A Multisite Cluster RCT of the Dementia Symptom Management at Home Program
Phase: NA
Conditions: Dementia
Sponsor: NYU Langone Health

 
 
Official Title: 
A Multisite Cluster RCT of the Dementia Symptom Management at 
Home Program   
NCT Number: 
NCT03255967 
Study Number: 
17-00810 
 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
July 27, 2021 
 
 

 
 
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Tool Revision History: 
 
Version 
Number 
Version 
Date 
Summary of Revisions Made 
1.0 
30 JUNE 
2017 
Original version 
1.1 
29 SEPT 
2017 
Change behavioral tool from HABC to the NPI-Q; make clear the endpoint of the NPI-Q is 
individual symptoms, not composite, add DSMB Chair, Cognition screening instrument 
changed from HABC-M to QDRS, QDRS inadvertently left out of section 7.1 on initial 
protocol; Clinicaltrials.gov number added 
1.2 
27 NOV 
2017 
Changes based on DSMB review of protocol: Remove “Demonstration of efficacy” as a 
means to warrant termination or suspension; Include delirium screening instrument (3D-
CAM); change:  PIs will follow “Standard Clinical Practice” in responding to AE and SAE 
by referring to patient/caregiver primary care provider. Clarified how contamination and 
fidelity monitoring will be performed. 
Add 3D-CAM to the PWD-Dyad Survey Instruments; Change name from VNAHG of New 
Jersey to VNAHG.  
  
1.3 
16 AUG 
2018 
Add the DSM-H Clinician Survey to recruitment materials. Make clear the clinician 
referrals are submitted through survey link operated by REDCap. Change the screening 
schedule so that the research coordinator administers the Quick Dementia Rating Scale 
over the phone with the caregiver to determine if the PWD meets eligibility before 
scheduling the initial home visit.  
1.4 
5 
OCT 
2018 
Remove Allegiance Home Health as the implementation site for Florida Atlantic 
University. Change “PAINAD or BPI” to include both instruments in assessing PWD for 
pain regardless of the PWD’s QDRS score.  Change Elixhauser comorbidity measure to 
Charlson comorbidity; Remove caregiver and home health care utilization from visit two.  
1.5 
22 JAN 
2019 
Edits were made to better clarify subject recruitment, consent and retention processes. 
Based on DSMB recommendations for maintaining subject retention, subjects will not be 
terminated from the study if they are unable to complete the intermediate visits. In 
addition, subjects will not be required during the intermediate visits to be interviewed at 
the same time. Language to clarify the time point for visit one has been changed from 2-3 
days to 3 days. Changes to rate of subject compensation has been clarified to cover 
subjects who miss intermediate visits.   
1.6 
5 JULY 
2019 
Changes to the recruitment process have been recorded in line with DSMB 
recommendations.  Clinicians will no longer be the point of referral. All referrals will be 
submitted by designated agency staff in line with PHI regulations.  Method of referral per 
agency site has been described therein. Changes to the first call scripts have been edited 
and updated. DSM-H research study information cards with research team contacts have 
been included in the recruitment process.  Minor formatting edits included. 
1.7 
31.JAN 
2020 
Added recruitment method for sites: CNS and FIRSTAT.  The updated process will include 
a designated agency point of contact who will generate a daily potential patient referral 
report in line with PHI regulations of newly admitted persons with dementia aged 65+ who 
live in a private residence. The report will be made accessible designated research team 
for the purpose of referral submissions. In addition, edits to better clarify reporting process 
of adverse events has also been included. Updated Dr. Galvin’s contact information.  
1.8 
3.JUNE 
2020 
The protocol has been modified to change the modality of subject visits to virtual from in-
person. To achieve this, Inclusion criteria additions: internet capabilities; caregiver 8+hrs 
of care management per week; edit retention strategies to replace “magnet” with email visit 
schedule; change the need for subjects to be together for virtual visits 2-4; add QDRS score 

 
 
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Interventional Template Version: 28 APR 2017 
of <12 to determine which PWD assessments will be administered; edit informed consent 
process to reflect remote consenting through REDCap; change 3D-CAM to FAM-CAM; 
adds COVID-19 related questions; add electronic gift cards as method of subject 
compensation; clarification provided on method of data collection; change criteria for 
subject disenrollment 
1.9 
12.July 
2021 
The protocol has been modified to include a waiver of documentation of consent on behalf 
of subjects who are unable to electronically sign the informed consent document due to 
technical issues. Additional clarity has also been added on how subjects will receive gift 
card compensation electronically. The REDCap project site has been used to communicate 
with subjects in the form of visit reminders, providing copies of informed consent, and also 
as a means to verify with the subject how they wish to receive their gift card 
(mail/electronically). For subjects wishing to have compensation sent electronically, a 
notification is sent via REDCAP to the subject with the gift card’s claim numbers. A record 
of the notification is also saved in the website file repository as a record of distribution.   
 
 

 
 
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A MULTISITE CLUSTER RCT OF THE DEMENTIA SYMPTOM 
MANAGEMENT AT HOME PROGRAM 
A phase 3 single 
randomized, multi-site 
evidence-based practice 
quality improvement program 
controlled trial targeting 
persons with dementia-
caregiver dyads. Principal 
Investigator (Lead Site): 
 
Abraham Aizer Brody, PhD, RN, GNP-BC, FPCN 
NYU Rory Meyers College of Nursing 
433 First Avenue, Room 504 
New York, NY 10010 
212-992-7341 
Ab.Brody@nyu.edu 
Additional Investigators 
(External Site PIs): 
 
 
James E. Galvin, MD, MS 
University of Miami  
Miller School of Medicine 
1600 NW 10th Ave #1140,  
Miami, FL 33136 
305-243-3234 
Jeg200@Miami.edu 
 
Rand Rupper, MD 
University of Utah 
School of Medicine 
C/O George V Whalen VAMC 
VA-Building #2 GRECC 182 
Salt Lake City, UT 84148 
801-584-2522 
Randall.Rupper@hsc.utah.edu 
 
Robert J. Rosati, PhD 
VNA Health Group 
23 Main Street, Suite D1 
Holmdel, NJ 07733 
732-224-6976 
Robert.Rosati@vnahg.org 
NYULMC Study Number: 
s17-00810 
Funding Sponsor: 
National Institutes of Health/National Institute on Aging 
PO: Kristina A McLinden, PhD 
7201 Wisconsin Avenue, Suite 3E500 
Bethesda, MD 20892-9205 
301-827-2563 
ClinicalTrials.gov 
Number                 
NCT03255967 
Initial version: 6-30-17 
Amended:9-29-17 
 
Amended:11-27-17 
Amended: 8-16-18 
Amended: 10-5-18 
Amended: 01-22-19 
Amended: 07-05-19  
Amended: 01-31-20 
Amended: 06-03-20  
Amended:07-12-21

Study number: s17-00810 
 
Page 1 
Version:  1.9 
 
 
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Interventional Template Version: 05 JAN 2017 
 
Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable 
US government research regulations, and institutional research policies and procedures. The International 
Conference on Harmonisation (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to 
as “ICH-GCP” or “E6”) as well as the National Clinical Effectiveness Committee Standards for Clinical 
Practice will be applied only to the extent that it is compatible with FDA and DHHS regulations. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the sponsor and documented approval from the Institutional Review Board (IRB), except 
where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the 
conduct of this study have completed Human Subjects Protection Training. 
 
 

 
 
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Table of Contents 
 
STATEMENT OF COMPLIANCE ................................................................................................................. 1 
LIST OF ABBREVIATIONS.......................................................................................................................... 5 
PROTOCOL SUMMARY .............................................................................................................................. 6 
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 8 
1 
KEY ROLES ......................................................................................................................................... 9 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ..................... 10 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE .............................................................. 10 
2.1.1 
Pain in ADRD ........................................................................................................................ 10 
2.1.2 
Behavioral and Psychosocial Symptoms in ADRD ............................................................... 11 
2.1.3 
Interrelation of Pain and BPSDs in ADRD ............................................................................ 11 
2.1.4 
Caregiving ............................................................................................................................. 11 
2.1.5 
Health Disparities in Care of the PWD .................................................................................. 11 
2.1.6 
Interprofessional Education ................................................................................................... 12 
2.1.7 
Existing Relevant Interventions ............................................................................................. 12 
2.2 
NAME AND DESCRIPTION OF THE QUALITY IMPROVEMENT PROGRAM .............................................. 13 
2.2.1 
Preclinical Data...................................................................................................................... 13 
2.3 
CLINICAL DATA TO DATE............................................................................................................... 13 
2.3.1 
Development and Implementation of the DSM-H. ................................................................. 13 
2.3.2 
Pilot testing ............................................................................................................................ 14 
2.4 
RATIONALE .................................................................................................................................. 14 
2.5 
POTENTIAL RISKS & BENEFITS ...................................................................................................... 14 
2.5.1 
Known Potential Risks ........................................................................................................... 14 
2.5.2 
Known Potential Benefits ...................................................................................................... 15 
3 
OBJECTIVES AND PURPOSE ......................................................................................................... 15 
3.1 
PRIMARY OBJECTIVES .................................................................................................................. 15 
3.2 
SECONDARY OBJECTIVES ............................................................................................................. 16 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................. 16 
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................. 16 
4.2 
STUDY ENDPOINTS....................................................................................................................... 16 
4.2.1 
Primary Study Endpoints ....................................................................................................... 16 
4.2.2 
Secondary Study Endpoints .................................................................................................. 17 
4.2.3 
Exploratory Endpoints ........................................................................................................... 17 
5 
STUDY ENROLLMENT AND WITHDRAWAL FOR PWD-CAREGIVER DYADS ........................... 17 
5.1 
INCLUSION CRITERIA .................................................................................................................... 17 
5.2 
EXCLUSION CRITERIA ................................................................................................................... 17 
5.3 
VULNERABLE SUBJECTS ............................................................................................................... 17 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................... 18 
5.5 
DURATION OF STUDY PARTICIPATION ............................................................................................ 20 
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES ................................................................................ 20 
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION ................................................................................ 20 
5.7.1 
Reasons for Withdrawal or Termination ................................................................................ 20 
5.7.2 
Handling of Participant Withdrawals or Termination ............................................................. 20 
5.8 
PREMATURE TERMINATION OR SUSPENSION OF STUDY .................................................................. 20 
6 
STUDY QUALITY IMPROVEMENT PROGRAM ............................................................................... 21 
6.1 
STUDY BEHAVIORAL OR SOCIAL QUALITY IMPROVEMENT PROGRAM ............................................... 21 

 
 
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6.1.1 
Champions training ............................................................................................................... 21 
6.1.2 
Non-champion clinician training ............................................................................................ 22 
6.1.3 
Validated Instruments ............................................................................................................ 22 
6.1.4 
Interprofessional care plans .................................................................................................. 22 
6.1.5 
Administration of Quality Improvement Program .................................................................. 23 
6.1.6 
Procedures for Training Quality Improvement Teams and Monitoring Fidelity ..................... 23 
6.1.7 
Assessment of Subject Adherence with Study Quality Improvement Program .................... 25 
7 
STUDY PROCEDURES AND SCHEDULE ....................................................................................... 25 
7.1 
STUDY PROCEDURES/EVALUATIONS ............................................................................................. 25 
7.1.1 
Study Specific Procedures .................................................................................................... 25 
7.1.2 
Standard of Care Study Procedures ..................................................................................... 26 
7.2 
STUDY SCHEDULE ...................................................................................................................... 266 
7.2.1 
Screening .............................................................................................................................. 26 
7.2.2 
Enrollment/Baseline .............................................................................................................. 26 
7.2.3 
Intermediate Visits ............................................................................................................... 277 
7.2.4 
Final Study Visit ................................................................................................................... 277 
7.2.5 
Collection of Home Health Record ...................................................................................... 287 
7.2.6 
Withdrawal/Early Termination Visit...................................................................................... 287 
7.3 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES .................................................. 288 
7.4 
JUSTIFICATION FOR SENSITIVE PROCEDURES .............................................................................. 288 
7.5 
PROHIBITED MEDICATIONS, TREATMENTS, AND PROCEDURES ...................................................... 288 
7.6 
PROPHYLACTIC MEDICATIONS, TREATMENTS, AND PROCEDURES ................................................. 288 
7.7 
RESCUE MEDICATIONS, TREATMENTS, AND PROCEDURES ........................................................... 288 
7.8 
PARTICIPANT ACCESS TO STUDY AGENT AT STUDY CLOSURE ........................................................ 28 
8 
ASSESSMENT OF SAFETY ............................................................................................................. 28 
8.1 
SPECIFICATION OF SAFETY PARAMETERS .................................................................................... 289 
8.1.1 
Definition of Adverse Events (AE) ....................................................................................... 299 
8.1.2 
Definition of Serious Adverse Events (SAE) ....................................................................... 299 
8.1.3 
Definition of Unanticipated Problems (UP) .......................................................................... 309 
8.2 
CLASSIFICATION OF AN ADVERSE EVENT ....................................................................................... 30 
8.2.1 
Severity of Event ................................................................................................................... 30 
8.2.2 
Relationship to Study Quality Improvement Program ........................................................... 30 
8.2.3 
Expectedness ........................................................................................................................ 30 
8.3 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP .................................... 30 
8.4 
REPORTING PROCEDURES – NOTIFYING THE IRB .......................................................................... 32 
8.4.1 
Unanticipated Problem Reporting ....................................................................................... 321 
8.5 
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR ...................................................... 32 
8.6 
REPORTING PROCEDURES – PARTICIPATING INVESTIGATORS ....................................................... 332 
8.7 
STUDY HALTING RULES .............................................................................................................. 332 
8.8 
SAFETY OVERSIGHT ..................................................................................................................... 33 
8.8.1 
Data Safety and Monitoring ................................................................................................... 33 
8.8.2 
Frequency and Reporting ...................................................................................................... 33 
8.8.3 
Data Safety and Monitoring Board ........................................................................................ 33 
9 
CLINICAL MONITORING .................................................................................................................. 34 
10 
STATISTICAL CONSIDERATIONS .................................................................................................. 34 
10.1 
STATISTICAL AND ANALYTICAL PLANS (SAP) ................................................................................. 34 
10.2 
STATISTICAL HYPOTHESES ........................................................................................................... 34 
10.3 
ANALYSIS DATASETS .................................................................................................................... 35 
10.4 
DESCRIPTION OF STATISTICAL METHODS ...................................................................................... 35 
10.4.1 
General Approach ........................................................................................................... 355 
10.4.2 
Safety Analyses ................................................................................................................ 35 

 
 
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10.4.3 
Adherence and Retention Analyses .................................................................................. 35 
10.4.4 
Baseline Descriptive Statistics ........................................................................................ 355 
10.4.5 
Planned Interim Analysis .................................................................................................. 35 
10.4.6 
Additional Sub-Group Analyses ...................................................................................... 365 
10.4.7 
Multiple Comparison/Multiplicity ...................................................................................... 365 
10.4.8 
Tabulation of Individual Response Data ......................................................................... 365 
10.4.9 
Exploratory Analyses ...................................................................................................... 365 
10.5 
SAMPLE SIZE ............................................................................................................................. 366 
10.6 
MEASURES TO MINIMIZE BIAS ....................................................................................................... 37 
10.6.1 
Enrollment/Randomization/Masking Procedures ............................................................ 376 
10.6.2 
Evaluation of Success of Blinding ..................................................................................... 37 
10.6.3 
Breaking the Study Blind/Participant Code ..................................................................... 376 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ............................... 376 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ..................................................................... 387 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 38 
13.1 
ETHICAL STANDARD ..................................................................................................................... 38 
13.2 
INSTITUTIONAL REVIEW BOARD ................................................................................................... 388 
13.3 
INFORMED CONSENT PROCESS .................................................................................................. 398 
13.3.1 
Consent/Assent and Other Informational Documents Provided to Participants ............. 398 
13.3.2 
Consent Procedures and Documentation ....................................................................... 398 
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................................. 409 
13.4.1 
Research Use of Stored Human Samples, Specimens, or Data ...................................... 39 
13.5 
FUTURE USE OF STORED SPECIMENS ........................................................................................... 40 
14 
DATA HANDLING AND RECORD KEEPING ................................................................................... 40 
14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 41 
14.2 
STUDY RECORDS RETENTION ....................................................................................................... 41 
14.3 
PROTOCOL DEVIATIONS ............................................................................................................... 41 
14.4 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 41 
15 
STUDY FINANCES ............................................................................................................................ 42 
15.1 
FUNDING SOURCE ........................................................................................................................ 42 
15.2 
COSTS TO THE PARTICIPANT ......................................................................................................... 42 
15.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 42 
16 
STUDY ADMINISTRATION ............................................................................................................... 42 
16.1 
STUDY LEADERSHIP ..................................................................................................................... 42 
17 
CONFLICT OF INTEREST POLICY .................................................................................................. 42 
18 
REFERENCES ................................................................................................................................. 443 
19 
ATTACHMENTS ................................................................................................................................ 51 
20 
SCHEDULE OF EVENTS .................................................................................................................. 52 
 
 
 
 
 
 
 
 
 

 
 
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List of Abbreviations 
ADRD 
Alzheimer’s Disease and Related Disorders 
AE 
Adverse Event/Adverse Experience 
BPSD 
Behavioral and Psychological Symptoms of Dementia 
CFR 
Code of Federal Regulations 
CG 
Caregiver  
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
DSM-H 
Dementia Symptom Management at Home Program 
DSMB 
Data and Safety Monitoring Board 
FFR 
Federal Financial Report 
FWA 
Federalwide Assurance 
GCP 
Good Clinical Practice 
HHC 
Home Healthcare 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIA 
National Institute on Aging 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
NPI-Q 
Neuropsychiatric Inventory Questionnaire 
OHSR 
Office of Human Subjects Research 
PI 
Principal Investigator 
PWD 
Persons With Dementia 
QA 
Quality Assurance 
QC 
Quality Control 
QDRS 
Quick Dementia Rating Scale 
QOL 
Quality of Life 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SCP 
Standard Clinical Practice  
SOP 
Standard Operating Procedure 
US 
United States 
 

 
 
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Protocol Summary 
Title 
 
A Multisite cluster RCT of the dementia symptom management at home 
program 
 
Brief Summary 
Alzheimer’s Disease and Related Disorders (dementia) poses a significant 
challenge to our public health. While many persons with dementia are cared 
for by friends and family in the community with the assistance of home 
healthcare, most home healthcare clinicians and agencies are ill prepared to 
care for this population and therefore have difficulty assisting patients and 
caregivers in maintaining quality of life leading to adverse patient outcomes, 
increased caregiver stress and burnout, and healthcare utilization. This study 
will therefore utilize a cluster randomized controlled design at 3 study sites to 
examine the ability of a multi-component evidence-based practice primary 
palliative care quality improvement program for home healthcare registered 
nurses, occupational therapists and physical therapists to improve the quality 
of life and reduce healthcare utilization for persons with dementia and their 
informal caregiver. 
Phase 
3 
Objectives 
1) Measure the effects of the DSM-H on quality of life (primary) and pain and 
BPSD severity (secondary) in the PWD.  
 
2) Assess the effects of the DSM-H on quality of life (primary), and physical 
and mental health (secondary) in the informal caregiver of the PWD.  
 
3) Assess the effects of the DSM-H on healthcare utilization in the PWD. 
Primary outcomes are ER visits and hospital admission rates. Secondary 
outcomes are outpatient visits and primary care provider contacts. 
 
Methodology 
Multi-site cluster randomized controlled trial of a quality improvement program 
Endpoint 
Primary Endpoints: PWD and caregiver QOL. Number of PWD ER visits and 
inpatient admissions 
 
Secondary Endpoints: PWD Pain and severity of individual BPSD, 
antipsychotic and analgesic use. PWD outpatient visits and primary care 
provider contacts. Caregiver burden, depression, functional health and well-
being. 
Study Duration 
3.75 years 
Participant Duration 
60 days 

 
 
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Population 
 
Dyad Population 
Total Sample: 345 Dyads (345 PWD + 345 caregivers) 
Sample at NYU Site (VNAHG): 207 
Sample at University of Utah Site (CNS; Central Utah): 86 
Sample at University of Miami Site (FirstStat; Southern Florida): 52 
Sample Description: PWD and their informal caregiver dyads. PWD must be 
65 or older and informal caregiver 18 or over; English or Spanish speaking; 
Informal caregiver is defined as spending at least 8 hours per week and had 
an established prior relationship (family, friend, neighbor). 
 
Study Sites 
 
NYU (lead): 0 clusters 
VNAHG: 12 clusters 
University of Utah: 5 clusters 
University of Miami: 3 clusters 
 
Number of participants 
 
Dyads: 345 across all sites (see population) 
 
Description of Study 
Procedure 
 
The DSM-H is a multi-component quality improvement program that consists 
of clinician training, patient- and family-centered assessment instruments, 
patient-caregiver dyadic centered care plans, a BPSD assessment and 
treatment algorithm, and caregiver teaching sheets. This study will examine 
outcomes of this quality improvement program.  
 
Reference Therapy 
Usual Care 
Key Procedures 
None 
Statistical Analysis 
 
Time trend analysis using repeated measure multivariate mixed effects linear 
models (PROC MCM in SAS) for all non-utilization outcomes. Utilization 
outcomes will be analyzed through logistic regression for odds of 
hospitalization or ER visit and Poisson Count regression for total number of 
hospitalizations and ER visits. Both will use random effects to measure for 
clustering. 
 
 
 
 

 
 
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Total 345 Dyads: Subjects receive care through usual home healthcare assignment 
process. Obtain informed consent for both PWD and Caregivers. Screen potential 
subjects by inclusion and exclusion criteria; document. Perform Visit 1 after consenting. 
Arm 1              
173 Subjects receiving 
QI program care 
Arm 2              
Control  
172 subjects 
Perform baseline assessments. See Section 19, Schedule of Events Table  
Perform Time 2 assessments (Day 15). See Section 19, Schedule of Events Table 
Perform Time 3 assessments (Day 30). See Section 19, Schedule of Events Table 
 
Final Assessments  
See Section 19, Schedule of Events 
Table 
Prior to  
Enrollment 
Visit 1 
Time 
Point 
Visit 2 
Time 
Point 
Visit 3 
Time 
Point 
Visit 4 
Time 
Point 
Schematic of Study Design 
 
 
 
 
 
 
  
 
 
 

 
 
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1 Key Roles 
LEAD SITE: NEW YORK 
 
Principle Investigator 
Abraham Aizer Brody, PhD, RN, GNP-BC, FPCN 
Assistant Professor 
NYU Rory Meyers College of Nursing 
433 First Avenue, Room 504 
212-992-7341 
Ab.Brody@nyu.edu 
 
Study Statistician 
Jason Fletcher, PhD 
Senior Biostatistician 
NYU Rory Meyers College of Nursing 
433 First Avenue, 7th Floor 
New York, NY 10010 
212-998-5401 
jason.fletcher@nyu.edu  
 
EXTERNAL SITE 1: NEW JERSEY  
 
Site PI-New Jersey 
Robert Rosati, PhD 
Vice President of Data, Research and Quality 
VNA Health Group 
23 Main Street, Tuite D1 
Holmdel, NJ 07733 
Robert.Rosati@vnahg.org  
 
EXTERNAL SITE 2: FLORIDA 
 
Site PI-Florida 
James E. Galvin, MD, MS 
University of Miami  
Miller School of Medicine 
1600 NW 10th Ave #1140,  
Miami, FL 33136 
305-243-3234 
Jeg200@Miami.edu 
 
EXTERNAL SITE 3: UTAH 
 
Site PI-Utah 
Rand Rupper, MD 
Associate Professor 
University of Utah 
School of Medicine 
C/O George V Whalen VAMC 
VA-Building #2 GRECC 182 
Salt Lake City, UT 84148 

 
 
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801-584-2522 
Randall.Rupper@hsc.utah.edu 
 
STUDY ADMINISTRATION 
 
Program Officer 
Kristina A McLinden, PhD 
National Institutes of Health/National Institute on Aging 
7201 Wisconsin Avenue, Suite 3E500 
Bethesda, MD 20892-9205 
301-827-2563 
 
DSMB Chair 
Malaz Boustani, MD, MPH 
Fairbanks Professor in Aging Research 
Indiana University School of Medicine 
1101 West Tenth St 
Indianapolis, IN 46202 
317-274-9235 
mboustan@iu.edu 
 
 
2 Introduction, Background Information and Scientific Rationale 
2.1 Background Information and Relevant Literature 
The population of people older than 65 in the United States is expected to almost double by 20301. 
As age is a significant risk factor, this will lead to a significant increase in patients with various 
causes of dementia including Alzheimer’s disease and related disorders (ADRD; including Lewy 
body dementia, frontotemporal degeneration, and vascular contribution to cognitive impairment 
and dementia)2.  The Institute of Medicine 2008 report sounded the alarm regarding the lack of 
properly trained clinicians in geriatrics in general3 yet 8 years later the healthcare system is no 
closer to building a workforce to provide high quality care for PWD as highlighted in the National 
Plan to Address Alzheimer’s4. The increase in the population of older adults is expected to 
overwhelm the healthcare system; the supply of hospital and long term care beds is not expected 
to be able to keep pace with the demand5.  Thus, these complex patients, many with ADRD, will 
be forced to return to the community in sicker condition than currently seen, after shorter lengths 
of stay in the hospital, placing a great strain on HHC agencies as they will be expected to take on 
care for many of these patients. While an estimated 36% of HHC patients currently have ADRD6, 
many HHC providers lack even basic training in their care due to a dearth of validated programs 
and the disseminated nature of the workforce makes developing these programs more complex. 
Clinicians also have a negative view, and do not recognize that substantial evidence exists 
showing differences in their care needs.7-15,16-19 
 
 Pain in ADRD  
Though no estimates have been recorded of the incidence of pain in the community dwelling PWD, the 
estimated incidence rate in older adults of over 50%20 due to high prevalence of painful conditions. 
However, pain is often not treated or undertreated21-23 and HHC clinicians have been found to be ill prepared 

 
 
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to provide adequate pain management to both cognitively intact and impaired patients24,25. Furthermore, 
PWD are less likely to report pain and receive less pain medication26. Elderly patients are also significantly 
less likely to discuss or label pain sensation, and more likely to be stoic in the face of pain, regardless of 
cognitive ability23. While guidelines for the treatment of pain in PWD exist27, they are often inappropriately 
treated, even when identified as having pain21. Poor recognition and management of pain is associated 
with delirium, agitation, falls, decreased function, and increased hospitalization and mortality 28-31.   
 
 Behavioral and Psychosocial Symptoms in ADRD  
BPSDs are one of the most common and distressing symptoms in the PWD, occurring in over 40% of 
cases32. BPSDs include agitation, depression, delusions, hallucinations, mania, personality changes and 
aggression. BPSDs are associated with weight loss33, functional disability34, caregiver burden and 
burnout35, nursing home admission36, and progression of dementia37. While multiple interventions are 
available for the treatment of BPSD38,39, they are often not appropriately used and certain common 
pharmacologic interventions in particular can cause harmful side effects. Few studies have examined the 
assessment and treatment of BPSD in the HHC setting. However, multiple studies have examined the effect 
of BPSD in ADRD in the home, particularly as it relates to caregivers, finding that interventions can decrease 
BPSD and improve function, QOL, and caregiver well-being40. Other studies have found BPSD plays a 
significant role in caregiver burden and burnout41,42, significantly increase the cost of care43 and familial 
economic burden44. 
 
 Interrelation of Pain and BPSDs in ADRD  
 
The interrelation of pain and BPSDs in ADRD can have large effects on illness burden and QOL, and many 
patients do not present with just a single symptom. Thus it is important to study their interrelatedness.45,46 
This is certainly true of pain, depression (one of the major BPSD) and agitation (another BPSD), where 
research has found they interact with each other, creating an additive effect when measuring their presence 
and/or severity.47-49  For instance, the presence of chronic pain in the elderly is known to induce or worsen 
symptoms of depression and agitation; and depression co-existing with pain is known to worsen the 
intensity of pain and complicate treatment50-52. When all three of these are present, patient function is 
substantially decreased53,54. 
 
 Caregiving  
 
Informal caregivers, including family, friends, neighbors and other acquaintances provide 83% of the care 
to PWD living in the community55, representing 15.9 million people providing 18.1 billion hours of care56. 
Despite this striking preponderance, a recent report from the National Academies of Sciences Engineering 
and Medicine (previously the IOM) finds that caregivers are largely marginalized and ignored as part of the 
healthcare system, and not provided the training or assistance they need in order to successfully care for 
their charge57. The primary tasks informal caregivers provide PWD assistance with include activities of daily 
living (ADLs) and instrumental ADLs, medication management and administration, adherence to treatment 
regimens, interfacing with the medical team, managing BPSDs, finding support services, and managing 
and hiring paid caregivers56. These tasks are known to cause informal caregivers stress, burden and 
burnout, and worsen their physical and mental health, including 2-3 times greater risk of developing 
depressive symptoms (40%). Furthermore, the biologic variable of sex plays an important role in informal 
caregiving, as caregiving is performed significantly more by female individuals (68%)58 and they spend 
between 1/3 and double the time providing care than male caregivers56. Additionally, caregivers who are 
older, female, spouses, or live in the same household with the PWD experience higher rates of caregiver 
burden58.  
 
 Health Disparities in Care of the PWD 
 

 
 
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There are significant disparities in care of the PWD. First and foremost, minorities have significantly higher 
prevalence of ADRD59. One of the most cited study found that a 2-3 fold higher risk in African-Americans 
and Hispanics compared to non-Hispanic whites (9.1%, 7.5%, 2.9% respectively in the 65-74 age cohort 
with even higher disparities as age increases)60. In addition to the higher prevalence rates, research has 
found that African-American and Hispanic caregivers frequently believe cognitive impairment is a normal 
part of aging61 and present for initial diagnosis with higher rates of symptoms62. Overall, Hispanics have 
been found to have higher rates of BPSDs than other groups63. However, both African-Americans and 
Hispanics have lower rates of institutionalization64,65. Therefore caregivers in these populations require 
more community-based support and training to counteract the longer duration of care.  
 
 Interprofessional Education 
 
Brody (PI) and Galvin (Site-PI) performed a systematic review of the literature in interprofessional education 
in ADRD66. They found 17 publications of 15 studies, 8 of which examined provider knowledge and attitudes 
and 7 showed improvement after an educational intervention.67-72 Three also showed some level of 
sustainability. Separately, 8 studies examined patient outcomes, 7 of which showed positive patient 
outcomes, including improved caregiver satisfaction, recognition of depression, and reductions in patient 
decline, BPSD, and inappropriate use of antipsychotics67,73-78.  While these studies found positive outcomes 
and improved knowledge and attitudes of clinicians, they did not all use standardized instruments, the 
interventions were highly variable, and none of them were performed in HHC. 
 
 Existing Relevant Interventions 
 
While no interventions have focused on an interprofessional intervention to improve QOL of the PWD-
informal caregiver dyad utilizing HHC, several interventions have been implemented in the home, outside 
of the HHC service delivery structure. The most established and utilized intervention, developed by Dr. 
Gitlin, is the Care of Persons with Dementia in their Environment (COPE) Program. This intervention 
focuses on enhancing the PWD’s functional capacity and improving caregiver skills in managing ADRD. It 
includes 10 visits by an occupational therapist along with 1 telephone contact by an advanced practice 
nurse40. The intervention is highly effective and has been implemented in the Connecticut Medicaid 
program79. The weakness of this approach is that in-person contact is solely with an occupational therapist, 
and only 14% of HHC visits are provided by occupational therapists80, reducing the ability to implement 
more broadly in the existing HHC service delivery model. Another program the MIND at Home program 
developed by Samus provides care coordination services linked to an RN and geriatric psychiatrist, and 
ADRD education and caregiving strategies. It is currently being studied in an NIA funded R01 and CMMI 
demonstration project. This interprofessional program has shown considerable strength in its pilot in 
reducing transition from home and improving QOL81. However, it did not show caregiver reported 
improvements in BPSD and is also not delivered through HHC. One intervention specifically tailored to HHC 
by Bruce, the CAREPATH program, assists HHC nurses to manage depression in older adults. CAREPATH 
provides 7 hours of training (4 in-person, 3 via web) to nurses, finding significant improvement in depressive 
symptoms in persons with higher symptom expression at baseline82. The primary limitations of this program 
as it relates to this work is that it is solely geared towards depression, it focuses 7 hours solely on 
depression, which may be more than many HHC agencies are willing to provide to a single condition, and 
that it did not integrate with other disciplines. Final, several successful interventions by Bakitis have been 
developed to perform palliative care for individuals with cancer and heart failure (ENABLE and ENABLE-
CHF)83-88. These multi-component nurse-led psycho-educational interventions seek to support the patient 
and their caregiver and ENABLE has shown positive outcomes on QOL, mood, and survival though not 
utilization, and caregiver stress and burden, while ENABLE-CHF is currently being examined through a 
clinical trial.  However, ENABLE and ENABLE-CHF are not performed through HHC, either utilizing tele-
health, which may not be adequate for PWD given the difficulty with phone assessment in this population, 
or a clinic model which may be difficult to access for homebound PWD. Lessons learned from these 
interventions have been used in developing the DSM-H intervention. 
 

 
 
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2.2 Name and Description of the Quality Improvement Program  
 
The DSM-H, is an evidence-based practice quality improvement program that combines training, 
mentorship, workflow enhancements, assessment instruments, a BPSD treatment algorithm, and caregiver 
teaching pamphlets for clinical staff in HHC agencies.  
 
 Preclinical Data 
2.2.1.1 
Under-recognition of symptoms in HC 
Because symptoms such as pain and depression are 
significant causes of agitation in PWD, Dr. Brody undertook a 
study89 that examined the recognition of symptoms in 
advanced illnesses in HHC. Using a 5% sample of nationwide 
OASIS (home health minimum data set collected on every 
patient) and Medicare data, he examined the rates of symptom 
prevalence in persons with advanced illnesses including 
advanced dementia post-discharge from an acute care stay. 
He found pain and depression in PWD were significantly under-recognized in HHC (See table 1). Using 
multivariate ordinal logistic regression controlling for age, race, sex, Charlson Score, and rural/urban 
location, he found that persons with advanced dementia were 2.5 times less likely to have had pain reported 
on the OASIS than the other advanced illnesses he examined. One highly methodical and well cited 
nationwide study found that late life pain incidence rate is 46% the month prior to death; the majority of this 
pain coming from arthritis; with no difference by terminal diagnosis category90.  
 
Thus the investigators would not expect significantly different rates across these disease categories, and 
the rates of pain in advanced dementia are likely significantly under-recognized. Similarly, using multivariate 
logistic regression with the same control variables, persons with advanced dementia were 1.7 times less 
likely to have depressive symptoms reported than persons with advanced illness, despite other studies that 
have found persons with dementia have similar if not higher rates of depression91,92.  These data support 
the under-recognition of pain and depression in older adults with dementia in the HHC setting. 
2.3 Clinical Data to Date 
 Development and Implementation of the DSM-H.  
 
As part of Dr. Brody’s National Palliative Care Research Center Career Development Award, Dr. Brody and 
Dr. Galvin (Mentor) developed the DSM-H. The development utilized the NIH ORBIT Model for Behavioral 
Intervention Development93 and later on the Structural Model for Caregiving Stress94. The DSM-H focuses 
on assisting skilled HHC clinicians to identify and managing behavioral symptoms associated with 
dementia, and work as a team with the primary care provider and informal caregiver. In this initial trial, two 
registered nurse, physical therapist, and occupational therapist educators (6 total educators) at the study 
site were trained as “champions” and received 14 hours of in-person, case based interprofessional 
instruction over two days in dementia care; the remaining 209 RNs, PTs, and OTs received 4.5 hours of 
modular, on-line interactive learning training. Champions served as resources for other clinicians and 
helped ensure smooth implementation and completion of the program. In addition to the education, 
participants were provided with resources and workflow changes including previously validated assessment 
tools for assessing and managing symptoms in PWD, and care plans based on evidence based practice 
for PWD. As a measure of program evaluation, Drs. Brody and Galvin developed the Dementia Symptoms 
Knowledge and Attitudes Survey to be utilized as a pre- and post-test. The survey incorporates three well-
validated instruments for assessing clinician knowledge and attitudes regarding pain95, depression96 and 
agitation97 in PWD, with an investigator-derived set of four questions about confidence in treating each of 
these symptoms in PWD.  The survey had an excellent internal consistency in HHC clinicians (Cronbach 

 
 
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alpha=.94) and took an average of 15 minutes to complete. In our sample of 209 clinicians, we found 
significant improvements in knowledge, attitudes and care confidence in treating PWD following program 
completion that varied by specialty. Overall, clinicians showed the most improvement in knowledge (20.9%) 
and confidence (27.1%) in managing BPSD from baseline with additional gains in knowledge (14.8%) and 
confidence (36.1%) in managing depression and knowledge (5.9%) and confidence (26.5%) in managing 
pain (p<.0001)25. Additionally, on the post-test evaluation, 97% of RNs and 100% of PTs and OTs stated 
the education was highly applicable to their work setting and helped them care for patients. Therefore, the 
DSM-H is an evidence-based practice integrated multi-component intervention that has shown 
improved clinician knowledge, attitudes and confidence in treating PWD. 
 
 Pilot testing 
 
Based on feedback from this initial trial of the DSM-H, Dr. Brody refined the clinical education programs to 
reduce pharmacology content and increase content on recognition of dementia and non-pharmacologic 
management and working with caregivers. Drs. Brody and Galvin performed a site controlled trial of the 
DSM-H at 2 divisions of a large HHC agency and retrospectively collected OASIS and chart data for PWD 
on admission and at the first 60-day re-certification or discharge from HHC. Overall, during the study period 
158 PWD were seen by the control site and 174 by the intervention site. Overall, patients were older, 
primarily spoke English or Spanish, were either Medicare or dual Medicare/Medicaid insured, and were 
admitted either from home or the acute care setting (See Appendix A). There were fewer black/African 
American participants in the control, the only clinically significant difference (34.2% vs 51.7%; p=.0002). 
Overall, we found in multivariate analysis that recognition of pain, depression, and behavioral symptoms, 
were all clinically and statistically significantly higher in the intervention group, and there were significantly 
increased odds of analgesics use (OR=2.01; p<.05) and decreased odds of antipsychotic use (OR-0.53; 
p<.05) in the intervention cohort98. These results show the DSM-H has the potential to be improve 
patient care and the QOL of PWD receiving HHC. 
 
2.4 Rationale 
While significant focus has been placed on implementing solutions for use in the acute care, nursing home, 
and primary care settings, few studies have focused on improving symptom management and caregiving 
training for PWD through HHC.  Drs. Brody and Galvin have adapted interprofessional, evidence-based 
practices, from other settings to HHC, creating the DSM-H. The DSM-H has been piloted with over 600 
HHC clinicians25,98. It is a multi-component performance improvement program that consists of clinician 
training, patient- and family-centered assessment instruments, patient-caregiver dyadic centered care 
plans, a BPSD assessment and treatment algorithm, and caregiver teaching sheets. The pilot studies have 
shown improved clinician knowledge, confidence and attitudes, and pain and BPSD recognition and 
management. We therefore seek to test the efficacy of the DSM-H in a behavioral phase III cluster 
randomized controlled trial. 
2.5 Potential Risks & Benefits 
 Known Potential Risks 
 
The performance improvement program itself is inherently not risky (minimal risk) as it is an 
implementation of evidence-based practices. The primary risk to patients and caregivers in this study is 
the emotional nature of the questions from study data collection, which is solely an immediate risk. While 
the measures being used are all evidence based and thoroughly tested, they cover issues such as 
increased severity of dementia, depression, agitation, burden and quality of life that could create 
emotional problems. This will be minimized by implementing a thorough training plan and manual for the 
research assistant performing the assessments, laying out responses that should be provided to sensitive 
questions, ensuring that the assessment instruments are uniformly administered, and methods and 
contact numbers for referrals in case of any emotional disturbance related to the research. We are 

 
 
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currently performing a study using these instruments and have a set training for research assistants 
administering these instruments. Additionally, other peer reviewed studies have not reported any adverse 
reactions to these instruments, so we see this risk as minimal. Additionally, we will perform an informed 
consent with both the caregiver and PWD if able, or patient surrogate if unable, so that they have full 
awareness of the purpose of the project, potential types of questions, and the voluntary nature of the 
study. The second risk is loss of confidentiality. We minimize the risk by maintaining the data in a secured 
fashion (see section 11). This vulnerable population is included as the focus of the research is in 
improving the quality of care they receive.  
 
As the potential risks are minimal and there are potential direct benefits to subjects in the performance 
improvement cohort, including improved PWD and caregiver QOL and symptom management, and 
reduced utilization, the potential benefits of this study far outweigh the minimal risks to this study. The 
value in this study is that if efficacy is found, the intervention can be created into a product that is 
disseminated to some of the over 12,000 active HHC agencies in the country to improve the quality of 
care in these settings and QOL for hundreds of thousands of PWD-informal caregiver dyads. 
 Known Potential Benefits 
 
Potential benefits to patients in the intervention includes improved quality of care and quality of life, including 
reduction in pain and BPSD, and reduced healthcare utilization, which could lead to lower out of pocket 
costs. For caregivers receiving care from care teams who are part of the performance improvement 
program, potential benefits include reduced depression, burden, and improved physical and mental health. 
These hypothesized benefits are based on our preliminary data found in section 2.3.2. 
3 Objectives and Purpose 
3.1 Primary Objectives 
 
Aim 1: Measure the effects of the DSM-H on quality of life and symptom severity in the PWD. 
H1: PWD cared for by a HHC team utilizing the DSM-H performance improvement program will show 
reduced symptoms and improved ratings of pain, BPSD, and caregiver-rated QOL at the end of the first 
60-day HHC certification period compared to the control (usual care) group. 
 
The primary outcome of Aim 1 is caregiver rated QOL. It will be measured using the Quality of 
Life-Alzheimer’s Disease99.  
 
Aim 2: Assess the effects of the DSM-H on quality of life, and physical and mental health in the 
informal caregiver of the PWD. 
H2: Informal caregivers of PWD cared for by a HHC team utilizing the DSM-H performance improvement 
program will show reduced ratings of burden, and depression, and improved functional health and well-
being at the end of the first 60-day HHC certification period compared to the control (usual care) group. 
 
The primary outcome of Aim 2 is informal caregiver QOL. It will be measured using the Caregiver-Targeted 
Quality of Life Measure100. 
 
Aim 3: Assess the effects of the DSM-H on healthcare utilization in the PWD.  
H3: PWD cared for by a HHC team utilizing the DSM-H performance improvement program will show a 
reduction in emergency room visits and hospital admissions compared to the control (usual care) group, 
and a greater number of outpatient visits. 
 
The primary outcomes to be measured are the number of emergency room visits and hospital admission 
rates of the PWD at 30 and 60 days. It will be measured through interviews with the informal caregiver 
using the Resource Utilization Inventory101. 

 
 
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3.2 Secondary Objectives 
 
The secondary objectives of Aim 1 are to assess the effects of the performance improvement program on 
pain and individual BPSDs in the PWD, and the use of antipsychotic and analgesic. They will be measured 
at all four time points (0, 15, 30, and 60 days). BPSD will be measured using the NPI-Q102. The type of pain 
assessment administered to the PWD will depend on their level of cognitive impairment.  The level of 
impairment will be determined by the Quick Dementia Rating System (QDRS) score. The PWD who obtains 
a score of <12 will receive the  Brief Pain Inventory Short Form103 and those whose score ≧12 on the 
QDRS will receive the PAINAD which will be used to measure pain at rest and with movement. All PWD 
subjects will be assessed for pain during each visit using the respective measure.   
 
The secondary objectives of Aim 2 are to assess the effects of the performance improvement program on 
informal caregiver burden, depression, and functional health and well-being. The PHQ-9104 will be used to 
measure caregiver depression, the Zarit Burden Interview 105 for caregiver burden and the SF-12 for 
caregiver health at 0 and 60 days. 
 
The secondary objectives of Aim 3 are to assess the effects of the performance improvement program on 
the number of outpatient visits and contacts with the primary care provider. These will be measured through 
interviews at 30 and 60 days with the Resource Utilization Inventory101. 
4 Study Design and Endpoints 
4.1 Description of Study Design 
 
This study will use a blinded cluster randomized controlled trial methodology. Each HHC care team will be 
randomized to either partake in the DSM-H performance improvement program or provide usual care. The 
project director based at NYU and RAs at all sites will be blinded to prevent bias in data collection. The 
study statistician based at NYU will perform the randomization utilizing SAS 9.4 stratified by agency and 
geographic location. The study PI will relay to the agencies which teams will serve as intervention or control. 
The study PI and statistician will not collect study data in order to maintain the integrity of the blinding. The 
potential for contamination between care teams randomized to receive the DSM-H performance 
improvement program and those who will provide usual care is minimal due to the nature of HHC clinician 
workflow where minimal time is spent in the office, and different care teams do not generally congregate 
with each other except during highly structured staff meetings. The investigators considered randomizing 
by site and using other HHC agencies; however, given the lack of contamination found in prior studies of 
the DSM-H combined with differences in care provision at other sites/locations and the need for a large 
number of clusters when using this methodology, the investigators felt this method was the most likely to 
provide valid and reliable results. It is not possible to randomize by patient in HHC because patients are 
seen by care teams in a given geographic region. Patients in the performance improvement group will 
receive care from a care team who has received the DSM-H performance improvement program, and those 
in the control will receive usual care from a care team who has not received the performance improvement 
program. Patients at the study sites are only cared for by members of the same care team and therefore 
there is no potential for patients to receive a mixture of care teams.  
4.2 Study Endpoints 
 Primary Study Endpoints 
 
Given that this is a dyadic, implementation science intervention, it is not appropriate to look at a single 
primary endpoint. There are therefore 3 primary endpoints that will be examined in this study. For the Aim 
1 primary endpoint, PWD QOL, a 0.5 SD difference between the baseline and 60 day visit would be clinically 
meaningful based on prior studies40 and therefore considered a positive outcome. For the Aim 2 primary 

 
 
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endpoint, informal caregiver QOL, given its rate of variability and floor and ceiling effects, a 0.5 SD 
difference between the baseline and 60 day visit would be clinically meaningful and therefore considered a 
positive outcome100. For the Aim 3 primary endpoint, a 10% reduction in readmissions and ER visits at 60 
days will be considered a clinically meaningful positive outcome. This would results in 220 fewer ER visits 
and 63.8 fewer admissions per 1000 patients based on prior evidence106.  
 Secondary Study Endpoints 
 
Aim 1 secondary endpoints include individual BPSDs, pain, antipsychotic use and analgesic use. These 
endpoints were chosen secondary to their relationship to QOL and caregiver QOL as noted above in 
sections 2.1.1 and 2.1.2 as well as their interrelationship as noted in section 2.1.3. 
 
Aim 2 secondary endpoints include informal caregiver burden, depression, and health, which as noted in 
section 2.1.4. 
 
Aim 3 secondary endpoints include outpatient visits and primary care provider contacts. These endpoints 
are included as BPSDs and pain are both indicators of additional concerns amongst caregivers and can 
increase burden due to the coordination that is required of caregivers107. 
 Exploratory Endpoints 
 
In this study we will explore both sub-group analysis by gender, race/ethnicity, health literacy, and high 
and low symptom individuals. 
5 Study Enrollment and Withdrawal for PWD-Caregiver Dyads 
5.1 Inclusion Criteria 
 
1. PWD over the age of 65 
2. Admitted to one of the three HHC agencies  
3. The patient and family caregiver speak English and/or Spanish.  
4. The informal caregiver is ≥18 years of age and manages the PWD’s care for at least 8 hours per 
week.  
5. Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment).  
6. PWD and the caregiver have internet connection. 
5.2 Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study. 
1. Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety.  
2. PWD residing in assisted living facilities or board and care homes  
3. PWD solely receiving infusion or home health aide services.  
5.3 Vulnerable Subjects 
This research will be performed exclusively with cognitively impaired subjects and their informal 
caregivers. The research is specifically focused on whether the intervention improves the quality of care 
and quality of life for persons with dementia and their caregivers. It is therefore necessary to work with 
this vulnerable population. All patients in this study will be cognitively impaired, and some may lack the 
capacity to consent. These patients will all be included in this study. Capacity will be assessed at baseline 
as described in section 5.4 below. They will not be monitored over the study period as dementia is a 
chronic, progressive disease there is no reasonable expectation that the PWD would have a capacity 
status change in such a short period of time (60 days). Should the person with dementia subject become 
distressed from participating in the study, they will be withdrawn from the study. 

 
 
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5.4 Strategies for Recruitment and Retention 
 
A centralized referral system will be customized to each of the three HHC agency's organizational structure 
and workflow. Each agency will determine which staff will be designated as the point of contact (POC) to 
submit patient referrals to the DSM-H research team. The method of referral will differ among agencies 
based on each organizational workflow. Each HHC agency accepts new referrals for patient admission 
through an intake process prior to the patient meeting with a nurse to initiate start of care (SOC).  The nurse 
who completes the patient’s admission visit, administers an OASIS assessment and OASIS cognitive 
screen or administers a mini-cog test108 for the patient’s SOC report.  The HHC agency’s POC will review 
patient information obtained through intake and the SOC report.  New admissions who are aged 65 years 
and older with a diagnosis of dementia or cognitive impairment, and who reside in a private residence will 
be referred to the DSM-H research study. Referral submissions will be received via REDCap, encrypted 
transfer, or secure email based on agency and NYU guidelines. If sent by encrypted transfer or secure 
email, the research coordinator or project director will upload the referral information directly into redcap, 
the study log. 
 
 Each agency has determined how their centralized referral system will be facilitated as noted below:   
 New Jersey site (VNAHG) there will be a single point of contact in their research/innovation group who 
will run twice-daily reports of persons with dementia newly admitted to the agency who live in a private 
residence. Reports are based on the nurse’s SOC report submitted at the end of the day.  
 Utah site (CNS) there will be a single point of contact within the agency who will generate a daily report 
of persons with dementia newly admitted to the agency who live in a private residence. The report will 
be based on the nurse’s SOC report and made available to designated study staff or care team office 
referral specialist for referral submission. 
  Florida site (FIRSTAT) there will be a single point of contact within the agency who will generate a daily 
report of persons with dementia newly admitted to the agency who live in a private residence. The 
report will be based on the nurse’s SOC report and made available to designated study staff or care 
team office referral specialist for referral submission. 
  
Persons with dementia who are newly admitted into each HHC agency will be included in an "opt-out" 
referral process. Admission packets, provided to those who have been identified as meeting DSM-H 
inclusion criteria, will include a DSM-H research study information card. The DSM-H info-card provides an 
overview of the research study, the duration of participation, contact information for the research 
coordinators, as well as, ways in which the patient and caregiver can opt out from being contacted.  
 
In follow up to the patient referrals received by each agency, the research team will contact the patient 
and/or caregiver to introduce them to the research study and to screen the referral for subject eligibility. To 
determine if the PWD’s level of cognitive impairment meets eligibility for inclusion, the QDRS is 
administered to the caregiver who will rate the PWD’s symptoms and behaviors. A PWD who scores >6 on 
the QDRS will meet eligibility for study inclusion as this score indicates mild impairment, similar to a score 
of <23 on the MMSE. The research team will also inquire about whether the caregiver makes decisions on 
behalf of the PWD, or if there is a legally authorized representative who acts on the PWD’s behalf.  If the 
PWD has a LAR, then that representative’s contact information will be obtained and the LAR will be included 
in the consent process.  A virtual visit is scheduled for both the PWD and caregiver within 3 business days 
of the PWD’s admission date so that additional information about the study can be provided and informed 
consent can be conducted. Weekend days and U.S. recognized business holidays are not counted as a 
business day. The PWD must have the capacity to consent in order to sign their consent form.  
 
Capacity to consent will be determined using a standardized 3-question approach109 performed by the 
research assistant or project director. These individuals will receive training from the PI and Site PI in the 
form of two simulations prior to being allowed to consent using this procedure. In these simulations, one 
will have capacity and the other will not. They must correctly assess both simulations prior to being allowed 

 
 
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to perform the consent process. This standardized approach has been shown to be valid for use by research 
assistants with PWD. The three questions that will be asked after reviewing the study consent form are: 1) 
What is the purpose of the study, 2) What are the risks, and 3) What are the benefits. If the initial response 
is vague or suggests misunderstanding, the interviewer re-explains or clarifies the question without 
redisclosing information about the study. The interviewer scores the answer to each question as as either 
0 (incapable) 1 (questionable) or 2 (capable).  Definitions of these are as follows: “2-point score reflects 
clear understanding of the disclosed material, a 0-point score reflects definite misunderstanding of the 
disclosed material, and a 1-point score reflects either partial but less than fully adequate understanding or, 
if this persists even after prompting for clarification, an uncertain level of participant understanding.” The 
score is then totaled and a score of less than 3 is considered to not have capacity. This method has a high 
level of sensitivity and specificity and is more accurate than using other methods including the mini-mental 
status exam (MMSE). 
 
This standardized process is accurate and objective. There is limited conflict of interest in having the study 
personnel perform this assessment as opposed to an independent assessor as the study could still recruit 
dyads through surrogate consent should a subject not have capacity, and the patient flow at the participating 
HHC agencies far exceeds the needs of this study thus limiting pressure to enroll on the part of the study 
staff.  
 
In instances where a PWD does not have the capacity to consent, their enrollment will be contingent upon 
consent being provided by either their LAR or a legal surrogate as determined by their state of residence.  
Further, once consent on the behalf of the PWD has been acquired, the PWD will be asked to assent 
verbally and if able, by signature. If the PWD provides verbal assent but is unable to provide their signature 
due to disability (cognitive/physical), the researcher will note on the assent form that the PWD provided 
verbal assent but was unable to sign.  
 
The legal surrogate will be verified by either the HHC agency or through written documentation. Should 
they not have written documentation of being an appointed surrogate, the law of the state of residence will 
determine the priority order for determining the surrogate, which is as follows: 
 
Florida:         spouse, adult child, parent, adult sibling, close friend 
New Jersey: spouse, adult child, parent, sibling, close friend 
Utah:             spouse, adult child, parent, sibling, grandchild, grandparent, individual who is healthcare proxy 
 
Because PWD in HHC are primarily homebound, tend to receive HHC for at least 60 days, with follow-up 
is provided through scheduled home visits, we do not anticipate significant retention problems. Additionally, 
the study burden is minimal, requiring approximately an hour per dyad at baseline and 60-days, and 20 
minutes at the 15 and 30 days. Study staff will obtain detailed contact information for the PWD, caregiver, 
and where applicable proxy, will schedule the follow-up visits at the initial visit, email or text the visit 
schedule to the caregiver (based on caregiver preference; no PHI or PII included, see templates), and call 
4 days and 1 day prior to each follow-up appointment to confirm and/or reschedule.  
 
The greatest risks to retention are re-hospitalization and institutionalization, either for short-term post-acute 
rehabilitation after a re-hospitalization or long-term institutionalization for ADRD. Subjects are not required 
to attend the intermediate and final visits together. Efforts to accommodate the subjects’ schedules will be 
considered in data collection. Phone interviews with the PWD and caregiver to collect participant survey 
data will occur for all time points. If both subjects are unavailable to complete an intermediate visit, the visit 
will be recorded as missed. To maintain subject retention, subjects will be terminated from the study only if 
the caregiver, as respondent, does not complete visit four. 
 
Dyads will be enrolled starting in month 6 of year 1 and continuing through month 9 of year 4 (3 years, 3 
months). Follow-up will continue through Month 2 of year 5. The investigators therefore anticipate recruiting 
9 new dyads per month at all sites throughout the 4 years, with 5-6 through the VNA Health Group, 2-3 at 
the University of Utah and 1-2 at University of Miami. 
 

 
 
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Given that this research study is of short duration (60 days) there is no reasonable expectation 
that there to be a change in capacity during the time period of the study and will therefore not 
monitor for capacity beyond the initial visit. 
5.5 Duration of Study Participation 
This study will last at most 65 days from recruitment to completion. The total duration is intended to be 60 
days, however, for the interim study visits (visits 2 and 3) we will allow the visit +/- 3 days to allow for PWD-
caregiver schedule, and at visit 4, up to +5 days leeway. 
5.6 Total Number of Participants and Sites  
Recruitment will end when approximately 345 dyads (345 PWD and 345 caregivers) are enrolled. It is 
expected that approximately 345 dyads will be enrolled in order to produce 300 evaluable dyads. 
 
Sample at VNAHG Site: 207 dyads (207 PWD, 207 caregivers) enrolled, with expectation of 180 complete 
dyad cases (180 PWD, 180 caregivers). 
Sample at University of Utah Site: 86 dyads enrolled (86 PWD, 86 caregivers) with expectation of 75 
complete dyad cases (75 PWD, 75 caregivers). 
 
Sample at University of Miami Site: 52 dyads enrolled (52 PWD, 52 caregivers) with expectation of 45 
complete dyad cases (45 PWD, 45 caregivers). 
 
5.7 Participant Withdrawal or Termination 
 Reasons for Withdrawal or Termination 
The primary potential cause for withdrawal from the study is if either member of the dyad choses to 
withdraw from the study at any point.  
 
Participants are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
• 
The study team is unable to maintain or appropriately reschedule study appointments. 
 Handling of Participant Withdrawals or Termination 
Given the minimal risk nature of this study, individuals who chose to withdraw from the study will not 
continue to be followed in any form. We have factored in a 15% study non-completion rate and anticipate 
recruiting 345 dyads to meet the 300 dyads required study participants.   Subjects will not be disenrolled 
based on data related issues.  If subjects are unable to attend intermediate visits (Visit 2 and/or 3), those 
visits will be counted as missed. If the caregiver does not complete visit four, both subjects will be  
terminated from the study.   
 
5.8 Premature Termination or Suspension of Study 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. 
Written notification, documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to the principle investigator, the NIA program officer, and the DSMB. If the 
study is prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 

 
 
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• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
• 
DSMB or NIH halts study for any other reasons not listed above. 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the NIH, IRB and DSMB. 
 
6 Study Quality Improvement Program 
6.1 Study Behavioral or Social Quality Improvement Program 
 
The DSM-H is a quality improvement program that has been tested in several HHC agencies in New York. 
It is a multi-modal quality improvement program for improving the quality of care provided to PWD-informal 
caregiver dyads through HHC. All training was initially created through participatory research with an 
interprofessional team of clinicians, and then refined through feedback from clinicians who completed the 
training. It has been culturally tailored for use in diverse settings and tested with multiple minority 
communities in New York, including multiple Hispanic groups and African-Americans and Caribbean blacks. 
Components of the intervention are described in detail below and in Figure 2 (see below). The DSM-H 
quality improvement program presented in this section is not in and of itself a study intervention. We are 
solely in this study measuring the outcomes of the quality improvement program, however include the 
components of the program here so it is easier to understand the research protocol around the study of 
outcomes. 
 
 Champions training  
 
Champions training consists of two full days of interactive in-person didactic content, case studies, and 
role-playing simulation cases. There are three core components of the champion training, the Leadership 
Training Program, training on care of the PWD and their caregiver, and communication both within the team 
and with the PWD-caregiver dyad in a patient-centered fashion. The leadership content is modeled after 
the Hartford Institute for Geriatric Nursing’s highly successful NICHE program leadership training program, 
which provides implementation training on geriatric principles for acute care hospitals and has been 
implemented in over 700 hospitals nationwide and internationally110. The leadership training portion also 
includes performance improvement and methods for ensuring implementation in their agency and serve as 
the change leaders in their agency. ADRD specific content mirrors non-champion training (see below) in 
more depth, and includes assessing patients for ADRD, assessing and managing pain and BPSD in PWD 
using the safest, least restrictive, non-pharmacologic and pharmacologic treatments, caring for individuals 
who are either resistant or unable to complete care due to ADRD, working with caregivers who work with 
PWD. It also covers additional topics in palliative care of ADRD including goals of care discussions, 
utilization of advanced directives, and transitioning to hospice. The third component, dyadic person-
centered team based care is based on three well validated programs, AHRQ TeamSTEPPS111 and SBAR112 
for healthcare team communication and the Antecedent-Behavior-Consequence method of problem 
solving113 to help clinicians work with caregivers to identify and solve the most problematic behaviors. 
Champions are designated from each discipline by each agency participating and serve as facilitators, 
resources/mentors and ensures quality improvement program fidelity in implementation throughout the 
study. 
 

 
 
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 Non-champion clinician training  
 
Non-champion clinician training (registered nurses, physical therapists, occupational therapists) will 
undergo five hours of online interactive learning modules which are each one hour in length and will be 
available over two months.  This is done based on our prior experience to ensure completion of the modules 
without over-burdening staff or requiring them to take a lower patient workload, which could have significant 
fiscal impact on the agency and thus reduce the likelihood of involvement.  The content of the modules 
largely mimics the larger champion course but in less detail, focusing more on assessment/recognition of 
conditions. The five 1-hour modules are: 1. Defining and distinguishing types of ADRD, assessing patients 
for ADRD; Basic non-pharmacologic and pharmacologic treatments for decline in PWD; Working with PWD 
to complete care tasks (e.g. registered nurse care, physical or occupational therapy care, instructing 
caregivers); 2. Assessing PWD for pain; non-pharmacologic and pharmacologic strategies for treating pain 
in the PWD; 3. Understanding, assessing and recognizing BPSD; 4. Non-pharmacologic and 
pharmacologic treatments for managing BPSD; 5. Dyadic person-centered team based care concepts 
derived from AHRQ TeamSTEPPS, SBAR, and Antecedent-Behavior Consequence method of problem 
solving. 
 Validated Instruments 
 
Validated assessment instruments are integrated into the workflow of HHC clinicians who are part of the 
teams receiving the DSM-H performance improvement program to allow for better assessment of cognition, 
pain, and BPSD and are validated in both English and Spanish. These tools are reviewed in the education 
of both champions and non-champions. Instruments included are the mini-cog108 for cognition, NPI-Q102 for 
BPSD, the Cornell Scale for Depression in Dementia114 in moderate/severe dementia, the Geriatric 
Depression Scale-Short Form115 in mild dementia for depression, the PAINAD116 and BPI for pain 
assessment in moderate/severe dementia, and the caregiver strain index117. These instruments are not part 
of research and are for clinical use by the HHC agency clinicians as they see fit in their clinical judgement. 
 Interprofessional care plans 
 

 
 
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Interprofessional care plans that guide overall care for PWD, with modules specific to pain and BPSD, are 
available to clinicians in the performance improvement care teams.  These care plans provide algorithms 
to guide clinicians when dealing with specific issues in older adults and are consistent with the information 
taught in the online and champion education programs. For instance, in PWD with sleep disturbance, care 
plans describe evidence based practices around implementing appropriate sleep hygiene and habits, 
stimulating patients during the day through activities, and environmental changes to improve sleep quality. 
Each plan is associated with tailored caregiver and/or patient education pamphlets that are written in both 
English and Spanish (generalized Latin American Spanish) that can be reviewed on site electronically and 
then mailed or brought to the next visit. 
 Administration of Quality Improvement Program 
The administration will be delivered by the HHC team as part of their practice in the community. The number 
of sessions may be variable as HHC teams see patients a variable number of times depending on the 
condition they are seeing the patient for and operational needs of the HHC agency. 
 Procedures for Training Quality Improvement Teams and Monitoring Fidelity 
Because there are multiple care teams receiving the performance improvement program, and we need to 
understand how well the program is implemented in order to assess the research outcomes, we will 
measure fidelity of implementation (e.g. clinician exposure to the performance improvement program) as 
well as differences across control and performance improvement teams through assessing registered 
nurse, physical and occupational therapist knowledge, attitudes and confidence using Drs. Brody and 
Galvin’s previously validated dementia symptom knowledge and attitudes survey at baseline, 6 months, 
and annually thereafter25, comparing differences across intervention and control teams for contamination, 
and through measuring the number of care plans initiated, caregiver teaching sheets provided to caregivers, 
and assessment instruments used at each site and in each care team throughout the trial.  
 
As the survey is primarily being collected for research purposes and not quality improvement purposes, we 
will consent clinicians who participate in the completion of the knowledge surveys. Completion of the 
training and clinical performance however will be seen as an operational, quality improvement requirement 
of the agencies, similar to Drs. Brody and Galvin’s prior successfully IRB approved studies. Champions will 
hold a monthly conference call with the investigators and spend 4 additional hours each month performing 
performance improvement through PDSA methodology and Audit and Feedback and will receive guidance 
by the investigators to ensure adequate implementation, and are provided training in this during champions 
training. Additionally, as is standard practice with complex performance improvement programs118 we will 
hold annual site visits and include process-based interviews with managers and executive leadership to 
elicit suggested improvements, whether there have been any changes in usual care during the time, or any 
concerns that have not been previously addressed. Finally, we will collect OASIS data, which is a 
standardized nationwide clinical data set entered usually by the RN in HHC to examine difference between 
documentation and our gold standard assessments, as well as for performance improvement on a quarterly 
basis. 
 
6.1.6.1 
Clinician Procedures for Fidelity Monitoring 
6.1.6.1.1 
Sample population and justification of Clinician Fidelity Monitoring 
We will include all registered nurses, physical therapists, and occupational therapists serving in 
the performance improvement or control teams who are providing direct care to patients in the 
field. Given the professions included, we expect the population to be overwhelmingly female and 
white. We have received staffing information from the agencies involved and subjected to 
turnover, expect that the overall population will be 85% female, 64% Caucasian non-Hispanic, 
14% black non-Hispanic, 21% Caucasian Hispanic, and 1% Asian. A total of 300 clinicians will be 
recruited and perform fidelity monitoring through an online survey at the NYU study site. 
 

 
 
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6.1.6.1.2 
Recruitment and retention strategies of Clinician Fidelity Monitoring   
6.1.6.1.2.1 Recruitment Strategy of Clinician Fidelity Monitoring  
The PI and/or site-PI will perform an introduction to the study and its purpose to all eligible clinicians at a 
site visit at a regularly scheduled staff meeting to explain the purpose of the trial. This will be followed by 
an all-staff email regarding the study from the agency CEO or delegate. We will also receive a list of eligible 
staff from the HHC agency. We will send several emails requesting participation in the study. For those 
individuals who do not respond to email, we will also perform a recruitment phone call to their agency cell 
phone. We will seek a waiver of documentation of consent and provide a statement at the beginning of the 
Qualtrics survey using a standardized statement approved by the NYU School of Medical IRB at onset of 
collection of fidelity surveys. 
6.1.6.1.2.2 Retention Strategy of Clinician Fidelity Monitoring  
For clinicians on performance improvement care teams, we will offer CEUs for completion of the surveys 
and online training. For those in control teams, we will offer upon completion of the study access to the 
online modules for their own training, as well as CEUs upon completion. In our past studies we have shown 
high recruitment and retention rates (92-100%) using these methods. 
6.1.6.1.2.3 Criteria for inclusion/exclusion of Clinician Fidelity Monitoring  
All English speaking registered nurses, physical therapists and occupational therapists employed or 
contracted by the agency who are part of an intervention or control care team and greater than 18 years of 
age will be eligible. This includes both bedside clinicians as well as the managers, team leads, and 
educators who support them. 
6.1.6.1.2.4 Risks to Clinician in Fidelity Monitoring 
There is minimal risk to the healthcare staff. The greatest risk is the loss of confidentiality. We will not share 
individual data to supervisors. We will not be providing individualized data back to the agencies on care 
team performance and will only use it for internal research team monitoring of fidelity. Champions at the 
agencies are trained as part of the champions training to perform their own performance improvement 
identification and management based on chart audits, OASIS data, and feedback from agency staff. No 
staff will have job actions performed secondary to fidelity monitoring by the researchers. 
6.1.6.1.2.5 Data Collection and Security for Clinician Fidelity Monitoring    
All fidelity measurement data will be collected using Qualtrics, which is hosted by NYU Data Services. In 
order to access Qualtrics, you must use your NYU campus login credential and starting September 1, 2017, 
multifactor authentication, to access through a secure portal. Once data is collected and being prepared for 
analysis, it will be downloaded into a NYU Box folder owned by the PI that will only be accessible to the 
appropriate study personnel. NYU Box is controlled by NYU and only accessible through NYU campus 
login credentials with multifactor authentication. It is HIPAA compliant and approved by NYU for maintaining 
sensitive information. Data will be collected through the Qualtrics survey by the clinician either on a personal 
or agency owned device. Data collected by Qualtrics is secure and encrypted. 
6.1.6.1.2.6 Potential Benefits for Clinician Fidelity Monitoring 
There are no inherent benefits associated with performing the DSKA as part of participation in this study. 
6.1.6.1.2.7 Source of Materials for Fidelity Review 
The DSKA will be collected at baseline, six months, and annually thereafter. It takes approximately 20 
minutes to complete. It includes baseline demographics (first survey only for an individual) and 79 likert 
style items regarding their knowledge, confidence and attitudes towards pain, depression and behavioral 
symptom assessment and management in persons with dementia. We have administered, and clinicians 
have completed the DSKA hundreds of times in the past four years in intervention and control settings and 

 
 
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it has a Cronbach Alpha of .94. An additional source material includes chart data from subjects at the 
agencies compared to our gold standard assessments. 
6.1.6.1.2.8 Importance of Knowledge to be Gained in Fidelity Monitoring 
This will help the investigators to understand the fidelity of implementation of the quality improvement 
program as well as whether there are environmental changes across the agency. 
6.1.6.1.2.9 Withdrawal or Termination of Clinicians in Fidelity Monitoring 
Clinicians may choose to withdraw from the study at any point. They will be terminated from the study only 
if they leave the agency. We will continue to maintain enrollment even if clinicians miss a survey at a given 
time point and anticipate that not all clinicians will complete at all time points. 
 Assessment of Subject Adherence with Study Quality Improvement Program 
Subjects will not be monitored for any specific adherence to care interventions suggested by HHC team 
members as this is a service delivery, evidence based practice intervention.  
7 Study Procedures and Schedule 
7.1 Study Procedures/Evaluations 
 Study Specific Procedures 
All data will be collected virtually via telephone and through internet capabilities. The following 
questionnaires will be collected by the research team as part of research assessment of efficacy of the 
intervention as it relates to the aims for both performance improvement and control subjects: 
 
 
• 
Quick Dementia Rating Scale (QDRS): Is a 10-item tool that measures cognitive impairment based on 
the severity of dementia. 
• 
Neuropsychiatric Inventory Questionnaire (NPI-Q): Is a 13-item tool that measures caregiver 
perceptions of dementia BPSD presence and severity. 
• 
Quality of Life in Alzheimer’s Disease (QOL-AD): Is a 13-item tool that measures caregiver perceptions 
of quality of life in the PWD 
• 
PAINAD: Is a pain assessment tool for use in persons with moderate to severe dementia who cannot 
provide reliable report. 
• 
Brief Pain Inventory Short Form (BPI) is a 9-item tool that measures pain location, severity and intensity. 
• 
FAM-CAM: Is an 11-item tool that is an informant-based assessment of delirium. 
• 
Medication Record and use: We will create a list of medications the PWD is taking as well as the 
frequency of administration of any PRN medications taken, including any OTC or herbal supplements. 
The primary reason for collecting this data is to examine analgesic and antipsychotic use. 
• 
Caregiver Targeted Quality of Life Tool (CGQOL): Is an 80-item tool with 10 domains for measuring the 
quality of life of the caregiver of the PWD. 
• 
Public Health Questionnaire 9 (PHQ-9): Is a 9-item tool that measures depressive symptoms. 
• 
Zarit Burden Inventory: Is a 22-item tool that measures caregiver burden. 
• 
SF-12: The SF-12 is a 12-item tool that measures functional health and well-being. 
• 
ADLs and IADLS: Are 12 items that measure functional status as part of the QOL-AD. 
• 
Charlson Comorbidity Index: Is a reliable and valid comorbidity assessment tool.    
• 
The Short Assessment of Health Literacy (SAHL): Is an 18-item test designed to examine health literacy 
levels 
• 
Other non-instrumented questions that will be asked include sociodemographics (DOB, sex, highest 
education level attained, race, ethnicity, primary language, religion, marital status, household members, 
number type and frequency of unpaid and pain caregivers, and primary care provider name and contact 
for both PWD and caregiver. 

 
 
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• 
Information obtained from the chart includes: Number of visits by the home healthcare staff by type, 
comorbidities. 
• 
Resource Utilization Inventory: Is a 13-item tool to measure healthcare resource utilization. 
• 
HHCAHPS: Is a 32-item standardized patient satisfaction survey. While home healthcare agencies 
attempt to collect this on all patients, they are not always successfully able to do so and we will 
therefore measure independently to avoid missing data. 
• 
Investigator derived questions asking if their caregiving practices have shifted due to the COVID-19 
pandemic. The COVID-19 related questions are included in the subject dyad instruments.  
 Standard of Care Study Procedures 
Individuals who are in the control group will receive usual care as provided by the HHC agency. 
7.2 Study Schedule 
 Screening 
Screening is initiated during the initial call and completed prior to subjects being introduced to 
the informed consent process.   
The research team will contact patients and caregivers who have “not opted out” from being contacted 
based on their HHC agency’s referral. The research team will inquire on their interest in learning about 
the study and whether they may be interested in participating prior to screening for eligibility. Screening 
will be initiated in the first contact to ensure that they have met the inclusion/exclusion criteria. To 
determine if the PWD’s level of cognitive impairment meets eligibility for inclusion, the QDRS will be 
administered to the caregiver who will rate the PWD’s symptoms and behaviors. Caregivers will be 
provided with a copy of the QDRS assessment form for their review.  A research team member will 
complete the form with the caregiver over the phone. A score will be tallied to determine the PWD’s level 
of cognitive impairment. A PWD who obtains a score >6 on the QDRS will meet eligibility for study 
inclusion. If the screening is positive and the PWD and caregiver are interested in participating, the 
research team member will conduct the informed consent process. The screening, informed consent, and 
visit one assessments for each subject will be completed within 3 business days from the PWD’s start of 
care date. In circumstances where subjects who provide their consent verbally yet lack the ability to 
electronically sign the informed consent document due to lack of internet access or computer literacy, we 
will mail them a copy of the consent form to review and confirm at visit 2 their intent to continue 
participation in order to ensure equity in participation. Providing consent/assent has been obtained, the 
remainder of the virtual visit will be utilized for subject data collection. Further, the QDRS score will 
determine which assessments are administered to the PWD.   
 
 Enrollment/Baseline 
The enrollment and baseline visit (if eligible and enrolled) will occur on the same day.  
 
Enrollment/Baseline Visit  
Visit 1, (Day 0/1) the following surveys will be collected during visit one. Surveys administered to the 
PWD are indicated by their QDRS score: 
 
o 
PAINAD (if QDRS>12) 
o 
FAM-CAM 
o 
Brief Pain Inventory Short Form (BPI; if QDRS<12). 
o 
Quality of Life in Alzheimer’s Disease (QOL-AD) (if QDRS <12) 
o 
Neuropsychiatric Inventory Questionnaire (NPI-Q) 
o 
Caregiver Targeted Quality of Life Tool (CGQOL):  
o 
Public Health Questionnaire 9 (PHQ-9) 
o 
Zarit Burden Inventory 
o 
SF-12 
o 
Charlson Comorbidity  

 
 
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o 
Katz ADLs and Lawton IADLS (through the QOL-AD) 
o 
The Short Assessment of Health Literacy (SAHL) 
o 
Other non-instrumented questions that will be asked include sociodemographics (DOB, sex, 
highest education level attained, race, ethnicity, primary language, religion, marital status, 
household members, number type and frequency of unpaid and pain caregivers, medication 
record and use, primary care provider name and contact for both PWD and caregiver. 
o 
Information obtained from the chart includes: Number of visits by the home healthcare staff 
by type, comorbidities, COVID-19 questions. 
 
 
Intermediate Visits:  
  
Visit 2 (Day 15+/-3)  
The following surveys will be administered for visit two:   
Surveys administered to the PWD are indicated by their QDRS score: 
 
o 
BPI (If QDRS<12) 
o 
PAINAD (If QDRS >12) 
o 
FAM-CAM 
o 
NPI-Q   
o 
Katz ADLs and Lawton iADLs (through the QOL-AD)  
o 
Non-instrumented: Medication Record and Usage, AE and SAE  
 
Visit 3 (Day 30+/-3)  
The following surveys will be administered for visit three: 
Surveys administered to the PWD are indicated by their QDRS score: 
 
o 
PAINAD (If QDRS >12) 
o 
FAM-CAM 
o 
BPI (If QDRS<12) 
o 
NPI--Q 
o 
Katz ADLs and Lawton iADLs (through the QOL-AD)  
o 
Resource Utilization Inventory 
o 
Non-instrumented: Medication Record and Usage, Resource Utilization Inventory, AE and 
SAE, COVID-19 questions 
 Final Study Visit 
Final Study Visit (Visit 4, Day 60+5)  
The following surveys will be administered for visit four: 
Surveys administered to the PWD are indicated by their QDRS score: 
 
o 
PAINAD (If QDRS >12) 
o 
FAM-CAM 
o 
BPI (If QDRS<12). 
o 
QOL-AD (If QDRS<12) 
o 
NPI-Q 
o 
CGQOL:  
o 
Public Health Questionnaire 9 (PHQ-9) 
o 
Zarit Burden Inventory 
o 
SF-12 
o 
Charlson Comorbidity  
o 
Resource Utilization Inventory 

 
 
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o HHCAHPS 
o 
Katz ADLs and Lawton IADLS (through the QOL-AD) 
o 
Non-instrumented: Medication Record and Usage, Resource Utilization Inventory, AE and SAE 
o 
Information obtained from the chart includes: Number of visits by the home healthcare staff 
by type, comorbidities, COVID-19 questions. 
 
 Collection of Home Health Record 
 
Following the final study visit, the home health agency will extract the PWD subject’s health record, 
including OASIS documentation, symptom scores, assessment information, and administrative visit 
information. 
 Withdrawal/Early Termination Visit 
Should individuals withdraw from the study for any reason, we will attempt to ask for the reason and ask if 
any SAE or AE have occurred if the PWD/caregiver are reachable. We will also if withdrawal is for non-
communication with the study team we will review the HHC medical record to ascertain if there was an SAE 
or AE. 
7.3 Concomitant Medications, Treatments, and Procedures 
Not Applicable 
7.4 Justification for Sensitive Procedures 
There are no sensitive procedures, provocative testing or deception inherent in this study. 
7.5 Prohibited Medications, Treatments, and Procedures 
Not applicable 
7.6 Prophylactic Medications, Treatments, and Procedures 
Not applicable 
7.7 Rescue Medications, Treatments, and Procedures 
Not applicable 
7.8 Participant Access to Study Agent at Study Closure 
Not applicable. Should the individual still be receiving HHC from the intervention team at the close of the 
study period they will continue to receive the intervention. 
8 Assessment of Safety 
8.1 
This study is a minimal risk study given that it is an evidence-based implementation science 
intervention. However, the investigators will monitor for the following safety parameters and events 
throughout this study. In instances where an adverse event (AE) or a serious adverse event (SAE) 
has been identified, the investigators will follow standard clinical practice (SCP) whereby the 
investigator will notify the subject’s health care provider responsible for initiating and/or approving 
the subject’s enrollment into HHC services. In situations where an AE or SAE has been determined 
to be related to the study and the subject has withdrawn, investigators will actively monitor in follow 
up.  Specification of Safety Parameters  
 

 
 
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Due to the pragmatic nature of the trial, the DSMB has directed this trial to perform a highly focused AE 
collection process which requires following single adverse event: a PHQ-9 score worsened by greater than 
or equal to 5 points during the course of the study. The DSMB further requires monitoring the following 
severe AEs: Caregiver attempted suicide; death of caregiver; death of person with dementia a; medical 
event that may jeopardize the subject, including hospitalization of either the person with dementia or 
caregiver, suicidal ideation, elder neglect or abuse, or an environmental threat such as unsecured firearm.  
 
In cases of the following safety parameters, the site-PI and PI shall be notified immediately, a telephone 
triage performed, and then SCP will be followed by notifying the subject’s primary care provider to advise 
of the situation. 
 
Due to the virtual nature of data collection, safety monitoring will be done to the best of abilities for: 
Imminent home safety threats/hazards (e.g. hoarding/cluttering, unsecured gun). 
Suspected elder abuse or neglect. 
 
Caregiver Depression: Should caregivers have a score of ≥10 on the PHQ-9 or exhibit suicidal ideation 
via item 9 of the PHQ-9 or verbally outside of any instrumentation, Definition of Adverse Events (AE) 
 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.  Intercurrent illnesses or injuries should be regarded as adverse events.  
Abnormal results of diagnostic procedures are considered to be adverse events if the abnormality: 
• results in study withdrawal 
• is associated with a serious adverse event 
• is associated with clinical signs or symptoms 
• leads to additional treatment or to further diagnostic tests 
• is considered by the investigator to be of clinical significance 
 
The following AEs will be monitored in this study: 
 
Worsening of depression symptoms: Caregivers whose PHQ-9 score worsen by greater than or equal to 5 
points during the course of the study 
 Definition of Serious Adverse Events (SAE) 
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
• fatal 
• life-threatening 
• requires or prolongs hospital stay 
• results in persistent or significant disability or incapacity 
• a congenital anomaly or birth defect 
• an important medical event 
 
Important medical events are those that may not be immediately life threatening but are clearly of major 
clinical significance. They may jeopardize the subject and may require intervention to prevent one of the 
other serious outcomes noted above. For example, drug overdose or abuse, a seizure that did not result in 
in-patient hospitalization, or intensive treatment of bronchospasm in an emergency department would 
typically be considered serious.  
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious 
adverse events.  
 
The following SAEs will be monitored in this study: 
 

 
 
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Caregiver attempted suicide: A case in which a caregiver is noted to have attempted suicide. This 
information may be provided by the PWD surrogate, PWD (if only mild dementia) or other family member, 
friend, or caregiver when attempting to complete follow-up visits.  
 
Death of Caregiver: A case in which a caregiver is noted to have died. This information may be provided 
by the PWD surrogate, PWD (if only mild dementia) or other family member, friend, or caregiver when 
attempting to complete follow-up visits. We will attempt to ascertain the cause of death of the caregiver 
 
Death of PWD: A case in which the PWD has died. We will attempt to contact the caregiver and primary 
care provider to ascertain the cause of death. 
 
Any SAE will be immediately reported to the site-PI and overall PI, who will follow SCP by notifying the 
subject’s health care provider and then notifying the IRB of record and DSMB for further review. 
 Definition of Unanticipated Problems (UP) 
 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
• Unexpected in nature, severity, or frequency (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc) 
• Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 
• Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 
 
This definition could include an unanticipated serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, the intervention, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the investigational plan or 
application (including a supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects (21 CFR 812.3(s)). 
 
8.2 Classification of an Adverse Event 
 Severity of Event 
 
For AEs not included in the protocol defined grading system, the following guidelines will be used to 
describe severity. 
 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating. 
 
 Relationship to Study Quality Improvement Program 
 
 

 
 
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The PI or site PI will assess the AE's relationship to study quality improvement program, and will be part of 
the documentation process, but it is not a factor in determining what is or is not reported in the study. If 
there is any doubt as to whether a clinical observation is an AE, the event should be reported. All AEs must 
have their relationship to study agent assessed. In a clinical trial, the study product must always be suspect. 
To help assess, the following guidelines are used. 
 
• Related – The AE is known to occur with the study agent, there is a reasonable possibility that the 
study agent caused the AE, or there is a temporal relationship between the study agent and event. 
Reasonable possibility means that there is evidence to suggest a causal relationship between the 
study agent and the AE. 
• Not Related – There is not a reasonable possibility that the administration of the study agent 
caused the event, there is no temporal relationship between the study agent and event onset, or 
an alternate etiology has been established. 
 
 Expectedness 
 
The site PI or PI will be responsible for determining whether an AE is expected or unexpected. An AE will 
be considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk 
information previously described for the study agent. 
8.3 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. All AEs 
including local and systemic reactions not meeting the criteria for SAEs will be captured on the appropriate 
RF. Information to be collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to study product (assessed only by those with the training and authority to make a diagnosis), 
and time of resolution/stabilization of the event. All AEs occurring while on study must be documented 
appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time 
during the study, it will be recorded as an AE. UPs will be recorded in the data collection system throughout 
the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of onset 
and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is obtained 
until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study 
visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit Events will be followed 
for outcome information until resolution or stabilization.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the 
subject is lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the 
investigator should instruct each subject to report any subsequent event(s) that the subject, or the subject’s 
personal physician, believes might reasonably be related to participation in this study.  The investigator 
should notify the study sponsor of any death or adverse event occurring at any time after a subject has 
discontinued or terminated study participation that may reasonably be related to this study.  The sponsor 
should also be notified if the investigator should become aware of the development of cancer or of a 
congenital anomaly in a subsequently conceived offspring of a subject that has participated in this study.  

 
 
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8.4 Reporting Procedures – Notifying the IRB  
 
All AEs and SAEs will be reported to the site-PI (if applicable) and study-PI immediately. The PI will assess 
the event for severity, consult with the co-investigators if necessary, and when an event has been 
determined to be severe, the site PI will follow SCP by notifying the subject’s health care provider. The PI 
will report all study related SAEs to IRB and DSMB within 24 hours of their knowledge of the incident.  The 
PI will be responsible for working with the DSMB, IRB, site-PIs and other individuals regarding related SAE 
to the trial. All AEs will be recorded and reviewed immediately and for patterns of AE on a quarterly basis 
and referred with a corresponding report to the IRB and DSMB. 
 Unanticipated Problem Reporting 
 
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP report 
form. It is the site investigator’s responsibility to report UPs to their IRB and to the DSMB/study sponsor. 
The UP report will include the following information: 
 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• A detailed description of the event, incident, experience, or outcome; 
• An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP; 
• A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
• UPs that are SAEs will be reported to the IRB and to the DSMB/study sponsor within 24 hours of 
the investigator becoming aware of the event. 
• Any other UP will be reported to the IRB and to the DSMB/study sponsor within 3 days of the 
investigator becoming aware of the problem. 
• All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and OHRP within<insert 
timeline in accordance with policy> of the IR’s receipt of the report of the problem from the 
investigator. 
 
8.5 Reporting Procedures – Notifying the Study Sponsor 
 
The study clinician will complete a SAE Form within the following timelines: 
 
• All deaths and immediately life-threatening events, whether related or unrelated, will be recorded 
on the SAE Form.  SAE that have been determined to be related to the study will be submitted to 
the DSMB/study sponsor within 24 hours of site awareness. See Section 1, Key Roles for contact 
information. 
• Other SAEs that are determined to be related to the study will be submitted to the DSMB/study 
sponsor within 72 hours of site awareness. 
 
All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be 
chronic or the adherence to be stable. Other supporting documentation of the event may be requested by 
the DSMB/study sponsor and should be provided as soon as possible.  
 
As a follow-up to the initial report, within the following 48 hours of awareness of the event, the investigator 
shall provide further information, as applicable, on the unanticipated event or the unanticipated problem in 
the form of a written narrative.  This should include a copy of the completed Unanticipated Problem form, 

 
 
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and any other diagnostic information that will assist the understanding of the event.  Significant new 
information on ongoing unanticipated adverse effects shall be provided promptly to the study sponsor. 
 
8.6 Reporting Procedures – Participating Investigators  
As noted in 8.4 all site PIs will take part in the classification of AEs, SAEs and UPs and will therefore be 
immediately contacted for discussion of the event. 
 
8.7 Study Halting Rules 
Temporary suspension of the trial will occur if there is a 20% or greater negative effect found in any of the 
primary outcomes. The study will also be halted if SAEs are found that are caused by the quality 
improvement program, or at the discretion of the IC or the DSMB in conjunction with the IC. Safety Oversight 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at his/her site.  This 
safety monitoring will include careful assessment and appropriate reporting of adverse events as noted 
above, as well as the construction and implementation of a site data and safety-monitoring plan. Medical 
monitoring will include a regular assessment of the number and type of serious adverse events. 
 
8.8 Safety Oversight 
 Data Safety and Monitoring 
 
The Principle Investigator will ensure overall safety of the subjects in the trial on a daily basis and will be 
responsible for all reporting. The site PIs will be responsible for managing safety at their sites in coordination 
with the PI. The study statistician will be responsible for running quarterly reports on data safety, 
consistency and outcomes and reviewing them with the study PI. A DSMB will act in an advisory capacity 
to the Primary IC Director in regards to the study. 
 
 Frequency and Reporting 
 
As noted in section 8.4, all AE and SAE will be reported directly to the site PI and then study PI. All events 
will be reported within 24 hours to the DSMB and the IRB at both the study site and the primary IRB (NYU). 
The DSMB will then discuss whether and how to convene. Outside of SAE, the DSMB will meet at least 
prior to onset of the trial and every 6 months at a minimum. Safety reports will be sent twice yearly including 
analysis of study progress and data and safety issues. These reports will include descriptive analyses of 
participant demographic data, interim analyses of primary and secondary outcomes, as well as any adverse 
or serious adverse events, and quality improvement program fidelity. Individuals who withdraw from the 
trial will be examined in sensitivity analyses, however will be replaced with completed cases for the 
purposes of the trial. There are no cases where the quality improvement program will be discontinued but 
follow-up will still occur unless an individual withdraws from the study due to an AE or SAE, in which case 
we will ensure safety of the individual/dyad and referral to existing resources. 
 Data Safety and Monitoring Board 
8.8.3.1.1 
DSMB Composition 
 
The investigators will develop with the IC a 3-member independent DSMB. The composition will include a 
chair who has experience performing Phase III behavioral clinical trials in dementia, a biostatistician, and 
an independent clinician-researcher with experience in home-based care of older adults. All members will 

 
 
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have no personal or professional conflict of interest in the study, a current affiliation with any of the study 
sites, has not served as an author or co-author on a grant or manuscript together with the PI or site PIs 
within the past 3 years. 
 
8.8.3.1.2 
DSMB Responsibilities and Powers 
 
The principle responsibility of the DSMB is to protect the safety of study participant. The DSMB will initially 
meet to evaluate the protocol to ensure minimization of risk prior to initiation and recommend when subject 
recruitment can be initiated. The DSMB will then meet and monitor primary and secondary outcome data, 
SAEs and AEs, performance data by site, and recruitment data by site, as well as other safety issues or 
risks to the PWD, caregiver, or dyad through bi-annual meetings, or if needed more frequently via 
conference call or webex. The DSMB will have the power to recommend halting of the trial to the IC and PI 
should it find any of these factors cause safety issues, serious adverse events or outcomes, or significantly 
better outcomes. It also has the power to report directly to the IC and the PI on its findings or any issues 
with the conduct of the study or enrollment, sample size, or data collection issues. The quality improvement 
program will be discontinued or temporarily halted if the IC closes the trial or DSMB recommends 
discontinuing or halting the trial based on determining the  study’s subjects (care recipient and care giver) 
safety is compromised or at risk. (see section 8.7). 
 
 
9 Clinical Monitoring 
 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial 
is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable 
regulatory requirement(s). As this is a minimal risk study, limited clinical monitoring will be performed by 
the study biostatistician in ensuring data entry verification and completeness and, the lead site principal 
investigator in ensuring appropriate and complete targeting of prospective subjects. As noted in fidelity 
measurement, we will also hold monthly meetings to ensure quality improvement program fidelity. 
Additionally, each research site will perform internal quality management of study conduct, data collection, 
documentation and completion.  
 
10 Statistical Considerations 
10.1 Statistical and Analytical Plans (SAP) 
A formal SAP will not be completed for this study. 
 
10.2 Statistical Hypotheses 
H1: PWD cared for by a HHC team utilizing the DSM-H will show reduced symptoms and improved ratings 
of pain, BPSD, and caregiver-rated QOL at the end of the first 60-day HHC certification period compared 
to the control (usual care) group. 
 
H2: Informal caregivers of PWD cared for by a HHC team utilizing the DSM-H will show reduced ratings of 
burden, and depression, and improved functional health and well-being at the end of the first 60-day HHC 
certification period compared to the control (usual care) group. 
 
H3: PWD cared for by a HHC team utilizing the DSM-H will show a reduction in emergency room visits and 
hospital admissions compared to the control (usual care) group, and a greater number of outpatient visits. 
 

 
 
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10.3 Analysis Datasets 
PWD, caregivers, and clinicians will each have a separate data set. Additionally, a data set with combined 
will be created to examine the interaction between PWD-caregiver dyad interactions and interactions 
between outcomes and quality improvement program fidelity. Separate SAE and AE data sets will be 
maintained for caregivers and PWDs. 
 
10.4 Description of Statistical Methods 
 General Approach 
 
Data Analysis will be performed using SAS 9.4120. We will perform statistical tests to examine baseline 
differences between the quality improvement program and control groups. We will then perform unadjusted 
comparison of both primary outcomes (patient and caregiver quality of life, emergency room visits) and 
secondary outcomes (pain, BPSD, delirium, caregiver depression burden, and burnout, hospital and 
emergency room admissions) between groups. We will focus on the endpoint measure for quality of life, 
and 30 and 60-day outcomes for emergency room utilization. For primary and secondary outcomes, we will 
perform a time trend analysis using a mixed effects linear model (PROC MCM). Mixed effects regression 
is used to analyze longitudinal data with repeated measures accounting for intra-individual and group 
clustering. We intend to use multivariate mixed effects regression modeling as opposed to traditional linear 
modeling or ANOVA in order to control for unobservable confounding variables that are constant over time 
but differ across PWD and/or caregivers121. For both primary and secondary outcomes, we will then repeat 
the above analyses adjusting for baseline variables as covariates for a more efficient measurement of the 
effects of the quality improvement program. We will also perform correlation analyses to explore the 
relationship between pain and BPSD, and PWD and caregiver QOL through plotting scores over time and 
then if a significant correlation is present through adding to our mixed effect model. For utilization data, we 
will perform logistic regression to examine whether the patient is more or less likely to have a hospitalization 
or ER visit compared when receiving the quality improvement program at 30 and 60 days. We will then 
perform a Poisson Count Regression to compare the total number of hospitalizations and ER visits at each 
timepoint. In these models we will utilize a random effect to measure for clustering.  
 Safety Analyses 
We will perform interim analyses using descriptive statistics and two-sided t-tests, monitoring for a 
significance of 0.05 starting at the end of year 1 of the grant for safety purposes. These results will be 
presented unblinded to the DSMB. 
 Adherence and Retention Analyses 
We will perform sensitivity analyses to examine whether there are differences in those who are retained in 
the study vs those who withdraw/are terminated. As this is a cluster randomized trial, adherence is related 
to the quality improvement program implementation at the care team level and therefore falls under fidelity 
monitoring. We will examine differences in annual DSKA scores submitted by HHC clinicians across control 
and quality improvement program care teams through paired t-tests and repeated measures ANOVA. 
 Baseline Descriptive Statistics 
We will compare quality improvement program cohorts based on baseline demographic variables 
including age, sex, education, race, ethnicity, healthcare literacy, functional status, and comorbidities 
using descriptive statistics and t-tests. 
 
 Planned Interim Analysis 
See. 10.4.2 

 
 
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10.4.5.1 Safety Review 
See 8.7 and 10.4.2. 
 
10.4.5.2 Efficacy Review 
See 10.4.2. Efficacy will not be considered in halting the study. 
 
 Additional Sub-Group Analyses 
We will perform sub-group analyses based on age, sex, and race/ethnicity. We will perform both 
descriptive and multivariate comparisons. 
 
 Multiple Comparison/Multiplicity 
Not Applicable 
 
 Tabulation of Individual Response Data 
Individual participant data will not be listed, with the exception of spaghetti plots of change over time. 
 
 Exploratory Analyses 
We will examine the effect of ADL function on non-QOL outcomes. We will also examine the interaction of 
caregiver and PWD primary and secondary outcomes. 
10.5 Sample Size 
 
Power analyses were conducted using Optimal Design software122.  Given that this study is randomized at 
the cluster level, we must control for intra-class correlation, and have therefore calculated all power with an 
intra-class coefficient of .05, which is more conservative than the most recent clustered palliative care 
study123 and aligns well with prior community-based cluster trials124. The Quality of Life in Alzheimer’s 
Disease as the primary outcome measure in aim 1 has an average score of 33.1, standard deviation of 5.9. 
A .5 standard deviation difference in this measure would be clinically meaningful. Therefore, in a 2-sample 
comparison with a power of .80, an alpha of .05 and covariates that account for a cumulative 15% of the 
variance in outcome would require 15 dyads per cluster, and 20 clusters (10 per arm) at 60 days to detect 
a medium effect (δ = .45). For mixed effects linear models, the projected sample size will also allow us to 
detect a medium linear treatment effect (δ = .45) between groups in unadjusted analyses (assuming 15 
dyads per cluster, 20 clusters, 4 observations, and an ICC = .05). Although there are no closed-form 
equations for calculating the power of linear models that include covariates, any non-zero correlation 
between covariates and the outcome will reduce the unexplained (error) variance thus increasing the 
statistical power of our tests, and reducing the minimum detectable effect size. As such, the detectable 
effect size estimated for the unadjusted analyses can be considered an upper bound estimate for the 
jneffect size detectable in adjusted analyses. We will recruit until we have reached 15 completed cases 
in each cluster (N=300). Conservatively anticipating a 15% dropout40,125 over the 60 days requires a total 
recruitment goal of 345 dyads. As almost 20,000 patients are seen each year in the three HHC agencies 
in this study, approximately 30% with ADRD, we do not expect any difficult recruiting this sample, even with 
an unanticipatedly high rate of dyads declining to participate.  
 
In addition, for fidelity monitoring, as discussed in section 6.1.6.1, we will consent 300 clinicians at the 
participating HHC agencies on usual care and quality improvement care teams to complete fidelity monitor 
by performing the DSKA survey. These clinicians are not study subjects but will be consented as they are 

 
 
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performing these surveys to assist the research team in monitoring fidelity of the quality improvement 
program. 
10.6 Measures to Minimize Bias 
 Enrollment/Randomization/Masking Procedures 
As randomization is done at the cluster (care team) level, this will only be performed at the beginning of the 
trial. The study statistician will perform the randomization utilizing SAS 9.4 stratified by agency. The PI will 
relay to the home care agencies which teams will serve as quality improvement program teams or control 
teams. The study RAs, study project director, and site-PIs will all be blinded to the assignment. Teams will 
be randomized in strata by agency and geographic location to ensure like care teams are assigned to each 
condition. Subjects will be assigned through usual practice to the care team that serves the geographic 
area they live in. We will sequentially recruit individuals as they are referred from agencies following the 
very clear, straightforward method described above in section 5.4. 
 
Clinicians will be enrolled sequentially if they are eligible and all study personnel with the exception of the 
lead site PI and study statistician will be blinded as to the assignment of the clinicians within a performance 
improvement or usual care team. 
 
 Evaluation of Success of Blinding 
Not applicable 
 
 Breaking the Study Blind/Participant Code 
Intentional breaking of the blind will only be performed in case of SAE, and then only to the site PI, but not 
the site RA or project director. 
 
11 Source Documents and Access to Source Data/Documents 
 
Source data is all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in source 
documents.  Examples of these original documents, and data records include: hospital records, clinical and 
office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing 
records, recorded data from automated instruments, copies or transcriptions certified after verification as 
being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, 
subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments 
involved in the clinical trial. It is acceptable to use CRFs as source documents. If this is the case, it should 
be stated in this section what data will be collected on CRFs and what data will be collected from other 
sources. 
 
All assessment data, which has no PHI, will be collected using Qualtrics, which is hosted by NYU Data 
Services. Any data with PHI will be collected and entered directly into REDCap, which is hosted by NYU 
Langone Medical Center. In order to access REDCap or Qualtrics, you must use your NYULMC or NYU 
login credential respectively to access through a secure portal. Data will be transferred from Qualtrics to 
REDCap by the study project director. All Qualtrics assessments will require a forced entry to ensure 
missing data is minimized 
 
PHI will only be collected in Redcap. A study ID will be created in NYU REDCap and used for all Qualtrics 
data that is collecting surveys. Once data is collected, it will be downloaded from Qualtrics to a NYU MCIT-
managed network drive on a weekly basis that will only be accessible to the appropriate study personnel 

 
 
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and added to RedCAP. The MCIT drive It is HIPAA compliant and approved by NYU MCIT for maintaining 
sensitive information.  
 
Data will be collected electronically through the use of computers or utilizing iPADs that are owned, centrally 
managed, passcode required, and distributed to the study RAs across sites by NYU MCIT. The iPads will 
be encrypted and locked so that only secure and approved apps, such as for collecting data offline 
(Qualtrics App) will be made available. Once data is collected through the use of Qualtrics surveys, it can 
only be transferred to the secure Qualtrics server and not extracted by other means. Thus, when the iPad 
is connected to secure wifi, the data will be automatically uploaded to the Qualtrics server and removed 
from the iPad. Electronic informed consent documents with subject information will be collected, stored and 
maintained on the REDCap system.  
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will 
permit study-related monitoring, audits, and inspections by the IRB/EC, the sponsor, government regulatory 
bodies, and University compliance and quality assurance groups of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data etc.).  The investigator will 
ensure the capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic 
laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
12 Quality Assurance and Quality Control 
 
QC procedures will be implemented beginning with the data entry system and data QC checks that will be 
run on the database will be generated. Any missing data or data anomalies will be communicated to the 
site(s) for clarification/resolution. 
 
The lead PI will verify that the clinical trial is conducted and data are generated, documented (recorded), 
and reported in compliance with the protocol, and GCP in coordination with the study statistician. 
 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory 
authorities. 
 
13 Ethics/Protection of Human Subjects 
13.1 Ethical Standard 
 
The investigator will ensure that this study is conducted in full conformity with Regulations for the Protection 
of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and/or the 
ICH E6. 
 
13.2 Institutional Review Board 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted 
to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained 
before any participant is enrolled. Any amendment to the protocol will require review and approval by the 
IRB before the changes are implemented to the study. All changes to the consent form will be IRB approved; 
a determination will be made regarding whether previously consented participants need to be re-consented. 
 

 
 
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13.3 Informed Consent Process 
 Consent/Assent and Other Informational Documents Provided to Participants 
 
Consent forms describing in detail the quality improvement program, study procedures, and risks are 
provided to each participant electronically through the REDCap database. The completion of all consent 
documents will include electronic signatures that will be obtained and maintained through the REDCap 
system prior to starting study-related activities. The following consent materials are submitted with this 
protocol.  
 
Consent-PWD 
Assent Form-PWD 
Consent-Caregiver 
Telephone Consent Script-PWD Surrogate 
Application for Waiver of documentation of consent-PWD and Caregiver 
Application for Waiver of Documentation of Informed Consent-Clinician 
Study Information Survey Header-Clinician 
 Consent Procedures and Documentation 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Extensive discussion of risks and possible 
benefits of participation will be provided to the participants and their families. Consent forms will be IRB-
approved and the participant will be asked to read and review the document. The investigator will explain 
the research study to the participant and answer any questions that may arise. All participants will receive 
a verbal explanation in terms suited to their comprehension of the purposes, procedures, and potential risks 
of the study and of their rights as research participants. Following the COVID-19 pandemic the method of 
completing informed consent with participants has transitioned from an in-person written consent to  remote 
with electronic signature. Where verbal consent is needed, the researcher will incorporate HIPAA 
authorization language to describe the study purpose, the type of questions asked and their ability to refrain 
from answering, the length of time expected of their participation, the method for keeping information 
confidential and who they may contact (PI; IRB) with questions, and that their participation is voluntary and 
can be stopped at any time without consequence to the PLWD’s treatment. The participants are given an  
opportunity to discuss the study with their surrogates or think about it prior to agreeing to participate. 
Participants will have the opportunity to carefully review the electronic consent form and ask questions prior 
to signing and/or providing verbal consent. The participant will electronically sign the informed consent 
document prior to any procedures being done specifically for the study. Only in cases where the subject 
due to lack of internet or poor computer literacy cannot electronically sign the consent form, we will accept 
their verbal consent to participate after all information on the consent document has been presented to 
them ensuring that regulatory HIPAA language has been heard and all questions have been answered. In 
these situations where verbal consent is received, the research will date and sign the informed consent 
document and advise the participant of their enrollment status, confirm with the subject that they want to 
participate, and then ask the subject if the researcher may begin the visit one assessments.  In the cases 
where verbal consent, as a secondary option has been provided by the participant, a copy of the consent 
form completed with the researcher’s signature will be sent to them and we will reconfirm their participation 
at visit 2. Where one part of the caregiver-PWD dyad can sign electronically and the other cannot, we will 
capture the signature of the individual who can sign, and verbal consent of the individual who cannot 
following said process, as they may be in different locations with differential access to internet. The 
participants may withdraw consent at any time throughout the course of the trial. A copy of the electronically 
signed informed consent document will be downloaded by participants for their records. The rights and 
welfare of the participants will be protected by emphasizing to them that the quality of their medical care 
will not be adversely affected if they decline to participate in this study. 
 

 
 
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A copy of the executed informed consent document will be stored in the subject’s research record on 
REDCap. The consent process, including the name of the individual obtaining consent, will be thoroughly 
documented in the subject’s research record. Any alteration to the standard consent process (e.g. use of a 
translator, consent from a legally authorized representative, consent document presented orally, etc.) and 
the justification for such alteration will likewise be documented.  
 
Consent will be performed remotely by study RAs or the study lead site project director. Determination of 
capacity for consent is discussed in section 5.4. Once the determination is made, the written informed 
consent will be completed by the RA or project director. Signatures for each subject’s informed consent will 
be collected electronically and stored in the subject record on REDCap. If the PWD does not have capacity, 
and verbal or electronic consent is provided by the surrogate decision maker for the patient to participate, 
the PWD will be asked for their assent.  
 
In addition to consent, in PWD who are determined to lack capacity, we will ask for their assent if they are 
verbally able to do so. If they chose not to assent, we will not enroll them in the study.  
 
 
 
13.4 Participant and Data Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations require a signed 
subject authorization informing the subject of the following:  
 
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information  
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, retains 
the ability to use all information collected prior to the revocation of subject authorization.  For subjects that 
have revoked authorization to collect or use PHI, attempts should be made to obtain permission to collect 
at least vital status (i.e. that the subject is alive) at the end of their scheduled study period. 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to participants. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No information 
concerning the study or the data will be released to any unauthorized third party without prior written 
approval of the sponsor. 
 
Authorized representatives of the sponsor and representatives of the IRB may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical records (office, 
clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site will permit 
access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use during 
the study. At the end of the study, all records will continue to be kept in REDCAP or an MCIT managed 
networked drive for as long a period as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored at NYU Langone Medical Center and the NYU School of Nursing. Transmission 
from external sites will be performed securely through the MCIT managed iPADs, or through secure 

 
 
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encrypted email. This will not include the participant’s contact or identifying information. Rather, individual 
participants and their research data will be identified by a unique study identification number. The study 
data entry and study management systems used by clinical sites and by NYU School of Nursing research 
staff will be secured and password protected. At the end of the study, all study databases will be de-
identified and archived at the NYU Langone Medical Center and NYU School of Nursing.  
 Research Use of Stored Human Samples, Specimens, or Data 
Not Applicable 
 
13.5 Future Use of Stored Specimens 
Not Applicable 
 
 
14 Data Handling and Record Keeping 
14.1 Data Collection and Management Responsibilities 
 
All data including the consent forms will be collected and maintained electronically in NYULMC RedCap or 
on an MCIT-managed network drive.  Referral submissions sent via encrypted transfer or secure email will 
be uploaded directly into redcap, the study log, by the research coordinator or project director.  
 
Enrolled subjects who request to receive an email or text message to reminder them of upcoming study 
visits, will receive a notification through REDCap.  Email notifications will be performed using REDCap 
survey function.  SMS (text) messages will be completed through a linked REDCap and Twilio account.  
When a subject requests to receive a text message to their cell phone, REDCap requests that action 
through Twilio. When the subject responds to the message, Twilio relays the information back to REDCap. 
The data from this exchange is stored in the REDCap database. Twilio does not store any data nor does it 
keep a log of its actions.  Further, REDCap goes to great length to ensure that SMS transcriptions do not 
stay in Twilio’s logs but are removed shortly after being completed. This is done for security and privacy 
concerns (e.g., HIPPA), in which the subject’s phone number and response to confirm the visit are not 
permanently logged on Twilio’s servers but instead remain securely in REDCap.  
 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of 
data. Black ink is required to ensure clarity of reproduced copies. When making changes or corrections, 
cross out the original entry with a single line, and initial and date the change. DO NOT ERASE, 
OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for 
recording data for each participant enrolled in the study. Data reported in the eCRF derived from source 
documents should be consistent with the source documents or the discrepancies should be explained and 
captured in a progress note and maintained in the participant’s official electronic study record. 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into RedCap, a 21 CFR Part 11-compliant data capture system provided by 
the NYU Langone School of Medicine and NYU College of Nursing. The data system includes password 

 
 
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protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents. 
 
14.2 Study Records Retention 
Study documents will be retained for the longer of 3 years after close-out, 5 years after final 
reporting/publication.  
14.3 Protocol Deviations 
 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the investigator, or 
the study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
 
These practices are consistent with ICH E6: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 5.1 Quality Assurance and Quality Control, section 5.1.1 
• 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report deviations 
within 5 working days of identification of the protocol deviation, or within 5 working days of the scheduled 
protocol-required activity. 
 
All protocol deviations must be addressed in study source documents, reported to the NIA Program Official. 
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling of 
protocol deviations will be included in the MOP. 
 
14.4 Publication and Data Sharing Policy 
 
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a clinical 
trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any research 
project that prospectively assigns human subjects to intervention or concurrent comparison or control 
groups to study the cause-and-effect relationship between a medical intervention and a health outcome. 
Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care 
changes, and the like. Health outcomes include any biomedical or health-related measures obtained in 
patients or participants, including pharmacokinetic measures and adverse events. The ICMJE policy, and 
the Section 801 of the Food and Drug Administration Amendments Act of 2007, requires that all clinical 
trials be registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National 
Library of Medicine. Other biomedical journals are considering adopting similar policies. For interventional 
clinical trials performed under NIH IC grants and cooperative agreements, it is the grantee’s responsibility 
to register the trial in an acceptable registry, so the research results may be considered for publication in 
ICMJE member journals. The ICMJE does not review specific studies to determine whether registration is 
necessary; instead, the committee recommends that researchers who have questions about the need to 

 
 
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register err on the side of registration or consult the editorial office of the journal in which they wish to 
publish. 
 
The trial will be registered through clinicaltrials.gov prior to starting. 
 
The investigators will follow the NIH policy on making available an anonymized, publicly available data set 
following conclusion of the study. 
15 Study Finances 
15.1 Funding Source 
This study is financed through a grant from the US National Institutes of Health. 
15.2 Costs to the Participant 
There will be no costs to participate outside of usual care that is performed. 
15.3 Participant Reimbursements or Payments 
PWD and caregivers will each receive $25 gift cards at visits 1 and 4 and $10 gift cards at visits 2 and 3. 
The gift cards will be sent to the subjects based on their preference for either post-mail or electronically 
via REDCap. Should the PWD or caregiver miss a visit, they will not receive compensation for the visit 
missed.  
 
15.4 Study Leadership 
The steering committee includes the Principle Investigator, two local site PIs, one representative designated 
by each HHC agency, and the biostatistician co-investigator. The Steering Committee will govern the 
conduct of the study in coordination with the program officer of the NIA. 
 
16 Conflict of Interest Policy 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the trial. The study leadership in conjunction with the NIA has 
established policies and procedures for all study group members to disclose all conflicts of interest and will 
establish a mechanism for the management of all reported dualities of interest.  
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Management Unit (CIMU) with a Committee-sanctioned conflict management 
plan that has been reviewed and approved by the study sponsor prior to participation in this study. All 
NYULMC investigators will follow the applicable conflict of interest policies. 
 
 

 
 
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118. 
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18 Attachments 
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are 
stored and modified separately. As such, modifications to these documents do not require protocol 
amendments. 
 
• 
Consent Form-PWD 
• 
Consent Form-Caregiver 
• 
Assent Form-PWD 
• 
Application for Temporary Waiver of documentation of consent-PWD 
• 
Application for Waiver of Documentation of Consent-Clinicians 
• 
Vulnerable Populations: Cognitive Impaired Subject Appendix 
• 
Study Manual 
• 
Assessment Instruments-PWD/Caregiver Dyads 
• 
Dementia Symptom Knowledge Assessment-Clinicians 
• 
Originally Submitted Grant 
• 
Follow-up requested modifications by NIA as submitted by NYU Campus OSP 
• 
COVID Questionnaire 
• 
Email and text templates 
 

Study number: s17-00810 
 
Page 52 
Version:  1.9 
 
 
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writing by the study sponsor 
Interventional Template Version: 05 JAN 2017 
 
19 Schedule of Events 

 
 
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Table 2. Variables and Timing of Data Collection from PWD-Caregiver Dyads 
Variable 
Instruments or Measures 
Items Min. 
Timing of Data Collection (Days) 
Patient 
Caregiver 
0 
15 
30 
60 
0 
15 
30 
60 
Consent 
 
 
 
 
 
 
 
 
 
Patient-Centered Outcomes 
 
 
 
 
 
 
 
 
 
Stage of Dementia 
Quick Dementia Rating Scale119 
10 
5 
 
 
 
 
 
 
 
 
BPSD 
Neuropsychiatric Inventory 
Questionnaire 
13 
5 
 
 
 
 
 
 
 
 
Quality of life 
Quality of Life in Alzheimer’s 
Disease99 
13 
5 
 
 
 
 
 
 
 
 
Pain 
Brief Pain Inventory Short Form  
9 
5 
 
 
 
 
 
 
 
 
Pain  
PAINAD 
5 
3 
 
 
 
 
 
 
 
 
Patient Satisfaction 
HHCAHPS 
32 
7 
 
 
 
 
 
 
 
 
Pain 
Analgesic use (collected by RA on 
each dyad visit) 
1 
1 
 
 
 
 
 
 
 
 
BPSD 
Antipsychotic use (collected by RA 
on each dyad visit) 
1 
1 
 
 
 
 
 
 
 
 
Delirium 
FAM-CAM126 
11 
3 
 
 
 
 
 
 
 
 
Caregiver Centered Outcomes 
 
 
 
 
 
 
 
 
 
 
Quality of Life 
Caregiver Targeted Quality of 
Life100 
80 
20 
 
 
 
 
 
 
 
 
Depression 
Public Health Questionnaire 9104 
9 
3 
 
 
 
 
 
 
 
 
Burden 
Zarit Burden Inventory105 
22 
10 
 
 
 
 
 
 
 
 
Health 
SF-12127 
12 
3 
 
 
 
 
 
 
 
 
Utilization Outcomes 
 
 
 
 
 
 
 
 
 
 
Healthcare Utilization 
Resource Utilization Inventory101 
13 
5 
 
 
 
 
 
 
 
 
Sociodemographics 
 
 
 
 
 
 
 
 
 
 
Sociodemographics 
Date of birth, sex, education, race, 
ethnicity 
6 
4 
 
 
 
 
 
 
 
 
Language, Religion and 
Culture 
Primary language, religion, literacy 
(SAHL-SE)128 
3 
3 
 
 
 
 
 
 
 
 
Supports 
 
 
 
 
 
 
 
 
 
 
Social Support 
Marital status, household members 
2 
<1 
 
 
 
 
 
 
 
 
Other unpaid caregivers 
# individuals, # visits, #hrs/week 
3 
1 
 
 
 
 
 
 
 
 
Paid Caregiver 
# visits, hrs/week 
2 
1 
 
 
 
 
 
 
 
 
Home nurse visits 
# visits (chart) 
1 
 
 
 
 
 
 
 
 
 
Physical/occupational therapy # visits (chart) 
2 
 
 
 
 
 
 
 
 
 
COVID-19 Effects on 
Caregiving 
University of Pittsburgh COVID 
Caregiving Questionnaire and  
Investigator Derived from the 
Resource Utilization Inventory 
18 
6 
 
 
 
 
 
 
 
 
Health and Functional Status 
 
 
 
 
 
 
 
 
 
 
Functional Status 
Katz Activities of Daily Living129, 
Lawton Instrumental  Activities of 
Daily Living130  
12 
2 
 
 
 
 
 
 
 
 
Comorbidities 
Charlson comorbidity 
Questionnaire131    (chart for patient, 
interview for caregiver) 
17 
3 
 
 
 
 
 
 
 
 

 
 
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Table 3. GANTT Chart 
 
 
 
 
TASK DESCRIPTION 
Pre-
Funding 
YR1 
YR2 
YR3 
YR4 
YR5 
-1 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
IRB approval and 
finalize procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hire and Train Project 
Director 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Develop and test Redcap 
database 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hire and Train RAs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Implement HHC EHR 
changes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Finalize sites, cluster 
randomization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Identify and train 
champions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Train non-champions 
 
 
 
 
Ongoing as turnover occurs-------------> 
 
 
 
 
 
 
Dyad enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Quality Improvement 
fidelity monitoring 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinician Knowledge and 
Attitudes Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DSMB meetings 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Manuscripts and 
Dissemination