Reducing Behavioral and Psychological Symptoms of Dementia (BPSD) for Acutely-Ill Persons With Alzheimers Disease and Related Dementias Via Patient Engagement Specialists
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias
Sponsor: Northwell Health

Version Date: 03/01/2021 
 
Page 1 of 39 
 
 
 
RESEARCH PROTOCOL 
 
 
Protocol Title: 
Reducing Behavioral and Psychological Symptoms of Dementia 
Principal Investigator: 
Liron Sinvani 
Primary Contact Name: 
Suzanne Ardito 
Primary Contact Phone: 
(516) 241-1580 
Primary Contact E-mail: 
SArdito@northwell.edu 
Date Revised: 
03/01/2021 
IRB Number: 
19-0800 
NCT Number: 
NCT04179721 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
• You do not need to complete this document if you are submitting an Application for 
Exemption or Application for a Chart Review.   
• Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical 
Trial Protocol Template. 
o Your study has a protocol from a sponsor or cooperative group.  In this case, use 
the Protocol Plus.   
o Your study is a registry or repository for data and/or samples,  In this case, use 
Protocol Template – Registry Studies.  .   
• If a section of this protocol is not applicable, please indicate such. 
• Do not delete any of the text contained within this document. 
• Please make sure to keep an electronic copy of this document.  You will need to use it, if 
you make modifications in the future.   
• Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
o Date Revised:  Indicate the date at which the protocol was last revised 
o IRB Number:  Indicate the assigned IRB number, when known.  At initial 
submission, this row will be left blank.   
• Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 
 Continue to next page to begin entering information about this study  
 

Version Date: 03/01/2021 
 
Page 2 of 39 
 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes −  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
• This section should be ½ page 
 
 
Persons with Alzheimer’s Disease and Related Dementias (ADRD) currently 
account for 3.2 million hospital admissions per year and have over three times 
more hospitalizations than those without cognitive impairment. Yet, hospital 
caregivers are currently ill-prepared to manage patients with ADRD, with less than 
5% reporting mandatory dementia care training. Three-quarters of hospitalized 
persons with ADRD display Behavioral and Psychological Symptoms of Dementia 
(BPSD), associated with functional and cognitive decline, increased resource 
consumption, institutionalization, premature death, and caregiver burden. The 
overall objective of this project is to test the feasibility and preliminary efficacy of 
an innovative model of care, the PES-4-BPSD, for reducing BPSD by empowering 
Patient Engagement Specialist (PES) to deliver dementia care for acutely-ill 
patients with ADRD. Traditionally, mental health assistants with training in crisis-
prevention techniques provide care to psychiatric patients. On the intervention unit, 
these mental health assistants, as PES, purposefully engage patients with BPSD. In 
our pilot study, we found that patients with cognitive impairment admitted to the 
PES unit were significantly less likely to require constant observation, chemical 
and physical restraints, suggesting improved management of BPSD. Our central 
hypothesis is that the PES-4-BPSD intervention will improve the ability of PES to 
create an “enabling” milieu that addresses the factors leading to BPSD and 
improves the experience of hospital caregivers. Guided by a social-ecological 
framework, the PES-4-BPSD model incorporates: dementia education and training, 
environmental modifications-cohorting, increased staffing-PES, and staff support. 
Our multidisciplinary research team is well-positioned to accomplish the following 
aims: Aim 1: Determine the preliminary efficacy of the PES-4-BPSD intervention 
for reducing BPSD during hospitalization and Aim 2: Evaluate whether dementia 
care training improves the perceived ability of PES staff (intervention) and nurse 
assistant staff (control) to care for hospitalized persons with ADRD. For Aim 1, we 

Version Date: 03/01/2021 
 
Page 3 of 39 
will conduct a non-randomized preliminary efficacy trial of the PES-4-BPSD 
intervention enrolling N=158 patients (79 control and 79 intervention). The 
primary outcome will be the presence (through a multi-modal approach) of BPSD 
during hospitalization using the Neuropsychiatric Inventory-Questionnaire (NPI-
Q). In Aim 2, we will use survey methodology in a repeated measures design to 
evaluate within and between-group differences in attitudes, experience, and 
satisfaction toward managing patients with ADRD. Measures will be completed at 
baseline (T1), immediately following training (T2), and at end of the intervention 
period (T3). In response to the 2017 NIA Workshop, “Innovating the Next 
Generation of Dementia and Alzheimer's Disease Care Interventions”, this proposal 
will be the first to study an innovative model of care utilizing PES as specialized 
hospital caregivers for reducing BPSD in the hospital setting. Our findings will lay 
the essential groundwork for a multi-site trial of PES-4-BPSD, and will inform the 
development of a program that can be easily implemented in other hospitals. 
Providing care for persons with dementia in the hospital setting is considered 
standard of care. However, it is well known that hospitalized persons with dementia 
have worst outcomes compared to those without dementia. The dementia training 
that will be provided for the staff on the control and intervention units will consist 
of ways to optimize the care already being provided (e.g. better ways to 
communicate with persons with dementia, ways to avoid restraints). The training 
will consist of 7 in-service modules for dementia care. The training is meant to 
improve the care for persons with dementia by providing the staff education on 
dementia care. The training will not change/alter the care but simply optimize the 
care already being provided. The training delivery is considered standard of care 
and is the way all hospital training is provided to hospital staff. The modules will 
be presented on both the intervention and control units to all nursing and NA/PES 
staff. The 7 modules will include: 1) overview of dementia and dementia care; 2) 
addressing unmet needs; 3) avoiding restraints; 4) communicating with persons 
with dementia; 5) delirium; 6) the impact of the physical environment; 7) 
connecting to the family caregiver. The in-service sessions will be given on all 
nursing shifts, therefore covering all staff. The training should not be considered as 
altering the care. The care provided to persons with dementia remains the same 
(considered standard of care), the approach to getting that care will be optimized. 
Persons with dementia are frequently admitted to the hospital and cared for by 
NA/PES/nursing staff. The care provided will be the same, the training will simply 
enhance the care already provided. The hypothesis is that the personnel on the units 
that receive the training will have more confidence to provide this care. Both the 
intervention and control units are already functioning, we are providing training to 
optimize the care. This study aims to evaluate whether the presence of PES is 
necessary to improve care for hospitalized persons with dementia. It is important to 
note that this R21 is a feasibility, exploratory trial that will inform future larger 
efficacy trials.  
 
 
 

Version Date: 03/01/2021 
 
Page 4 of 39 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
• Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
• Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
• Describe the importance of the knowledge expected to result 
 
Patients with Alzheimer’s disease and related dementias (ADRD) are 
frequently admitted to the hospital and have poor outcomes. Persons with 
dementia currently account for 3.2 million hospital admissions per year; they have 
over three times more hospitalizations than persons without cognitive 
impairment.1–3,24 Hospitalization in these patients is a seminal event that often leads 
to delirium, lasting functional and cognitive impairment, institutionalization, 
premature death, increased resource consumption, and family caregiver (FCG) 
distress.4–7,13,25–31 There is a need for interventions to improve the experience and 
outcomes of hospitalization for both the patient and the family caregiver. 
Three-quarters of hospitalized persons with ADRD display behavioral and 
psychological symptoms of dementia (BPSD). For persons with dementia, the 
unfamiliar, complex environment of the hospital and lack of meaningful cognitive 
and physical stimulation results in BPSD (agitation, depression, apathy, repetitive 
questioning, psychosis, aggression, sleep problems, and wandering) that precipitate 
poor outcomes.16,17 BPSD in the hospital setting stems from patient factors (unmet 
needs, e.g. pain, fear, nutrition, toileting), hospital caregiver factors (stress, lack of 
dementia knowledge, communication issues), and environmental factors (lack of 
activity and structure).17 There is a need for an intervention that addresses the 
multi-factorial contributants to BPSD. 
Hospital Caregivers (HCGs) are currently ill-prepared to prevent and manage 
BPSD. HCGs are currently ill-prepared to prevent and manage BPSD and 
experience low job satisfaction, stress and burnout.10–14,32–34 BPSD in the hospital 
setting is commonly associated with the use of psychoactive drugs and physical 
restraints, all associated with adverse events and increased mortality.9,35–40 The use 
of special observation (e.g. CO, sitters), usually performed by nurse assistants, has 
been expanded for the management of older adults with behavioral symptoms.13,41 
In addition to the unsustainable cost, CO by staff without training in dementia care 
and a clear understanding of their role results in poor patients outcomes.13,41,42 A 
National UK audit found that less than 5% of acute hospital staff receives 
mandatory training in dementia and less than a third of hospital providers 
considered staffing as sufficient.14 There is a need for innovative and practical 
approaches to improve dementia care of the acute care workforce. 

Version Date: 03/01/2021 
 
Page 5 of 39 
Theoretical Basis. The 
PES-4-BPSD model 
will be implemented 
within a social 
ecological in-patient 
framework that 
promotes specialized 
care for patients with 
ADRD. The 
framework consists of 
four domains (social 
climate, care system 
processes, policies and 
procedures, physical 
design) and assumes 
that: (a) people cannot 
be understood apart 
from their environmental context, and (b) physical as well as social and 
organizational environments must be studied.18–20 The social-ecological  
framework has been used to study hospitalized older adults with dementia.20 The 
components of the PES-4-BPSD address the factors that predispose hospitalized 
patients with ADRD to develop BPSD, namely: policies and procedures (dementia 
education and training); physical design (environmental modifications including 
cohorting, use of common area, limit noise, lights); care system processes 
(increased staff ratio for non-medical needs with PES); and social climate 
(providing staff support to improve staff attitude and empathy with group 
sessions).20 
Scientific Premise. Persons with dementia occupy 25% of hospital beds.3 The 
quality of their care is a national concern.23,43 HCGs report lack of knowledge, 
skills and confidence in caring for people with dementia.10–14 There is limited 
evidence about the most effective approaches to supporting HCG to deliver better 
care; two review articles have suggested that patients and HCGs might benefit from 
increasing involvement of mental health staff who have chosen to work with 
patients with psychiatric conditions.13,44 We pose that the PES-4-BPSD model, a 
multi-component intervention of mental health assistants with dementia training on 
a dedicated unit, will decrease BPSD and improve HCG experience in caring for 
hospitalized persons with dementia by creating an “enabling” milieu for both 
patients and HCG.  
Innovation. The status quo for caring for hospitalized patients with dementia 
results in poor outcomes and distress for patients, FCGs, and HCGs. Our proposal 
is innovative as it represents a substantive departure in the following ways: 1) it is 
the first study to explore the effectiveness of a new and enhanced model that adapts 
mental health assistants into Patient Engagement Specialists (PES) for the care of 

Version Date: 03/01/2021 
 
Page 6 of 39 
hospitalized persons with ADRD; 2) this study focuses specifically on BPSD, 
which is a critical outcome not only for patients, but also for FCGs and HCGs; and 
3) it evaluates a dementia training program that can be used in the real-world 
setting. 
Preliminary Studies. In our pilot study, we demonstrated the feasibility of 
utilizing PES to provide care for acutely-ill patients with BPSD.15 Patients admitted 
to the intervention unit (with PES) had lower in-hospital mortality (1.1% vs. 2.9%, 
p=.048) and decreased LOS (5.0 vs. 5.8 days, p=.004). They were also less likely to 
have an order for: constant or enhanced observation (12.0% vs. 45.8%, p<0.001 
and 22.1% vs. 79.6%, p<0.001, respectively), benzodiazepines (26.3% vs. 38.0%, 
p<.001), psychotropics (41.2% vs. 54.0%, p<.001), and restraints (3.2% vs. 6.9%, 
p=0.01). Decreased LOS and use of CO (5.94 FTE reduction) resulted in cost 
benefits.  
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
• A concise statement of the goal(s) of the current study.  
• The rationale for and specific objectives of the study.  
• The goals and the hypothesis to be tested should be stated. 
 
We propose an NIA Stage I study of an innovative model of care that aims to 
reduce behavioral and psychological symptoms of dementia (BPSD) during 
hospitalization and improve the experience of hospital caregivers working with 
persons with Alzheimer’s Disease and Related Dementia (ADRD).   
 
Our long-term goal is to implement and disseminate an innovative model of care, 
the PES-4-BPSD, which aims to reduce BPSD by empowering Patient 
Engagement Specialist (PES) to provide specialized dementia care for acutely-ill 
patients with ADRD. PES are mental health assistants with training in crisis 
prevention techniques, who provide care to psychiatric patients, under nursing 
supervision. On the intervention unit, which cohorts older patients with cognitive 
impairment and behavioral symptoms, these mental health assistants purposefully 
engage patients with BPSD, as an added layer of staff. In our pilot study, we found 
that patients with cognitive impairment admitted to the PES unit were significantly 
less likely to require constant observation (CO) (12.0% vs. 45.8%, p<0.001), 
chemical (41.2% vs. 54.0%, p<.001) and physical restraints (3.2% vs. 6.9%, 
p=0.01), suggesting improved management of BPSD.15 Furthermore, the decreased 
use of CO on the unit led to a reduction of 5.94 FTEs over 1 year. The PES in our 
study, however, had not received dementia care training. Given our promising 
findings, we now seek to refine the model by providing PES personnel with 
dementia care training and operational tasks geared to the care of hospitalized 
patients with ADRD.  
 

Version Date: 03/01/2021 
 
Page 7 of 39 
The overall objective of this application is to test the preliminary efficacy of the 
PES-4-BPSD model to reduce BPSD in hospitalized patients with ADRD. Our 
central hypothesis is that the PES-4-BPSD intervention will reduce BPSD by 
improving the ability of PES to create an “enabling” milieu that addresses the 
factors leading to BPSD in the hospital, namely: patient factors (unmet needs), 
hospital caregiver factors (lack of dementia knowledge, communication issues) and 
environmental factors (lack of activity and structure).16,17 Guided by a social-
ecological framework, the PES-4-BPSD model incorporates: policies and 
procedures (dementia education and training), physical design (environmental 
modifications-cohorting), care system processes (increased staffing-PES), and 
social climate (staff support).18–20 The attention control condition will consist of a 
medicine unit that also cohorts older adults in which patient care is performed by 
nurse assistants, rather than PES. To test the added layer of PES staff, nurse 
assistants on the control unit will receive equivalent dementia training. Our 
multidisciplinary research team is well-positioned to complete the following aims: 
 
Aim 1: Determine the preliminary efficacy of the PES-4-BPSD intervention 
for reducing BPSD during hospitalization. We will conduct a non-randomized 
preliminary efficacy trial, enrolling N=158 patients (79 control and 79 
intervention). The primary outcome will be presence of BPSD as measured by a 
patient’s total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q ) 
during hospitalization.21 A multi-modal approach (chart review and questionnaires) 
will be used to determine the presence and severity of BPSD. Secondary measures 
will include length of stay (LOS), BPSD management practices during hospital, 
and family caregiver satisfaction on discharge.14 The study will inform approaches 
to ensure treatment fidelity, use of outcome measures, and effect size estimates for 
a larger cluster-randomized trial. 
 
Aim 2: Evaluate whether dementia care training improves the perceived 
ability of nursing staff, PES staff (intervention) and nurse assistant staff 
(control) to care for hospitalized persons with ADRD. We will use survey 
methodology in a repeated measures design to evaluate within and between-group 
differences in attitudes, experience, and satisfaction toward managing patients with 
ADRD.11,22 Measures will be completed at baseline (T1), immediately following 
training (T2), and at end of the intervention period (T3). 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
• Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 

Version Date: 03/01/2021 
 
Page 8 of 39 
 
Aim 1: This study plans to enroll an equal number of patients (n=79) from the 
control unit and from the intervention unit. This study predicts a 50% recruitment 
rate and approximately 158 patients and FCGs will be approached on each unit 
(316 in total). Based on our preliminary results, the median length of stay for 
persons with dementia in the hospital is 5 on the intervention unit and 5.8 days on 
medicine units. After initial recruitment, all data will be collected through chart 
review and staff questionnaire, there will be minimal requirements from the patient 
and FCGs. In addition, a follow-up phone call to the FCGs will occur within 48 
hours of discharge to assess satisfaction with care. Therefore, attrition in the 
hospital, once patients and FCGs are recruited should be minimal, as they will be in 
the hospital. Telephone numbers for the FCGs will be obtained on recruitment and 
verified on discharge. The PI, with the support of the research team, will spend 12 
weeks to implement the program for the PES staff. Based on the John A. Hartford 
Institute for Geriatric Nursing and the National Alzheimer Association publications 
“Try This: Best Practices in Nursing Care for Persons with Dementia,” and the 
“Person-Centred Care Training Programme for Acute Hospitals (PCTAH)”, the 
PES staff will receive weekly 20 minute sessions.32,34,51,52 Sessions will cover the 
following: types and impact of dementia, providing person-centered care, 
identification of and meeting people's emotional and physical needs, effective 
communication, connecting to the FCG, the impact of the physical environment, 
and redefining and supporting behaviors staff may describe as challenging. To 
ensure all PES receive training, sessions will be repeated during 3 shifts changes. 
Once recruitment begins, the PI will hold monthly 20 minute group sessions, to 
reinforce training and discuss challenging patient behaviors; meant to improve the 
attitude and empathy of HCGs towards patients. 
 
 
Aim 2: All nursing staff on both units, PES staff on the intervention unit and 
nursing assistants on the control unit are eligible to participate in the study. The 
control unit has a total of 40 nurses and 39 nurse assistants and the intervention unit 
has a total of 20 nurses and 21 PES personnel that are eligible to participate. 
Following approval by Northwell’s IRB, the research coordinator/assistant with no 
authority over the staff will directly approach eligible staff, nurses on both units, 
nursing assistants on the control units and PES personnel on the intervention unit, 
to participate in the study, emphasizing that participation is voluntary, with an 
option to opt out of the study at any point without repercussion/effect on the their 
employment. All information collected on employees will be restricted to the 
research team and will not be accessible or discussed with persons in supervisory 
positions. Their participation/non-participation will not affect their job at Northwell 
Health. Reimbursements of $25 will be offered over three installments 
corresponding to the completion of the two surveys at the three time points. A total 
of $75 will be given if completing the two surveys across the three time points.  
 
 
 

Version Date: 03/01/2021 
 
Page 9 of 39 
 
6.  RECRUITMENT METHODS 
• Describe the source of potential subjects 
• Describe the methods that will be used to identify potential subjects 
• Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
• If monetary compensation is to be offered, this should be indicated in the protocol 
 
Aim 1 study plans to enroll an equal number of patients (n=79) from the control 
unit and from the intervention unit. This study predicts a 50% recruitment rate and 
approximately 158 patients and FCGs will be recruited on each unit (316 in total). 
Based on our preliminary results, the median length of stay for persons with 
dementia in the hospital is 5 on the intervention unit and 5.8 days on medicine 
units. After initial recruitment, all data will be collected through chart review and 
staff questionnaire, there will be minimal requirements from the patient and FCGs. 
If FCG participant expresses interest in the study, daily NPI-Q collection via staff 
and EMR will begin. In addition, a follow-up phone call to the FCGs will occur 
within 48 hours of discharge to assess satisfaction with care. Therefore, attrition in 
the hospital, once patients and FCGs are recruited should be minimal, as they will 
be in the hospital. Telephone numbers for the FCGs will be obtained on recruitment 
and verified on discharge. FCG participants will be compensated a total of $30 for 
their participation ($20 at enrollment, $10 upon complete of the discharge follow-
up) via ClinCard which will be given directly if interviewed in person or sent via 
mail if interviewed remotely. 
 
For Aim 2 of our study, all nursing staff on both units, PES staff on the intervention 
unit and nursing assistants on the control unit are eligible to participate in the study. 
Following approval by Northwell’s IRB, the consenting investigator will directly 
approach eligible staff, nurses on both units, nurse assistants on the control units 
and PES personnel on the intervention unit, to participate in the study. Participants 
will be reimbursed for their time. Reimbursements of $25 will be offered over three 
installments (total $75) corresponding to the completion of the two surveys at the 
three time points. 
 
 
 
7.  ELIGIBILITY CRITERIA 
• Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
• Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 

Version Date: 03/01/2021 
 
Page 10 of 39 
• Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
Aim 1: All patients 65 years and older who have an acute medical admission to 
either the control unit (Geriatric Care Model) or intervention unit (PES-4-BPSD).  
Inclusion criteria: age 65 and above, FCG is English-speaking/reading, 
documentation of dementia in the medical record (based on ICD-9 codes). For 
patients without a prior history of dementia documented in the EMR, an AD8 score 
of greater than or equal to 2 will be required. The AD8 is an eight item, informant-
based interview, used to screen for dementia. (57) 
 
Exclusion criteria: patients who are known to be terminally ill and/or receiving 
hospice or surgery; LOS of less than 48 hours, no documentation of dementia in the 
medical record (based on ICD-9), FCG is not English-speaking/reading. 
 
Aim 2: Inclusion criteria: All nursing staff (nurses on both units; PES on the 
intervention unit; and nursing assistant staff on the control unit).  
Exclusion criteria will include staff who decline to participate in the study and staff 
that are not permanently based on either the intervention or control units 
 
 
 
8.  NUMBER OF SUBJECTS 
• Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
• If your study includes different cohorts, include the total number of subjects in each 
cohort. 
• If this is multisite study, include total number of subjects across all sites.   
 
Aim 1 of the study plans to enroll n=158, an equal number of patients (n=79) from 
the control unit and from the intervention unit. 
 
Aim 2 of the study plans to enroll all nursing and PES staff on the intervention unit 
(n=21) and nursing and nursing assistants on the control unit (n=26) who meet 
eligibility criteria.  
 
 
9. STUDY TIMELINES 
• Describe the duration of an individuals participation in the study 
• Describe the duration anticipated to enroll all study subjects 
• The estimated date of study completion 
 
Participants in Aim 1 of our study will be enrolled for their entire stay in the 
control or intervention unit. They will be followed-up within 48 hours after 

Version Date: 03/01/2021 
 
Page 11 of 39 
discharge for a phone interview. The duration anticipated to enroll study subjects 
for Aim 1 is 12 months.  
 
Participants in Aim 2 of our study will be enrolled for 16 months. The duration 
anticipated to enroll study subjects for Aim 2 is 1 month.  
The proposed length of the study period will be 2 years.  
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
Aim 1: The primary endpoint of Aim 1 is the number, frequency, and severity of 
BPSD symptoms as assessed by repeated measures of the Neuropsychiatric 
Inventory-Questionnaire (NPI-Q) during a single acute hospital admission.  
Secondary endpoints will include length of stay, management practices of BPSD 
during stay on unit, and FCG satisfaction on discharge.  
 
Aim 2: The primary endpoints will consist of whether:  
1) Baseline nurses, patient engagement specialists (PES) and nurse assistant 
experience different with regard to caring for patients with dementia;  
2) Training improves the experience of nurses, PES and nurse assistant staff; 
and 
3) Nurses, PES and nurse assistant staff differ in the how they respond to 
dementia care training.  
Secondary endpoints will include the interaction of the nurses, PES and nursing 
assistant demographics (age, sex, race, ethnicity, education, and work experience) 
position (nurses vs. PES vs. nurse assistant) and previous exposure to dementia 
training on the attitude and satisfaction of staff.  
 
 
 
 
11.  RESEARCH PROCEDURES 
• Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 
• Include any screening procedures for eligibility and/or baseline diagnostic tests 
• Include procedures being performed to monitor subjects for safety or minimize risks 
• Include information about drug washout periods 
• If drugs or biologics are being administered provide information on dosing and route 
of administration 
• Clearly indicate which procedures are only being conducted for research purposes. 
• If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
• Describe any source records that will be used to collect data about subjects 
• Indicate the data to be collected, including long term follow-up 

Version Date: 03/01/2021 
 
Page 12 of 39 
 
Aim 1: Prior to patient recruitment, a 3 month dementia training program will be 
implemented on both the intervention and control units. On the intervention unit, 
training will target the PES and on the control to the nurse assistants. The 3 month 
dementia training program is based on the John A. Hartford Institute for Geriatric 
Nursing and the National Alzheimer Association publications Try This: Best 
Practices in Nursing Care for Persons with Dementia, ACT on Alzheimers guide to 
dementia friendly hospitals, and the Person-Centred Care Training Programme for 
Acute Hospitals (PCTAH), the research team will provide PES staff with weekly 
20 minute sessions. The sessions will the following topics: types and impact of 
dementia, providing person-centered care, identification of and meeting peoples 
emotional and physical needs, effective communication, connecting to the FCG, 
the impact of the physical environment, and redefining and supporting behaviors 
staff may describe as challenging. In order to ensure all staff get the training, 
sessions will be repeated 3 times per week during change of shift. Once patient 
recruitment begins, the PI will hold monthly 20 minute group sessions, to reinforce 
training and discuss challenging patient behaviors. 
 
Following the implementation of the dementia care training, eligible patients will 
be offered the opportunity to participate in the study. A waiver of consent will be 
obtained to pre-screen potential participants for age and history of dementia. For 
those eligible, the research coordinator/assistant (RC/RA) will contact the legally 
authorized representative (LAR) and FCG (who might be the same person) to 
provide study information and offer the opportunity to participate.  If enrolled in 
person, written informed consent will be obtained in a private space and stored in a 
secure location. If enrolled via phone, verbal consent will be obtained and 
documented in REDCap and a copy of the consent will be mailed or emailed to the 
participant. If FCG participant expresses interest in the study, daily NPI-Q 
collection via staff and EMR will begin. Once a participant has been enrolled in the 
study, demographic information will be obtained from the EMR and verified by 
FCG, including: age, gender, race/ethnicity, marital status, education, work status, 
current living situation, medical comorbidities, and reason for admission. A 
member of the research team will conduct a short interview with the FCG to verify 
patient background information and obtain baseline (1 month prior to admission) 
functional status (Barthel Index), dementia severity cognitive (Clinical Dementia 
Rating Scale)(5 stages of severity: no 0, questionable 0.5, mild 1, moderate 2, and 
severe 3), and behavioral symptoms using the Neuropsychiatric Inventory 
Questionnaire (NPI-Q). 
 
A member of the research team will then complete daily NPI-Qs to determine the 
number of behaviors and symptoms for each patient on a daily basis. The data 
collector will use a multi-modal approach drawing from electronic medical record 
(EMR) notes and interviews with nursing staff regarding the patients behavior and 
treatment over the past 24 hours (72 hours, if reviewing after a weekend). Delirium 
will be assessed daily by the RC using EMR keywords (e.g., forget, agitated), 
which will be used as a covariate. A final EMR chart review will be conducted 

Version Date: 03/01/2021 
 
Page 13 of 39 
collection information such as length of stay, discharge disposition, in-hospital 
mortality as well as total usage practices for management of BPSD: use of special 
observation (1:1 or enhanced), restraints, psychoactive medications, psychiatric 
evaluation. Within 48 hours of discharge, family caregivers (FCG) will be 
interviewed regarding satisfaction with care using the Carer Questionnaire Data 
from the National Audit of Dementia Round 3. 
 
Aim 2: Following recruitment into the study, participants will complete a short 
demographics survey. Participants will then complete the baseline (prior to 
training) surveys: Approaches to Dementia Questionnaire (ADQ) and Staff 
Experience of Working with Demented Residents Scale (SEWDR). The ADQ is a 
19-item scale designed to evaluate staff attitudes to people with dementia and 
providing dementia care.22, 31 The SEWDR is a 21-item scale measuring staff 
satisfaction in their experiences working with people with dementia as well as their 
work environment.11 A five-point Likert scale is used for both surveys. The total 
score for the ADQ ranges from 19 to 95 and 21 to 105 for the SEWDR, with higher 
scores indicating a more positive attitude or greater satisfaction, respectively. The 
total score for the ADQ and SEWDR will serve as primary outcomes. 
Providing care for persons with dementia in the hospital setting is considered 
standard of care. However, it is well known that hospitalized persons with dementia 
have worst outcomes compared to those without dementia. The dementia training 
that will be provided for the staff on the control and intervention units will consist 
of ways to optimize the care already being provided (e.g. better ways to 
communicate with persons with dementia, ways to avoid restraints). The training 
will consist of 7 in-service modules for dementia care. The PI and the research 
team will spend 3 months implementing the education and training program, which 
will consist of weekly 20 minute sessions. The training is meant to improve the 
care for persons with dementia by providing the staff education on dementia care. 
The training will not change/alter the care but simply optimize the care already 
being provided. The modules will be presented on both the intervention and control 
units to all nursing and NA/PES staff. The 7 modules will include: 1) overview of 
dementia and dementia care; 2) addressing unmet needs; 3) avoiding restraints; 4) 
communicating with persons with dementia; 5) delirium; 6) the impact of the 
physical environment; 7) connecting to the family caregiver. The dementia care 
training program is based on the John A. Hartford Institute for Geriatric Nursing 
and the National Alzheimer Association publications "Try This: Best Practices in 
Nursing Care for Persons with Dementia", ACT on Alzheimer's guide to dementia 
friendly hospitals, and the Person-Centred Care Training Programme for Acute 
Hospitals (PCTAH). 
The in-service sessions will be given on all nursing shifts, therefore covering all 
staff. In order to ensure all nursing, nurse assistants, and PES staff get the training, 
sessions will be repeated 3 times per week during shift change. The training is 
being given to everyone on the unit, but the research only involves those that 
provide consent. The staff (nurses, NA and PES) that give consent will participate 
in Aim 2 (completing the survey at the 3 time points). Since all staff will get the in-
service sessions on both the intervention and control units, this should not “muddy 

Version Date: 03/01/2021 
 
Page 14 of 39 
the waters”. The training should not be considered as altering the care. The care 
provided to persons with dementia remains the same (considered standard of care), 
the approach to getting that care will be optimized. Persons with dementia are 
frequently admitted to the hospital and cared for by NA/PES/nursing staff. The care 
provided will be the same, the training will simply enhance the care already 
provided. The hypothesis is that the personnel on the units that receive the training 
will have more confidence to provide this care.  
 
 
12.  STATISTICAL ANALYSIS 
• Describe how your data will be used to test the hypotheses.  
• State clearly what variables will be tested and what statistical tests will be used. 
• Include sample size calculations.  
• If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
Aim 1: Analysis of covariance (ANCOVA) will be used to compare the primary 
outcome (mean NPI-Q total score) between intervention and control patients. 
Significance will be evaluated based on a two-sided test, with α=.05. To control for 
potential confounding, the model will include a set of covariates selected a priori 
(patient age, gender, race/ethnicity, marital status, CCI, LOS, days of delirium, 
dementia severity, baseline NPI-Q score for the month prior to hospital admission, 
and NPI-Q score from ED to arrival on the unit). Based on a two-sample t-test and 
a type I error rate of .05, a sample size of 63 patients per group will provide at least 
80% power to detect a difference of 3 units in mean NPI-Q score, assuming the 
outcome has a sd of 6.0. A mean difference of 3 has been shown to be clinically 
significant. It has been shown that ANCOVA comparing groups of (1-R2) ∙n 
subjects has the same power as a t-test comparing n subjects, where R2 equals the 
multiple correlation between the selected covariates and the outcome variable (R2 
ranges from 0-1). We will enroll 79 patients per group (158 total) in order to 
account for 20% attrition. Differences in the intervention effect across patient 
subgroups will be assessed individually by testing the significance of the 
interaction between the intervention and the subgroup variable of interest in 
separate multiple linear regression models. We will assess whether sex, race, age, 
delirium days, and dementia severity modify the intervention effect for the primary 
NPI-Q score. 
As a secondary analysis, we will compare intervention and control patients on the 
mean number of NPI-Q behaviors (range 0-12) occurring during hospitalization 
using Poisson regression. Secondary BPSD management outcomes (i.e. use of 
restraints, CO, etc.) will be treated as binary (yes/no) variables and compared 
between intervention and control patients using logistic regression. Differences in 
LOS will be assessed based on a Cox proportional hazards regression model. 
Poisson regression will be employed to assess differences in the mean number of 
delirium days. Regression models for secondary outcomes will be adjusted for the 
covariates described previously. The difference in the proportion of intervention 
and control patients treated with antipsychotics will be assessed with a chi-square 

Version Date: 03/01/2021 
 
Page 15 of 39 
test. Differences in FCG satisfaction between intervention and control will be 
assessed based on responses to question 8 of the National Audit of Dementia Carer 
questionnaire (“Overall, how would you rate the care received by the person you 
look after during the hospital stay?”). Patient responses (excellent, very good, 
good, fair, and poor) will be compared using the Mann-Whitney U test. Lastly, we 
will report study feasibility measures that will be used to inform the planning of a 
future multi-site trial of the PES-4-BPSD intervention, namely: 1) number/percent 
of intervention and control unit patients meeting study eligibility criteria; 2) 
recruitment rate; 3) attrition rate 4) mean and standard deviation of the primary 
outcome (NPI-Q total score). 
 
Aim 2: We will provide descriptive statistics to summarize the demographic 
characteristics of nurses, PES and nursing assistants. For each measurement scale, 
we will perform a two-factor mixed ANOVA where ADQ/SEWDR score is the 
within subject factor having 3 levels (T1, T2, T3), and group is the between subject 
factor having 3 levels (nurses, PES, nurse assistant). We will assess the 
significance of the interaction between the two factors in order to determine 
whether nurses, PES and nurse assistant staff differ in their change in 
ADQ/SEWDR scores across the 3 time points. Post hoc tests will be used to 
compare scores between nurses, PES and nurse assistants at T1, and to assess 
whether the scores of each group differ across the 3 time points.  
 
 
13. SPECIMEN BANKING 
• If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
• List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
• Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• Describe the data and specimens to be sent out or received.  As applicable, describe: 
o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• Describe the steps that will be taken to secure the data during storage, use and 
transmission. 

Version Date: 03/01/2021 
 
Page 16 of 39 
 
The principal investigator (Dr. Liron Sinvani), co-investigator (Dr. Marie Boltz), 
and research team will be responsible for maintaining our data and maintaining 
security. We will use standard IRB-approved and HIPAA-compliant measures to 
maintain confidentiality, privacy and data security. Data privacy and security 
procedures will include: (1) training staff on data sensitivity and protocols for 
safeguarding confidentiality, (2) storing and processing sensitive hardcopy in a 
secured, centralized location, (3) securing sensitive hardcopies in locked files when 
not in use, (4) removing names, addresses, and other direct identifiers from 
hardcopy and computer-readable data when they are no longer necessary for patient 
tracking and then using encrypted codes for subsequent identification of 
participants, (5) destroying all identifiable linkages to data after data accuracy has 
been verified and final analyses have been completed, (6) capturing and storing 
follow-up assessments in REDCap, a secure web-based HIPAA compliant 
application designed to support data capture for research studies, and (7) using 
restricted logon identification and password protection computer protocols for all 
computerized entry, retrieval, and analysis. We have developed a clear and concise 
privacy and security plan. Northwell is well suited to develop such a plan as we are 
currently engaging in similar health technology projects that secure the electronic 
submittal of health information from patient to health system. 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 
•  Indicate who will perform the data and safety monitoring for this study.   
• Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
• List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
• Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
• Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
• Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   

Version Date: 03/01/2021 
 
Page 17 of 39 
 
The proposed project is a low-risk study. The study team will review the data on a 
weekly basis. The work will be conducted with approval from the Human Research 
Protection Program (HRPP). 
As per Northwell Health HRPP policies, the PI is required to notify the HRPP 
promptly of any unanticipated problems involving risks to subjects or others that 
might occur. The PI will monitor the progress of the study and safety of 
participants on an ongoing basis. The procedures of this study, such as regular 
meetings with research staff, will ensure discussion and reporting of all possible 
outcomes including any, though unlikely, adverse events. If the adverse event is 
due to the study and is unexpected, the PI will draft a safety report and send a copy 
to the HRPP. The HRPP committee will serve as an objective review mechanism. 
This policy/procedure means that any potential conflict of interest inherent in the PI 
being the sole reviewers of serious adverse advents is avoided. 
 
Plans for assuring adherence with requirements regarding the reporting of adverse 
events (AEs). All serious AEs (e.g., medical occurrences resulting in death) that 
occur during the study defined by the given protocol, regardless of the relation to 
the research, must be reported to the HRPP by telephone, e-mail, or fax within 24 
hours of the investigator’s awareness of the occurrence of the event. The PI will 
report SAEs to the HRPP and will disseminate information to other agencies as 
necessary. These initial reports are followed by a safety report which is a written 
account of the serious AE determined by a sponsor/investigator to be both related 
to the treatment under investigation and to be unexpected in nature. Serious AEs 
will be summarized annually in the HRPP application for continuation or 
termination of research. All expected non-serious AEs that occur at a greater 
frequency or severity than anticipated and all unexpected non-serious AEs will be 
reported to the HRPP within 15 working days of the investigators becoming aware 
of the event. These AEs are also summarized annually in the HRPP application for 
continuation or termination of the research. 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 
 
We plan to use a Safety Monitoring Committee (SMC) for this study. A SMC will 
be created to provide oversight and monitoring to ensure the safety of participants 
and the integrity of the data. Upon review and approval by the National Institute on 
Nursing Research (NINR) Program Official (PO), we plan the SMC to be chaired 
by a researcher (Renee Pekmezaris, PhD) who has extensive expertise in data 
safety and monitoring, clinical trials, and dementia caregiving research including 
bioethical considerations. The additional members of the DMSB will include a 
biostatisticians (Cristina Sison, PhD) who has experience on a SMC, a geriatrician 
(Gisele Wolf-Klein, MD) with extensive experience in care of older adults with 
dementia and a senior administrative manager for research (Tiffany Harvin, MBA). 

Version Date: 03/01/2021 
 
Page 18 of 39 
Given their clinical and research expertise, Drs. Pekmezaris and Wolf-Klein will be 
responsible for monitoring for adverse events and their potential relationship to the 
intervention. Dr. Sison and Ms. Harvin will ensure data security and privacy 
protections. Ms. Harvin will also be responsible for submitting necessary reports to 
the PI and if needed to IRB as well as NINR staff. The PI will be responsible for 
compliance with the SMC plan. The SMC will convene prior to the enrollment of 
subjects and then quarterly for the duration of the study. The group will meet prior 
to subject recruitment and then every 6 months for the duration of the study via 
web conferencing. Telephone conferencing and email may be used for additional 
interactions as needed. At the end of each meeting the committee will make 
recommendations to NIH, institutional review board(s) and the PI and investigative 
team concerning continuation or conclusion of the trial. 
 
 
16. WITHDRAWAL OF SUBJECTS 
• Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• Describe procedures for orderly termination 
• Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
Subjects will not be withdrawn from the study (both Aim 1 and Aim 2) without 
their consent.  
Aim 1: Patients do not have ability to remove themselves from the intervention 
unit, but can choose to not participate in the study and withdraw from the study at 
any point, even following discharge from the hospital. If they do opt out, the 
treatment will not be altered in any way. On the control unit, patients and FCGs 
still benefit for dementia care training for nurse assistant staff. While patients and 
FCGs cannot remove themselves from the unit, they can decline to participate in 
the study and can withdraw at any point, even after discharge. 
Aim 2: While nurses, PES and NA personnel cannot remove themselves from the 
intervention or control units, they can choose not to participate in the study and can 
withdraw at any point throughout the entire study. This will not alter their job in 
any way. If a nurse, PES or NA choose from withdraw from the study, data on the 
patients they are caring for may still be collected. This should not interfere with 
their job in any way. 
 
 
17. RISKS TO SUBJECTS 
• Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
• Include risks to others , like sexual partners (if appropriate) 

Version Date: 03/01/2021 
 
Page 19 of 39 
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to results 
• Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 
Aim 1: Risks to subjects 
The primary potential risk of participating in this study is breach of confidentiality. 
Northwell Health and the research team will take all possible steps to ensure the 
security of the collected information. Inclusion in the intervention unit does not 
qualify as more than minimal risk because all standard of care practices are still 
present on the unit; the implementation of the intervention only adds an additional 
layer of trained healthcare professionals whose presence has been shown to be 
beneficial. Patients do not have ability to remove themselves from the intervention 
unit, but can choose to not participate in the study and withdraw from the study at 
any point, even following discharge from the hospital. If they do opt out, the 
treatment will not be altered in any way. On the control unit, patients and FCGs 
still benefit for dementia care training for nurse assistant staff. While patients and 
FCGs cannot remove themselves from the unit, they can decline to participate in 
the study and can withdraw at any point, even after discharge. If the RC observes 
concerning behavior, she will alert the nurse or another staff member immediately. 
If the RC is called by the patient, the RC will alert the unit staff. The RC will have 
direct telephone numbers to Dr. Sinvani (PI) and Dr. Warner-Cohen (clinical 
psychologist) and can contact them at any time. 
Aim 1 Protections against Risk We do not expect any adverse events directly 
attributable to the presence of the PES-4-BPSD intervention on the unit or with the 
dementia care training for nurse assistant staff on the control unit.  
 
The primary risk of this study is loss of confidentiality. The researchers take the 
issue of confidentiality very seriously.  IRB-approved and HIPAA compliant 
measures will be used to maintain patient confidentiality, privacy and data security. 
Extensive efforts will be undertaken to maintain study participants’ confidentiality 
and privacy. All study materials will be stored in locked file cabinets to which only 
study personnel will have access. 
 
Northwell Health has policies and procedure in place to protect ePHI with 
reasonable administrative, technical, and physical safeguards to ensure the 
confidentiality, integrity and availability of the PHI and to prevent unauthorized 
and inappropriate access, use or disclosure of the data. Along with the 
organizational administrative, technical and physical safeguards and IRB approved 
measures, data privacy, security and confidentiality activities will include but not 
limited to -  
Training staff on data sensitivity and protocols for safeguarding confidentiality;  
Storing and processing sensitive hardcopy in a secured, centralized location;  
Securing sensitive hardcopies in locked files when not in use; which only study 
personnel will have access.   

Version Date: 03/01/2021 
 
Page 20 of 39 
Removing names, addresses, and other direct identifiers from hardcopy and 
computer-readable data when they are no longer necessary for patient tracking and 
then using encrypted codes for subsequent identification of participants;  
Destroying all identifiable linkages to data after data accuracy has been verified 
and final analyses have been completed (Disposal Policy for Protected Health and 
Confidential Health System Information – policy no 800.47); and  
Using restricted logon identification and password protection computer protocols 
for all computerized entry, retrieval, and analysis. 
 
Additionally, all personnel will be instructed in the ethics of electronic data access.  
All database servers are housed in Northwell Health’s secure data center and are 
subject to institutional policies on security, backup, recovery and control.  
Passwords for data files are managed in accordance with institutional policies. 
 
Aim 2: Risks to subjects 
The primary risk to the nursing staff, PES staff and nurse assistant staff 
participating in the study is a breach in confidentiality. However, to protect 
subjects’ privacy all data will be de-identified and stored on HIPPA compliant 
drives or applications such as REDCap. 
 
There is a risk of a negative impact on mood, anxiety levels, and emotions of 
participants due to the increased stress of being asked to evaluate their own care 
abilities and experiences. To address this, the PI and an on-site clinical 
psychologist (Dr. Jessy Warner-Cohen) will be available to provide staff support. 
The training and support provided to both groups (nurses, PES and nurse assistants) 
is anticipated to increase staff self-efficacy and experience in caring for patients 
with dementia. 
 
Aim 2 Protections Against Risk 
The researchers take the issue of confidentiality very seriously.  IRB-approved and 
HIPAA compliant measures will be used to maintain patient confidentiality, 
privacy and data security. Extensive efforts will be undertaken to maintain study 
participants’ confidentiality and privacy. All study materials will be stored 
electronically and in locked file cabinets to which only study personnel will have 
access. 
 
Northwell Health has policies and procedure in place to protect ePHI with 
reasonable administrative, technical, and physical safeguards to ensure the 
confidentiality, integrity and availability of the PHI and to prevent unauthorized 
and inappropriate access, use or disclosure of the data. Along with the 
organizational administrative, technical and physical safeguards and IRB approved 
measures, data privacy, security and confidentiality activities will include but not 
limited to -  
Training staff on data sensitivity and protocols for safeguarding confidentiality;  
Storing and processing sensitive hardcopy in a secured, centralized location;  
Securing sensitive hardcopies in locked files when not in use; which only study 

Version Date: 03/01/2021 
 
Page 21 of 39 
personnel will have access.   
Removing names, addresses, and other direct identifiers from hardcopy and 
computer-readable data when they are no longer necessary for patient tracking and 
then using encrypted codes for subsequent identification of participants;  
Destroying all identifiable linkages to data after data accuracy has been verified 
and final analyses have been completed (Disposal Policy for Protected Health and 
Confidential Health System Information – policy no 800.47); and  
Using restricted logon identification and password protection computer protocols 
for all computerized entry, retrieval, and analysis. 
 
Additionally, all personnel will be instructed in the ethics of electronic data access.  
All database servers are housed in Northwell Health’s secure data center and are 
subject to institutional policies on security, backup, recovery and control.  
Passwords for data files are managed in accordance with institutional policies. 
 
 
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
• If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 
We do not expect any adverse events directly attributable to the presence of the 
PES-4-BPSD intervention on the unit or with the dementia care training for nurse 
assistant staff on the control unit. 
 
The PI and an on-site clinical psychologist (Dr. Jessy Warner-Cohen) will be 
available to provide psychological resources to Aim 2 participants due to the risk of 
a negative impact on mood, anxiety levels, and emotions of participants due to the 
increased stress of being asked to evaluate their own care abilities and experiences. 
 
While we do not anticipate any adverse events, in the case of a study-related 
adverse event, in accordance with Northwell Health guidelines, this protocol will 
employ the following mechanisms for adverse event reporting: 1) alert IRB of any 
and all reports of adverse events; 2) inform all members of the study team of any 
and all reports of adverse events. If three or more adverse events are reported, the 
study team will assess potential causes of the adverse events and, if events are 
clearly linked to study participation, discontinue the study. 
 
 
 

Version Date: 03/01/2021 
 
Page 22 of 39 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
• Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
Aim 1: 
The presence of PES personnel on the intervention unit has been shown to be 
beneficial to patient care in a prior study.16 For the control unit, dementia care 
training has not been associated with any harm to patients, FCGs, or HCGs and can 
potentially improve care. 
 
Aim 2: 
Nurses, PES and nurse assistants who choose to participate in this study will 
benefit from training that is directly relevant to their employment. The 
implementation of this model aims to improve the experience of HCGs in caring 
for hospitalized persons with dementia – by improving their knowledge of 
dementia as well as tools to better engage persons with dementia. Patients on the 
intervention unit will benefit from the presence of staff that have been specifically 
trained in the management of BPSD and the care of patients with ADRD. 
 
 
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 
 Aim 1: 
A waiver of consent will be obtained to pre-screen potential participants for age 
and history of dementia or nurse report of confusion. Patients will be identified as 
being potential participants through either the electronic records system or nurse 
report. No PHI will be shared; all information will only be linked to a unique 
number that cannot be traced back to the participant. For those eligible, the 
research coordinator (RC) will contact the legally authorized representative (LAR) 
and FCG (who might be the same person) to provide study information and offer 
the opportunity to participate. Patient information will be password protected and 
kept on a PHI protected file on the health system’s server. This database is 
password protected and HIPAA compliant. All hard copies of documents (such as 
the original consents) will be kept in a locked cabinet that only the Northwell 
Health research staff will be able to access. 

Version Date: 03/01/2021 
 
Page 23 of 39 
 
Aim 2: All nurses on the control and intervention units as well as nursing assistants 
on the control unit and PES personnel on the intervention unit will be eligible to 
participate in the study. Potential participants will be informed of the study. 
 
Consent for both aims will be obtained in a private space.    
 
 
 
21.  COSTS TO SUBJECTS 
 
• Describe any foreseeable costs that subjects may incur through participation in the 
research 
• Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
n/a 
 
 
 
22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
FCG participants will be compensated a total of $30 for their participation ($20 at 
enrollment, $10 upon complete of the discharge follow-up) via ClinCard which will 
be given directly if interviewed in person or sent via mail if interviewed remotely. 
 
Reimbursements of $25 will be offered to participants of Aim 2 over three 
installments (total $75) corresponding to the completion of the two surveys at the 
three time points (baseline, after training, and at end of intervention.   
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 
• Any waiting period available between informing the prospective participant and 
obtaining consent 
• Steps that will be taken to assure the participants’ understanding 
• Any tools that will be utilized during the consent process 
•   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• Procedures for maintaining informed consent.   
 

Version Date: 03/01/2021 
 
Page 24 of 39 
Aim 1: 
A waiver of consent will be obtained to pre-screen potential participants for age 
and history of dementia or nurse report of confusion. For those eligible, the 
research coordinator (RC) will contact the legally authorized representative 
(LAR) and FCG (who might be the same person) to provide study information 
and offer the opportunity to participate. If the LAR is not present, the EMR will 
be reviewed for contact information to speak with the LAR via phone. The 
research team member will offer the participant’s LAR a study packet in person 
or electronically via email link to REDCap (study information, a copy of the 
consent form, research team contact numbers), explain all aspects of the study, 
and state that participation of the study is voluntary, that the participant or his 
or her legal representative may opt out at any time, and that the decision to 
decline to participate or to opt out will not affect the patient’s treatment. If FCG 
participant expresses interest in the study, daily NPI-Q collection via staff and 
EMR will begin. If enrolled in person, written informed consent will be 
obtained in a private space and stored in a secure location. If enrolled via 
phone, verbal consent will be obtained and documented in REDCap and a copy 
of the consent will be mailed or emailed to the participant. FCGs, who may or 
may not be the same person as the LAR, will be consented in the same manner. 
Once consented, the Research Coordinator/Research Assistant will proceed 
with research surveys. In the future, we may publish results of this study in 
scientific journals and may present it at scientific meetings. If we do, we will 
not identify the subject.  All data included in the publication will be de-
identified. 
 
Aim 2: The consenting investigator will directly approach eligible staff nurses 
on both units, nursing assistants on the control unit and PES personnel on the 
intervention unit, to participate in the study. Potential participants will be 
informed of the study. The investigator will emphasize that the study is 
voluntary, that the participant has the right to opt out of the study at any point 
without repercussion, and that the decision to decline to participate or to opt out 
of the study will not in any way affect their employment. Consent will be 
requested by a member of the research team trained in Northwell Health’s 
consent procedures. The RC will be someone who could not be interpreted to 
be in a position of power or influence over the participant 
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
• How parental permission will be obtained 
• From how many parents will parental permission be obtained 
• Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
• Whether or not assent will be obtained from the child 
• How will assent be documented 

Version Date: 03/01/2021 
 
Page 25 of 39 
• Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   
 
n/a 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 
• The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
• If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 
o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
 
The Comprehension Assessment Form was initially being used to determine 
whether an individual was capable of consenting to participate in the study; 
however, due to the requirement for documented history of dementia and 
the severe nature of the illness, patients are unable to understand and give 
consent. Therefore, it would be least disruptive to the patient to forgo the 
Comprehension Assessment Form and for the RC to go directly to the LAR 
to present study information and obtain consent. All patient observations 
are obtained through family caregiver, hospital caregivers, and electronic 
medical records as to not disrupt the patient. 
 
 
If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• Indicate whether or not consent forms will be translated into a language other 
than English 

Version Date: 03/01/2021 
 
Page 26 of 39 
• Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
na 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
 N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 
• Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
• Explain why it is impracticable to conduct this research if informed consent is 
required   
• Explain why it is not possible to conduct this research without using the 
information or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
We are seeking a waiver of consent to pre-screen potential participants for age 
and history of dementia; patients will be identified as being potential 
participants through the electronic records system. Once potential participants 
have been identified and express interest in the study, daily NPI-Q collection 
via staff and EMR will begin. If enrolled in person, written informed consent 
will be obtained in a private space or through REDCap (if contacted via 
phone) and stored in a secure location. If enrolled via phone, verbal consent 
will be obtained and documented in REDCap and a copy of the consent will be 
mailed or emailed to the participant. FCGs, who may or may not be the same 
person as the LAR, will be consented in the same manner In the future, we 
may publish results of this study in scientific journals and may present it at 
scientific meetings. If we do, we will not identify the subject.  All data 
included in the publication will be de-identified.  
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• Explain how the only record linking the subject to the research would be the 
consent document. 

Version Date: 03/01/2021 
 
Page 27 of 39 
• Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
N/A 
 
SUBSECTION 2 
•  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
• Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
We do not anticipate any risk of harm to the subjects. The study involves no 
more than minimal risk because all standard of care practices are still present on 
the unit; the implementation of the intervention unit only adds an additional 
layer of trained healthcare professionals whose presence has been shown to be 
beneficial. The primary risk of this study is loss of confidentiality. The 
researchers take the issue of confidentiality very seriously.  IRB-approved and 
HIPAA compliant measures will be used to maintain patient confidentiality, 
privacy and data security. Extensive efforts will be undertaken to maintain 
study participants’ confidentiality and privacy. REDCap will be used to store 
data. 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
• Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
• Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
•  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 
• Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
• Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 
 
N/A 

Version Date: 03/01/2021 
 
Page 28 of 39 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
• Describe how data will be collected and used:  
• Indicate why you need the PHI (e.g.PHI is required to determine eligibility, 
identifiers are necessary to contact the individual to discuss participation, other) 
• Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
Data will be collected from electronic health records. PHI is needed to 
determine eligibility of potential subjects, identifiers are necessary to contact 
the individual to discuss participation in the study.  
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 
 
If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
Informed consent will be obtained from the LAR/FCG of all patients participating in 
the study prior to any information gathering (except for 4 pre-screening items). Patients 
will be identified as being potential participants through the EMR (based on age and 
history of dementia). The research coordinator, trained in Northwell Health’s consent 
procedures will approach the LAR and FCG on the medical unit (or contact them via 
phone, if unavailable in person during research hours). The person obtaining consent 
will discuss the study with the patient’s legal representative to obtain consent. If the 
LAR is not present, the EMR will be reviewed for contact information to speak with 

Version Date: 03/01/2021 
 
Page 29 of 39 
the LAR via phone. The research team member will offer the participant's legally 
authorized representative (LAR) a study packet (study information, a copy of the 
consent form, research team contact numbers), explain all aspects of the study, and 
state that participation of the study is voluntary, that the participant or his or her legal 
representative may opt out at any time, and that the decision to decline to participate or 
to opt out will not affect the patient’s treatment. If enrolled in person, written informed 
consent will be obtained in a private space and stored in a secure location. If enrolled 
via phone, verbal consent will be obtained and documented in REDCap and a copy of 
the consent will be mailed or emailed to the participant. FCGs, who may or may not be 
the same person as the LAR, will be consented in the same manner. 
 
While an individual with dementia is at increased risk of hospital acquired 
complications such as delirium and functional decline, the intervention and control 
units do not pose an increased risk. Inclusion in the intervention and control units does 
not qualify as more than minimal risk because all standard of care practices are still 
present on the unit; the implementation of the intervention unit only adds an additional 
layer of trained healthcare professionals whose presence has been shown to be 
beneficial. Patients do not have ability to remove themselves from the intervention 
unit, but can choose to not participate in the study and withdraw from the study at any 
point, even following discharge from the hospital. If they do opt out, the treatment will 
not be altered in any way. On the control unit, patients and FCGs still benefit from 
dementia care training for nurse assistant staff. While patients and FCGs cannot 
remove themselves from the unit, they can decline to participate in the study and can 
withdraw at any point, even after discharge. If the RC observes concerning behavior, 
he will alert the nurse or another staff member immediately. If the RC is called by the 
patient, the RC will alert the unit staff. The RC will have direct telephone numbers to 
Dr. Sinvani (PI) and Dr. Warner-Cohen (clinical psychologist) and can contact them at 
any time. 
 
We do not expect any adverse events directly attributable to the presence of the PES-4-
BPSD intervention on the unit or with the dementia care training for nurse assistant 
staff on the control unit. While the RC will be on the intervention and control units to 
collect NPI-Q information, they will not have any direct interactions with the patients. 
If the RC observes concerning behavior, she will alert the nurse or another staff 
member immediately. If the RC is called by the patient, the RC will alert the unit staff. 
The RC will have direct telephone numbers to Dr. Sinvani (PI) and Dr. Warner-Cohen 
(clinical psychologist) and can contact them at any time. The PI plans to hold weekly 
meetings with the PES and nursing assistants to conduct patient reviews to support 
treatment fidelity and safety. 
 
The primary risk of this study is loss of confidentiality. The researchers take the issue 
of confidentiality very seriously.  IRB-approved and HIPAA compliant measures will 
be used to maintain patient confidentiality, privacy and data security. Extensive efforts 
will be undertaken to maintain study participants’ confidentiality and privacy. Only 
study team members that are on the Institutional Review Board (IRB) approved 
protocol will have access to the data that will be saved on a secured Northwell Health 

Version Date: 03/01/2021 
 
Page 30 of 39 
drive. Individuals will be provided with a simple and timely means to access the 
collected data. They will meet the minimum and mandatory requirement to access the 
identifiable information as per the standards set by Northwell Health. Access and use 
of the data will be strictly monitored by the Principal Investigator (PI) and the research 
team. Northwell Health’s Administrative Policy and Procedure Manual policy number 
800.42 titled Confidentiality of Protected Health Information particularly addresses the 
access and use of the electronic protected health information (ePHI). The purpose of 
this policy is to establish the general requirements for protecting the confidentiality of 
protected health information (PHI) while allowing the use, access and disclosure for 
the purpose of providing high quality care at Northwell Health. PHI is any oral, written 
or electronic individually identifiable health information collected or stored by a 
facility. PHI includes also any demographic information and any information that 
relates to past, present or future physical or mental condition of an individual. 
 
Northwell Health has policies and procedure in place to protect ePHI with reasonable 
administrative, technical, and physical safeguards to ensure the confidentiality, 
integrity and availability of the PHI and to prevent unauthorized and inappropriate 
access, use or disclosure of the data. Along with the organizational administrative, 
technical and physical safeguards and IRB approved measures, data privacy, security 
and confidentiality activities will include but not limited to -  
1. 
Training staff on data sensitivity and protocols for safeguarding confidentiality;  
2. 
Storing and processing sensitive hardcopy in a secured, centralized location;  
3. 
Securing sensitive hardcopies in locked files when not in use; which only study 
personnel will have access.   
4. 
Removing names, addresses, and other direct identifiers from hardcopy and 
computer-readable data when they are no longer necessary for patient tracking and then 
using encrypted codes for subsequent identification of participants;  
5. 
Destroying all identifiable linkages to data after data accuracy has been verified 
and final analyses have been completed (Disposal Policy for Protected Health and 
Confidential Health System Information – policy no 800.47); and  
6. 
Using restricted logon identification and password protection computer 
protocols for all computerized entry, retrieval, and analysis. 
 
Additionally, all personnel will be instructed in the ethics of electronic data access. 
Everything will follow the strict Health care Information and Technology – Privacy 
and Security rules, regulations, policies and procedures, and protocols established at 
Northwell Health based on the industry standards. Application and data access will be 
controlled by appropriate authentication and authorization measures. It is the policy of 
the health system to use encryption safeguards on Sensitive and Highly Sensitive data 
as defined in the Data Classification Policy (900.12), such as ePHI, to ensure data 
authenticity and integrity where reasonable and appropriate, and in accordance with 
applicable laws and regulations.  
 
The purpose of the Data Encryption and Integrity Policy (900.25) from the 
administrative policy and procedure manual is to state what cryptographic techniques 
are acceptable and how cryptography will be used at Northwell Health.  

Version Date: 03/01/2021 
 
Page 31 of 39 
 
Facility Access Controls Policy (100.99) identifies the security plan to safeguard its 
facilities from unauthorized physical access and to safeguard the equipment from 
unauthorized physical access, tampering, and theft while ensuring that environmental 
safeguards are in place to protect the confidentiality, access and integrity of protected 
health information as commensurate with data criticality and risk assessment. This is to 
ensure and prevent from unauthorized physical access and to safeguard the equipment 
and business documents including, but not limited to, clinical and business documents 
from unauthorized physical access, tampering and theft.  
 
We will establish and ensure that appropriate limits on the type and amount of 
information collected, used, and/or disclosed are in place. This will increase privacy 
protections and is essential to building trust in electronic exchange of individually 
identifiable health information because it minimizes potential misuse and abuse. 
Northwell Health’s Information System Review and Audit Controls Policy (900.27) 
will allow us to maintain a comprehensive internal security control and audit program, 
and established procedures and record keeping activities to ensure proper legal, ethical 
and business practices. This will complement the user authentication process and acts 
as a deterrent to internal abuse by making users aware that audit trails, access reports, 
and security incident tracking reports are produced, reviewed and, where applicable, 
investigated. These internal security controls may take various forms including regular 
information system activity review. These reviews incorporate logon monitoring, audit 
trails and logs, access reports, and manually produced security incident tracking reports 
for network and ePHI systems.  
 
It is the policy of health system to have departmental procedures (e.g. human resource, 
corporate security and information services) to grant, modify and revoke access, 
permissions and rights to health system networks, systems, applications, facilities and 
physical locations to staff based on their roles and responsibilities.  
 
We plan to use a Safety Monitoring Committee (SMC) for this study. A SMC will be 
created to provide oversight and monitoring to ensure the safety of participants and the 
integrity of the data. Upon review and approval by the National Institute on Nursing 
Research (NINR) Program Official (PO), we plan the SMC to be chaired by a 
researcher (Renee Pekmezaris, PhD) who has extensive expertise in data safety and 
monitoring, clinical trials, and dementia caregiving research including bioethical 
considerations. The additional members of the DMSB will include a biostatisticians 
(Cristina Sison, PhD) who has experience on a SMC, a geriatrician (Gisele Wolf-Klein, 
MD) with extensive experience in care of older adults with dementia and a senior 
administrative manager for research (Tiffany Harvin, MBA). Given their clinical and 
research expertise, Drs. Pekmezaris and Wolf-Klein will be responsible for monitoring 
for adverse events and their potential relationship to the intervention. Dr. Sison and 
Ms. Harvin will ensure data security and privacy protections. Ms. Harvin will also be 
responsible for submitting necessary reports to the PI and if needed to IRB as well as 
NINR staff. The PI will be responsible for compliance with the SMC plan. The SMC 
will convene prior to the enrollment of subjects and then quarterly for the duration of 

Version Date: 03/01/2021 
 
Page 32 of 39 
the study. The group will meet prior to subject recruitment and then every 6 months for 
the duration of the study via web conferencing. Telephone conferencing and email may 
be used for additional interactions as needed. At the end of each meeting the committee 
will make recommendations to NIH, institutional review board(s) and the PI and 
investigative team concerning continuation or conclusion of the trial. 
 
The group will meet at least annually via web conferencing. Telephone conferencing 
and email may be used for additional interactions as needed. The first meeting of the 
SMC will be prior to recruitment of participants and will focus on review of the study 
protocol and recruitment plan, consideration of participant burden, and a review of our 
plan for participant safety and comfort. The subsequent meetings will focus on the 
progress of the study with regard to data quality and timeliness, participant consent, 
accrual and retention of participants, participant risk versus benefit, performance of 
intervention units, and any adverse events that occur during the course of the study to 
date. One or more major adverse events will also trigger a SMC meeting.  At the end of 
each meeting the committee will make recommendations to NIH, institutional review 
board(s) and the PI and investigative team concerning continuation or conclusion of the 
trial.  
 
Vulnerable Subjects 
The study will consider long-term care residents as eligible for the study. For nursing 
home patients who are eligible for study, the RC will present study information to the 
patient's LAR and family caregiver. Participation in the study is voluntary and 
patients/caregiver may decline. Given the prevalence of dementia in the nursing home 
setting, it will be important to include this patient population. 
 
All subject information will be kept confidential and only shared with the research 
staff. All Northwell Health employees will be assured that there will be no 
consequences to their job status should they chose to participate or not to participate in 
this study. In addition, no one in a supervisory position over an employee will be 
involved in obtaining consent. No one with authority in, or affiliation to, the control 
and intervention units will have access to identifiable data. 
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
N/A 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 

Version Date: 03/01/2021 
 
Page 33 of 39 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful. 
 
References 
1. 
Phelan EA, Borson S, Grothaus L, Balch S, Larson EB. Association of incident 
dementia with hospitalizations. Jama. 2012;307(2):165–172. PMID:22235087 
PMCID: PMC3312921 DOI: 10.1001/jama.2011.1964 
 
2. 
Feng Z, Coots LA, Kaganova Y, Wiener JM. Hospital and ED use among 
Medicare beneficiaries with dementia varies by setting and proximity to death. 
Health Aff (Millwood). 2014;33(4):683–690. PMID:24711331 DOI: 
10.1377/hlthaff.2013.1179 
 
3. 
Alzheimer’s Association. 2017 Alzheimer’s disease facts and figures. 
Alzheimers Dement. 2017;13(4):325–373. 
 
4. 
Stern Y, Tang M-X, Albert MS, Brandt J, Jacobs DM, Bell K, et al. Predicting 
time to nursing home care and death in individuals with Alzheimer disease. 
Jama. 1997;277(10):806–812. PMID:9052710 
 
5. 
Andrieu S, Reynish E, Nourhashemi F, Shakespeare A, Moulias S, Ousset PJ, 
et al. Predictive factors of acute hospitalization in 134 patients with 
Alzheimer’s disease: a one year prospective study. Int J Geriatr Psychiatry. 
2002;17(5):422–426. PMID:11994930 DOI:10.1002/gps.624 
 
6. 
Wancata J, Windhaber J, Krautgartner M, Alexandrowicz R. The consequences 
of non-cognitive symptoms of dementia in medical hospital departments. Int J 
Psychiatry Med. 2003;33(3):257–271. PMID:15089007 DOI:10.2190/ABXK-
FMWG-98YP-D1CU. 
 
7. 
Fick DM, Steis MR, Waller JL, Inouye SK. Delirium superimposed on 
dementia is associated with prolonged length of stay and poor outcomes in 
hospitalized older adults. J Hosp Med. 2013;8(9):500–505. PMID: 23955965 
PMCID: PMC3928030 DOI: 10.1002/jhm.2077 
 
8. 
Sampson EL, White N, Leurent B, Scott S, Lord K, Round J, et al. Behavioural 
and psychiatric symptoms in people with dementia admitted to the acute 
hospital: prospective cohort study. Br J Psychiatry. 2014;205:186–196. PMID: 
25061120 PMCID: PMC4432387 DOI: 10.1192/bjp.bp.113.130948 
 
9. 
White N, Leurent B, Lord K, Scott S, Jones L, Sampson EL. The management 
of behavioural and psychological symptoms of dementia in the acute general 
medical hospital: a longitudinal cohort study. Int J Geriatr Psychiatry. 
2017;32(3):297–305. PMID: 27019375 PMCID: PMC5324689 DOI: 
10.1002/gps.4463 
 

Version Date: 03/01/2021 
 
Page 34 of 39 
10. 
Hessler JB, Schäufele M, Hendlmeier I, Junge MN, Leonhardt S, Weber J, et al. 
Behavioural and psychological symptoms in general hospital patients with 
dementia, distress for nursing staff and complications in care: results of the 
General Hospital Study. Epidemiol Psychiatr Sci. 2018;27(3):278–287. PMID: 
28065176 DOI: 10.1017/S2045796016001098 
 
11. 
Åström S, Nilsson M, Norberg A, Sandman P-O, Winblad B. Staff burnout in 
dementia care—relations to empathy and attitudes. Int J Nurs Stud. 1991 Jan 
1;28(1):65–75. PMID: 1856035 
12. 
Coffey A, Tyrrell M, Buckley M, Manning E, Browne V, Barrett A, et al. A 
multicentre survey of acute hospital nursing staff training in dementia care. Clin 
Nurs Stud. 2014;2(4):39. 
 
13. 
Dewing J, Dijk S. What is the current state of care for older people with 
dementia in  
general hospitals? A literature review. Dementia. 2016;15(1):106–124. PMID: 
24459188 DOI: 10.1177/1471301213520172 
 
14. 
Royal College of Psychiatrists. National Audit of Dementia Care in General 
Hospitals 2016-2017: Third Round Report Audit [Internet]. Healthcare 
Improvement Quality Partnership; 2017 Jul. Available from: 
https://www.hqip.org.uk/resource/national-audit-of-dementia-care-in-general-
hospitals-2016-2017-third-round-of-audit-report/ 
 
15. 
Sinvani L, Warner-Cohen J, Strunk A, Halbert T, Harisingani R, Mulvany C, et 
al. A Multicomponent Model to Improve Hospital Care of Older Adults with 
Cognitive Impairment: A Propensity Score-Matched Analysis. J Am Geriatr 
Soc. 2018;66(9):1700-7. PMID: 30098015 DOI: 10.1111/jgs.15452 
 
16. 
Kales HC, Gitlin LN, Lyketsos CG, Assessment DEP on the, Dementia M of 
the NS of. Management of neuropsychiatric symptoms of dementia in clinical 
settings: recommendations from a multidisciplinary expert panel. J Am Geriatr 
Soc. 2014;62(4):762–769. PMID: 25731881 PMCID: PMC4707529 
 
17. 
Kales HC, Gitlin LN, Lyketsos CG. Assessment and management of behavioral 
and psychological symptoms of dementia. bmj. 2015;350(7):h369. PMID: 
24635665 PMCID: PMC4146407 DOI: 10.1111/jgs.12730 
 
18. 
Parke B, Chappell N. Transactions between older people and the hospital 
environment: a social ecological analysis. J Aging Stud. 2010;24(2):115-24. 
 
19. 
Parke B, Hunter KF, Bostrom A-M, Chambers T, Manraj C. Identifying 
modifiable factors to improve quality for older adults in hospital: a scoping 
review. Int J Older People Nurs. 2014;9(1):8–24. PMID: 23067226 DOI: 
10.1111/opn.12007 
 

Version Date: 03/01/2021 
 
Page 35 of 39 
20. 
Parke B, Hunter KF, Marck PB. A novel visual method for studying complex 
health transitions for older people living with dementia. Int J Qual Methods. 
2015;14(4):1609406915614150. PMID: 23219329 DOI: 
10.1016/j.ijnurstu.2012.11.005. 
 
21. 
Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, et al. 
Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric 
Inventory. J Neuropsychiatry Clin Neurosci. 2000;12(2):233–239. PMID: 
11001602 DOI: 10.1176/jnp.12.2.233. 
 
22. 
Lintern TC. Quality in dementia care: evaluating staff attitudes and behaviour. 
[PhD Thesis]. Prifysgol Bangor University; 2001. 
 
23. 
Dementia Caregivers. Innovating the Next Generation of Dementia and 
Alzheimer’s Disease Care Interventions: Addressing the Needs of Persons 
Living with. 2017 
 
24. 
Bynum JP, Rabins PV, Weller W, Niefeld M, Anderson GF, Wu AW. The 
relationship between a dementia diagnosis, chronic illness, medicare 
expenditures, and hospital use. J Am Geriatr Soc. 2004;52(2):187-94. 
 
25. 
Shankar KN, Hirschman KB, Hanlon AL, Naylor MD. Burden in caregivers of 
cognitively impaired elderly adults at time of hospitalization: a cross-sectional 
analysis. J Am Geriatr Soc. 2014;62(2):276–284. PMID: 14728626 
 
26. 
Boltz M, Chippendale T, Resnick B, Galvin JE. Anxiety in family caregivers of 
hospitalized persons with dementia: contributing factors and responses. 
Alzheimer Dis Assoc Disord. 2015;29(3):236. PMID: 25635341 PMCID: 
PMC4714710 DOI: 10.1097/WAD.0000000000000072 
 
27. 
Boltz M, Chippendale T, Resnick B, Galvin JE. Testing family-centered, 
function-focused care in hospitalized persons with dementia. Neurodegener Dis 
Manag. 2015;5(3):203–215. PMID: 26107319 PMCID: PMC4529403 DOI: 
10.2217/nmt.15.10 
 
28. 
Bloomer M, Digby R, Tan H, Crawford K, Williams A. The experience of 
family carers of people with dementia who are hospitalised. Dementia. 
2016;15(5):1234–1245. PMID: 25394556 DOI: 10.1177/1471301214558308 
 
29. 
Feast A, Orrell M, Charlesworth G, Melunsky N, Poland F, Moniz-cook E. 
Behavioural and psychological symptoms in dementia and the challenges for 
family carers: systematic review. Br J Psychiatry J Ment Sci. 2016;208(5):429–
434. PMID: 26989095 PMCID: PMC4853642 DOI: 
10.1192/bjp.bp.114.153684 
 

Version Date: 03/01/2021 
 
Page 36 of 39 
30. 
Jamieson M, Grealish L, Brown J-A, Draper B. Carers: The navigators of the 
maze of care for people with dementia—a qualitative study. Dementia. 
2016;15(5):1112–1123. PMID: 25305279 DOI: 10.1177/1471301214554930 
 
31. 
Burgstaller M, Mayer H, Schiess C, Saxer S. Experiences and needs of relatives 
of people with dementia in acute hospitals—A meta-synthesis of qualitative 
studies. J Clin Nurs. 2018;27(3–4):502–515. PMID: 28639361 DOI: 
10.1111/jocn.13934 
 
32. 
Surr CA, Smith SJ, Crossland J, Robins J. Impact of a person-centred dementia 
care training programme on hospital staff attitudes, role efficacy and 
perceptions of caring for people with dementia: A repeated measures study. Int 
J Nurs Stud. 2016;53:144–151. PMID: 26421910 DOI: 
10.1016/j.ijnurstu.2015.09.009 
 
33. 
Scerri A, Innes A, Scerri C. Dementia training programmes for staff working in 
general hospital settings–a systematic review of the literature. Aging Ment 
Health. 2017;21(8):783–796. PMID: 27662075 DOI: 
10.1080/13607863.2016.1231170 
 
34. 
Surr CA, Gates C, Irving D, Oyebode J, Smith SJ, Parveen S, et al. Effective 
dementia education and training for the health and social care workforce: a 
systematic review of the literature. Rev Educ Res. 2017;87(5):966–1002. 
PMID: 28989194 PMCID: PMC5613811 DOI: 10.3102/0034654317723305 
 
35. 
Jones C, Bäckman C, Capuzzo M, Flaatten H, Rylander C, Griffiths RD. 
Precipitants of post-traumatic stress disorder following intensive care: a 
hypothesis generating study of diversity in care. Intensive Care Med. 
2007;33(6):978–985. PMID: 17384929 DOI: 10.1007/s00134-007-0600-8 
 
36. 
Nirmalan M, Dark PM, Nightingale P, Harris J. Editorial IV: physical and 
pharmacological restraint of critically ill patients: clinical facts and ethical 
considerations. Br J Anaesth. 2004;92(6):789–792. PMID: 15145832 DOI: 
10.1093/bja/aeh138 
 
37. 
Lyketsos CG, Colenda CC, Beck C, Blank K, Doraiswamy MP, Kalunian DA, 
et al. Position statement of the American Association for Geriatric Psychiatry 
regarding principles of care for patients with dementia resulting from 
Alzheimer disease. Am J Geriatr Psychiatry. 2006;14(7):561–573. PMID: 
16816009 DOI: 10.1097/01.JGP.0000221334.65330.55 
 
38. 
Schneider LS, Dagerman K, Insel PS. Efficacy and adverse effects of atypical 
antipsychotics for dementia: meta-analysis of randomized, placebo-controlled 
trials. Am J Geriatr Psychiatry. 2006;14(3):191–210. PMID: 16505124 DOI: 
10.1097/01.JGP.0000200589.01396.6d 
 

Version Date: 03/01/2021 
 
Page 37 of 39 
39. 
Gill SS, Bronskill SE, Normand S-LT, Anderson GM, Sykora K, Lam K, et al. 
Antipsychotic drug use and mortality in older adults with dementia. Ann Intern 
Med. 2007;146(11):775–786. PMID: 17548409 
 
40. 
Jeste DV, Blazer D, Casey D, Meeks T, Salzman C, Schneider L, et al. ACNP 
White Paper: update on use of antipsychotic drugs in elderly persons with 
dementia. Neuropsychopharmacology. 2008;33(5):957. PMID: 17637610 
PMCID: PMC2553721 DOI: 10.1038/sj.npp.1301492 
 
41. 
Dewing J. Special observation and older persons with dementia/delirium: a 
disappointing literature review. Int J Older People Nurs. 2013;8(1):19–28. 
 
42. 
Moyle W, Olorenshaw R, Wallis M, Borbasi S. Best practice for the 
management of older people with dementia in the acute care setting: a review 
of the literature. Int J Older People Nurs. 2008;3(2):121–130. PMID: 20925901 
DOI: 10.1111/j.1748-3743.2008.00114.x 
 
43. 
US Department of Health and Human Services. National Plan to Address 
Alzheimer’s Disease: 2016 Update [Internet]. ASPE. 2016 [cited 2018 Jun 5]. 
Available from: https://aspe.hhs.gov/report/national-plan-address-alzheimers-
disease-2016-update 
 
44. 
Handley M, Bunn F, Goodman C. Dementia-friendly interventions to improve 
the care of people living with dementia admitted to hospitals: a realist review. 
BMJ Open. 2017;7(7):e015257. PMID: 28713073 PMCID: PMC5541590 DOI: 
10.1136/bmjopen-2016-015257. 
 
45. 
Boltz M, Capezuti E, Shabbat N. Building a framework for a geriatric acute 
care model. Leadersh Health Serv. 2010;23(4):334–360. 
 
46. 
Boltz M, Capezuti E, Kim H, Fairchild S, Secic M. Factor structure of the 
geriatric institutional assessment profile’s professional issues scales. Res 
Gerontol Nurs. 2010;3(2):126–134. PMID: 20055337 DOI: 10.3928/19404921-
20091207-98 
 
47. 
Boltz M, Capezuti E, Shuluk J, Brouwer J, Carolan D, Conway S, et al. 
Implementation of geriatric acute care best practices: Initial results of the 
NICHE SITE self-evaluation. Nurs Health Sci. 2013;15(4):518–524. PMID: 
23656606 PMCID: PMC3949432 DOI: 10.1111/nhs.12067 
 
48. 
Sinvani L, Kozikowski A, Pekmezaris R, Akerman M, Wolf-Klein G. 
Delirium: A Survey of Healthcare Professionals' Knowledge, Beliefs, and 
Practices. J Am Geriatr Soc. 2016;64(12):e297-e303. PMID: 27879983 DOI: 
10.1111/jgs.14544 
 

Version Date: 03/01/2021 
 
Page 38 of 39 
49. 
Galvin JE, Roe CM, Xiong C, Morris JC. Validity and reliability of the AD8 
informant interview in dementia. Neurology. 2006;67(11):1942–1948. PMID: 
17159098 DOI: 10.1212/01.wnl.0000247042.15547.eb 
 
51. 
The Hartford for Geriatric Nursing. Dementia [Internet]. ConsultGeri. [cited 
2018 Jun 5]. Available from: https://consultgeri.org/try-this/dementia 
 
52. 
Alzheimer’s Association. 50 Ways to Become a Dementia Friendly Hospital 
[Internet]. [cited 2018 Jun 5]. Available from: 
http://preview.alz.org/stl_archive_6_29_2017/documents/50_Ways_To_Becom
e_A_Dementia_Friendly_Hospital.pdf 
 
53. 
van Doorn C, Bogardus ST, Williams CS, Concato J, Towle VR, Inouye SK. 
Risk adjustment for older hospitalized persons: a comparison of two methods of 
data collection for the Charlson index. J Clin Epidemiol. 2001;54(7):694–701. 
PMID: 11438410 
 
54. 
Pfeffer RI, Kurosaki TT, Harrah CH, Jr., Chance JM, Filos S. Measurement of 
functional activities in older adults in the community. J Gerontol. 
1982;37(3):323-9. 
 
55. 
Hughes CP, Berg L, Danziger W, Coben LA, Martin RL. A new clinical scale 
for the staging of dementia. Br J Psychiatry. 1982;140(6):566–572. PMID: 
7104545. 
 
 
56. 
Puelle, Margaret R., et al. "The language of delirium: keywords for identifying 
delirium from medical records." Journal of gerontological nursing 41.8 (2015): 
34-42. 
 
57. 
Morris JC. The Clinical Dementia Rating (CDR): current version and scoring 
rules. Neurology. 1993;43(11):2412-4. PMID: 8232972 
 
58. 
Knight ADRC Washington University in St. Louis. Clinical Dementia Rating 
2003  [Internet] [cited 2018 Dec 20}. Available from: 
http://alzheimer.wustl.edu/adrc2. 
 
59. 
Mao H-F, Kuo C-A, Huang W-N, Cummings JL, Hwang T-J. Values of the 
minimal clinically important difference for the Neuropsychiatric Inventory 
Questionnaire in individuals with dementia. J Am Geriatr Soc. 
2015;63(7):1448–1452. PMID: 26046666 DOI: 10.1111/jgs.13473 
 
60. 
Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis 
of covariance in randomized clinical trials. J Clin Epidemiol. 
2007;60(12):1234–1238. PMID: 17998077 DOI: 
10.1016/j.jclinepi.2007.02.006 

Version Date: 03/01/2021 
 
Page 39 of 39 
61.  
Boltz M, Chippendale T, Resnick B, Galvin JE. Testing family-centered, 
function-focused care in hospitalized persons with demenita. Neurodegener Dis 
Manag. 2015; 5(3):203-15. PMID: 26107319 PMCID: PMC4529403 doi: 
10.2217/nmt.15.10