The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)
Phase: NA
Conditions: Dementia
Sponsor: NYU Langone Health

 
 
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THE HOSPICE ADVANCED DEMENTIA SYMPTOM MANAGEMENT 
AND QUALITY OF LIFE TRIAL (HAS-QOL) 
 
 
Principal Investigator  
 
 
Abraham Aizer Brody, PhD, RN, FAAN, FPCN 
NYU Rory Meyers College of Nursing 
433 First Avenue, Room 504 
New York, NY 10010 
212-992-7341 
Ab.Brody@nyu.edu 
 
 
Co-Investigators 
 
Tara Cortes, PhD 
NYU Rory Meyers College of Nursing 
433 First Avenue, Room 502 
New York, NY 10010 
212-998-5320 
tc13@nyu.edu 
 
Bei Wu, PhD 
NYU Rory Meyers College of Nursing 
433 First Avenue, Room 520 
New York, NY 10010 
212-992-5951 
bei.wu@nyu.edu 
 
Keith Goldfeld, PhD 
NYUSOM Population Health 
227 East 30th Street 
New York, NY 10016 
212-263-4249 
Keith.goldfeld@nyumc.org 
 
 
NYULMC Study Number 
 
18-01265 
 
Funding Sponsor 
 
 
National Institutes of Health 
 
ClinicalTrials.gov Number  
             
NCT03681119 
 
Initial version: 3.28.19 
 
 
 

Study Number: 18-01265 
 
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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), any other applicable US government research regulations, and 
institutional research policies and procedures. 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. 
 
 

Study Number: 18-01265 
 
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Table of Contents 
 
STATEMENT OF COMPLIANCE .................................................................................................................. II 
LIST OF ABBREVIATIONS ........................................................................................................................ VI 
PROTOCOL SUMMARY ............................................................................................................................... 8 
1 
KEY ROLES ........................................................................................................................................ 10 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ..................... 10 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE .............................................................. 10 
2.1.1 
DSM-H .................................................................................................................................... 10 
2.1.2 
Provision of Hospice .............................................................................................................. 11 
2.1.3 
Hospice agencies are particularly underprepared to care for PWD leading to sub-optimal 
outcomes ............................................................................................................................................. 11 
2.1.4 
Hospice care in the home for PWD is particularly understudied ........................................... 11 
2.1.5 
Behavioral and Psychological Symptoms of Dementia (BPSD) are ineffectively treated ..... 11 
2.1.6 
Pain is under-recognized and under-treated in PWD receiving hospice ............................... 12 
2.1.7 
PWD receiving hospice have significantly longer lengths of service ..................................... 12 
2.1.8 
Caregivers are largely marginalized and ignored as part of the healthcare system ............. 12 
2.1.9 
There are significant racial and ethnic disparities in PWD and their caregivers ................... 12 
2.1.10 Interprofessional community education and training programs in dementia have not focused 
on advanced dementia care or hospice .............................................................................................. 13 
2.1.11 Existing relevant interventions ............................................................................................... 13 
2.2 
NAME AND DESCRIPTION OF THE QUALITY IMPROVEMENT PROGRAM............................................... 13 
2.2.1 
Champions training ................................................................................................................ 14 
2.2.2 
Non-champion clinician training ............................................................................................. 14 
2.2.3 
HHA training ........................................................................................................................... 14 
2.2.4 
Validated instruments............................................................................................................. 14 
2.2.5 
Interprofessional care plans ................................................................................................... 15 
2.2.6 
BPSD treatment algorithm ..................................................................................................... 15 
2.3 
CLINICAL DATA TO DATE ............................................................................................................... 15 
2.3.1 
Development and Implementation of the DSM-H for Home Healthcare................................ 15 
2.3.2 
Conversion of the DSM-H for Home Hospice ........................................................................ 16 
2.4 
RATIONALE ................................................................................................................................... 16 
2.5 
POTENTIAL RISKS & BENEFITS ...................................................................................................... 16 
Known Potential Risks ........................................................................................................................ 16 
2.5.1 
Known Potential Benefits ....................................................................................................... 17 
3 
OBJECTIVES AND PURPOSE .......................................................................................................... 17 
3.1 
PRIMARY OBJECTIVES ................................................................................................................... 17 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................. 17 
4.1 
DESCRIPTION OF STUDY DESIGN ................................................................................................... 17 
4.1.1 
Aim 1: Establish the infrastructure to implement a pragmatic clinical trial of the DSM-H 
Hospice Edition. .................................................................................................................................. 17 
4.1.2 
Aim 2: Tailor the DSM-H Hospice Edition specifically for hospice IDT members caring for 
PWD and adapt for wide-scale implementation in hospice. ............................................................... 19 
4.1.3 
Aim 3: Pilot test the complete protocol and DSM-H Hospice Edition in 2 hospice agencies and 
refine further based on feedback from the pilot agencies. .................................................................. 19 
4.1.4 
Additional activities ................................................................................................................. 20 
4.2 
STUDY ENDPOINTS ....................................................................................................................... 20 
4.2.1 
Milestones .............................................................................................................................. 20 
5 
STUDY ENROLLMENT ...................................................................................................................... 21 

Study Number: 18-01265 
 
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5.1 
INCLUSION CRITERIA ..................................................................................................................... 21 
5.2 
EXCLUSION CRITERIA .................................................................................................................... 21 
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION .......................................................................... 21 
5.3.1 
Clinicians ................................................................................................................................ 21 
5.3.2 
Persons with Dementia .......................................................................................................... 21 
5.4 
TOTAL NUMBER OF PARTICIPANTS AND SITES ................................................................................ 22 
5.5 
PARTICIPANT WITHDRAWAL OR TERMINATION ................................................................................ 22 
5.5.1 
Reasons for Withdrawal or Termination ................................................................................ 22 
5.5.2 
Handling of Participant Withdrawals or Termination .............................................................. 22 
6 
STUDY QUALITY IMPROVEMENT PROGRAM ............................................................................... 22 
6.1 
STUDY BEHAVIORAL OR SOCIAL QUALITY IMPROVEMENT PROGRAM ................................................ 22 
6.1.1 
Procedures for Training Quality Improvement Teams and Monitoring Fidelity ..................... 22 
7 
STUDY PROCEDURES AND SCHEDULE ........................................................................................ 23 
7.1 
STUDY PROCEDURES/EVALUATIONS .............................................................................................. 23 
7.1.1 
Study Specific Procedures ..................................................................................................... 23 
7.1.2 
Standard of Care Study Procedures ...................................................................................... 24 
7.2 
STUDY SCHEDULE ........................................................................................................................ 24 
7.2.1 
Screening ............................................................................................................................... 24 
7.2.2 
Pre-Training Assessment ....................................................................................................... 24 
7.2.3 
Post-Training Assessment ..................................................................................................... 24 
7.2.4 
Collection of Hospice Record ................................................................................................. 24 
7.2.5 
Withdrawal/Early Termination Visit ........................................................................................ 24 
8 
ASSESSMENT OF SAFETY .............................................................................................................. 25 
8.1 
STAFF (CLINICIANS) ...................................................................................................................... 25 
8.2 
PERSONS WITH DEMENTIA ............................................................................................................. 25 
8.2.1 
Data Safety and Monitoring ................................................................................................... 25 
8.2.2 
Frequency and Reporting....................................................................................................... 25 
9 
CLINICAL MONITORING ................................................................................................................... 25 
10 
STATISTICAL CONSIDERATIONS ................................................................................................... 25 
10.1 
STATISTICAL AND ANALYTICAL PLANS (SAP) .................................................................................. 25 
10.2 
STATISTICAL HYPOTHESES ............................................................................................................ 25 
10.3 
ANALYSIS DATASETS..................................................................................................................... 26 
10.4 
DESCRIPTION OF STATISTICAL METHODS ....................................................................................... 26 
10.4.1 General Approach .................................................................................................................. 26 
10.4.2 Adherence and Retention Analyses....................................................................................... 26 
10.5 
SAMPLE SIZE ................................................................................................................................ 26 
11 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 26 
12 
QUALITY ASSURANCE AND QUALITY CONTROL ........................................................................ 27 
13 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 27 
13.1 
ETHICAL STANDARD ...................................................................................................................... 27 
13.2 
INSTITUTIONAL REVIEW BOARD ..................................................................................................... 27 
13.3 
INFORMED CONSENT PROCESS ..................................................................................................... 27 
13.3.1 Consent/Assent-PWD ............................................................................................................ 27 
13.3.2 Consent-Clinicians ................................................................................................................. 27 
13.4 
PARTICIPANT AND DATA CONFIDENTIALITY ..................................................................................... 28 
13.4.1 Data security-PWD ................................................................................................................. 28 
13.4.2 Data security-Clinicians.......................................................................................................... 28 
13.4.3 Research Use of Stored Human Samples, Specimens, or Data ........................................... 28 
13.5 
FUTURE USE OF STORED SPECIMENS ............................................................................................ 28 
14 
DATA HANDLING AND RECORD KEEPING ................................................................................... 28 

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14.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 28 
14.2 
STUDY RECORDS RETENTION........................................................................................................ 29 
14.3 
PROTOCOL DEVIATIONS ................................................................................................................ 29 
14.4 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 29 
15 
STUDY FINANCES ............................................................................................................................. 30 
15.1 
FUNDING SOURCE ........................................................................................................................ 30 
15.2 
COSTS TO THE PARTICIPANT ......................................................................................................... 30 
15.3 
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................. 30 
16 
STUDY ADMINISTRATION ................................................................................................................ 30 
16.1 
STUDY LEADERSHIP ...................................................................................................................... 30 
17 
CONFLICT OF INTEREST POLICY ................................................................................................... 30 
18 
REFERENCES .................................................................................................................................... 31 
19 
ATTACHMENTS ................................................................................................................................. 36 
20 
ANCILLARY STUDY .......................................................................................................................... 36 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Number: 18-01265 
 
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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 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
DSM-H 
Dementia Symptom Management at Home Program 
DSKA 
Dementia Symptom Knowledge Assessment 
DSMB 
Data and Safety Monitoring Board 
FFR 
Federal Financial Report 
FWA 
Federalwide Assurance 
GCP 
Good Clinical Practice 
HHA 
Home Health Aide 
 
HHC 
Home Healthcare 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IDT 
Interdisciplinary Team 
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIA 
National Institute on Aging 
NIH 
National Institutes of Health 
NPI-Q 
Neuropsychiatric Inventory Questionnaire 
OHRP 
Office for Human Research Protections 
OHSR 
Office of Human Subjects Research 
PI 
Principal Investigator 
PWD 
Persons With Dementia 
QA 
Quality Assurance 
QC 
Quality Control 
QOL 
Quality of Life 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
US 
United States 
 

Study Number: 18-01265 
 
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Study Number: 18-01265 
 
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Protocol Summary 
Title 
 
The Hospice Advanced dementia Symptom Management and Quality of Life 
Trial (HAS-QOL) 
Brief Summary 
 
As the population ages, the incidence rate of Alzheimer’s Disease and 
Related Disorders (dementia) is expected to triple. The National Alzheimer’s 
Plan recognizes that while the number of persons with dementia (PWD) is 
increasing substantially, the healthcare and long term care systems are 
unprepared to provide high quality, effective and efficient care to the PWD 
and their caregivers. PWD often have many behavioral and psychological 
symptoms of dementia (BPSD) including agitation, depression and sleep 
disturbances, that affect both the quality of life of the PWD and the caregiver. 
Unfortunately, due to a lack of programs to insert evidence-based care into 
the community, and hospice system specifically, PWD receive inappropriate 
and even harmful care. We have developed the Dementia Symptom 
Management at Home (DSM-H) Program to implement dementia friendly 
care for PWD and their caregivers in the community. Initially developed for 
use in home healthcare, we have modified the program for use in hospice. 
The DSM-H Hospice Edition is a systems level change program that 
includes workforce training, and agency level workflow changes. 
Objectives 
 
Through the 1-year R61 phase we will accomplish the following: 
Aim 1: Establish the infrastructure to implement a pragmatic clinical trial of the 
DSM-H Hospice Edition. We will establish a steering committee that will 
oversee all facets of the trial and integrate the work of the following work 
groups: 1. Intervention refinement; 2. Intervention implementation; 3. 
Measurement; 4.Statistical methods; 5. Data management; 6. Stakeholders; 
7. Human subjects and data safety. 
 
Aim 2: Tailor the DSM-H Hospice Edition specifically for hospice IDT 
members caring for PWD and adapt for wide-scale implementation in 
hospice. We will further refine the intervention focusing specifically 
on ensuring the following: 1. The content and training align specifically with 
hospice IDT members caring for PWD at the end of life; 2. The content can 
be implemented in a wide-scale fashion in hospice agencies. 
 
Aim 3: Pilot test the complete protocol and DSM-H Hospice Edition in 2 
hospice agencies and refine further based on feedback from the pilot 
agencies. 
 
The agencies themselves are not engaging in research but performing a 
performance improvement process and providing feedback, and the data 
received will be deidentified so that we will not have any personally 
identifiable information. 
 
Methodology 
pre-post study  
Endpoint 
None 
Study Duration 
1 year 

Study Number: 18-01265 
 
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Participant Duration 
1 month 
Population 
Hospice clinicians (RNs, Social Workers, Chaplains) 
Persons with dementia newly admitted for hospice care. 
Study Sites 
 
This is a single site study with NYU being the only site. Study activities will 
take place at MJHS Hospice and Providence Trinity Care Hospice. 
 
Number of participants 
200 persons with dementia 
400 clinicians 
Description of Study 
Procedure 
This pre-post study will implement the intervention at two hospice agencies, 
and test clinicians and hospice aides prior to and after implementation for 
knowledge of dementia care, and test whether the hospices implement 
assessment instruments or care plans included in the intervention. 
Statistical Analysis 
Persons with dementia: Descriptive Statistics 
Clinicians: descriptive statistics and Paired t-tests 
 
 
 

Study Number: 18-01265 
 
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1 Key Roles 
 
Principle Investigator 
Abraham Aizer Brody, PhD, RN, FAAN, FPCN 
Associate Professor of Nursing and Medicine 
NYU Rory Meyers College of Nursing 
NYU School of Medicine 
433 First Avenue, Room 504 
212-992-7341 
Ab.Brody@nyu.edu 
 
 
 
2 Introduction, Background Information and Scientific Rationale 
2.1 Background Information and Relevant Literature 
Dementia consists of a group of serious illnesses with a high symptom burden that significantly affect both 
persons with dementia (PWD) and their caregivers1,2. In the advanced stage, the PWD becomes eligible for 
hospice, whose goal is to alleviate suffering through symptom and psychosocial care delivered by an 
interdisciplinary team (IDT). Hospice provides routine home care (1-2 visits/week, more than 95% of hospice 
care3), continuous care (24h/d in-home nursing during symptom crises), inpatient care (when advanced 
symptoms require intensive management), and respite care (when caregivers need respite to avoid burnout, 
usually in a nursing home). Continuous care has been shown to significantly reduce inpatient care use and 
hospital mortality, allowing for more hospice patients to die at home4,5. Professional quality, job satisfaction, 
burnout and turnover are important for interdisciplinary hospice care workers.1 
 
Hospice was developed initially for persons with advanced cancer living at home, but of the 1.4 million hospice 
recipients, 16.5% have a principal diagnosis of dementia3. PWD have the longest hospice length of stay (Mean 
105 days, Median 56 days) and make up an outsized portion of spending (23.9%)3.  Evidence-based practices 
exist for managing behavioral and psychological symptoms of dementia (BPSD), such as aggression and 
depression, but they have not been implemented, reducing hospice’s effectiveness in supporting PWD and 
caregivers6. Hospices often fall back on antipsychotics (prescribed in 64.6% of cases)7, which are usually 
ineffective at treating BPSD, cause serious adverse events, and can reduce quality of life (QOL).  Furthermore, 
hospices may be ineffective in managing pain in this population due to the difficulty assessing PWD for pain. 
This can worsen BPSD and QOL. The National Alzheimer’s Plan8 recognizes poor care and lack of caregiver 
support as two core areas in need of change. In hospice, there is a clear and convincing case for action through 
wide- scale adoption of effective, evidence-based systems-level change programs.  
2.1.1 DSM-H  
We developed the Dementia Symptom Management at Home Program (DSM-H) to assist home healthcare 
agencies to implement systems-level evidence-based practice change for PWD and their caregivers and found 
improved clinician abilities and patient outcomes2,3. The DSM-H is a multi-component, evidence-based 
intervention. While much of the DSM-H carries over from home healthcare to hospice, some of the program 
needed refinement for regulatory content, and clinical care content, and addition of a home health aide (HHA) 
program. We have made these adaptions for hospice care and tested them with strong clinician outcomes 
through two separate extramural awards. The next logical step is to refine and test the program for effectiveness 
in a large pragmatic clinical trial. 
 
 
 

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2.1.2 Provision of Hospice  
Hospice is a care model that provides care for persons with serious illness with a life expectancy of less than 6 
months. Care can be provided across settings, though the majority is provided in the home. The aim of hospice 
care is to provide symptom, psychosocial, and spiritual support to the patient and family. Hospice consists of 
an interdisciplinary team (IDT) that primarily includes nurses, social workers, spiritual counselors, physicians, 
advanced practice nurses, HHAs and volunteers. When a patient elects to receive hospice through the Medicare 
Hospice Benefit, all of the care for their terminal condition is paid through hospice, which receives a per-diem 
reimbursement from Medicare. Patients may not receive curative care for their terminal condition. Hospices 
provide most of their care through routine home care services, which are a mix of visits, usually weekly to 
biweekly, by nurses, social workers, spiritual counselors and HHAs. If symptoms become severe and require 
more intensive care, patients may receive either continuous care, which is care by a nurse in the home for the 
duration of the symptom crisis, or general inpatient care, which is short-term acute care services in a hospital 
or inpatient hospice. Should caregivers become burned out while serving in hospice, the hospice can also 
provide short-term respite care in a nursing home to prevent permanent institutionalization. Continuous care 
can reduce hospital transfers, inpatient care, hospital death and hospice discharge, however it is not always 
offered4,5. Many PWD would prefer to die at home6, and hospice services can assist in achieving this goal 
through continuous care if it was made available more readily. 
 
2.1.3 Hospice agencies are particularly underprepared to care for PWD leading to sub-
optimal outcomes 
 
16.5% of the over 1.4 million hospice patients annually have a primary diagnosis of dementia7, and many more 
have dementia as a secondary diagnosis8, including 18.8% of cancer patients9. However, many hospice 
providers lack even basic training in their care due to a dearth of validated programs10. Furthermore, the 
disseminated nature of the workforce makes developing these programs more complex. Clinicians also have a 
negative view of caring for PWD, and do not recognize that substantial evidence exists showing differences in 
their care needs.11-23. Family members of PWD thus report significant unmet needs related to both symptom 
management and information about symptoms and the dying process, although at lower rates than those not 
receiving hospice 24. Moreover, hospice has not shown to improve care quality for PWD25. 
2.1.4 Hospice care in the home for PWD is particularly understudied 
Precise estimates regarding place of care for PWD receiving hospice are difficult to find, but it has been reported 
that about 25% of care occurs at home and about 50% in nursing homes25.  However, the majority of extant 
research on hospice care for PWD is situated in the nursing home and is typically focused on demographics26,27, 
current care provided25,28-31, and bereaved family perceptions of care24,32-34—not on interventions for improving 
quality. 
2.1.5 Behavioral and Psychological Symptoms of Dementia (BPSD) are ineffectively treated 
BPSD are one of the most common and distressing symptoms in the PWD, occurring in over 40% of cases35. 
BPSD include agitation, depression, delusions, hallucinations, personality changes and aggression. BPSD are 
associated with weight loss36, functional disability37, caregiver burden and burnout38, nursing home admission39, 
and progression of dementia40. While multiple non-pharmacologic interventions are available and been found 
effective for the treatment of BPSD41,42, they are often not used. Pharmacologic interventions are mostly 
ineffective in PWD unless they are targeting the underlying cause. For instance, aggression and resistance to 
care are often treated by antipsychotics, but antipsychotics do not treat the cause of these BPSD and have 
significant side effects including sedation that lower the quality of life (QOL), as well as adverse events including 
stroke, and death, even with short-term use43-45. There is a “black box” warning on use in PWD, indicating that 
antipsychotics should only be used in cases of last resort where the patient is a danger to self or others, 
experiencing concerning psychosis, or in need of palliative sedation for terminal sedation where the patient is 
in the last days of life46. In hospice, antipsychotics are widely overused; 61% of PWD nationwide are prescribed 
an antipsychotic29.  
 

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2.1.6 Pain is under-recognized and under-treated in PWD receiving hospice 
 
Though no estimates have been recorded of the incidence of pain in the community-dwelling PWD, the 
estimated incidence rate in older adults is over 50%47 due to high prevalence of painful conditions. However, 
pain is often not treated or undertreated in the communitt48-50, and PWD are less likely to report pain and receive 
less pain medication51. 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 ability50. While guidelines for the treatment of 
pain in PWD exist52, PD are often inappropriately treated, even when identified as having pain48. Poor 
recognition and management of pain is associated with delirium, agitation, falls, decreased function, and 
increased hospitalization and mortality 53-56.  In hospice patients specifically, lower rates of standing analgesic 
orders25 have been found, despite similar rates of pain (if not intensity) compared to other hospice populations. 
There have been conflicting reports regarding family perception of the quality of pain management24,33,57. 
Furthermore, recent studies have shown limited efficacy for opioids in some of the most common forms of pain 
PWD may present with such as osteoarthritis58. Yet given hospice’s culture and initial organization around 
cancer care and relief of suffering, where opioid use is the standard of care, PWD may receive opioids for these 
forms of pain where efficacy is questionable and  side effects are common, including delirium, constipation, 
reduced cognition, nausea, and urinary retention59. 
 
2.1.7 PWD receiving hospice have significantly longer lengths of service 
 
PWD receiving hospice have significantly longer lengths of service than other populations receiving hospice 
(mean 105 days vs 69.5 overall, median 56 days vs 23 overall)60 but have poor care quality. Because of the 
long length of service, if care quality improved, the benefit for PWD and their caregivers could be highly 
significant. If symptoms could be managed in the home through proactive routine or continuous care, the need 
for temporary respite care (e.g. care in a nursing home due to caregiver burnout), and inpatient care could be 
reduced. It could also help more PWD die in their home. This would both lead to better patient- and family-
centered care and reduce costs. In one of the few studies looking at the breakdown of type of hospice care in 
PWD, 22% of PWD required continuous care and 25% required inpatient care in the last 7 days of life61. 
 
2.1.8 Caregivers are largely marginalized and ignored as part of the healthcare system 
 
Caregivers are largely marginalized and ignored as part of the healthcare system and not provided the training 
or assistance they need to successfully care for PWD62. Informal caregivers, including family, friends, 
neighbors, and other acquaintances provide 83% of the care to PWD living in the community63, representing 
15.9 million people providing 18.1 billion hours of care64. The primary tasks informal caregivers provide include 
activities of daily living (ADLs) and instrumental ADLs, medication management and administration, adherence 
to treatment regimens, interfacing with the medical team, managing BPSD, finding support services, and hiring 
and managing paid caregivers64. These tasks are known to cause caregivers stress, burden, and burnout and 
worsen their physical and mental health, including 2-3 times greater risk of developing depressive symptoms 
(40%)64. Furthermore, the biologic variable of sex plays an important role in informal caregiving, as caregiving 
is performed significantly more by female individuals (68%)65, and they spend between 2-3 times more hours 
providing care than male caregivers64. Caregivers who are older, female, spouses, or live in the same household 
with the PWD experience higher rates of caregiver burden65. Caregivers of PWD receiving hospice feel more 
supported than those whose loved ones are not receiving hospice, but they still have significant unmet 
needs24,28 
2.1.9 There are significant racial and ethnic disparities in PWD and their caregivers 
 
First and foremost, minorities have significantly higher prevalence of dementia66. One of the most cited study 
found 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)67. In addition to higher 
prevalence rates, African-American and Hispanic caregivers frequently believe cognitive impairment is a normal 

Study Number: 18-01265 
 
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part of aging68 and present for initial diagnosis with higher rates of symptoms69. Overall, Hispanics have been 
found to have higher rates of BPSD than other groups70, but both African-Americans and Hispanics have lower 
rates of institutionalization71,72 and are less likely to be discharged to hospice following a hospitalization73. 
Therefore caregivers in these populations require more community-based support and training to counteract 
the longer duration of caregiving.  
2.1.10 Interprofessional community education and training programs in dementia have not 
focused on advanced dementia care or hospice 
 
Our systematic review of the literature in interprofessional education in dementia74 found 17 publications of 15 
studies. Eight examined provider knowledge and attitudes, and 7 showed improvement after an educational 
intervention.75-80 Three 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 antipsychotics75,81-86.  While 
these studies found positive outcomes and improved knowledge and attitudes of clinicians, many did 
not use standardized instruments, the interventions were highly variable, and none were performed in 
hospice. 
 
2.1.11 Existing relevant interventions 
 
While no interventions have focused on an interprofessional intervention to improve QOL of the PWD-informal 
caregiver dyad utilizing home hospice, several interventions have been implemented in the home, outside of 
hospice service delivery. For instance, the COPE program focuses on enhancing the PWD’s functional 
capacity and improving caregiver skills in managing dementia. It includes 10 visits by an occupational therapist 
along with 1 telephone contact by an advanced practice nurse87. The intervention is highly effective and has 
been implemented in the Connecticut Medicaid program88. The weakness of this approach is that in-person 
contact is solely with an occupational therapist, and few hospice visits are provided by occupational therapists, 
reducing the ability to implement more broadly in the existing hospice service delivery model. Another program 
the MIND at Home program developed by Samus, which provides care coordination services linked to an RN 
and geriatric psychiatrist and dementia 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 QOL89. However, caregivers did not report 
improvements in BPSD, and it is not delivered through hospice. The REACH, REACH II, and REACH VA trials 
have examined a flexible caregiver support intervention that has been implemented nationwide outside of 
hospice and found to improve QOL, particularly in minority populations, and reduce healthcare utilization and 
costs90,91. The Aging Brain Care Model focuses on population health management in PWD and depression 
through an interprofessional team, finding reductions in caregiver stress and potential for scalability92. Multiple 
interventions specifically for advanced dementia have been implemented in the nursing home setting around 
BPSD93-95, advanced care planning96, or tube feeding97, though have not been translated for use in hospice. 
Lessons learned from these interventions have been used in developing the initial DSM-H intervention2 and 
updating the DSM-H for use in hospice. The DSM-H Hospice Edition is intended to reduce the significant 
quality of care gap in hospice for PWD and their caregivers, improving QOL, decreasing antipsychotic 
use and the impact of BPSD, and the subsequent need for emergent care, while increasing bereaved 
caregiver satisfaction. 
2.2 Name and Description of the Quality Improvement Program  
 
The DSM-H Hospice Edition, 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 hospice agencies.  
Figure 1. DSM-H Hospice Edition Components 

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2.2.1 Champions training  
Consists of two full days of interactive 
in-person 
didactic 
content, 
case 
studies, and role-playing simulated 
cases for members of the IDT at each 
agency. 
There 
are 
three 
core 
components of the champion training: leadership, care of the PWD and caregiver, and communication within 
the team and with the PWD-caregiver dyad. The leadership content is modeled after the Hartford Institute for 
Geriatric Nursing’s highly successful NICHE program, which provides implementation training on geriatric 
principles for acute care hospitals and has been implemented in over 650 hospitals nationwide and 
internationally98. The leadership content also includes quality assurance and performance improvement (QAPI) 
methods for ensuring effective implementation. Dementia-specific content mirrors non-champion training (see 
below) in more depth. The third component, dyadic person-centered team based care is based on three well 
validated programs, AHRQ TeamSTEPPS99 and SBAR100 for healthcare team communication and the 
antecedent-behavior-consequence method of problem solving101 to help the IDT work with caregivers to identify 
and solve the most problematic behaviors. Champions also participate in monthly troubleshooting calls with the 
coordinating center. Champions serve as the change leaders in their agency to “hardwire” systems-level 
practice change. 
 
2.2.2 Non-champion clinician training  
 
All skilled IDT members (e.g. RNs, social workers, and spiritual counselors) undergo five, one-hour modules of 
online interactive learning (CEUs provided) available over one month.  This ensures completion of the modules 
without burdening staff or requiring them to take a lower patient workload, which could have significant fiscal 
impact on the agency and reduce the likelihood of involvement. The content aligns with the champion course 
but in less detail. Module 1: Defining and distinguishing types of dementia; assessing patients for dementia; 
basic non-pharmacologic and pharmacologic interventions for decline in PWD; working with PWD to complete 
care tasks. Module 2: Assessing PWD for pain; non-pharmacologic and pharmacologic strategies for treating 
pain in the PWD. Module 3: Understanding, assessing and recognizing BPSD, acute delirium, and terminal 
delirium in PWD. Module 4: Non-pharmacologic and pharmacologic interventions for managing BPSD and 
terminal delirium in PWD. Module 5: Dyadic team-based care concepts derived from AHRQ TeamSTEPPS, 
SBAR, and the patient-family centered antecedent-behavior-consequence model of problem solving. The 
nursing version includes more pharmacologic intervention information and the IDT version includes basic 
pharmacologic information and more psychosocial care modalities.  
 
Hospice provider training All MDs, NPs, and PAs undergo a 1 hour online training module, focusing on the 
treatment algorithm; differentiating acute delirium, terminal delirium, and chronic worsening of BPSD; care plans 
that will be activated by IDT members, and their role in improving quality as part of the IDT. 
 
2.2.3 HHA training  
 
Training must be provided to all HHA annually by the hospice. HHA training for PWD described in D.3. is 4 
hours and includes 1) dementia basics; 2) Alzheimer’s and dementia progression; 3) communication and 
providing effective care; 4) promoting wellness in a safe environment; 5) providing care to PWD with BPSD. 
The piloted version was instructor-led, but we received feedback from HHA and agencies that they are 
performing their continuing education online, so in the R61 phase we will convert this program to a video/online 
program. 
2.2.4 Validated instruments  
 
Instruments are integrated into the electronic health record (EHR) and workflow to allow for better 
Training 
Resources 
IDT Champions 
2 days, in person, dementia content +QAPI content;  
Systems- and team-level change agents 
HHAs 
4 hours, 
online, 
interactive 
Skilled IDT 
members 
5 hours, 
online, 
interactive 
Providers 
1 hour 
online, 
interactive 
Caregiver 
education 
pamphlets 
English & 
Spanish 
BPSD 
treatment 
algorithm 
Care plans 
& 
assessment 
instruments 

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assessment of cognition, pain, and BPSD and are validated in both English and Spanish. The tools are 
reviewed in the training components. Instruments included are the mini-cog102 to screen for cognitive 
impairment, NPI-Q103 for BPSD, the Cornell Scale for Depresion in Dementia104 in moderate/severe 
dementia, the Geriatric Depression Scale-Short Form105 for depression in mild dementia, the PAINAD106 
for pain assessment in moderate/severe dementia, and the caregiver strain index107. 
 
2.2.5 Interprofessional care plans  
 
Interprofessional care plans that guide overall care for PWD with specific plans for pain, 7 BPSD categories 
(aggression, apathy, depression, psychomotor agitation, psychosis, sexual disinhibition, sleep disturbance), 
and terminal delirium, are available to clinicians. These care plans provide assessment and management 
guidance to clinicians 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 education 
pamphlets in English and generalized Latin American Spanish that can be reviewed on site electronically and 
provided on paper.  
2.2.6 BPSD treatment algorithm 
 
A BPSD treatment algorithm is provided that reinforces the education, care plans, and caregiver education 
pamphlets. The algorithm takes clinicians through a differential process to determine whether the event is likely 
acute delirium, terminal delirium, or a worsening of a chronic BPSD; and then through potential triggers for the 
symptom, non-pharmacologic and pharmacologic approaches, and monitoring parameters. 
2.3 Clinical Data to Date 
2.3.1 Development and Implementation of the DSM-H for Home Healthcare.  
 
As part of Dr. Brody’s National Palliative Care Research Center Career Development Award, Dr. Brody 
developed the DSM-H. The development utilized the NIH ORBIT Model for Behavioral Intervention 
Development108 and later on the Structural Model for Caregiving Stress109. 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 
pain110, depression111 and agitation112 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 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)2. 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.  
 

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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 cohort3. These 
results show the DSM-H has the potential to be improve patient care and the QOL of PWD receiving HHC. 
 
2.3.2 Conversion of the DSM-H for Home Hospice 
 
Dr. Brody, during the first part of his Robert Wood Johnson Nurse Faculty Scholars Award converted the 
materials of the DSM-H for use in hospice care. During this conversion, he worked with two hospice and 
palliative social workers to alter materials for the setting and change in personnel, as hospice primarily is served 
by registered nurses, social workers, and chaplains, whereas home healthcare is served by registered nurses 
and physical and occupational therapists. Upon completing the conversion, he pilot tested the educational 
models with a nationwide sample of hospice social workers for face validity. 
 
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 hospice.  Dr. Brody has adapted interprofessional, evidence-based practices, from other 
settings to hospice, creating the DSM-H Hospice Edition. 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. We now seek to test the efficacy of the DSM-H Hospice Edition in a behavioral pilot cluster randomized 
controlled trial in the hospice setting. 
2.5 Potential Risks & Benefits 
Known Potential Risks 
This is a minimal risk study and that the agencies themselves are not engaging in research but performing a 
performance improvement process and providing feedback, and the data we receive will be de-identified other 
than zip code and service dates so that we will not have minimal personally identifiable information. 
 
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 clinicians is loss of confidentiality. We minimize 
the risk by maintaining the data in a secured fashion (see section 11). These vulnerable populations are 
included as the focus of the research is in improving the quality of care PWD receive, and the applicability of 
the DSM-H Hospice Edition to hospice workers and their knowledge. The DSM-H could affect hospice 
workers professional quality of life.  
 
As the potential risks are minimal and there are potential direct benefits to subjects in the performance 
improvement cohort, including improved PWD QOL and symptom management, the potential benefits of this 
study far outweigh the minimal risks to this study. The value in this study is that if feasibility, applicability and 
fidelity are found, a large-scale pragmatic trial will be performed in 25 hospices nationwide to examine the 
effectiveness of the intervention, thus leading to the disseminated to some of the over 4,000 active hospice 

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agencies in the country to improve the quality of care in these settings and QOL for hundreds of thousands of 
PWD and their caregivers. 
2.5.1 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.  
3 Objectives and Purpose 
3.1 
Primary Objectives 
 
We developed the Dementia Symptom Management at Home Program (DSM-H) to assist home healthcare 
agencies to implement systems-level evidence-based practice change for PWD and their caregivers and 
found improved clinician abilities and patient outcomes. The DSM-H is a multi-component, evidence-based 
intervention. While much of the DSM-H carries over from home healthcare to hospice, some of the program 
needed refinement for regulatory content, and clinical care content, and addition of a home health aide (HHA) 
program. We have made these adaptions for hospice care and tested them with strong clinician outcomes 
through two separate extramural awards. The next logical step is to refine and test the program for 
effectiveness in a large pragmatic clinical trial. Through the 1-year R61 phase we will accomplish the 
following: 
 
Aim 1: Establish the infrastructure to implement a pragmatic clinical trial of the DSM-H Hospice 
Edition. We will establish a steering committee that will oversee all facets of the trial and integrate the work of 
the following work groups: 1. Intervention refinement; 2. Intervention implementation; 3. Measurement; 4. 
Statistical methods; 5. Data management; 6. Stakeholders; 7. Human subjects and data safety. 
 
Aim 2: Tailor the DSM-H Hospice Edition specifically for hospice IDT members caring for PWD and 
adapt for wide-scale implementation in hospice. We will further refine the intervention focusing specifically 
on ensuring the following: 1. The content and training align specifically with hospice IDT members caring for 
PWD at the end of life; 2. The content can be implemented in a wide-scale fashion in hospice agencies. 
 
Aim 3: Pilot test the complete protocol and DSM-H Hospice Edition in 2 hospice agencies and refine 
further based on feedback from the pilot agencies. 
 
4 Study Design and Endpoints 
4.1 Description of Study Design 
 
4.1.1 Aim 1: Establish the infrastructure to implement a pragmatic clinical trial of the DSM-H 
Hospice Edition.  
 
We will establish a steering committee that will oversee all facets of the trial and integrate the work of the 
following work groups: 1. intervention refinement; 2. intervention implementation; 3. measurement; 4. statistical 
methods; 5. data management; 6. stakeholders; 7. human subjects and data safety. 

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including in PWD 
 
• 
Advisors: Dr. Joseph Shega, MD, Nationwide Medical Director for Vitas Hospice, and Associate 
Professor at University of Central Florida, with expertise on care quality for PWD and their caregivers 
receiving hospice care 
 
• 
Ms. Mollie Gurian, JD, MPH, the Chief Strategy Officer of the National Partnership for Hospice 
Innovation, an expert in health policy, innovation, and coalition leadership in hospice care 
 
These above individuals will not engage in research (e.g. will not have access to data, will not perform any 
recruitment). 
 
Work groups. Each work group will be chaired by a member of the steering committee, and additional members 
will come from the core investigative team and partner agencies. Each committee will be staffed by either the 
project director or post-doctoral associate during years 1-2, and then the project director in the remaining years. 
Groups will meet at the frequency necessary to complete the assigned charge throughout the R61 phase of the 
trial. 
4.1.2 Aim 2: Tailor the DSM-H Hospice Edition specifically for hospice IDT members caring 
for PWD and adapt for wide-scale implementation in hospice.  
We will further refine the intervention focusing specifically on ensuring (1) that the content and training align 
specifically with hospice IDT members caring for PWD at the end of life and (2) that the content can be 
implemented in a wide-scale fashion in hospice agencies.  
 
Aligning existing content with the hospice IDT. The intervention refinement and stakeholder work groups will 
refine the DSM-H Hospice Edition. For existing content, the intervention refinement group will review and edit 
all materials. The stakeholder work group will provide an additional review of this edition.  
 
Revising the HHA training as an online program. The intervention refinement work group and our project staff 
will convert our HHA training program for PWD to an online format to allow for wider dissemination. This will 
include short, skills-based videos recorded at the NYU Rory Meyers College of Nursing Simulation Center with 
standardized patients and HHA actors depicting scenarios in which HHAs assist the PWD with care tasks while 
exhibiting BPSD. The videos will be embedded within interactive learning modules at a 6th grade reading level 
and include embedded questions and remediation. The modules will follow the curriculum from the successful 
in-person training we developed. We will storyboard and script the simulation videos and interactive learning 
modules, and the stakeholder group will review them prior to producing. 
4.1.3 Aim 3: Pilot test the complete protocol and DSM-H Hospice Edition in 2 hospice 
agencies and refine further based on feedback from the pilot agencies. 
 
Pilot testing the revised DSM-H Hospice Edition. Following revision, we will perform a pilot implementation in 3 
IDTs at MJHS Hospice and Palliative Care, a large local hospice that serves a diverse patient population across 
New York City and Long Island.  
 
Testing the refined intervention components for skilled IDT members. We will test the components of the refined 
intervention for skilled IDT members. We will perform a summative evaluation through pre-post testing using 
the DSKA, which has established content and face validity and internal consistency to measure the 
intervention’s effects on knowledge, confidence and attitudes2. We will also perform a formative evaluation with 
completers regarding the applicability of the content through both quantitative and qualitative survey feedback. 
Data will be collected in Qualtrics survey software. We will also conduct a short focus group with champions to 
obtain feedback on the revised champion training. For this focus group we will use field notes rather than 
recording, as the goal is not to perform a thorough scientific qualitative analysis but obtain feedback on what 
did and did not work in terms of applicability, relatability to the IDT and implementability. The Focus groups and 
DSKA are being used for program evaluation and not research. 
 

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Testing the online HHA training for usability and applicability. Second, we will evaluate HHA knowledge and 
confidence, using the same tool we used in its initial development, to ensure that the effect of the online program 
is at least as good as in person program. We will also complete a standard systematic usability evaluation 
through anonymized screen recording, analyzing answers to embedded questions within the modules, and a 
formative evaluation by users (i.e., HHA who complete and do not complete the program)113. 
 
Testing the methods for collecting and merging patient-level data from the hospice agency. We will not receive 
identified data. The measurement, data management, and human subjects and data safety work groups will 
refine the specifications and protocol for securely transferring data from hospices to the study coordinating 
center. In this pilot, we will test collection of data from one month prior to implementation to one month after 
implementation. The data manager will clean and analyze the data descriptively and report back to these work 
groups and the statistical analysis work group for refinement of the analytic plan and to ensure that all the 
necessary elements are present and usable. 
 
Further refinement of intervention components and data collection. Following initial pilot testing the respective 
committees will review data regarding the intervention, implementation, measurement, data management, 
statistical analysis, and data safety. The stakeholder work group will also review information on how the 
intervention affects stakeholders. Should further refinement of any of these components be required the 
respective work groups will meet to make changes that will be submitted to the steering committee for 
integration.  
 
Second pilot test. Following integration of all necessary revisions, we will perform a second pilot at Providence 
Trinity Care Hospice in Torrance, CA. We chose this hospice because it is culturally and geographically different 
from MJHS, has a smaller daily census, and serves a suburban area with a high population of Spanish 
speakers. We will perform the same pilot testing as described in 4.1.3.a, unless the work groups seek additional 
or different data points. 
 
4.1.4 Additional activities 
During the R61 phase, the work groups and steering committee will complete additional activities to prepare for 
the R33: 1. Update and finalize sites to participate in the trial with our partner agencies; 2. Update power 
analysis and adjust methodology accordingly; 3. Finalize data management plan and infrastructure; 4. Finalize 
analytic plan; 5. Perform randomization; 6. Prepare timeline for individual sites and engage with the agencies 
in preparatory work. 7. Obtain data use agreements from each site; 8. Set up Data Safety Monitoring Board; 9. 
Obtain approval for R33 phase from IRB; 10. Register in clinicaltrials.gov; These activities will be carried out by 
the appropriate work groups and the steering committee. 
4.2 Study Endpoints 
4.2.1 Milestones  
Transition from the R61 (this protocol/IRB) to the R33 phase (separate second phase where new IRB 
application will be submitted) will be based on readiness for implementation as measured by feasibility, 
applicability, and fidelity thresholds achieved at the second pilot hospice agency. 
 
1) Feasibility. Milestone: completion of all required education and training by at least 80% of eligible 
hospice IDT members 
 
2) Applicability. Milestone: post-implementation surveys indicating 80% of IDT members feel the 
program is applicable to their work and that they will implement changes in their practice 
 
3) Fidelity. Milestone: at least 75% of advanced dementia patients receiving home hospice having at least 
1 care plan or assessment instrument utilized within the month following implementation. 
 
During this R61 year, we are also required by the NIH to submit an IRB for the full R33 pragmatic clinical trial. 

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5 Study Enrollment  
5.1 Inclusion Criteria  
 
CLINICIANS/AIDES; All English speaking interdisciplinary team (IDT) members employed or contracted 
by the agency who are receiving DSM-H online or champion training greater than 18 years of age will be 
eligible. 
 
PWD: All PWD who are newly admitted to a participating hospice during the timeframe following 
implementation of the intervention who are over the age of 50 will be eligible.  
5.2 Exclusion Criteria  
 
None 
 
5.3 Strategies for Recruitment and Retention 
5.3.1 Clinicians 
The NYU study team will send an IRB approved recruitment email to all eligible clinician subjects inviting them 
to the study. Upon entering the learning management system or champion training to complete their training, 
all eligible clinician subjects will be prompted as whether they would like to participate (online for online training, 
and privately, in person by a NYU study staff member for champion training). For training, they may forgo this 
research and move straight to taking the training. All subjects completing online training will be consented 
electronically through electronic survey data collection using a standardized consent approved by the NYU 
School of Medical IRB at onset of fidelity data collection and a waiver of documentation will be requested, as 
the act of taking the survey will serve as their consent.  
 
In the last question of the initial survey clinicians will be asked if they want to complete an additional optional 
survey questionnaire. If they choose to participate they will be provided a link to complete these questions. 
Upon completion of this survey they will receive a $25 gift card. Those who choose to complete this survey will 
be sent an addition follow up survey three months afterwards. At the end of this survey they will be asked if 
they would like to complete a telephone interview. If they say yes, they will be contacted to schedule to call. 
They will receive an additional $50 gift card to complete the phone interview. Total remuneration for the 
professional quality of life optional questions if both surveys and telephone interview are completed is $100. 
 
For clinicians who complete online training, they will be prompted following completion of the training to 
complete a post-survey (DSKA or HHA assessment). They will be prompted up to 3 times to complete the 
survey. Following the third time, we will not request further completion and will not contact the subject again 
unless they contact us. These same procedures will be used for additional optional survey and telephone 
interview about professional quality of life.  
 
For champions who are serving in focus groups, we will notify all champions prior to the champion training that 
at the end of the training we will perform a focus group that is voluntary. They will then have the opportunity 
privately to notify us ahead of time that they do not want to participate, or can notify us in person at any time 
throughout the champion training. As the focus groups are for program evaluation and not research purposes, 
we will not consent clinicians. 
5.3.2 Persons with Dementia 
 
We will seek to obtain de-identified data (with exception of dates of service and zip codes) of PWD who receive 
care from the hospices who participate in the study in order to determine the fidelity of the study (See milestone 
3 above). We will seek a waiver of consent and authorization for this population as NYU will not be performing 

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any research directly with this population. The only contact between the PWD/surrogate in this study would be 
to perform informed consent, and would not be practical given the dispersed nature of the subject population 
and number of subjects we’d have to contact. In addition to IRB approval, a Data Use Agreement will be 
executed to obtain this data. 
 
5.4 Total Number of Participants and Sites  
 
An estimated 400 clinicians and 200 PWD will serve as participants at the two hospice agencies.  
5.5 Participant Withdrawal or Termination 
5.5.1 Reasons for Withdrawal or Termination 
Given the nature of the study, we do not see any reason a PWD would withdraw as they would not be actively 
participating in research and only their de-identified data other than dates of service and zip codes provided to 
the investigators. 
 
Regarding clinician subjects, the primary reason for withdrawal would be leaving employment or not 
completing the online training.  
 
Clinician subjects are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
 
• 
The subject is unable to complete training or the individual leaves the hospice agency during the time 
period of the study. 
5.5.2 Handling of Participant Withdrawals or Termination 
Given the minimal risk nature of this study, should individuals choose to withdraw from the study, we will not 
continue to follow-up or follow them in any form. 
 
6 Study Quality Improvement Program 
6.1 Study Behavioral or Social Quality Improvement Program 
 
The DSM-H Hospice Edition as described in section 2.2 is a quality improvement program that has been 
adapted from and heavily based on the pre-existing DSM-H HHC edition. The adaptation took into account 
regulatory and clinical team differences between the two. The original DSM-H was tested in several HHC agencies 
in New York and the hospice edition’s educational components were tested with a nationwide sample of hospice 
social workers. The DSM-H Hospice edition is a multi-modal quality improvement program for improving the 
quality of care provided to PWD-informal caregiver dyads through hospice. The initial DSM-H home health 
edition 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. This new hospice edition is based on the prior home 
health edition. The DSM-H Hospice Edition 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. 
6.1.1 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 

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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 Dr. Brody’s previously validated 
dementia symptom knowledge and attitudes survey at baseline, 3 months, and 1 year2, and through measuring 
the number of care plans initiated, caregiver teaching sheets provided to caregivers, and assessment 
instruments used at each site throughout the trial.  
 
7 Study Procedures and Schedule 
7.1 Study Procedures/Evaluations 
7.1.1 Study Specific Procedures 
7.1.1.1 
Clinician Knowledge, Confidence, Attitudes 
We will implement the DSM-H Hospice Edition first at MJHS, then make iterative changes for usability and 
applicability based on feedback from our stakeholder workgroup and the MJHS hospice participants, and 
implement at Providence Trinity Hospice. 
 
To assess knowledge of the clinicians, the DSKA (skilled clinicians) or HHA assessment (hospice aides) will be 
collected prior to and post online training via Qualtrics survey. It takes approximately 15 minutes to complete 
the former and 10 minutes the latter. The DSKA 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 it has a Cronbach Alpha of .94.  
 
The HHA assessment takes approximately 10 minutes to complete and following demographic also includes 
17 true false and likert style questions regarding knowledge and confidence in managing care tasks in PWD. 
We have administered this survey to over 1100 HHA in the past two years and it has strong internal consistency 
and validity.  
7.1.1.2 
Optional Professional Quality of Life 
We will implement the professional quality of life survey at pilot site 2 to assess professional quality of life of the 
clinicians before and after DSM-H hospice training. It takes approximately 10 minutes to complete the surveys. 
The survey instruments include the professional quality of life (ProQOL-5), which is a 30 question self-report 
questionnaire measuring professional quality of life on a 5-point Likert scale.  about how frequently the 
participant experienced the things being asked about in the last 30 days. The scale starts at one indicating 
never and goes to five indicating very often. It measures professional quality of life on three subscales including 
compassion satisfaction, burnout and secondary traumatic stress. Higher scores on the burnout and secondary 
traumatic stress indicate higher risk for burnout and higher secondary traumatic stress, respectively. Higher 
scores on the compassion satisfaction scale indicate greater satisfaction in your ability to be an effective 
caregiver at your job.114 A 9-item Well-being Index (WBI) will be used to identify U.S. workers in distress and 
stratify quality of life. The WBI is a successful screening tool to identify distress and identify those with high 
well-being among nurses115,116 and among a variety of workers. 115 Supplemental questions asked will be taken 
from the National Sample Survey of Registered Nurses question numbers: 36, 66, 67. The last question 
included is a retention question that asks: “Do you plan to be with your employer one year from now?” Yes or 
No. 
7.1.1.3 
Applicability to the setting 
 
In addition to asking clinicians and hospice aides about their knowledge, confidence and attitudes, we will also 
ask them about the applicability of the program through a series of questions via the online survey (see 
questions under other materials). 

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We will also perform a focus group with all champions who consent to participate. The focus group will be held 
in the same room where the champion training was performed at the end of that day and will take approximately 
20 minutes to complete. The focus group will ask three open ended questions about the champions training, 
with follow-up questions based on response. These questions are: what did you feel were the best parts of the 
champion training and why; what did you feel were the parts you liked least about the champion training and 
why; how do you think it will help you change the practice of clinicians in your agency; what would you change 
about the champions training?  
 
7.1.2 Standard of Care Study Procedures 
PWD subjects who are in the control group will receive usual care as provided by the hospice agency. 
7.2 Study Schedule 
7.2.1 Screening  
 
The NYU study team will be provided a list of all staff by the hospice agency who are in the applicable care 
teams at the participating hospices. We will then invite them to take part in this research study consisting of 
pre- and post-training survey assessments. The initial survey will ask them the eligibility questions at the 
beginning following review of the consent document, and should they not click the eligible options will be 
directed to the end of survey where a message will be performed stating they are not eligible. All eligible clinician 
subjects will continue on to the remainder of the pre-training survey assessment. 
7.2.2 Pre-Training Assessment 
At baseline the HHA will take the HHA assessment, and skilled clinicians will take the DSKA assessment. 
They will then at completion receive access to their respective training modules. Champions will be scheduled 
to take the in-person training together. 
 
7.2.3 Post-Training Assessment  
 
Following completing the online training modules, the clinician subjects will proceed to the appropriate post-
training assessment. 
 
7.2.4 Collection of Hospice Record 
 
Following completion of the pilot, we will collect de-identified data of eligible PWD other than zip codes and 
dates of service. This is pre-existing routinely collected data by the agencies of all PWD who are receiving care 
at the participating hospice agencies. We will primarily be looking to describe the population as well as 
determine how many assessment instruments or care plans have been initiated, and types and frequency of 
symptoms, and pharmacologic and non-pharmacologic interventions utilized. 
7.2.5 Withdrawal/Early Termination Visit 
Clinician subjects can withdraw from the study at any time, and will not have to complete the assessment 
instruments, though they may be required by the hospice agency to complete the training as an operational 
initiative. 

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8 Assessment of Safety 
8.1 Staff (Clinicians) 
There is minimal risk to the healthcare staff as the content is not sensitive in nature and the surveys do not 
significantly relate to measures on which staff are measured for job accountability. The greatest risk to staff is 
the loss of confidentiality. We will not share any data collected back to the agency. For reporting purposes in 
conference proceedings, abstracts and manuscripts, data will be aggregated to ensure lack of identifiability to 
the staff level.  
 
8.2 Persons with Dementia 
 
We will not be monitoring efficacy or effectiveness during the R61 pilot phase of this evidence-based practice 
intervention, and therefore will not be actively monitoring for adverse events. 
 
8.2.1 Data Safety and Monitoring 
 
The Principle Investigator will ensure overall safety of the subjects in the R61 pilot phase on a daily basis and 
will be responsible for all reporting. The study statistician will be responsible for running reports on data safety, 
consistency and outcomes and reviewing them with the study PI. 
8.2.2 Frequency and Reporting 
 
As this is a R61 pilot and not a clinical trial, and outcomes are around feasibility, acceptability and fidelity, we 
will not perform routine reporting other than the annual continuing review. If we find through our analyses any 
negative outcomes the PI will report them within 24 hours to the IRB and NIH program officer. 
 
9 Clinical Monitoring 
 
Clinical site monitoring will not be conducted during this R61 pilot project. 
 
10 Statistical Considerations 
10.1 Statistical and Analytical Plans (SAP) 
A formal SAP will not be completed for this study. 
 
10.2 Statistical Hypotheses 
There are no hypotheses for this R61 pilot phase. Instead, we have milestones we must achieve in order to 
proceed to the R33 phase of the grant (to be submitted under separate IRB): 
 
1. Feasibility. Milestone: completion of all required education and training by at least 80% of eligible 
hospice IDT members 
 
2. Applicability. Milestone: post-implementation surveys indicating 80% of IDT members feel the 
program is applicable to their work and that they will implement changes in their practice 
 

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3. Fidelity. Milestone: at least 75% of advanced dementia patients receiving home hospice having at least 
1 care plan or assessment instrument utilized within the month following implementation. 
10.3 Analysis Datasets 
We will maintain separate data sets nested by site for skilled clinicians, hospice aides, and PWD. 
 
10.4 Description of Statistical Methods 
10.4.1 General Approach 
 
Data Analysis will be performed using SAS 9.4117. We will perform basic descriptive tests to examine baseline 
characteristics of the patient populations and clinician populations. We will perform paired t-tests to examine 
differences in knowledge, confidence and attitudes from baseline, as well as tests of validity and reliability. 
10.4.2 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 DSKA scores submitted by hospice clinicians across control and quality 
improvement program care teams through paired t-tests and repeated measures ANOVA. 
10.5 Sample Size 
 
This study will utilize a convenience sample for both PWD and clinicians based on those available and eligible 
at the time of implementation as this is a R61 pilot phase study. 
 
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 clinician data, which has no PHI, will be collected using Qualtrics, which is hosted by NYU Data Services. 
All de-identified data sets (other than zip codes and dates of service) will be maintained on a secure MCIT 
managed research drive. 
 
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. 

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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 PI will verify that the R61 pilot phase study is conducted and data are generated, documented (recorded), 
and reported in compliance with the protocol, and GCP in coordination with the study statistician. 
 
NYU will provide direct access to all 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. 
 
The following consent materials are submitted with this protocol: 
 
Study Information Survey Header-Clinician 
Application for Waiver of Documentation of Informed Consent-Clinician 
Application for Waiver of Authorization and Informed Consent-PWD 
13.3 Informed Consent Process 
13.3.1 Consent/Assent-PWD 
 
Because we are only obtaining data that is routinely collected by the participating hospices as part of the care 
provided, we will be seeking waiver of authorization and informed consent. Therefore, there will be no 
recruitment or retention per se as we will only be obtaining de-identified data other than dates of service and 
zip codes from PWD and caregivers who have received care at a participating hospice.  
 
13.3.2 Consent-Clinicians 
 
We will seek a waiver of documentation of consent and provide a statement at the beginning of the Qualtrics 
survey using a standardized consent statement approved by the NYU School of Medical IRB at onset of 
collection of fidelity surveys as we will only be performing a pre-post survey that is minimal risk in nature and 
obtaining signed consent would not be feasible. 
 

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13.4 Participant and Data Confidentiality 
13.4.1 Data security-PWD 
There will be no prospectively collected data for this trial and no prospective assignment of individuals and 
therefore, this trial does not require use of REDCap or TrialMaster for data collection. This study uses QA 
methodologies, and therefore falls under item 12 of table 1 of NYU EDC Policy dated 4-18-18, which allows for 
use of an MCIT managed network drive. Therefore, all retrospective data provided by participating hospice 
agencies will be collected through secure, NYU approved data transfer methods from the hospice agency, and 
data will be secured on an MCIT managed networked research drive that is encrypted behind the NYU Langone 
Health Firewall that is partitioned and solely accessible by the research team members authorized by the PI. 
Login using unique credentials is required with two factor authentication. 
 
13.4.2 Data security-Clinicians 
 
No PHI will be collected from clinicians. All clinician related survey data will be collected using NYU Qualtrics. 
In order to access completed data in Qualtrics, you must use your NYU login credential and 2 factor 
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 login credentials and 2 factor 
authentication. It is approved by NYU College of Nursing IT and Campus IT for maintaining sensitive 
information, though we are not collecting PHI. Data will be collected through the Qualtrics survey by the clinician 
either on a personal or agency owned device but entered data are not retained on the device. Data collected 
by Qualtrics is secure and encrypted end-to-end.  
13.4.3 Research Use of Stored Human Samples, Specimens, or Data 
• Intended Use: Data collected under this protocol may be used to study dementia or hospice care 
• Storage: Only approved investigators will have access to the study data. 
 
13.5 Future Use of Stored Specimens 
Not Applicable 
 
 
14 Data Handling and Record Keeping 
14.1 Data Collection and Management Responsibilities 
 
All data other than the consent forms will be collected and maintained electronically in on an MCIT-managed 
network drive. 
 
Data collection is the responsibility of the study 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 

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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 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. 
 
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 
 
 
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 register err on the side of registration or consult the editorial 
office of the journal in which they wish to publish. 

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The trial will be registered through clinicaltrials.gov prior to starting. 
 
The investigators will follow policy on making available an anonymized, publicly available data set following 
conclusion of the study. 
15 Study Finances 
15.1 Funding Source 
This study will be financed through the National Institutes of Health. 
15.2 Costs to the Participant 
There will be no costs to participate. 
15.3 Participant Reimbursements or Payments 
There will be no reimbursements or payments to participants. 
16 Study Administration 
16.1 Study Leadership 
The steering committee includes the Principle Investigator, 3 additional NYU co-investigators, 4 subject experts 
at other universities, two hospice stakeholder representatives (Dr. Joe Shega, MD of Vitas Hospice and Ms. 
Molly Gurian, JD, MPH of the National Partnership for Hospice Innovation) and a caregiver stakeholder 
representative (TBN). The Steering Committee will govern the conduct of the study. 
 
17 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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18 References 
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19 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 may not require protocol 
amendments. 
 
• 
Consent Language for Survey-Clinician 
• 
Application for Waiver of authorization and consent-PWD 
• 
Application for Waiver of Documentation of Consent-Clinicians 
• 
Vulnerable Populations: Cognitive Impaired Subject Appendix 
• 
Dementia Symptom Knowledge Assessment-Clinicians 
• 
Home Health Aide Assessment-Clinicians 
 
20 Ancillary Study  
 
Impact of a dementia care expert care program on burnout, job satisfaction and turnover rate for 
interdisciplinary hospice care teams 
Aims 
Purpose: To evaluate the influence of the Aliviado dementia care training on professional quality of life and well-being of 
the hospice staff 
Quantitative Aim:  
1. To examine the association between a dementia care expert care program on burnout, job satisfaction and 
turnover rate for interdisciplinary hospice care teams  
Qualitative Aim:  
2. To explore interdisciplinary hospice teams’ experiences with burnout, job satisfaction and turnover when 
providing care to persons with dementia  
Mixed Methods Aim:  
3. Compare the qualitative results to findings from the quantitative surveys (ProQOL and well-being) and gain 
insight into the reasons behind varying scores 
 
Background 
Hospice provides expert medical care, pain management, and emotional and spiritual support tailored to 
individuals living with a terminal illness [1]. In 2016, 1.43 million Medicare beneficiaries were enrolled in hospice care 
for one day or more; among which 18% had a principal diagnosis of dementia [1]. As the dementia progresses, persons 
with dementia (PWD) tend to display a plethora of behavioral changes, collectively termed Behavioral and Psychological 
Symptoms of Dementia (BPSD). Research conducted with professional caregivers of PWDs showed that understanding 
PWDs’ behavior and behavioral change is a crucial factor to achieve and sustain good working relationships between 
professionals and PWDs receiving care [2]. Helping hospice professionals understand BPSD has great potential in 
sustaining good working relationships between professionals and PWDs, and subsequently improve hospice staff’s 
professional quality of life (QoL). Research also shows that the role of homecare workers supporting PWDs up to the end 
of life remains under-researched, with unmet needs for informational, technical and emotional support [3]. The Aliviado 
Dementia Care-Hospice Edition provides training and a toolbox to hospice professionals on dementia behavioral symptom 
assessment and management. To understand the potential impact of the Aliviado Dementia Care-Hospice Edition on 
hospice staff’s professional QoL, we propose the addition of the following measures that will be collected at the existing 
baseline survey, and during a new 6 months post-intervention survey.  
 
Methods 
 
Design 
This ancillary study will use a mixed method model and will utilize a pre-post methodology in pilot 2 described in the 
primary study. Quantitative survey questions from the validated instruments outlined below will be inserted in the 
existing baseline survey. A new, optional, 6 month survey timepoint will be added, with  an additional option at  the end 

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of the 6 month  survey to check a box stating they would be interested in participating in a telephonic based qualitative 
interview. 
 
Quantitative Measures 
 
The quantitative measurements that will be used to evaluate burnout and job satisfaction include: 
1) Professional Quality of Life (ProQOL-5)—The ProQOL is a 30 question self-report questionnaire measuring 
professional quality of life measured through a 5-point Likert scale that asks questions about how frequently the 
participant experienced the things being asked about in the last 30 days. The scale starts at one indicating never 
and goes to five indicating very often. It measures professional quality of life on three subscales including 
compassion satisfaction, burnout and secondary traumatic stress. Higher scores on the burnout and secondary 
traumatic stress indicate higher risk for burnout and higher secondary traumatic stress, respectively. Higher 
scores on the compassion satisfaction scale indicate greater satisfaction in your ability to be an effective 
caregiver at your job (Stamm, 2009 & 2010).  
a. 
The concise ProQOL manual . Pocatello, ID. Retrieved from ProQOL. org. 
https://proqol.org/ProQol_Test.html   (See measure below P.2) 
2) 9-item Well-being Index (WBI)—The WBI is an index used to identify U.S. workers in distress and stratify 
quality of life. The WBI is a successful screening tool to identify distress and identify those with high well-
being among nurses (Dyrbye, Johnson, Johnson, Satele & Shanafelt, 2019) and among a variety of workers 
(Dyrbye, Satele & Shanafelt, 2016).  
a. 
Retreived from https://www.mededwebs.com request form. (See measure below P. 5).  
3) Supplemental questions asked will include:  
a. 
National Sample Survey of Registered Nurses question numbers: 36, 66, 67,  
b. Retention Question: Do you plan to be with your current employer one year from now?  
Yes or No 
 
Qualitative Measures 
 
Qualitative Interview. Example questions in the table below.  
Questions 
Follow Up Probes 
Comments/Field Observations 
Tell me about your experience 
with the Aliviado training 
What did you expect to gain from 
the training?  
What part of the training was most 
helpful? 
Any barriers or facilitators to 
completing the online training? 
 
 
Tell me about your ability to 
care for persons with dementia 
(PWD) in the hospice setting 
What have you done differently 
since the training?  
What 
changes 
have 
you 
experienced in your job after the 
training?  
 
 
Tell me about your satisfaction 
with your current professional 
role responsibilities 
How has the training influenced 
your feelings of compassion? 
How much stress do you experience 
daily at work?  
How has your stress changed since 
the training?  
 
 
Tell me about how you feel 
about being able to provide 
How much patience do you have 
when you provide care for PWD?  
 

Study Number: 18-01265 
 
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compassionate care on a daily 
basis 
How do you feel your job supports 
your 
ability 
to 
provide 
compassionate care?  
 
What aspects of your job or 
patient caseload impact your 
ability to carry out your job?  
How are these aspects influencing 
your desire to stay in your current 
role?  
 
Is there anything else you 
would like to share that I did 
not ask about?  
 
 
 
 
 
All qualitative interviews will conducted by telephone and tape recorded. Transcripts will be created from the recordings. 
 
Inclusion/Exclusion Criteria 
Per Primary Study 
 
Number of Subjects 
Quantitative: Per Primary Study 
Qualitative:  
 
Analytic Plan 
Survey data will be analyzed quantitively. Descriptive and frequency statistics will be used to demographic data. Paired 
T-test will be used to analyze between pre and post survey results. Data from qualitative interviews will be coded using 
open coding methodology. The team members will code the interviews separately and will compare coding to reach 
interrater reliability. Codes will then be merged into categories. From the categories themes will be identified. A similar 
team member checking will also occur during the development of categories and themes.  
 
Participant Burden 
This ancillary study will include 43 additional questions, each question is on a simple Likert-scale and is not open ended. 
These questions will not add significant participant burden as it is anticipated answering these questions will take 
approximately 15 min. The qualitative interviews will occur post-training and will occur at the convenience of the 
participant over the phone by willing participants. Answering these questions will take approximately 45- 60 minutes.  
 
Participant Incentives 
Participants will receive a $25 gift card for completing the 6-month survey, and an additional $50 gift card for completing 
the telephonic interview. 
 
Consent Procedures 
The existing informational header for the quantitative surveys (waiver of written documentation) has been updated to 
reflect the addition of this ancillary study. A separate waiver of written consent will be requested for the qualitative study. 
During the qualitative interview, potential subjects will be emailed the informational header ahead of time and telephone 
consent will be performed (see waiver of written documentation-ancillary study request). 
 
Data Safety 
All data downloaded from the survey system will be maintained in accordance with the Data Safety Plan as outlined above 
and in concordance with NYULH data management policies. All identified data will be maintained on the MCIT research 
mounted drive. All de-identified data will be maintained on NYU Box per NYU campus data security protocols. 
 
Potential Risks and Benefits 
This ancillary study presents no greater risk that the original study (minimal risk). The greatest risk is of loss of 
confidentiality. Prior experience with these measures have not found to cause any harm, and data will not be provided back 
to the subjects’ employer. There are no potential benefits to the subject, but generalized knowledge will be obtained that 
can potentially assist in reducing hospice workforce burden and burnout. 
 
 

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