocol. This is because without home enrollments, many of
 the subjects would not be able to access the study.
Note - from 3/19/2020, we will no longer plan to conduct home enrollments, due to the risk of transmission to patients
 from COVID-19. Instead, we will transition to using an electronic consent protocol. Baseline and follow up interviews
 will be conducted telephonically in all cases. 
Total Number of Subjects Needed
 To Complete Study
250
Feasibility of Meeting Recruitment Goals
Our enrollment target is 4 dyads per month (50 dyads per year). Through preliminary analysis, we have identified
 around 1700 patients per quarter who have a diagnosis of dementia, and around 60% of these are in the advanced
 stages. To meet our enrollment target, we would have to enroll 5% of these patients. We are therefore confident of
 reaching our target. 
Facilities To Be Used for Conducting Research
The Department of Geriatrics and Palliative Medicine is consistently ranked as one of the top programs in the nation.
 The Department provides expert care for the most frail and complex patients; conducts research in aging with an
 emphasis on medical decision-making and palliative medicine; and teaches geriatrics and palliative medicine to
 medical students, house staff, attending physicians, and other health professionals. The principal investigator is Dr.
 Nathan Goldstein, a geriatrician and palliative care physician who has experience in administering large clinical trials,
 as is demonstrated by his multi-center trial that enrolled more than 550 patients across 6 sites. Dr. Sean Morrison is
 a geriatrician and palliative care physician whose research has focused on enhancing decision making for patients
 with dementia and developing health system interventions to improve outcomes. Dr. Amy Kelley is a geriatrician,
 palliative care physician, and a health services researcher who will lead the use of models to identify eligible patients
 based on diagnostic codes from the electronic health record. Dr. Linda DeCherrie is a geriatrician and the Director of
 Mount Sinai Visiting Doctors as well as Clinical Director of Mount Sinai Hospital at Home. She has expertise in the
 delivery of clinical models that provide care to complex older adults living in the community.
Multi-Center Study
No
Community-Based Participant
 Research Study
No
  PI must attest to the following. 
   * Process is adequately described to ensure that all persons assisting with the trial are
 adequately informed about the protocol, the investigational product(s), and their trial-
related duties and functions.
     
    
Page 9 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
8. Subjects - Populations
Inclusion Criteria
Patients must have: advanced dementia (any form of dementia, including Alzheimer's, vascular, mixed), based on
 Global Deterioration Score (GDS) > or equal to 6; impairment in at least one ADL (which is inherent in this level
 of GDS); a physician who is primarily responsible for their dementia-related care whose clinical outpatient site is
 associated with one of the four Mount Sinai sites in Manhattan; an informal/ unpaid caregiver willing to enroll; a
 residence in Manhattan where they are currently living (not in a long-term care facility); capacity to consent or a legal
 representative available to provide consent; conversant in English or Spanish, or their legal representative must be
 conversant in English or Spanish. We will only enroll adults over the age of 18 - dementia does not occur in patients
 below the age of 18 and our team is not trained to manage the needs of pediatric patients. Most of our subjects
 either live with their caregiver or have a home health aide who administers the care. In either case, we will only enroll
 subjects where they have consistent access to the internet and a device on which they can download video visit
 software. We will follow the rules outlined by the Office for Civil Rights which guide the type of software that can be
 used during the COVID-19 pandemic. 
Caregivers: the caregiver will be the relative or unpaid nonrelative who provided the most hours of help with activities
 of daily living or instrumental activities of daily living in the prior week; they must be over the age of 18; conversant in
 English or Spanish 
Exclusion Criteria
Exclusion criteria are: patient receiving hospice care or enrolled in another study of a patient/caregiver intervention. 
There are no specific exclusion criteria for caregivers where they meet the inclusion criteria above. 
Enrollment Restrictions Based
 Upon Gender, Pregnancy,
 Childbearing Potential, or Race
No
Age Range(s)
18 to 64 Years, 65 Years and Over
Targeted Population(s)
Adults - Patients , Impaired Mental Capacity,
 Decisionally Impaired
Other Aspects that Could Increase Subjects Vulnerability
The clinical team caring for the patients in this study have extensive experience of caring for patients with advanced
dementia, and are well aware that procedures carried out in routine clinical care may incur greater burden and
distress for individuals with moderate-severe dementia. The procedures involved in this study for the patients do not
differ from those which would be provided by any in-home clinical service designed to improve the clinical care of
patients with dementia.
Safeguards to protect Subjects rights and welfare
We have undertaken numerous steps to protect patients' rights and safeguard their welfare, in light of their likely
impaired capacity.
1. The patient's healthcare provider will introduce the study and determine interest before we approach the patient
 and caregiver. 
2. We will ask the patient's healthcare provider to complete a capacity assessment. Where the patient lacks capacity
 to consent to study involvement (which we anticipate in most cases) we will follow standard protocol for consent in
 patients lacking capacity (i.e., their LAR will provide authorization)
3. We will clearly state the dyad's right to refuse participation and to withdraw at any time during the study period
 without affecting their routine clinical care.
4. The intervention will be provided by a team of highly trained professionals, who have extensive experience in
caring for patients with moderate-severe dementia and their caregivers.
5. The procedures undertaken in the patient's home (which may include: clinical examination, recording of
vital observations, blood draws, X rays, ultrasound) will be dictated only by the clinical needs identified using
standardized assessments. The clinical team will record all encounters with the patient or caregiver in the secure

electronic medical record. Note - as of 3/19/2020 we will no longer be doing home visits as part of the intervention
 due to the risk of transmission of COVID-19 to a high risk population, with the exception of clinical emergencies that
 cannot be managed using telemedicine as previously documented. 
6. Medications will be prescribed and de-prescribed according to need to treat clinical problems on the basis of
clinicians' experience and in accordance with relevant guidelines. In all cases, medications will be prescribed
by licensed providers, either the palliative care MD or the palliative care advanced practice nurse. Risks and
benefits will be discussed in all cases of prescribing or de-prescribing a medication with the patient where they have
capacity, or with their LAR when the patient lacks capacity. Additionally, the provider will communicate all medication
changes to the patient's nominated physician. 
7. All appropriate measures will be taken to ensure the secure transmission, storage and use of protected health
information. 
NOTE: The clinical intervention will provide an additional layer of support for patients with dementia and their
caregivers and is designed to extend high quality palliative care to patients and their caregivers who, through
 functional and behavioral impairment, would not otherwise be able to access such services. Additionally, for patients
 in the control arm, the baseline interview will provide valuable information about the patient and caregiver needs
 which will be relayed to the patient's physician, potentially improving their care. In other words - what we are testing
 is a new, additional layer of support for individuals with profound needs, and adding more care to their care team -
 the drugs/ interventions/protocols that we are using are already well established best practice guidelines for the care
 of patients with advanced dementia.
Page 11 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
9. Subjects - Participation
Duration of an Individual Subjects Participation in the Study
6 months
Duration Anticipated to Enroll All Study Subjects
2 years
Estimated Date for the Investigators
 to Complete This Study
Within 3-5 years
Procedures for Subjects to Request Withdrawal
At the time of enrollment, we will emphasize subjects' right to withdraw. If a subject/ their LAR wishes to withdraw,
 they will make contact with either the research staff or the Principal Investigator. When this happens, the research
 coordinator will complete a study termination form to indicate subject withdrawal from the study. We will record
 why the subject wished to withdraw (with their or LAR agreement) as this will provide additional data around the
 acceptability of the intervention. Where subjects/ LAR wish to withdraw from the study, we will request permission to
 collect information from their routine medical care (for patients only), as documented on the consent form.
Procedures for Investigator to Withdraw Subjects
1. Death of patient (caregiver will be withdrawn)
2. No available caregiver
3. Transition to long term care (patients and caregivers)
4. Transition to skilled nursing facility for longer than 30 days (patients and caregivers)
5. Inpatient hospitalization for longer than 30 days (patients and caregivers)
6. Relocation of patient outside of Manhattan
7. Safety of clinical team cannot be assured
8. Study stopped
9. Principal Investigator deems it to be in the subject's best interest
10. The subject withdraws permission to use their PHI for research
Participants Will Be Recruited
Yes
Recruitment Method(s)
Clinical Practice, Records (e.g. Medical,
 Employment, School), Information Letter/
Pamphlets, Physician Referral
How Participants Will Be Identified
1. Patients will be identified either by physician referral or through a data warehouse query and subsequent chart
 screen. 
Data warehouse query 
Every quarter, we will obtain a cohort of patients from the Mount Sinai Data Warehouse who have a diagnosis of
 dementia (this is obtained either from their problem list or as a billing encounter). The problem list is contained within
 the patient's EMR and collated centrally by the data warehouse. The billing codes are diagnosis codes generated at
 the time of the clinical encounter by the treating provider and collated centrally. 
We will then screen the charts to see whether these patients have evidence of moderate to severe dementia as one
 of the following:
(i) Physician note of behavioral or psychological symptoms of dementia (i.e., agitation, anxiety, depression, irritability,
 apathy, elation, disinhibition, delusions, hallucinations, sleep disturbance)
(ii) Psychotropic medication (antidepressant, anxiolytic, antipsychotics)
(iii) Documented MMSE < 20
(iv) Other evidence of advanced dementia: any from: needs assistance with dressing, bathing, toileting; urinary or
 fecal incontinence; weight loss; dysphagia/ aspiration; immobility; loss of ability to communicate.
The data collection sheets for the data warehouse and chart screening are contained in this application. 
We will email these patients' physicians to introduce the study, confirm eligibility (moderate to severe dementia,
 available caregiver, resident in Manhattan outside of long term care, not receiving hospice). We will then ask the

 physician to introduce the study to the patient and their caregiver, in the way they see fit, and if the patient and
 caregiver are interested in the study, we will contact the patient and caregiver to discuss. 
Physician referral
We will outreach to physicians at targeted practices (Geriatrics, Primary Care, Internal Medicine) to inform them of
 the study and request that they refer dyads who may be interested. For these patients, we will confirm eligibility with
 the physician (moderate to severe dementia, available caregiver, residence in Manhattan outside of long term care,
 not receiving hospice) before meeting with the dyad. 
Finally, we will distribute information to clinic physicians by hand.
2. Caregivers will be identified by the patient or their LAR at the time of introducing the study. It is highly likely that the
 patient's LAR and caregiver are the same. 
Who Will Initially Approach
 Potential Participants
Member of Primary Care Team, Treating
 Physician, Clinic Personnel
How Research Will Be Introduced to Participants
In all cases, we will ask the patient's treating provider to introduce the study to the patient or their legally authorized
 representative and if they are interested, the study team will contact them by telephone.  
How Participants Will Be Screened
Prior to contacting the dyad, the study team will ensure they meet inclusion criteria. Specifically, they will confirm with
 the physician that they have moderate-severe dementia, a caregiver who may be willing to enroll, are resident in
 Manhattan, outside of long term care and not receiving hospice. 
When the research coordinator introduces the study to the dyad by telephone they will once again ensure they meet
 these criteria. 
The RC will additionally confirm ahead of sending consent forms to the patient whether they have capacity (this will
 be documented by the patient's treating physician). 
Page 13 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
10. Subjects - Risk and Benefits
Risks to Subjects
The clinical intervention is intended to improve outcomes for subjects, including symptoms, quality of life, caregiver
burden, depression, satisfaction, and self-efficacy. In particular, the intervention seeks to align healthcare received by
 patients with their preferences. However, there are some risks associated with participation, outlined below.
1. Medications (patient subjects only)
There are risks to patients related to the prescription of medications, particularly those that may be prescribed for
pain (including opioids) and behavioral and psychiatric symptoms (antipsychotics). These medications will only
prescribed in accordance with clinical guidance, after careful consideration of the risks and benefits of their use. In
 particular, we will only use antipsychotics for the management of behavioral symptoms where reversible causes
 have been considered and treated as appropriate, and the patient is at extreme risk or in severe distress. In all cases
 where a new medication is commenced we will inform the patient's treating physician and counsel the caregiver
 about the medication.
 
Please note that we are enrolling patients with advanced dementia who are by definition at high risk of both
worsening delirium and function, hospitalization, death and other serious events. As such these outcomes are
expected and will not be considered SAEs.
2. Breach of confidentiality (patients and caregiver subjects)
Information about any encounter with a patient or caregiver by the clinical team during the course of the study will
be recorded in the electronic medical record (EPIC), a HIPAA secure platform used for storage and transmission of
 healthcare information across the clinical network. Any video visits that are used in the course of clinical care will use
 software compliant with Office for Civil Rights framework. While there is a theoretical risk of breach of confidentiality,
 this is no more than would be encountered in routine clinical care. There is a theoretical risk of loss of protected
 health information for subjects in both intervention and control arm that is recorded for the purpose of research.
 However, this risk is minimized through precautions detailed in the "Data" section of this proposal.
3. Risks of interviews
Talking about illness may arouse difficult emotions in patients, their proxies, and caregivers. However, research
coordinators are trained to recognize these emotions, and to respond with sensitivity. Where subjects show signs
of significant distress, the research coordinator will discuss the case with the Principal Investigator, who will decide
 on whether it is necessary to inform the subject's healthcare team. This course of action will only be taken with the
 subject's consent, unless there is significant risk of harm to the subjects or others, in which case consent to share the
 information arising from the interview is not a requirement (but should be sought).
Description of Procedures Taken to Lessen the Probability or Magnitude of Risks 
Patients in the intervention arm will be cared for by a highly trained team of providers, with experience in caring for
 patients with dementia and their caregivers. Our intention is to have written communication with the PCP at the time
 the patient comes on to the program to establish roles within this co-management model of care. As part of this
 communication, we would include the statement: "Where there is a need to prescribe medications, we will seek your
 agreement prior to prescribing. However, if we do not receive a response within 48 hours, or the clinical situation
 demands a more urgent response, we will not await your agreement before prescribing medications. In all cases, we
 will inform you of our action." This written statement is also included in the Attachments tab. 
The research team are highly experienced and all research coordinators will be trained on sensitive interviewing and
 research protocols. 
Any expression of significant mental health issues exposed in a survey response will be discussed with the PI
 or study manager. We will set thresholds for escalation to the PI based on scores on Zarit Burden Inventory
 and PHQ-9, any expressions of distress, and any concerns by the study team. The PI or study manager would
 then contact the caregiver to encourage them to seek additional support from their primary physician and/or the
 intervention team as appropriate.
Provisions for Research Related Harm / Injury
It is not anticipated that patients or caregivers will come to harm during this study, as the intervention does not differ
substantially from routine clinical care that is based on clinical guidelines. The clinical team has vast experience
 and competence in managing side effects and adverse events related to medication use in these patients. Where
 adverse events related to medication use cannot
be managed in the home, the patients will be admitted to hospital at Mount Sinai. Generally, this medical care will

be billed to the research subject and/or his/her health care insurance in the ordinary manner and the research
 subject will be responsible for all treatment costs not covered by insurance, including deductibles, co-payments and
 coinsurance. This does not prevent the research subject from seeking payment for injury related to malpractice or
 negligence. As outlined above, interviews can arouse emotions in patients and caregivers. We have outlined the
 provisions for this eventuality above.
Expected Direct Benefit to Subjects
The study is anticipated to have a number of benefits for subjects (patients and caregivers) in both intervention and
control arms.
1. Intervention subjects
Patients and caregivers in the intervention arm will benefit from receiving an additional in-home care program
 delivered through video visits and telephone by highly trained and skilled professionals, and designed to address
 their needs. It is hoped that the intervention will bring about reduction in patients' symptom burden and improvement
 in quality of life, and reduce burdensome hospitalizations. Additionally, it is hoped that the intervention will lead to
 reduction in caregiver burden, and improvement in overall caregiver satisfaction. Subjects will receive the benefit of
 participating in a research study, which is a cited as a highly valued opportunity for patients with end-stage illness
 and their caregivers.
2. Control subjects
While control subjects will not receive clinical care, research coordinators will undertake interviews with patients
 (or proxies) and caregivers at baseline. The results of these interviews will be relayed to the patient's nominated
 physician. These will serve to highlight previously unrecognized problems. Additionally, caregivers in the control arm
 will be offered coaching from a health coach on health improvement (e.g., dietary education, smoking cessation).
 The health coach will be certified in providing health education. 
Benefit to Society
There is an urgent imperative to develop in-home models of palliative care to address the significant needs of
 patients with advanced dementia and their caregivers. In the context of COVID-19 these are being delivered
 increasingly through the use of telemedicine. Such models of care must be scalable and deliverable in the context
 of limited numbers of specialist trained providers. This study, and the program of research it advances, will be of
 great benefit to the wider population of patients with dementia and their caregivers through the development and
 evaluation of an innovative new care model mapped to their needs. 
Provisions to Protect the Privacy Interests of Subjects
1. Recruitment
Patients will be recruited through a member of their Mount Sinai healthcare team. The research team will contact the
 patient and their caregiver only after they have demonstrated interest in the study. 
2. Enrollment
The consent forms will be emailed to the patient's proxy (in the event that they lack capacity to consent) and the
 baseline interview for both the patient/ informant and caregiver will be conducted via telephone. The research team
 will ensure the subject has understood all the information in the consent forms. 
3. Privacy protections during the study
At the time of enrollment all subjects will be informed that information arising in the course of clinical care will be
recorded in the patient's electronic medical record, which can be viewed by the clinical team and other providers
within the Mount Sinai Health System as necessary to provide clinical care. Clinical information will not be shared
with providers not involved in the patient or caregiver's care without their prior consent. Information arising from
 interviews will only be shared with the subject's provider with their consent, unless in the case that they are
 considered to be at risk to themselves or otherwise mandated by law. 
Economic Impact on Subjects
We do not anticipate that subjects will incur any economic costs through participation in the research study. Subjects
 will not be charged for their care or participation in this study. 
Page 15 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
11. Subjects - Adults Without Capacity
There is Anticipated Direct Benefit
 to the Subjects
Yes
Assent is Required of
All Subjects Capable of Being Consulted
  
  Select Which of the Following Best Describes the Risk to Subjects 
  * Intervention: the risk to the subjects is presented by an intervention or procedure that
 holds out the prospect of direct benefit for the individual subject.  
  * Monitoring Procedure: more than minimal risk to subjects is presented by a monitoring
 procedure that is likely to contribute to the subject’s well-being.  
  
 
Risk to Subjects
Intervention
  
  PI must attest that all of the following are true. 
  * The risk is justified by the anticipated benefit to the subjects.  
  * The relation of the anticipated benefit to the risk is at least as favorable to the subjects as
 that presented by available alternative approaches. 
  * The proposed plan for the assessment of the capacity to consent is adequate (and the PI
 states he/she will comply with institutional policy GPP-312). 
  * The assessment of the capacity to consent will be performed by a qualified attending
 physician with appropriate training, licensing and certification, with special attention paid
 to qualifications re: assessing incapacity due to mental illness, mental retardation or
 developmental disability. 
  * The proposed plan for the assessment of capacity includes the assessment of the cause
 and extent of the incapacity and likelihood that the subject will regain capacity. 
  * The PI has indicated that he/she will document this determination with the above details
 of the assessment appropriately (eg. In the medical record when applicable and in research
 record). 
  * The consent document includes a signature line for a legally authorized representative.
  
 
Page 16 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
12. Procedures - Narrative
Description of the Study Design
The study is a randomized controlled trial design. Participating dyads will be randomized to receive either the
 intervention (home based palliative care) or usual care, in a 1:1 randomization, parallel design. 
The patient/ caregiver dyad will not be blinded. However, the research coordinator (outcome assessor) conducting
 the follow-up interviews will be unaware of assignment, hence calling this a single-blind trial.
Description of Procedures Being Performed
Intervention dyads 
For intervention dyads, the CHW, RN, and SW team conduct in-depth intake assessments that may include
 assessment of the following: disease stage (RN); physical, psychological and behavioral symptoms (RN); cognitive,
 functional and nutritional status (RN); medication reconciliation (RN); durable medical equipment needs (RN);
 dyad understanding of disease, goals of care, and advance directives (RN+SW); caregiver support network (SW); 
 caregiver burden and unmet needs (SW); legal, financial and insurance needs (SW); spiritual concerns (SW). The
 CHWs accompany the RN and SW on initial visits to develop an understanding of the family and cultural context and
 their need for connections to community resources. The care team creates a comprehensive care plan to address
 the needs identified at the intake assessment. The care plan is implemented with the support of the CHWs, SW and
 RN and evaluated regularly. From 3/19/20 and due to the COVID-19 pandemic, all initial video visits and subsequent
 assessments will be conducted using video visit software. However, in the exceptional case that the the patient has
 a clinical emergency that, according to the MD/NP cannot be managed using telemedicine and/or transfer to the
 hospital (e.g., uncontrolled agitation in a patient whose goals of care are to remain at home) we will consider the
 option of a home visit, after a thorough assessment and documentation in the clinical record of the risks and benefits,
 and guided by Institutional procedures for home visits in the context of the COVID-19 emergency which include strict
 adherence to infection control procedures. Note, to provide for this unlikely event, all team members have been
 trained in the use of personal protective equipment. 
As a co-management model, the team works collaboratively with the PCP and existing in-home services such as
 home health aides or visiting nurse services with the goal to provide an added layer of support, rather than replace
 existing care. 
Frequency of contacts with the team will be individualized according to the dyad's needs. Some assessments will
 include multiple team members simultaneously while others will be done individually. Intervention dyads receive
 access to 24-hour telemedicine support, using the pre-existing infrastructure within our Department. We will also
 use Mount Sinai's 24/7 community paramedic program whereby physicians can dispatch Mount Sinai paramedics to
 provide in-home treatments without automatic transport to the emergency department. Community paramedicine are
 operating under guidelines to reduce the risk of COVID-19 transmission. 
At the end of their time on the program, the dyad continues care with their usual providers, or is referred onward to
 other services as appropriate (e.g., Mount Sinai Visiting Doctors, hospice). 
Control dyads 
Dyads randomized to control will continue to receive care with their usual care providers. In addition, a copy of their
 baseline assessment will be uploaded into the EMR with the subject's consent, and the provider notified of this by
 email, with explicit notification of any areas for concern (i.e., uncontrolled symptoms). In addition, the caregiver-
subject within control dyads will receive a health coach who will identify a physical health goal with the caregiver (e.g.
 weight reduction, smoking cessation) and work, through monthly visits, towards this goal. This control arm will assure
 balance between the groups in terms of "attention received" in a way that will not impact study outcomes. 
All dyads - data collection
For dyads in both arms, there will be an interview undertaken at baseline, 3 months, and 6 months. This will be
 undertaken either in person (at the dyad's home or a Mount Sinai facility) or over the telephone. At all times
 confidentiality will be assured. These interviews will last around 30 minutes.
Any concerns that arise during interview will be shared with the patient's treating provider (either the palliative care
 team or for control patients, their PCP). 
Description of the Source Records that Will Be Used to Collect Data About Subjects 

1. EMR - we will abstract data from the patient's EMR at baseline, 3 months, and 6 months and after every
 hospitalization. 
2. Mount Sinai Data Warehouse. We will request data on utilization and costs of care from the data warehouse on
 enrolled subjects. 
3. Claims databases. We will request claims data for enrolled patients (using the same variables as the data
 warehouse) to study the impact of the intervention on utilization and costs. 
Description of Data that Will Be Collected Including Long-Term Follow-Up
1. Patient/ proxy and caregiver reported data - through interviews.
Data to be collected will include: (i) patient demographics; (ii) symptoms; (iii) quality of life; (iv) resource use; (v)
 physical function; (vi) agitation; (vii) care preferences; (viii) financial burden. 
We will obtain information from the patient's caregiver (as a subject) about: (i) caregiver demographics; (ii) caregiver
 health; (iii) caregiver function; (iv) caregiver burden; (v) caregiver depression; (vi) caregiver satisfaction; (vii)
 caregiver self-efficacy. 
2. Data warehouse/ claims database (ClaimsStar)
We will abstract data from the data warehouse and the claims database on utilization, diagnoses, and costs of care. 
Research Requires HIV Testing
No
Page 18 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
13. Procedures - Genetic Testing
Genetic Testing Will Be Performed
No
Guidance and Policies > Future Use Data Sharing and Genetic Research
  
Page 19 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
14. Procedures - Details
Surveys or Interviews
Yes
Type of Instruments Being Used
Standardized, Created By Research Team
Names of Standardized Instruments
1. Symptom management at the end of life in dementia 
2. Quality of Life in Alzheimers Disease
3. Zarit Burden Inventory (caregiver subject)
4. Patient Health Questionnaire-9 (caregiver subject)
5. FAMCARE-10 (caregiver subject)
6. Resource Use Instrument 
7. KATZ ADL (caregiver and patient)
8. KATZ comorbidity questionnaire (caregiver subject)
9. Cohen Mansfield Agitation Inventory 
10. Revised scale for caregiving self-efficacy (caregiver subject)
11. Neuropsychiatric Inventory Questionnaire 
Description of Instruments Created By Research Team
1. Patient demographics 
2. Caregiver demographics 
3. Record of advance care planning documentation and preferences for care 
4. Financial burden questionnaire 
Audio / Photo / Video Recording
No
Deception
No
Results of the Study Will Be Shared
 with Subjects or Others
Yes
How the Results Will Be Shared
1. Peer review publication
2. Presentation at conferences
When the Results Will Be Shared
After the conclusion of the study and completion of analysis 
Page 20 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
15. Procedures - Instruments
Instruments Created By Research Team
Type
Study team created instruments
Name
Upload
Study instruments.docx
Page 21 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
16. Procedures - Compensation
Compensation for Participation
No
Page 22 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
17. Consent - Obtaining Consent
Consent Process
Adult Consent, Legally Authorized
 Representative (LAR) Permission
Where and When Consent Will Be Obtained
Consent will be obtained at enrollment. Consent forms will be emailed to the patient or their proxy and the caregiver
 subject. The RC will ensure that the subject has understood all elements of the consent form and had adequate time
 to read them prior to enrollment. 
Waiting Period for Obtaining Consent
Patients and caregiver will be given a study information leaflet prior to the study team obtaining consent. This will be
 emailed to the patient or their legally authorized representative and their caregiver. 
In all cases, the study team will ensure the LAR has had sufficient time to read the study information, ask any
 questions, and will provide the possibility of contacting the study team at a later date if they require further time to
 consider participation. 
SOP HRP-090 Informed Consent
 Process for Research Is Being
 Used
Yes
PPHS Worksheets, Checklists and SOPs
  
Process to Document Consent in
 Writing
Will Use Standard Template
Non-English Speaking Participants
 Will Be Enrolled
Yes
What Languages Other Than English Will Be Used
Spanish 
What Process Will Be Used
Long Form
  
  The consent document must be translated into the language of the potential subject, and
 approved by the IRB, before you can go through the consent process with the non-English
 speaking person. If, after the project is approved, a short form consent process is needed,
 please see the PPHS policy and submit a modification.
     
 
Page 23 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
18. Consent - Legally Authorized Representative
Process to Determine Whether an Individual is Capable of Consent
Capacity to consent will be determined by a qualified attending physician with the necessary license, training, and
 certification who is familiar with the patient's clinical situation (in most cases, this will be the physician who provides
 authorization for the study team to introduce the study to the dyad). 
The capacity assessment will focus on the subject's understanding of the purpose of the study, the experimental
 nature, risks and intended benefits, the right to withdraw, and alternatives to participation. The assessment of
 capacity will include a determination of the cause and extent of the incapacity and the likelihood that the subject will
 regain capacity. The determination of capacity procedure and results will be documented in the electronic medical
 record, and a copy kept for the research study.
For patients lacking capacity to consent to participation (likely the majority) we will require consent from the patient's
 legally authorized representative (LAR).
In the unlikely event that the patient has capacity to consent to participation at baseline, it is likely that they will
subsequently lose capacity to consent during the study period. Therefore, even where patients have capacity, as
an additional safeguard we will seek additionally seek the consent of the LAR at baseline, such that if the patient
subsequently loses capacity, we can transition to LAR consent.
We have understood and will follow the procedures outlined in the following policies and documents: A3-113 and
 A3-113.9 and HRP-422. 
Prioritized List of Individuals from whom Permission will be Obtained
In accordance with SOP HRP013, we will define the prioritized list of individuals who can act as the patient's legally
 authorized representative as a court appointed guardian who is specifically given authorization to consent to
 participation in research. In the absence of a court appointed guardian who is specifically given authorization to
 consent to participation in research, any of the following individuals:
1. A court appointed guardian who is specifically given authorization to consent to health care
2. A previously designated health care proxy
3. Spouse (if not legally separated) or domestic partner
4. Children > 18 years of age
5. Parents
6. Siblings > 18 years of age
This is in accordance with New York State Law (New York Family Health Care Decisions Act, Mental Hygiene Law)
and Mount Sinai Policies.
Process for Assent of the Subjects
Where patients lack capacity to consent, we will seek assent to study participation where they are capable of being
consulted.
We will seek patient assent for all procedures/ interactions with the clinical team members (as would happen in the
normal course of clinical care) where capable of being consulted. Dissent will always be respected.
  For research conducted in New York State, review “SOP HRP-013 Legally Authorized
 Representatives, Children, and Guardians” to be aware of which individuals in the state
 meet the DHHS and FDA definition of “legally authorized representative."
  For research conducted outside of New York State, obtain consultation from Mount Sinai
 legal counsel as to the definition of “legally authorized representative” in the jurisdiction(s)
 where you are performing your research.  After receiving consultation with Legal, provide
 an explanation in this section about which individuals are authorized under applicable
 law to consent on behalf of a prospective subject to their participation in the procedure(s)
 involved in this Human Research.
     
 

Page 25 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
19. Consent - Documents
Consent Documents
Type
Patient without capacity
Name
Upload
Adult without capacity 5.22
 COVID_clean.docx
Type
Patient with capacity
Name
Upload
Adult with capacity COVID amended - clean
 5.22.docx
Type
Caregiver 
Name
Upload
Caregiver consent clean 5.22 for
 COVID.docx
Consent Templates
  
Page 26 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
20. Data - Collection
Health Related Information Will Be
 Viewed, Recorded, or Generated
Yes
Description of Health Information That Will Be Viewed, Recorded, or Generated
Data warehouse query (screening purposes):
1. Patient name
2. Patient MRN 
3. All encounters within the Mount Sinai system in quarter of request and 12 months prior:
a. Encounter ID
b. Dates of encounter (admit and discharge)
c. Encounter type (e.g., outpatient, inpatient)
d. Discharge disposition
e. Discharge location to 
f.  ICD10 code and diagnosis description 
g. ICU admission
h. Encounter site
i.  Provider 
j. Payer 
k. Wheelchair order
l. Hospital bed order 
4. Patient zipcode
5. Patient date of birth 
From this information, we will generate a list of patients with a diagnosis of dementia. We will then review the charts
 of these patients to determine potential eligibility. 
Chart review (screening purposes):
1. Name, MRN, date of birth 
2. Physician note of behavioral or psychological symptoms of dementia (yes/no)
3. Psychotropic medication (yes/no; type)
4. Documented MMSE < 20 in past 6 months (yes/no).
5. Evidence of any of the following: needs assistance with dressing, bathing, toileting; urinary or fecal incontinence;
 weight loss; dysphagia/ aspiration; immobility; loss of ability to communicate (yes/no; checkbox for each)
Interviews (enrolled subjects):
Patients: 
Demographics (study team)
Symptoms (SM-EOLD) - standardized
Quality of life (QOL-AD) - standardized 
Function (KATZ ADL and IADL) - standardized 
Resource use (RUI) - standardized 
Care preferences - study team
Cohen Mansfield Agitation Inventory - standardized
Financial burden - study team
Neuropsychiatric Inventory Questionnaire - standardized
Caregivers: 
Caregiver demographics (study team)
Caregiver burden (Zarit Burden Inventory) - standardized
Caregiver depression (PHQ-9) - standardized 
Caregiver satisfaction with care (FAMCARE-10) - standardized
Caregiver self efficacy (revised scale for caregiving self-efficacy) - standardized 
Caregiver comorbidities (KATZ) - standardized

Chart reviews at baseline and follow up (enrolled subjects)
1. Medications (name, dose)
2. Hospitalizations and ED visits in past 12 months (yes/ no/ number)
3. Advance care planning documentation 
4. Receipt of any of the following: (i) IV fluids (ii) IV antibiotics (iii) PEG (iv) Intubation (v) CPR 
Data warehouse (enrolled subjects):
All encounters in the Sinai health system from enrollment until study termination:
1. Patient name
2. Patient MRN 
3. All encounters within the Mount Sinai system in quarter of request and 12 months prior:
a. Encounter ID
b. Dates of encounter (admit and discharge)
c. Encounter type (e.g., outpatient, inpatient)
d. Discharge disposition
e. Discharge location to 
f.  ICD10 code and diagnosis description 
g. ICU admission
h. Encounter site
i.  Provider 
j. Payer 
k. Wheelchair order
l. Hospital bed order 
4. Patient zipcode
5. Patient date of birth 
6. Costs associated with care 
Non-Health Related Information Will
 Be Viewed or Recorded
Yes
Description of Non-Health Information That Will Be Viewed or Recorded
1. Patient and LAR address, telephone number, email address
2. Caregiver address, telephone number, email address
HIV / AIDS Related Information Will
 Be Viewed or Recorded
Yes
Informed Consent Will Be Obtained
 to Access Identifiable HIV / AIDS
 Information
Yes
Data That Will Be Viewed,
 Recorded, or Generated Contains
 ANY of the Following Directly
 Identifiable Information
Yes
Will Be Viewed
Name, Medical Record Number, Address by
 street location, Telephone number, Health
 Plan Beneficiary Number, Account Number,
 Geographical Subdivisions Smaller Than
 a State, All Elements of Dates for Dates
 Directly Related to an Individual (i.e., Birth
 Date, Admission Date, Discharge Date),
 Email Address
Will Be Recorded
Name, Medical Record Number, Address by
 street location, Telephone number, Health
 Plan Beneficiary Number, Account Number,
 Geographical Subdivisions Smaller Than
 a State, All Elements of Dates for Dates
 Directly Related to an Individual (i.e., Birth
 Date, Admission Date, Discharge Date),
 Email Address

Data Collection Sheet
Datasheet for data warehouse and
 screening.xlsx
        
        A Data Collection Sheet is required if you are either performing a retrospective review,
 or your study meets the category of exempt 4 research, or your study meets the category
 of expedited 5 research. Please upload it here.
        
    
Data Collection Source(s)
Participant, Medical Chart (Paper or
 Electronic), Data Warehouse
Page 29 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
21. Data - HIPAA
Obtaining HIPAA Authorization
Yes
How PHI Will Be Protected from Improper Use or Disclosure
All data will be recorded stored in a restricted folder on Mount Sinai's secure server. Each person who will work
with the data has a unique username and password to log onto the server, and then only these individuals will have
access to a folder on the server for the Department of Geriatrics and Palliative Medicine. No data will be stored
on local hard drives or movable media (i.e. no data will be stored on flash drives, etc). Any printouts that have PHI
(which will be extremely rare) will be stored in locked cabinets in locked offices. All printouts will be destroyed/
shredded as soon as they are no longer needed.
PHI Will Be Destroyed at the
 Earliest Opportunity Consistent
 with the Research
Yes
When and How PHI Will Be Destroyed 
We will remove all PHI at the earliest time possible be deleting these variables from the dataset. Any PHI that is
printed will be shredded as soon as possible.
PHI Will Be Shared
No
  PI must attest to the following.
  * I assure that the protected health information (PHI) will not be disclosed to any other
 person or entity not listed on this form except where required by law or for the authorized
 oversight of this research project. If at any time I want to reuse this PHI for other purposes
 or disclose it to other individuals or entities I will seek approval from the IRB. 
  
 
Page 30 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
22. Data - HIV/AIDS
Name
Harriet Mather
Clinical / Adminstrative
 Role
Study coordinator
Name
Nathan Goldstein
Clinical / Adminstrative
 Role
Principal Investigator
Page 31 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
23. Data - Storage
Location Where Data Will Be Stored
Data, obtained from the subject interviews and the clinical record, will be stored in on Sinai's secure server in a
restricted-access folder. Access to the database will be restricted to the Principal Investigator, Co-Investigators,
study coordinator and data analysts. The database will be maintained on the Mount Sinai Medical School's server
which is firewall protected. We are not proposing to analyze the content of the video visits, and thus the video
 consults will not be recorded, saved, or stored.
All aspects of the intervention will be in the treating record as the intervention is provision of clinical care to patients
 and their caregivers and it is important that the information is documented within the electronic medical record as
 it would be for any clinical care. The results of the interviews with patients at baseline will be shared with patients'
 providers through the EMR.
How will the data be stored?
Other
Specify How Data Will Be Stored
Data on patients, caregivers, and legally authorized representatives will be stored with identifiers intact. It is
necessary to keep these identifiers intact as the data may be subdivided into separate databases for portions of the
analyses and these identifiers will be needed to link it back with other portions of the data. All data will be stored
on Sinai's secure server that is accessible only through password protected individual logins. Once all of the data
analyses are done, the identifiers will be removed from the dataset such that at some point in the research it will
become an anonymous dataset stripped of identifiers.
Research Personnel Responsible
 for:
Nathan Goldstein
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Harriet Mather
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Christian Espino
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Magdalena Grzebyk
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Mohammed Husain
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants

Research Personnel Responsible
 for:
Meng Zhang
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Brenda Green
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Latoya Sealy
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Marie Persaud
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Linda DeCherrie
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
R Morrison
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Amy Kelley
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Lihua Li
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Barbara Vickrey
Accessing Data
Receipt or Transmission of Data

Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Katherine Ornstein
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Carolyn Zhu
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Research Personnel Responsible
 for:
Xiaobo Zhong
Accessing Data
Receipt or Transmission of Data
Holding Code That Can Be Linked
 to Identity of Participants
Duration Data Will Be Stored
We will maintain our records for three years after closing out the Human Research
Steps That Will Be Taken to Secure the Data During Storage, Use, and Transmission
All data will be recorded and stored on Sinai's secure servers in a restricted access folder. Interview data will be
recorded using a REDCaP platform on the secure server. All users will have a unique user ID and password to log
 onto the Sinai server and then only the individuals on this trial will have access to the folder which contains the data
 files and
PHI associated with them. As soon as possible, all identifiable information is removed from the databases and related
 files so that PHI is removed from the dataset as soon as possible. No data will be stored on local drives or removable
 media of any type.
Power Analysis/Data Analysis Plan (Including Any Statistical Procedures)
Please see the data analysis plan in the accompanying proposal. 
Page 34 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
24. Data - Safety Monitoring
More Than the Minimum Data
 Safety Monitoring Will Be Done
Yes
Principal Monitor
Additional Monitors
Specific Items That Will Be Monitored for Safety
All SAEs, regardless of treatment group or relationship to research, will be reported to the IRB within 24 hours in a 
 full written report. Note that these patients have advanced illness and are receiving palliative care. As such deaths
 will be recorded and regularly reported to the IRB but deaths are not in and of themselves considered SAEs due
 to the nature of the patient population. We will review each death and evaluate the relationship of that death to
 any medications prescribed or recommended by the study team. If the team believes there is a causal relationship
 between the prescription of the medication and the subject's death, this will be reported to the IRB as a serious
 adverse event. 
Frequency of Data Review
All adverse events that are both serious and unexpected will be reported to the IRB, NIA PO, and the independent
 study monitor within 48 hours of the study's knowledge of the SAE. All adverse events will be reported as per the
 IRB's policies. 
The PI and program manager will also report data on enrollment, data collection, adverse events, serious adverse
 events and unanticipated problems every quarter to the independent safety monitor. 
The PI will report all adverse events and serious adverse events every 6 months to the program officer at the NIA.
The PI and program manager will meet every week for the duration of the study. 
Note that in the first month of the study, Dr. Goldstein and the project manager will review all adverse events/ serious
 adverse events with the independent safety monitor to ensure they agree with the determinations as to which ones
 are study related.
Rules for Alteration of Study Design
This is a pilot randomized controlled trial and there are no provisions for alterations in study design. 
Selection Procedures to Minimize Toxicity
Not applicable. 
Grading System to Evaluate Adverse Events
We will consider adverse events according to the grading system to include: unanticipated events, adverse events,
 and serious adverse events. 
Procedures to Assure Data Accuracy
All data will be checked on a quarterly basis by the program manager to ensure the data is being entered with a high
 degree of accuracy. 
Suspension Reported to
If the study is suspended for any reason, we will report this to the IRB and the program officer at the NIA. 
Anticipated Circumstances of Subject Withdrawal
While we do not anticipate subjects wishing to withdraw, we do have procedures in place should subjects wish to
 withdraw and these are detailed in the consent form and will be emphasized by the research coordinator at the
 time of enrollment. Subjects will be withdrawn if they die, they transition to long term care, they have a hospital stay
 exceeding 30 days, or they relocate outside of Manhattan. 
Primary or Secondary Safety Endpoints
We are not performing any interim analyses.
Data Monitoring Committee
 Description
Goldstein - DSMP - Pall Care Home
 Dementia - R 56 - March 30 2020.pdf
DMC Charter Available
No
Will the Research Include Data
 Coordinating Center Activities?
No

Page 36 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
25. Funding
Funding Source Name
National Institutes Of Health/DHHS
Contact
Funding Category
Federal/State
Meditrack (https://contracts.tractmanager.com/Contracts/Login.aspx)
Grant or Contract Title
Palliative Care at Home for Patients with Dementia and their Caregivers
Grant or Contract 
 Number
19-1232
Funding Status
Funded
Project Initiated By
Investigator
Grant / Contract Principal
 Investigator (PI)
Nathan Goldstein
Department
Geriatrics and Palliative Medicine
Department
Geriatrics and Palliative Medicine
Phone
212-241-1446
Email
nathan.goldstein@mssm.edu
Protocol and Funding
 Proposal Match
Yes
Identify Substantive
 Differences Between
 Protocol and Funding
 Proposal
Funding Source Name
Fan Fox And Leslie R. Samuels Foundation
Contact
Funding Category
Foundation
Meditrack (https://contracts.tractmanager.com/Contracts/Login.aspx)
Grant or Contract Title
Palliative Care at Home for Patients with Dementia
Grant or Contract 
 Number
19-0935-00001-01-PD
Funding Status
Funded
Project Initiated By
Investigator
Grant / Contract Principal
 Investigator (PI)
Nathan Goldstein
Department
Geriatrics and Palliative Medicine
Department
Geriatrics and Palliative Medicine
Phone
212-241-1446
Email
nathan.goldstein@mssm.edu
Protocol and Funding
 Proposal Match
Yes
Identify Substantive
 Differences Between
 Protocol and Funding
 Proposal
Page 37 of 38

IRB-19-01975
Initial Application
Nathan Goldstein
26. Attachments
Type
Name
Version Status
Filename
Uploaded
 Date
Consent Documents
Adult consent - with
 capacity.docx
1
approvedAdult with capacity
 COVID amended -
 clean 5.22.docx
05/22/2020
Funding Proposal /
 Grant Application
Completed
 Application
 Downlaoded 3 15
 19.pdf
1
approvedCompleted
 Application
 Downlaoded 3 15
 19.pdf
06/02/2019
Other - Participant
 Educational
 Materials
Patient/caregiver
 letter for mailing
1
approvedPatient mailing
 letter_ng_clean.docx
03/06/2020
Consent Documents
Adult consent
 patient - lacking
 capacity.docx
1
approvedAdult without
 capacity 5.22
 COVID_clean.docx
05/22/2020
Consent Documents
Adult consent
 caregiver.docx
1
approvedCaregiver consent
 clean 5.22 for
 COVID.docx
05/22/2020
Data Collection Sheet Datasheet for data
 warehouse and
 screening.xlsx
1
approvedDatasheet for data
 warehouse and
 screening.xlsx
06/02/2019
Instruments
Study
 instruments.docx
1
approvedStudy
 instruments.docx
06/02/2019
Consent - Phone
 Script
Telephone script - not
 consent - patient or
 LAR
1
approvedTelephone
 script_patient or
 LAR.docx
06/02/2019
Consent - Phone
 Script
Telephone script - not
 consent - caregiver
1
approvedTelephone
 script_caregiver.docx
06/02/2019
Funding Proposal /
 Grant Application
Goldstein -
 R56 for R01
 AG067045-01.pdf
1
approvedGoldstein -
 R56 for R01
 AG067045-01.pdf
03/06/2020
Other - Other IRB
 Correspondance
Comparative review
 form
1
approvedHRP-215 - FORM -
 19-01975.doc
04/08/2020
Consent - Consent
 Document
Adult with capacity
1
approvedAdult with capacity
 CoC tracked.docx
04/10/2020
Data Monitoring
 Committee
 Description
Goldstein - DSMP
 - Pall Care Home
 Dementia - R 56 -
 March 30 2020.pdf
1
approvedGoldstein - DSMP
 - Pall Care Home
 Dementia - R 56 -
 March 30 2020.pdf
05/22/2020
Other - Other IRB
 Correspondance
Continuation form for
 study 
1
approvedContinuing review
 19-01975_v2.doc
05/28/2020
 
Page 38 of 38