Comparative Effectiveness of Health System-based Versus Community-Based Dementia Care / A Pragmatic Clinical Trial of the Effectiveness and Cost-Effectiveness of Dementia Care
Phase: NA
Conditions: Dementia
Sponsor: University of California, Los Angeles

 
A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
1 
 
STUDY PROTOCOL 
 
TITLE:   
COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED 
VERSUS COMMUNITY-BASED DEMENTIA CARE/ A PRAGMATIC 
TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF 
DEMENTIA CARE 
PI:  
 
 
 
 
DAVID B. REUBEN, MD 
 CO-I’S AND SITE PI’S: 
DAVID BASS, PHD; THOMAS GILL, MD; LEE JENNINGS, MD; MAYA 
LICHTENSTEIN, MD; PETER PEDUZZI, PHD; ALAN STEVENS, PHD; 
ELENA VOLPI, MD; JEFFREY WILLIAMSON, MD  
APPLICANT CONSORTIUM: 
 
FUNDING AGENCIES: 
 
PCORI/NIA 
PCORI GRANT NUMBER: 
 
PCS-2017C1-6534 
NIA GRANT NUMBER: 
 
1 R01 AG061078-01 
APPLICANT ORGANIZATION: 
UCLA 
DATE OF INITIAL IRB APPROVAL: 1/15/2019 
VERSION DATE: 
 
 
07/01/24 
VERSION NUMBER:  
 
8.0 
 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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Title 
COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED 
VERSUS COMMUNITY-BASED DEMENTIA CARE/ A PRAGMATIC 
TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF 
DEMENTIA CARE  
Study Design 
The design is a pragmatic randomized 3-arm superiority trial.  The unit 
of randomization is the patient/caregiver dyad. 
Study Duration 
6 years 
Trial Sites 
4 trial sites: Baylor, Scott, & White Health; Geisinger Health; University 
of Texas Medical Branch Health Care System; Wake Forest University 
Objective 
Conduct a pragmatic randomized trial to determine the comparative 
effectiveness and cost-effectiveness of two evidence-based models of 
comprehensive dementia care as well as the effectiveness and cost-
effectiveness of both arms versus usual care.  
Number of Subjects 
(Target) 
2150: 1000 in each intervention arm and 150 in the usual care group  
Main Inclusion 
Criteria 
Community-living, including Assisted Living Facilities (cannot reside in 
a nursing home at the time of recruitment), persons with diagnosis of 
dementia established by a physician or other primary care provider 
(PCP), have family or friend caregiver(s) who speak English or 
Spanish, and have a PCP who is willing to partner with the program  

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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Interventions 
Health systems-based dementia care (based on the UCLA Alzheimer’s 
and Dementia Care program) provided by a nurse practitioner or 
physician’s assistant Dementia Care Specialist who works within the 
heath system. 
Community-based dementia care (using the BRI Benjamin Rose 
Institute Care Consultation model) provided by a social worker or nurse 
Care Consultant who works at a community-based organization (CBO).  
Both arms include structured assessments and creation of care or 
action plans, care coordination, and caregiver education and support, 
but they differ in key areas including the frequency and mode of 
communication with persons with dementia and caregivers, the degree 
of integration into the health system, including order-writing capability 
and use of the electronic health record.  
Usual care with consistent referral to Alzheimer’s Association Helpline 
(1-800-272-3900) to speak to master’s level consultants for decision-
making support, crisis assistance, and caregiver education, and 
referral to local programs and services. 
Duration of 
Intervention and 
Follow-up 
18 months 
Primary Outcome 
Behavioral symptoms and resulting caregiver distress as measured by 
the NPI-Q Severity and Modified Caregiver Strain Index scales.  
Primary Analysis 
All analyses will be according to intent-to-treat. The analysis of the two 
primary outcomes – NPI-Q Severity and Modified Caregiver Strain 
Index scores – will be done using a longitudinal repeated measures 
analysis based on maximum likelihood methods adjusted for the 
stratified randomization by site. Treatment differences will be 
summarized by least square means and multiplicity corrected 
confidence intervals.  
Secondary 
Outcomes 
NPI-Q Distress, caregiver unmet needs and confidence, and caregiver 
depressive symptoms.  
Tertiary Outcomes 
Patient long-term nursing home placement, functional status, cognition, 
goal attainment scaling (GAS), “days spent at home”, Dementia Burden 
Scale-Caregiver, a composite measure of clinical benefit, Quality of Life 
of persons with dementia, Positive Aspects of Caregiving 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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Cost-effectiveness 
Analysis 
Ratio of incremental net Medicare costs to incremental effects of the 
two primary outcomes, costs to Medicaid and consumers, changes in 
utilization by type of use, caregiver costs for spouses who have fee-for-
service Medicare 
Interim Analysis 
Because this is a minimal risk trial with a relatively short follow-up 
period (18 months), no monitoring for efficacy or futility is proposed; 
only monitoring for safety will be done. 
 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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ABBREVIATIONS 
ADC=Alzheimer’s and Dementia Care 
BRI=Benjamin Rose Institute 
CPM=central project management 
CTS=clinical trial sites 
CBDC=Community-based dementia care 
CBO=community-based organization 
DCC=data coordinating center 
DCM=Dementia Care Manager (now changed to Dementia Care Specialist [DCS]) 
DCS=Dementia Care Specialist (formerly Dementia Care Manager) 
DQCQ=Data Quality Control Query 
DSMB=data safety monitoring board 
EDC=Electronic Data Capture 
EHR=Electronic Health Record 
HSDC=Health system-based dementia care 
HTE=Heterogeneity of Treatment Effects 
IRB=Institutional Review Board 
LPSC=local Patient and Stakeholder Committee 
MAR=missing at random 
MCID=minimal clinically important difference 
MCSI=modified caregiver strain Index 
MMSE=Mini-Mental State Exam 
MOCA=Montreal Cognitive Assessment 
MOP=manual of procedures 
NP=nurse practitioner 
NPI-Q=Neuropsychiatric Inventory 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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NPSC=national Patient and Stakeholder Committee 
PA=physician’s assistant 
PCORI=Patient-Centered Outcomes Research Institute 
PCP =primary care provider 
PHQ-8=Patient Health Questionnaire-8 
QOL-AD=Quality of Life Alzheimer’s Disease 
SAC=Study Advisory Committee  
SAE=Serious Adverse Events 
SNF=skilled nursing facility 
SOP= standard operating procedures 
STRIDE=Strategies to Reduce Injuries and Develop confidence in Elders 
 
 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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CONTENTS 
1. INTRODUCTION ................................................................................................................................................ 9 
2. STUDY OBJECTIVES ........................................................................................................................................ 9 
3. BACKGROUND.................................................................................................................................................. 9 
4. STUDY DESIGN ............................................................................................................................................... 10 
4.1 NUMBER OF SUBJECTS.................................................................................................................................. 10 
4.2 SUBJECT SELECTION AND WITHDRAWAL ....................................................................................................... 10 
4.2.1 Inclusion and Exclusion Criteria ........................................................................................................... 10 
4.3 SCREENING, RECRUITMENT, AND ENROLLMENT............................................................................................. 11 
4.3.1 Screening ............................................................................................................................................. 11 
4.3.2 Recruitment and Enrollment................................................................................................................. 11 
4.3.3 Early Withdrawal of Participants .......................................................................................................... 11 
5. STUDY INTERVENTIONS ............................................................................................................................... 12 
5.1 HSDC........................................................................................................................................................... 13 
5.2 CBDC........................................................................................................................................................... 15 
5.3 USUAL CARE .............................................................................................................................................. 16 
6. OUTCOME MEASURES AND OTHER DATA TO BE COLLECTED ............................................................ 17 
6.1 DEFINITION AND ASCERTAINMENT OF OUTCOMES .......................................................................................... 16 
6.1.1 Primary Outcomes ................................................................................................................................ 18 
6.1.2 Secondary Outcomes ........................................................................................................................... 19 
6.1.3 Tertiary Outcomes ................................................................................................................................ 19 
6.2 OTHER MEASURES TO BE COLLECTED............................................................................................................ 21 
7. STUDY PROCEDURES AND VISITS.............................................................................................................. 22 
7.1 RANDOMIZATION ........................................................................................................................................... 22 
7.2 SCHEDULE OF EVENTS .................................................................................................................................. 23 
8. STATISTICAL ANALYSIS, SAMPLE SIZE AND POWER CALCULATIONS ............................................... 23 
8.1 DESIGN OVERVIEW ....................................................................................................................................... 23 
8.2 ANALYSIS OF PRIMARY, SECONDARY, AND TERTIARY OUTCOMES .................................................................. 23 
8.2.1 Analysis of Primary Outcomes ............................................................................................................. 23 
8.2.2 Analysis of Secondary Outcomes ........................................................................................................ 24 
8.2.3 Analysis of Tertiary Outcomes ............................................................................................................. 24 
8.2.4 Missing Data ......................................................................................................................................... 24 
8.3 SAMPLE SIZE ................................................................................................................................................ 25 
8.3.1 PRIMARY OUTCOMES ................................................................................................................................. 25 
8.3.2  SECONDARY OUTCOMES……………………...……………………………………………………………26 
8.4 COST EFFECTIVENESS AND UTILIZATION………………..………………………………………………...27 
8.5 SAFETY ......................................................................................................................................................... 28 
8.6 INTERIM MONITORING………………………………………………………………………………………..…28  
9. DATA COLLECTION AND MANAGEMENT ................................................................................................... 28 
9.1 DATA COLLECTION ........................................................................................................................................ 28 
9.1.1 D-CARE Study Portal Website ............................................................................................................. 28 
9.1.2 REDCap ............................................................................................................................................... 28 
9.1.3 Site Management Services .................................................................................................................. 28 
9.1.4 Staff Management Services ................................................................................................................. 29 
9.1.5  Data Quality Control ............................................................................................................................ 29             

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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9.1.5.1 Preventive Data Quality Control…………………………………………………………………………..29             
9.1.5.2 Proactive Data Quality Control……………………………………………………………………………29             
9.1.5.3 Batch Error Checks and Error Resolution……………………………………………………………….29   
9.2 INTERVENTION SUPPORT ............................................................................................................................... 30 
9.2 THE DATA MART ........................................................................................................................................... 29 
10. SAFETY AND ADVERSE EVENTS............................................................................................................... 30 
10.1 BACKGROUND ............................................................................................................................................. 30 
10.2 DEFINITIONS ............................................................................................................................................... 30 
10.3 RESPONSIBILITIES ....................................................................................................................................... 31 
10.4 LEVEL OF MONITORING IN THIS STUDY ........................................................................................................ 31 
10.5 ASCERTAINMENT OF AE, UNANTICIPATED PROBLEMS (UP), AND SAE ......................................................... 31 
10.5.1 Adverse events ................................................................................................................................... 31 
10.5.1 Unanticipated Problems (UP) ............................................................................................................ 32 
10.5.2 Ascertainment of SAEs and Deaths .................................................................................................. 33 
10.6 SAFETY PERSONNEL ................................................................................................................................... 33 
11. ETHICAL AND REGULATORY CONSIDERATIONS ................................................................................... 34 
11.1 GOOD CLINICAL PRACTICE STATEMENT....................................................................................................... 34 
11.2 INFORMED CONSENT ................................................................................................................................... 34 
11.3 INSTITUTIONAL REVIEW BOARD ................................................................................................................... 35 
11.3.1 IRB of Record ..................................................................................................................................... 35 
11.3.2 Authorization/Reliance Agreement .................................................................................................... 35 
11.3.3 Communication Plan .......................................................................................................................... 35 
11.4 PROTOCOL CHANGES .................................................................................................................................. 36 
11.5 RISKS TO HUMAN SUBJECTS ....................................................................................................................... 36 
11.5.1 Protection Against Risks .................................................................................................................... 36 
11.5.2 Potential Benefits of the Proposed Research to Human Participants and Others ........................... 36 
11.5.3 Importance of the Knowledge to be Gained ...................................................................................... 36 
11.6 SAFETY MONITORING PROTOCOL ................................................................................................................ 36 
11.7 INCLUSION OF WOMEN AND MINORITIES ...................................................................................................... 36 
12. STUDY DOCUMENTS ................................................................................................................................... 36 
12.1 RETENTION OF RECORDS ............................................................................................................................ 36 
13. PUBLICATION AND DISSEMINATION POLICY .......................................................................................... 37 
13.1 DISSEMINATION ........................................................................................................................................... 37 
14. ORGANIZATIONAL FRAMEWORK OF AN INTERDISCIPLINARY TEAM OF INVESTIGATORS, 
PATIENTS, AND STAKEHOLDERS ................................................................................................................... 37 
14.1 REPORTING STRUCTURE ............................................................................................................................. 38 
14.2 MEETING SCHEDULE AND FUNCTIONS OF THE LEADERSHIP ......................................................................... 39 
14.3 INTEGRATION OF PATIENT AND STAKEHOLDERS IN THE TRIAL’S PLANNING, IMPLEMENTATION, ANALYSES AND 
DISSEMINATION ................................................................................................................................................... 39 
14.3.1 Local Patient and Stakeholder Councils ............................................................................................ 40 
14.3.2 National Patient and Stakeholder Council ......................................................................................... 40 
14.3.3 Training patients, stakeholders, and investigators ............................................................................ 41 
14.3.4 Engaging patients and other stakeholders as partners in all phases of the research ...................... 41 
14.3.5 Monitoring the study’s progress ......................................................................................................... 41 
14.3.6 Dissemination and implementation of study findings ........................................................................ 41 
15. REFERENCES……………………………………………………………………………………………………… 43 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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1. INTRODUCTION 
This document is a protocol for a human research study to be conducted according to US and international 
standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization 
guidelines), applicable government regulations, and institutional research policies and procedures.  
2. STUDY OBJECTIVES 
 
This pragmatic randomized clinical trial of 2150 participants at four diverse clinical trial sites will compare the 
effectiveness and cost-effectiveness of 18 months of health systems-based dementia care (based on the 
UCLA Alzheimer’s and Dementia Care program) provided by a nurse practitioner Dementia Care Specialist 
who works within the heath system versus community-based dementia care (using the BRI Benjamin Rose 
Institute Care Consultation model) provided by a social worker or nurse Care Consultant who works at a CBO 
and will compare both dementia care interventions to usual care. Caregivers and patients bring their unique 
personal perspectives of how dementia affects their lives, what outcomes are important to them, and what 
attributes of the interventions render them feasible, scalable, and sustainable. The clinical sites bring 
participants, clinical environments, and expertise in patient-centered research and implementation.  The 
investigators, patients, and other stakeholders planned and prepared this protocol jointly; these partners will 
continue to be collaboratively engaged in all aspects of the trial’s implementation.  
The study’s Specific Aims are: 
1. To engage 4 sets of health systems and community-based organizations, patients, families, and other 
stakeholders in a pragmatic clinical trial 
2. To adapt and implement 2 dementia care interventions at each CTS, including training of DCS’ and 
Care Consultants and pilot testing of the interventions, assessments, and outcomes 
3. To recruit 2150 participants and randomize them to receiving HSDC (N=1000), CBDC (N=1000), or 
usual care (N=150) 
4. To administer the interventions for 18 months for all participants 
5. To collect self/caregiver-reported outcomes and use claims data to evaluate other secondary and 
tertiary outcomes 
6. To compare the effectiveness of the 2 dementia care interventions versus each other and versus usual 
care 
7. To conduct a cost-effectiveness analysis of the two intervention arms versus each other and versus 
usual care 
8. To conduct analyses of tertiary outcomes of both interventions versus usual care including mortality, 
time spent at home, long-term nursing home placement, patient/caregiver satisfaction, goal attainment 
scaling (in the 2 active intervention groups), and comparing all three groups on several types of 
utilization and out-of-pocket expenses. We will assess physician satisfaction with dementia care 
provided by the 3 treatment groups. 
3. BACKGROUND 
In the United States, an estimated 5.7 million persons are affected by Alzheimer’s disease, the most common 
type of dementia.1 The total number with dementia is higher because Alzheimer’s disease is responsible for 
only 60-80% of dementias and is expected to grow to 7.7 million in 2030. The clinical manifestations of 
dementia are devastating including cognitive impairment, immobility and falls, swallowing disorders and 
aspiration pneumonia, and behavioral disturbances. These sequelae often lead to caregiver stress, burnout, 
and medical illnesses. Thus, dementia can be considered the prototype for a disorder with complex needs that 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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span both the patient and caregiver, medical and social domains, and health system and community-based 
organizations (CBOs). 
In response, several dementia care programs have been developed to comprehensively meet the needs of 
patients and their families including providing care coordination, high quality dementia care, and caregiver 
support.  Some have been based within health care systems and reach out to the communities whereas others 
are based in the community and reach in to the health care system. Although both approaches have 
demonstrated effectiveness on quality and clinical outcomes, the comparative effectiveness of these two 
models is unknown.  
4. STUDY DESIGN 
The study is a pragmatic randomized clinical trial of 2150 participants at four diverse clinical trial sites to 
compare the effectiveness of 18 months of health systems-based dementia care (based on the UCLA 
Alzheimer’s and Dementia Care program) provided by a nurse practitioner Dementia Care Specialist (DCS) 
who works within the heath system versus community-based dementia care (using the BRI Benjamin Rose 
Institute Care Consultation model) provided by a social worker or nurse Care Consultant who works at a CBO 
versus usual care. 
4.1 Number of Subjects 
The study will enroll 2150 dyads of participants and their caregivers. Note, throughout this protocol, families 
and caregivers are used interchangeably. The vast majority of caregivers are expected to be family members 
but, occasionally, a friend may be the primary or sole caregiver and would be eligible for participation. 
4.2 Subject Selection and Withdrawal 
4.2.1 Inclusion and Exclusion Criteria 
Table 1 lists the inclusion and exclusion criteria for participation in the trial 
Table 1: Inclusion and Exclusion Criteria 
Inclusion Criteria 
 
i. 
The participant must have a diagnosis of dementia established by a physician or 
other primary care provider 
 
ii. 
The participant must have a caregiver who speaks English or Spanish and has a 
phone 
 
iii. 
The participant must have a PCP who is willing to partner with the program 
iv. 
Persons living with dementia in assisted living facilities will be eligible if they do not 
meet any exclusion criteria (however, no more than 25% of participants can be living 
in assisted living facilities at the time of enrollment.  This will be monitored when the 
first 25% of the sample has been enrolled.) 
 
 
Exclusion Criteria 
 
i. 
The participant resides in a nursing home at the time of recruitment.  
ii. 
The participant is enrolled in hospice (at the time of screen) 
iii. 
The participant plans to move out of the area within the coming year 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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Because many of the outcomes have not been translated into other languages, it is not feasible to enroll 
participants who do not speak English or Spanish.  
4.3 Screening, Recruitment, and Enrollment 
4.3.1 Screening 
To facilitate recruitment, each site will generate a list of patients at participating practices site who have a 
diagnosis of dementia established by charge diagnosis (ICD 9/10) or on problem list and/or past medical 
history codes. Lists will be forwarded to the PCPs, practice nurses, or likely partnering physicians (determined 
by the sites) to review and obtain permission to contact patient/caregiver and confirm willingness to partner.  
4.3.2 Recruitment and Enrollment 
Participants will be recruited through physician referral. PCPs will be made aware of the trial through e-mail, 
fliers, and other traditional marketing techniques. In addition, clinical trial site staff will make presentations at 
meetings of participating medical practices, support groups, council meetings, senior centers, and health fairs. 
Local Patient and Stakeholder Committees (LPSC) will also provide advice about local strategies to promote 
recruitment (e.g., wording of documents, incentives). Some physicians or practices may opt to provide a 
“blanket” referral for all their patients with dementia and, if so, study team members may reach out directly to 
recruit participants. Alternatively, PCPs may choose to review their lists of persons with dementia and delete 
any patients who should not be contacted about the study or for whom they would not be willing to fill the role 
of the partnering physician.  
Patients and/or caregivers may also self-refer.  Self-referrals may originate from a variety of ways.  For 
instance, an individual may see a poster in a clinic waiting room, or they may be informed about the study by 
an existing participant, or from an employee of a community-based organization.  If potential participants would 
like to know more about the study, they must contact the site’s staff directly (i.e., self-refer). Then the site 
coordinator will provide further information about the study (and answer any of their questions), and if the 
patient and/or caregiver is interested in participating, the site coordinator should assess whether the dyad 
meets the study’s eligibility criteria (i.e., conduct an eligibility screening). If eligible, the potential participant’s 
PCP will be notified and will be asked about her or his willingness to partner. If the potential participant meets 
iv. 
The participant’s caregiver is unwilling or anticipates being incapable of providing 
self-reported outcome measures for 18 months 
v. 
Baseline measures refused or not completed 
vi. 
The caregiver is paid and is not a relative or close friend of the participant 
vii. 
At telephone or in-person screener, the caregiver has cognitive impairment 
viii. 
The patient or caregiver is participating in another dementia intervention study 
ix. 
Patients and caregivers who are members of a sites’ Local Patient & Stakeholder 
Committee  
x. 
There is already a member of the same household participating in the study. 
 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
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DEMENTIA CARE 
 
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eligibility criteria and does not meet exclusion criteria and if the PCP is willing to partner, an enrollment/ 
baseline interview will be scheduled. 
At the time of enrollment, study staff at each site will identify the primary and a back-up caregiver (in the event 
that the primary caregiver is no longer able to participate), review inclusion and exclusion criteria, discuss the 
study with the caregiver over the telephone, and schedule the baseline assessment.  
Upon successful completion of baseline assessment, caregivers and patients who are able to consent (see 
informed consent section 11.2) will be consented and enrolled into the study.  
4.3.3 Early Withdrawal of Participants 
Because this trial is based on the principle of “intent-to-treat”, all participants will be analyzed in the group to 
which the participant was randomly assigned, regardless of whether they complete the intervention or not.  
This preserves the effect of randomization. Because the intervention will be integrated into the work flow of the 
practice and community-based care, we expect relatively few withdrawals from the interventions. We will have 
four levels of study withdrawal: 
• 
Withdrawal from study interventions but willing to provide study outcomes by questionnaire/interview 
and allow analysis of medical records and CMS claims data. Subsequent Information on health care 
utilization outcomes will be obtained from CMS claims data and medical records. 
• 
Withdrawal from study interventions and willing to provide study outcomes by questionnaire/interview 
but unwilling to allow analysis of medical records and CMS claims data. 
• 
Withdrawal from study interventions and unwilling to provide study outcomes by questionnaire/interview 
but willing to allow analysis of medical records and CMS claims data. Subsequent Information on health 
care utilization outcomes will be obtained from CMS claims data and medical records. 
• 
Withdrawal from study interventions and unwilling to provide study outcomes by questionnaire/interview 
or allow analysis of medical records and CMS claims data. If the participant elects full withdrawal from 
the study, this will be recorded on the Participant Final Disposition Form and no further information will 
be obtained about the participant.  
For participants who are lost to follow-up but who have not withdrawn from the study, we will be able to obtain 
information from the electronic health record or from the utilization or claims data on secondary and tertiary 
outcomes.   
 
Each of the interventions will be administered until the final 18-month assessment is completed unless any of 
the following occur:  
• 
Patient or caregiver withdraw and there is not a willing replacement caregiver (see 4.3.3) 
• 
Patient Death 
• 
Moves out of the catchment area and unable to continue to receive the intervention 
5. STUDY INTERVENTIONS 
There are three arms to the study: 
 

A PRAGMATIC TRIAL OF THE EFFECTIVENESS AND COST-EFFECTIVENESS OF DEMENTIA 
CARE/COMPARATIVE EFFECTIVENESS OF HEALTH SYSTEM-BASED VERSUS COMMUNITY-BASED 
DEMENTIA CARE 
 
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1. Health systems-based dementia care (HSDC) – Comprehensive dementia care delivered by a nurse 
practitioner or physician’s assistant Dementia Care Specialist who works within the heath system, and 
reaches out to the community for additional services;  
 
2. Community-based dementia care (CBDC) – Comprehensive dementia care delivered by a social 
worker, nurse or licensed therapist within a community-based organization who reaches out to the 
health system by coaching persons with dementia and their caregivers to more effectively interact with 
their doctors;  
 
3. Usual care with consistent referral to Alzheimer’s Association Helpline (1-800-272-3900) to speak to 
master’s level consultants for decision-making support, crisis assistance and education on issues 
families face every day and referral to local programs and services 
 
 
Table 2 highlights the differences and similarities of the three arms. 
 
Table 2: Comparison of HSDC, CBDC and Usual Care 
 
 
HSDC 
CBDC 
Usual Care 
Key personnel 
Dementia Care 
Specialist 
(Nurse practitioner 
or physician’s 
assistant) 
Care Consultant 
(Social worker, 
nurse, or therapist) 
Care Consultant 
(masters-level) 
Key personnel base 
Health system 
CBO 
Alzheimer’s 
Association 
Face-to-face or telemedicine 
visits 
At least annually 
None 
None 
Structured assessments 
 
 
None 
Creation of individualized 
care plans 
Care Plan 
Action Plan 
None 
Monitoring and revising care 
plans 
 
 
None 
Access 24/7 365 days/year 
 
No or Alzheimer’s 
Association 
helpline 
Alzheimer’s 
Association helpline 
Identification and 
prioritization of goals 
 
 
No 
Communication with 
physicians 
Electronic health 
record/phone 
Mail or fax 
None 
Order writing 
 
No 
No 
Caregivers support and 
education 
 
 
Existing local 
resources 
Helping caregivers access 
community services 
 
 
Existing local 
resources 
Geri’s List (online directory 
of local resources) 
 
 
 
Coaching on physicians’ 
visits 
No 
 
No 
 

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DEMENTIA CARE 
 
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5.1 HSDC 
This intervention will be based on the model originally developed at Indiana University and subsequently 
modified in the UCLA Alzheimer’s and Dementia Care (ADC) program8, a 2012 Center for Medicare and 
Medicaid Services Healthcare Innovations Challenge Awardee. The UCLA ADC program is based at an 
academic health care system and partners with CBOs to provide comprehensive, coordinated, patient-
centered care for patients with dementia. The goals of the program are to optimize patient function, 
independence and dignity, minimize caregiver strain and burnout and reduce unnecessary costs through 
improved care. 
 
HSDC utilizes a nurse practitioner (NP) or physician assistant (PA) Dementia Care Specialist (DCS) 
supervised by a physician dementia specialist to tailor and facilitate dementia care delivery in collaboration with 
the primary care physician (co-management). Based on input from stakeholders who will be key to 
disseminating this intervention if it is successful, the name of this professional has been changed from 
Dementia Care Manager, which was used in the original UCLA Alzheimer’s and Dementia Care program, to 
Dementia Care Specialist. NPs and Pas can write orders, communicate directly through the EHR, and facilitate 
clinical care. Dementia care is based in the health care system, which partners with CBOs to provide 
comprehensive, coordinated, patient-centered care for persons with dementia. Key components include:  
o Structured needs assessments of patients and their caregivers. HSDC begins with an in-person visit or via 
telemedicine, with a Dementia Care Specialist (DCS) including the patient and at least one family member 
or primary caregiver.  To prepare for the visit and make it most efficient, patients (if early stage) and/or 
caregiver are asked to complete a structured pre-visit instrument 
(http://dementia.uclahealth.org/workfiles/for-physicians/Intake-Form-2017.pdf ) that includes information 
about the patient and caregivers.  The assessment is scheduled as a 90-minute in-person or via 
telemedicine session during which additional information is obtained by structured interview and 
examination.  In this manner, the DCS assesses the patient and caregiver’s needs and their resources.  
 
o Creation and implementation of individualized dementia care plans based on needs assessments. Based 
on these initial assessments, the DCS works with the patient and family to draft a personal care plan, which 
is sent to the referring PCP for approval or modification. This interaction with the PCP is aimed at ensuring 
continuity of care. To be efficient and succinct, this EHR-delivered information is divided into medical 
recommendations that the primary care physician is asked to address (and respond back through the EHR) 
and social and behavioral recommendations that the DCS implements independently. When the DCS has 
received a response from the referring physician, the assessment note is finalized and uploaded to the 
EHR. The patient/caregiver then receives a phone call from the DCS to discuss the final recommendations. 
 
All patients and their families receive ongoing dementia care management by a DCS supervised by a 
physician dementia specialist, which may include: 
• 
In-person or telemedicine sessions at which patient and family members’ specific questions about 
problems, resources, and implementing care plans are answered 
• 
Telephone follow-up to monitor implementation of dementia care plans 
• 
Facilitation of appointments with consultants when needed 
• 
Teaching dementia management skills to caregivers through individual counseling including information 
on: legal and financial planning with referral to community services, behavioral techniques to 
avoid/manage behavioral problems, and coping strategies for caregivers. 
 
Other components of the care plan are tailored to the individual and can include the following components: 
• 
Consultation with neurology, geriatric psychiatry, psychology, or geriatrics for additional diagnostic 
evaluation (e.g., if there are unusual symptoms) or management of refractory complications 
 
 
• 
Caregiver support groups, either community-based or provided by the health system  

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• 
Caregiver education through a community lecture series. These monthly webinars are archived on 
program’s website, http://dementia.uclahealth.org/aces-webinars .  
• 
Referral to community-based organizations for services such as delivered meals, adult day care, 
care/case management, financial and legal counseling, and transportation assistance as well as 
caregiver training. 
o Monitoring and revising care plans, as needed, including active monitoring and support of the caregiver’s 
emotional and physical health. Adjustments to the care plan are made as deemed appropriate by the DCS 
and communicated to the referring physician. All patients are re-evaluated for disease progression and 
adequacy of resources every 3-4 months by phone and at no greater than 1-year intervals in person or via 
telemedicine.   
 
o Access 24/7, 365 days a year for assistance and advice. Daytime calls are handled by the DCS, and nights 
and weekend calls are managed by on-call physicians who are aware of the program.  
 
Participants in this arm will also have access to Geri’s List, an on-line program that lists community-based 
services, customized to fit local resources, that caregivers or persons with dementia can access. 
 
HSDC will be guided by custom-designed dementia care management software created for the UCLA ADC 
and subsequently adapted for the STRIDE Falls study to include electronic data capture using REDCap. The 
software will be further modified to use STRIDE-developed software innovations. 
Fidelity Documentation of care will be site-specific using common instruments customized to local and will 
include: 
i. Initial and annual visits 
ii. Calls/emails to patient/caregiver with frequency per acuity protocol 
a) 
Red < 1 month  
b) 
Yellow < 2 months 
c) 
Green 3-4 months  
iii. DCS added as part of the care team on EHR (all sites are using EPIC) to receive 
Admission/Discharge/Transfer (ADT) alerts  
iv. DCS contacts inpatient team within 48 hours of admission to offer assistance with dementia-related 
issues, care transitions and/or goals of care, if hospitalized  
5.2 CBDC 
BRI Care Consultation is a care coaching program for patients with dementia and/or other chronic illnesses 
and for their family or friend caregivers. Grounded in the Stress Process Conceptual Framework2,3, BRI Care 
Consultation is consumer-driven, with a focus on problems or concerns that are important to patients and 
caregivers.  
Care Consultants deliver the program. They have bachelor’s or master’s degrees in social work, nursing, or 
other helping professionals and work in community-based organizations. BRI Care Consultation gives equal 
attention to the patients and their primary family or friend caregivers. Despite their dementia, patients are 
engaged in the program, whenever possible.4 Caregivers can be the sole program participant when patients 
are too impaired. The program establishes a long-term relationship between Care Consultants and families. 
The exact content of assistance provided is tailored to the preferences of individual patients and caregivers 
and is holistic in the range of potential concerns of problems addressed. General areas of assistance include: 
• 
Increasing access to and monitoring the use of community services and resources,  

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• 
Mobilizing support from the informal network of family and friends, 
• 
Providing and helping families use care- and caregiving-related information and consumer-ready 
educational materials about medical and non-medical issues,  
• 
Offering emotional support to both patients and caregivers, and 
• 
Facilitating communication and coordination of assistance among patients/caregivers, health care 
providers, and community service providers.  
BRI Care Consultation is low-cost and convenient to use because it is delivered by telephone, computer, and 
mail; no in-person contacts are required. It has a standardized protocol that requires at least monthly contacts 
between Care Consultants and patients and/or caregivers during the first four months. Required contacts 
decrease to every three months thereafter, although more frequent contacts can be made as part of the Action 
Plan (described below). Contacts often increase when there are changes in patients’ symptoms, caregivers’ 
availability or capacity, when new problems arise, or when there are transitions in care settings (e.g., after a 
hospital admission, nursing home placement).  
BRI Care Consultation has 3 main components: 1) Action Plan, 2) Initial- and Re-assessment, and 3) Ongoing 
monitoring.  
o Action Plan: The first priority, when patients and caregivers begin the program, is creating and 
implementing the Action Plan to address concerns identified by patients and/or caregivers as most 
important to them.  With coaching from Care Consultants, the action plan is populated with simple, 
achievable Action Steps, each with an expected completion date and responsible person. Action steps 
should be feasible to accomplish by whoever is the responsible person; most are assigned to caregivers, 
patients, and Care Consultants. Care Consultants provide guidance on action-step content and new action 
steps are added to deal with changes in the illness, caregiving, and preferences of patients and caregivers.  
Needed adjustments and modifications to Action Steps are regarded as opportunities for learning and 
reformulation. As Action Steps cumulate, patients and caregivers move toward informing and/or finding 
solutions to identified problems. 
 
The initial action plan is mailed or emailed to patients and/or caregivers by the end of week three in the 
program. Updates are sent as action steps are added. The action plan is also sent to the PCP to be 
integrated into the larger medical or service records of the organization implementing the program.  
 
o Initial- and Re-assessment: Although patient- and caregiver-identified needs drive BRI Care Consultation, 
the initial- and re-assessments act as a safety net to ensure that Care Consultants discuss with patients 
and/or caregivers 39 common problems related to dementia. There are 23 potential problems for patients 
(e.g., coordinating and accessing services, medication management, getting and understanding the 
diagnosis), and 16 for caregivers (e.g., finding and accessing community services, care-related strains and 
depression). Single-item trigger questions are provided to Care Consultants and can be used to prompt 
discussion. The 39 potential problem areas must be at least touched upon in discussions with patients 
and/or caregivers sometime during the first four months of enrollment and re-assessed at least every six 
months. More frequent re-assessment is recommended for persistent problems.  
 
o Ongoing Monitoring: A key feature that facilitates development of the long-term relationship between Care 
Consultants and patients/caregivers is monitoring activities, including scheduled follow-up contacts by Care 
Consultants to check whether Action Steps were accomplished by their due dates. Depending on 
experiences with assigned Action Steps, follow-up contacts often are used to set new Action Steps 
representing next steps in the process of moving toward solutions. When there are no active Action Steps, 
ongoing monitoring is done by Care Consultants completing pre-scheduled check-in calls. The timing of 
these check-ins is set at the time of enrollment according to the program’s protocol. Check-in contacts can 
be brief when there are no new issues that patients and/or caregivers want to bring up. These contacts 

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also provide opportunities to complete required re-assessments and assure patients and caregivers that 
Care Consultants are still available whenever they are needed.  
 
Participants in this arm will also have access to Geri’s List, customized to fit local resources. 
 
Fidelity Documentation of care will be site-specific and will include: 
i. 
all contacts 
ii. 
initial and every 6-month action steps 
iii. 
initial and every 6-month assessment domains for patients and caregivers 
iv. 
consumer-ready educational resources from the Educational Resources Library 
v. 
direct and indirect time associated with providing the intervention 
 
Data will be available through the Care Consultant Software being used for the study. 
 
5.3 USUAL CARE  
After enrollment, participants in the UC arm will receive standardized educational materials (hard copies and 
internet-based resources); referral to the national Alzheimer’s Association helpline (1-800-272-3900) to speak 
to master’s level consultants for decision-making support, crisis assistance and education on issues 
families face every day, and referral to local programs and services; and access to Geri’s List, an online 
directory of local resources. 
6. OUTCOME MEASURES AND OTHER DATA TO BE COLLECTED 
6.1 Definition and Ascertainment of Outcomes 
Primary, secondary, and tertiary outcomes are summarized in Table 3. Most of these outcomes are 
patient-reported and all are clinically meaningful to patients and caregivers as well as payers.  
 
 
 

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Table 3. Outcome Domains, Instruments and Timing 
Measure 
Administration 
Month 
 
 
Baseline 
(in-
person)* 
3 
(phone) 
6 
(phone) 
12 
(phone) 
18 
(phone) 
Sociodemographic 
characteristics 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Primary outcomes 
 
 
 
 
 
 
NPI-Q Severity (patient 
behaviors) 
Questionnaire 
X 
X 
X 
X 
X 
Caregiver strain (MCSI) 
Questionnaire 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
Secondary Outcomes 
 
 
 
 
 
 
NPI-Q Distress (caregiver) 
Questionnaire 
X 
X 
X 
X 
X 
Caregiver depression (PHQ-8) 
Questionnaire 
X 
X 
X 
X 
X 
Caregiver self-efficacy 
Questionnaire 
X 
 
X 
 
X 
 
 
 
 
 
 
 
Tertiary Outcomes 
 
 
 
 
 
 
Cognition (MOCA) 
Interview 
X 
 
 
 
X 
Functional status (FAQ) 
Interview 
X 
 
 
 
X 
Functional Status (Katz ADL) 
Interview 
X 
 
 
 
X 
Goal attainment scaling *** 
Interview 
 
 
X 
 
X 
Mortality 
CMS 
 
 
 
 
X 
Interview 
 
X 
X 
X 
X 
Time spent at home 
CMS 
 
 
 
 
X 
Inpatient hospital use** 
CMS 
 
 
 
 
X 
Acute inpatient rehabilitation 
use** 
CMS 
 
 
 
 
X 
Post-acute SNF use** 
CMS 
 
 
 
 
X 
Hospice use** 
CMS 
 
 
 
 
X 
Long-term nursing home use** 
CMS 
 
 
 
 
X 
Caregiver Rating of Dementia 
Care Quality   
Questionnaire 
 
 
 
X 
 
Caregiver satisfaction with 
dementia care 
Questionnaire 
 
X 
 
X 
X 
Dementia Burden Scale-
Caregiver 
 Composite 
X 
X 
X 
X 
X 
Clinical Benefit 
 Composite 
X 
X 
X 
X 
X 
Quality of Life in Alzheimer’s 
Disease 
Questionnaire 
X 
 
 
 
X 
Positive Aspects of Caregiving 
Questionnaire 
X 
 
X 
 
 
Cost-effectiveness analysis 
CMS 
 
 
 
 
X 

 
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CMS=Center for Medicare and Medicaid Services and site-obtained claims data; 
*Switched to telephone-collected after beginning of COVID-19 pandemic, with option for in-person visits 
** Also used to calculate time spent at home 
** Goal Attainment Scaling will be obtained only on a subset of caregivers (i.e., it will not be performed in 
caregivers  in the usual care group nor on all caregivers in the two active intervention groups; this will be 
completed by an unblinded assessor (i.e., the Dementia Care Specialist or Care Consultant with goal setting 
occurring at baseline, and goal attainment scaling occurring 6 months [6-12 months window] and 18 months 
[15-18 months window] after enrollment)  
 
Self/caregiver-reported outcomes will be assessed at baseline and at 3, 6, 12, and 18 months. Baseline 
measures, which were initially conducted in person, will be collected by telephone due to COVID-19. To 
accommodate participants who cannot conduct the baseline interview via telephone (e.g., hearing impairment) 
or prefer an in-person visit, the option of conducting the baseline visit in-person will be provided but all baseline 
assessments must follow the telephone interview administration exactly. In-person research procedures will 
not commence until the clinical trial site provides CPM with written assurance of adhering to their local 
institution's COVID restrictions and a copy of their respective local policy/procedures. Because many persons 
with dementia become home bound and it is difficult for caregivers to leave the patients, all patient/caregiver 
outcomes will be collected over the telephone. All baseline and follow-up data collection will be completed by 
blinded site staff. At 59 months into the study (6 months after final outcomes have been collected to ensure 
completeness), Medicare claims and Medicare Advantage utilization data will be requested for all time in the 
trial to assess long-term nursing home placement and calculate time (in days) spent at home. Utilization data 
for 1 year prior to enrollment will also be collected to conduct analyses that include prior utilization as a 
predictor or covariate. 
 
To minimize ascertainment bias during the collection of the 18-month outcomes, a letter will be sent at least 1 
month prior to the 18-month assessment to participants in all three arms reminding them that a study team 
member will call to schedule their final (18-months) assessment.  
 
For participants enrolled in the active intervention arms, the interventions will continue until each participant 
has completed the final (18-month) assessment.  
 
6.1.1 Primary Outcomes 
Because of the importance of both the patient and caregiver in dementia care, the primary outcome measures 
will be both the Severity scale of the Neuropsychiatric Inventory Questionnaire (NPI-Q)5 and the Modified 
Caregiver Strain Index (MCSI). The NPI-Q Severity is a validated survey that assesses the caregiver’s 
perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score 
ranges from 0-36 with higher scores indicating more severe symptoms. In a nursing home population, the 
minimal clinically important difference (MCID) was determined to be 2.8-3.2 points.6 The MCSI7 is a 13-item 
validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, 
and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. 
The MCID is 1.5-2.3 points. 
6.1.2 Secondary Outcomes  
Secondary outcomes include caregiver self-efficacy, distress in response to dementia-related psychiatric and 
behavioral symptoms, and depressive symptoms. 

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The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver 
in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 
with higher scores indicating more severe distress. In a nursing home population, the MCID was determined to 
be 3.1-4.0 points for distress.6 
Caregiver Self-Efficacy is measured with a 4-item self-efficacy scale assessing the caregiver’s ability to 
manage dementia-related problems and ability to access help, including community resources.  
Patient Health Questionnaire-8 (PHQ-8)8 is a shortened version of the PHQ-9 (item 9 is omitted) that is often 
used when the instrument is administered by telephone and intervention cannot be adequately provided. The 
PHQ-9 is 9-item validated tool used to assess depressive symptoms in the caregiver using the DSM-IV criteria 
for major depression and is scored from 0-27 with scores >10 indicating moderate symptoms and scores >20 
indicating severe depressive symptoms. Because of the infrequency of positive responses to item-9, its 
deletion has minimal effect on scoring and identical scoring thresholds for depression severity can be used. 9 
6.1.3 Tertiary Outcomes 
Tertiary outcomes include cognition and functional status, long-term nursing home placement, goal attainment 
(a measure developed through a previous PCORI Methodology grant), mortality, PCP and proxy ratings of care 
and satisfaction, quality of life in Alzheimer’s Disease, positive aspects of caregiving, and a new and novel 
outcome, time spent at home.10  
Montreal Cognitive Assessment (MoCA)11 is a validated widely used test of cognition that captures mild 
cognitive impairment as well as dementia. This will be collected by telephone at baseline and at the end of 
study12 to document disease progression. To reduce respondent burden and missing data, we will use a 
shortened form13,14 for reporting study participant baseline characteristics and measuring decline in cognition, a 
tertiary outcome. Participants who score 8 or higher on the shortened version will receive the full telephone 
MOCA to determine whether they have capacity to provide informed consent (see 11.2). 
Functional status will be measured using the Functional Activities Questionnaire (FAQ) measures functional 
status and ranges from 0 to 30 with higher scores indicating more functional dependence.15 We will also 
measure activities of daily living16 (Katz ADL), which has been validated and is well-established in research 
and clinical use. 
 
Goal attainment scaling, developed through PCORI funding to the Principal Investigator, asks patients and 
caregivers to select their most important goal and assesses progress towards meeting it. These goals were 
identified in focus groups of caregivers and patients and additional goals were identified when integrating goal-
setting into clinical care in the PCORI Methodology study. An inventory of 53 dementia goals captures virtually 
all goals that have been articulated.17 For this study, we will use a shorter inventory designed to help 
caregivers consider categories of goals that may be important to them. Goal attainment, defined as whether a 
person’s individual goals are achieved as a result of the study intervention, will be measured using a 5-point 
goal attainment scale (GAS). Using the SMART goal framework, GAS describes the person’s expected level of 
goal achievement over a specified timeframe, ranging from much worse than expected (scored as -2) to much 
better than expected (scored as +2). Scales are dynamically set according to a person’s needs, while 
measurement of attainment is standardized. The mean 6-month GAS score in a previous study of similar 
patients was 52.4 (SD 11.7) on a 0-100 scale with a T-score of 50 indicating that on average the expected 
level of goal attainment was achieved. Measurement of goal attainment will be performed with caregivers by 
clinicians involved in the intervention (Dementia Care Specialists and Care Consultants), who are unblinded, 
and can be performed over the telephone.  
Conceptually, time spent at home is a composite measure of control of dementia symptoms (e.g., problem 
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services that avoid days spent in other settings. Time spent at home has previously been operationalized43 as 
within the last 6 months of life but we will modify it to include each person’s total follow-up time spent after 
randomization that is spent at home. Total follow-up time will be determined from time of randomization to time 
of death, withdrawal (if CMS utilization data are allowed by the participant to be used), or to the end of the 
study for those who are administratively censored. Hence, the time spent at home is:  
 
“Number of days since randomization (540) minus  (1) number of inpatient days spent at an acute care 
hospital, inpatient rehabilitation facility, skill nursing facility, long-term care facility, or inpatient hospice unit), 
and (2) number of days not alive”. 
 
Caregiver Satisfaction will be collected using a 11-item questionnaire modified from the UCLA ADC, which will 
be collected at 3, 12, and 18 months.  
 
Quality of Life in Alzheimer’s Disease (QOL-AD)18 is a 13-item (range 4-52) instrument that can be 
administered to persons with dementia and caregivers.  It has demonstrated sensitivity to psychosocial 
intervention19 correlates with health-utility measures, is widely translated and used internationally and can be 
used by people with MMSE scores as low as three20. 
 
Positive Aspects of Caregiving (PAC) is measured with 11 items focusing on favorable aspects of the 
caregiving experience,21 with range 0-44 (most positive) and Cronbach’s alpha 0.92.22 The items ask about 
their mental or affective state related to their caregiving experience For example, providing help to care 
recipients has ‘made me feel more useful’, ‘made me feel strong and confident’, ‘given more meaning to my 
life’, ‘enabled me to develop a more positive attitude toward life’, and ‘enabled me to learn new skills’. 
 
Two additional tertiary outcomes will be examined that use measures described above. 
 
Dementia Burden Scale-Caregiver (DBS-CG)23 is a composite of the NPI-Q Distress, MCSI, and PHQ-8 scales 
with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores 
indicating higher caregiver burden. The minimal clinically important difference (MCID) for the DBS-CG is 5 
points.  
 
Clinical benefit24- Measured patient symptoms using the NPI-Q severity scale (the only patient outcome 
anticipated to benefit from the program) and caregiver symptoms using the DBS-CG scale. Benefit on the NPI-
Q severity scale is defined as having a 1-year score of < 6 (the lowest tertile of symptoms) or improving by at 
least 3 points, the MCID. DBS-CG benefit is defined as having a 1-year score of < 18.8 (the lowest tertile of 
symptoms) or improving by at least 5 points, the MCID. Defining benefit in this manner allows us to capture 
both preventive (those who have few symptoms at baseline and do not deteriorate) and therapeutic (those who 
improve) benefit from the program. We will then determine clinical benefit using 3 perspectives: patient benefit 
only, caregiver benefit only, patient or caregiver benefit. 
 
6.2 Other measures to be collected  
We will collect baseline sociodemographic data, including zip code to determine rural/urban status, to 
characterize the study population and for subgroup analyses. We will also ask caregivers about several 
personal health items including hospitalizations and inability to get health care (e.g., missing appointments) 
because of caregiving demands as well as items assessing informal caregiving hours from the BRFSS 
Caregiver module.25 These data sources are well validated using the data collection approaches that the study 
will use. As a measure of process of care, we will ask whether participant contacted the Alzheimer’s 
Association Helpline during the 18-month interview.  
 
Physician Satisfaction Measures 

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Physician Satisfaction will be collected using an 5-item questionnaire modified from the UCLA ADC, which will 
be linked to specific patients and conducted when the provider’s first enrolled patient completes the study. The 
instrument will be revised so that the same survey can be administered to evaluate participants in all 3 arms. 
All providers with at least one enrolled patient in the study will be surveyed. This will be very valuable in 
disseminating the interventions. 
 
Fidelity and Quality Measures 
We will also collect fidelity measures (see above sections describing each intervention) that capture whether 
the interventions are being implemented as planned. In addition, at 12 months, we will collect 10 ACOVE and 
Physician Consortium for Performance Improvement (PCPI) quality indicators quality measures of dementia 
care that can be collected by self-report including: 
 
Domain: Assessment/Screening 
• 
Annual assessment of cognition 
• 
Annual assessment of function 
• 
Annual depression screening 
• 
Annual screening for dementia-related behavioral symptoms 
 
Domain: Counseling 
• 
Dementia prognosis 
• 
Community resources 
• 
Behavioral interventions for neuropsychiatric symptoms 
• 
Safety 
• 
Driving 
• 
Advance care planning or palliative care 
 
COVID-19 Measures for Caregivers 
To assess the potential impacts of the coronavirus pandemic on study participants, we will administer a 10-
item questionnaire (modified from the Pain Management Collaboratory and National Alzheimer’s Coordinating 
Center questionnaires) evaluating how COVID-19 has affected caregivers’ emotional, physical, and social well-
being (e.g. caregiver distress, ability to care for person with dementia, social support) and care recipients’ 
mental and emotional well-being over the past 3 months. The COVID-19 Measures for Caregivers 
questionnaire is obtained over the telephone at the participants’ next scheduled outcomes assessment call, 
after the change has been approved by the IRB, by a blinded assessor (e.g. the Research Assistant). 
 
Finally, we will ascertain self-report (by caregiver) of serious adverse events (SAEs) of death and 
hospitalizations at each outcome assessment time point and through claims data. 
 
7. STUDY PROCEDURES AND VISITS 
7.1  Randomization 
At the time of the in-person or telephone (after the start of the 2020 COVID-19 pandemic) baseline 
assessment, caregiver and, if the person with dementia is capable, patient informed consent will be obtained. 
Upon successful completion of baseline measures, eligible persons will then be randomized to either HSDC or 
CBDC or UC in a 7:7:1 ratio. The randomization will be stratified by site using a permuted block design with a 
fixed block size of 15; using variable block sizes was not practical given the size of the block and the few 
numbers of participants to be enrolled in the usual care arm at each site. The randomization scheme will be 
computer-generated and the allocation sequence concealed.  Intervention assignment will be delivered by the 
web-based clinical trial management system. Because all of the care processes employed in all arms reflect 

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standard of care, the consent will focus only on the collection of data. This approach is the same as that 
employed in the PCORI- and NIA-funded Strategies to Reduce Injuries and Develop confidence in Elders 
(STRIDE) pragmatic multisite trial aimed at reducing serious falls-related injuries. 
7.2 Schedule of Events 
The trial Schedule of Events is shown in Table 4. 
Table 4. Schedule of Events (see also Table 3 for timing of outcome measures) 
Task 
Year 
 
 
1 
2 
3 
4 
5 
6 
IRB approval 
X 
 
 
 
 
 
Engaging patients and stakeholders 
X 
X 
X 
X 
X 
X 
Refining the interventions and tailoring to CTS 
X 
 
 
 
 
 
Training DCS’ and CBDC Care Consultants 
X 
 
 
 
 
 
Piloting the intervention and outcomes at CTSs 
X 
 
 
 
 
 
Recruitment of participants 
 
X 
X 
 
 
 
Follow-up of participants 
 
X 
X 
X 
X 
 
Data collection, quality management and analysis 
 
X 
X 
X 
X 
 
Data analysis 
 
 
 
 
X 
X 
Write papers and dissemination 
 
 
X 
X 
X 
X 
Obtain claims data  
 
 
 
 
X 
 
Conduct cost-effectiveness analysis 
 
 
 
 
X 
X 
Write papers and dissemination 
 
 
X 
X 
X 
X 
PCORI Peer-Review Process 
 
 
 
 
 
X 
8. STATISTICAL ANALYSIS, SAMPLE SIZE AND POWER CALCULATIONS 
8.1 Design Overview 
This section describes the general approach for the analysis of the primary, secondary and tertiary outcomes, 
including safety. The trial will be registered on clinicaltrials.gov before the first patient is enrolled and results 
will be reported within one year of obtaining the primary outcome on the last patient. Current versions of SAS 
and R will be used for all analyses. 
8.2 Analysis of Primary, Secondary, and Tertiary Outcomes 
8.2.1 Analysis of Primary Outcomes  
All analyses will be according to intent-to-treat or as-randomized. The analysis of the two primary outcomes – 
NPI-Q Severity and MCSI scores – will be done using a constrained longitudinal repeated measures analysis26 
based on maximum likelihood methods adjusted for the stratified randomization by site.  Treatment differences, 
averaged over all follow-up time points, will be summarized by least square means and 97.5% confidence 
intervals.  Significance testing for each outcome will be done by the Hochberg procedure27 using an overall 
type I error of 2.5% (2-sided) to control for the 3 pairwise comparisons, i.e., testing each outcome at 2.5% will 
maintain the overall type I error at 5% (2-sided). This analysis will be implemented as a mixed methods 
repeated measures (MMRM) model which uses all available records under the assumption that visit-specific 
data are missing at random (MAR).  Inclusion of the baseline 3, 6, 12, and 18-month data as outcomes in the 
model will assist in meeting the MAR assumption. We will test for the treatment by time interaction at the 10% 
significance level. If significant, we will also report treatment differences at each time point. We will also 

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examine for treatment by site interactions, although there may not be power to detect them. Sensitivity 
analyses will investigate the MAR assumption, such as methods that jointly model missingness and outcome 
distributions (e.g., pattern mixture models).28,32   
 
We will conduct an exploratory analysis to test whether giving any intervention is superior to usual care if there 
is no significant difference between the two interventions, and if neither intervention is superior to usual care 
for either or both outcomes. We will test this hypothesis using the same longitudinal repeated measures 
analysis described for the primary outcomes at the 0.05 (2-sided) level of significance uncorrected for 
multiplicity. The difference between giving any intervention and usual care will be reported as least square 
means with 95% confidence intervals. 
Heterogeneity of treatment effects (HTE) for the primary outcomes will be assessed in six key subgroups of 
participants: higher vs. lower patient function by FAQ, independent vs. dependent patient function by ADL, 
more vs less NPI-Q Severity, more vs less MCSI at baseline, spouse caregiver vs. other caregiver, and white 
non-Latino vs. nonwhite or Latino. These subgroup analyses are aimed at determining whether there is 
differential effectiveness of the interventions among patients with more and less severe disease, perhaps 
elucidating a preventive (if effect is greater among those with less severe disease) versus therapeutic (if effect 
is greater among those with more severe disease) effect. Similarly, the high vs low distress subgroup 
comparison will determine whether the intervention is more effective among those with more distress at 
baseline (a therapeutic benefit) versus less distress (a preventive benefit). Evidence of HTE will be based on 
tests of interaction within the longitudinal model structure described above. Because six tests of interaction will 
be conducted, we will use the Hochberg procedure to control for multiplicity using an overall type I error of 
2.5% (2-sided) for each outcome; subgroup treatment differences will be reported using 99% confidence 
intervals.  
 
Exploratory analyses to assess HTE for the primary outcomes will be also be conducted in demographic 
subgroups (e.g., age, race and ethnicity) as well as the effects of the COVID-19 pandemic and not adjusted for 
multiplicity.  
 
8.2.2 Analysis of Secondary Outcomes  
The analysis of the continuous secondary outcomes – NPI-Q Distress, caregiver depression (PHQ-8), 
Caregiver self-efficacy– will be analyzed like the primary outcomes. The Hochberg procedure will be used to 
control for the testing of each secondary outcome using an overall type I error of 5% (2-sided); treatment 
differences will be reported using 95% confidence intervals.  
8.2.3 Analysis of Tertiary Outcomes  
The analysis of tertiary outcomes will be considered exploratory and, thus, no control for multiplicity will be 
done. Continuous outcomes will be analyzed by longitudinal methods, time to event data by survival methods 
and count data by Poisson, Negative Binomial, hurdle models or rank based methods depending on the 
distribution of the counts. Time spent at home is calculated as 540 minus (1) the number of days in a health 
care facility, including hospital, nursing home, acute rehabilitation, and inpatient hospice, and (2) the number of 
days not alive. The analytical approach will depend on the distribution of the outcome (e.g., skewed 
distributions will require rank-based methods.)   
8.2.4 Missing Data  
Several strategies will be implemented to address the issue of missing data during this study. Prevention is the 
most obvious and effective manner to control bias and loss of power from missing data.29 (see section 9.1.7 
“Data Quality Control” for a discussion of our plans to minimize missing data and other errors during data 

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collection). This protocol will follow the intent-to-treat principle, requiring follow-up of all participants 
randomized regardless of the actual treatment received.30  The primary source of missing data will result from 
death since we expect relatively few dropouts (< 10%). Whenever a participant drops out of the study, we will 
document the specific reason for dropout, who decided that the participant would drop out, and whether the 
dropout involves some or all types of participation. For example, some participants may drop out of the 
patient/caregiver-reported outcomes but permit use of claims data to determine some secondary and tertiary 
outcomes.  
 
The follow-up period of 18 months was set to capture the time period during which treatment benefits would be 
maximized while minimizing the impact of deaths. Also, the timing and frequency of follow-up assessments at 
3, 6, 12, and 18 months was designed to minimize missing primary outcome data on participants by having 
measurements at early time points. 
 
Because the study population has dementia, the primary source of data collection (including primary and all 
secondary outcomes) will be from caregivers. To minimize missing data, all follow-up data will be collected by 
telephone, making it much easier, compared to in person visits, for participants (and caregivers) to complete 
the outcomes assessments. Because most instruments, including the two primary outcome measures are self-
administered, we can also offer the options of collecting these data by fax, secure website, or secure email, 
which will also reduce the likelihood of missing data. We will also employ a risk-based approach to trial 
monitoring with timely data entry combined with weekly missing data reports that will trigger protocols for 
tracking and obtaining missing data items or outcome assessments31 data.  
 
Despite these prevention efforts, it is reasonable to assume missing data will occur. Our primary analysis is 
valid under the assumption that missing data is missing at random (MAR). Sensitivity analyses will investigate 
the MAR assumption, such as methods that jointly model missingness and outcome distributions(e.g., pattern 
mixture models).29,31  . The results of these techniques to account for missing data will be incorporated into the 
interpretation of findings and conclusions of the study. 
8.3 Sample Size 
8.3.1 Primary Outcomes  
The assumptions used to determine sample size for testing differences among the three treatment arms for the 
two primary outcomes were: 1) type I error 0.05/6 = 0.0083 adjusted for 3 treatment comparisons (HSDC vs. 
CBDC, HSDC vs. UC and CBDC vs. UC) times 2 primary outcomes, 2) standard deviation (SD) for NPI-Q 
severity of 6.5 units and SD for MCSI of 6.7 units, 3) treatment difference for HSDC vs. CBDC of  1.5 units, 4) 
treatment difference for HSDC and CBDC vs. UC = 3 and 5) lost to follow up over 18 months because of death 
and dropout of  25%. The detectable treatment difference of 1.5 units for HSDC vs. CBDC is based on data 
reported in the literature suggesting a minimally clinical important difference (MCID) ranging from 2.8 to 4.0.6 
Given that both intervention arms will be receiving an intervention, we reduced the detectable difference in half 
to 1.5. Data from two studies32, 33 indicate that the expected benefit between HSDC and UC would be 3.2 units 
for NPI-Q Severity score. Based on these data we used a difference of 3 units for comparisons with UC. The 
estimates of the standard deviations (SD) for the 18-month NPI-Q Severity score and MCSI are 6.5 and 6.7, 
respectively, based on UCLA pilot data.  An 18-month censoring rate of 25% was assumed because of death 
(15%) and dropout (10%). The death rate was taken from fee-for-service claims data on 274 UCLA patients 
with a mean survival time of 1.5 years.  
 
Sample size was first determined for the comparison between HSDC and CBDC because the effect size is 
smaller. The goal was to achieve at least 90% overall power for testing both outcomes. Testing each outcome 
at 95% power with a sample size of 1000 subjects per treatment group (adjusted for censoring) gives at least 
90% overall power for testing both outcomes. Given these sample sizes, the sample size is 150 (for UC 

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adjusted for censoring) for comparisons with the two interventions giving an overall power of at least 90%. For 
conservativism, we assumed the same effect size for both interventions compared with UC even though we 
hypothesize that HSDC will be superior to CBDC. The total sample size for the trial is 2150 individuals 
(adjusted for censoring). 
  
Table 5:Power and Sample Size for the Two Primary Outcomes 
Comparison 
Difference 
to be 
detected  
Power for 
MCSI 
Power for  
NPI-Q 
Severity 
Overall 
Power 
Adjusted Sample 
Sizes 
HSDC vs. 
CBDC 
1.5 
95% 
95% 
90% 
1000 per group 
HSDC or 
CBDC vs. UC 
3.0 
95% 
95% 
90% 
1000 HSDC and 
CBDC vs. 150 UC 
 
The inflation of sample size for censoring due to deaths and losses is conservative because the data will be 
analyzed using longitudinal methods under the MAR assumption that include all available data on each 
participant. Considering the first patient follow-up for the two primary outcomes is at 3 months, the effective 
censoring rate for analytical purposes is approximately 5% for the primary analysis (i.e., those without any 
primary outcome follow-up data).  
 
Heterogeneity of treatment effects (HTE) for the two primary outcomes will be assessed in six subgroups of 
participants: high vs. low patient function by FAQ, high vs. low patient function by ADL, high vs. low NPI-Q 
Severity, high vs low MCSI at baseline, spouse caregiver vs. other caregiver, and white non-Latino vs. 
nonwhite or Latino. The study will have approximately 90% power to detect interactions (differences in 
treatment effects between subgroup categories) of about 3 units for both NPI-Q severity and MCSI for the 
HSDC vs. CBDC comparisons. Interactions on the order of 6 units can be detected with approximately 90% 
power for comparisons of HSBC and CBDC with UC for the two primary outcomes. These detectable 
interactions assume a conservative Bonferroni adjusted type I error of 0.05/(6x3x2) = 0.0014 to control for 
multiplicity. (In the analysis, we will conduct one global test of interaction per subgroup for 6 subgroups). Using 
an anchor-based approach that compares changes in NPI-Q measures with other clinical measures, the MCID 
for the severity scale is 3.2.6 Hence, based on this range of MCID, the study will have adequate power to 
detect clinically meaningful differences in subgroups for comparisons between the two interventions. However, 
only large interactions can be detected for the comparisons with UC because of the smaller sample size in this 
arm. Although equal subgroup sample sizes were assumed in the calculations, power will not be greatly 
affected if the imbalance in subgroup sample sizes is not more extreme than a ratio of 2:1. 
8.3.2 Secondary and Tertiary Outcomes  
For the three secondary outcomes (NPI-Q Distress, caregiver depression (PHQ-8), Caregiver self-efficacy), we 
determined the detectable effect sizes assuming a Bonferroni adjusted type I error of 0.05/(3x3) = 0.006 to 
control for multiplicity. The detectable effect sizes with 90% power for the three continuous measures (NPI-Q 
Distress, caregiver depression (PHQ-8), Caregiver self-efficacy) are on the order of 0.20 for testing HSDC vs. 
CBDC. For testing HSDC/CBDC vs. UC, there will be approximately 90% power to detect effect sizes on the 
order of 0.40. Thus, we will have good power to detect small to moderate effects for the three continuous 
outcomes. 
 
The goal attainment scaling (GAS) tertiary outcome will be collected only from caregivers (in the two active 
intervention groups) enrolled through December 15th, 2020. Goals will be set at baseline and will be assessed 
at two follow-up time points: at 6-12 months and 15-18 months after enrollment. After considering the expected 
loss to follow up, we anticipate 80% power (appropriate for a tertiary outcome) to detect a 10% difference 
between HSDC and CBDC arms. 

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Power determinations for tertiary outcomes were not performed because these are considered exploratory. 
Sample size and power were calculated using Power and Sample Size (PASS) software (Kaysville, UT, 2013). 
8.4 Cost-effectiveness and utilization analysis 
The cost-effectiveness of the interventions compared to UC is the ratio of incremental net costs to incremental 
effects of the two primary outcomes. Thus, the ratio will be the net costs per X point change in NPI-Q-Severity 
and Y point change in MCSI. Costs will be taken from the perspective of Medicare. The net costs of the 
interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical 
care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the 
sites. The cost offsets come from changes in various kinds of utilization, which will primarily be based on the 
Medicare claims of participants in FFS, MA, or commercial health plans, or records of utilization priced using 
Medicare prices. We will model the cost offsets using differences in differences using general estimating 
equations with a gamma family and log link, as was done in a prior CMMI analysis that showed significant cost 
savings.34 The cost effectiveness ratio can be transformed into the clinical benefit gained (patient, caregiver) 
per $1000 investment per year. After we have calculated intervention costs and savings, we will compute 
return on investment = (cost savings – intervention costs)/(intervention costs).  
 
We will use the Master Beneficiary Summary File (MBSF), Medicare Provider Analysis and Review (MedPAR) 
file, Outpatient file, Hospice file, and Carrier file (non-institutional providers) to determine costs and utilization. 
The MBSF includes the base segment with beneficiary demographic information, date of death, and chronic 
conditions, and a costs and use segment with payment and utilization information. The costs will be computed 
as total Medicare payments across all services (hospital outpatient, acute inpatient, other inpatient, skilled 
nursing facility, hospice, home health, Part B carrier, and durable medical equipment). The MedPAR files 
contain inpatient hospital and skilled nursing facility (SNF) records for all Medicare beneficiaries, the outpatient 
files include claims submitted by emergency departments, and the hospice file contains claims for hospice 
stays. For participants in MA or commercial health plans, we will use internal records of utilization, and 
compute costs using Medicare prices.  
 
Secondary analyses will be from a societal perspective and include costs to Medicaid and consumers as well 
as Medicare. Long-stay nursing home stays will be identified using place of service codes and Current 
Procedural Terminology (CPT) codes for nursing facility services (from carrier and outpatient claims), and the 
absence of SNF claims in an initial month.35 To compute nursing home costs, nursing home stays will be 
multiplied by a weighted average reimbursement rate paid by Medicaid and private plans. Costs to consumers 
will include beneficiary cost-sharing payments for services as well as caregiving costs using questions from the 
Aging, Demographics, and Memory Study.25 The cost of paid caregiving will be estimated based on average 
hourly rates from caregiver agencies, and the cost of family care will be estimated based on the market wage 
paid to formal caregivers or the cost of foregone wages by caregivers based on average market wages.36 
 
In tertiary analyses to understand where the cost savings arise, we will study changes in utilization by type of 
use including all-cause hospital admission rate stratified by psychiatric versus general hospital admission, 30-
day hospital readmission rate, ambulatory-care sensitive hospital admissions, length of hospital stay, ED visit 
rate, ICU use, post-acute nursing home admission rate and length of stay, proportion of enrollees 
institutionalized in nursing homes, and hospice enrollment. Analyzing the types of utilization will allow us to 
have a better understanding of the drivers behind the overall cost offsets. We will model expected utilization, 
adjusted for hospital and ED use in the 12 months prior to date of enrollment for each participant. We will 
inspect the actual distribution of our data to guide statistical modeling but expect to use negative binomial 
regression to model utilization rates (i.e., count of hospitalizations). Negative binomial regression will allow us 
to account for heterogeneity in individual rates, repeated events within patients, and different months of 
available claims data for each patient. 

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8.5 Safety 
Because this is a minimal risk trial, we will ascertain self-report (by caregiver) of SAEs of death and 
hospitalizations at each outcome assessment time point, which will be monitored by the DSMB. At the end of 
the follow-up, we will confirm any between-group differences in self-reported SAEs by examining data on 
mortality and hospitalizations from CMS data files and site-obtained utilization data. In addition, if a caregiver’s, 
PHQ-8 score is >14, Research Assistants will immediately (that day) notify the site’s clinical director (or 
covering physician) and this clinician can decide on next appropriate steps.  
 8.6 INTERIM MONITORING 
Interim monitoring will focus on safety, recruitment, adherence to protocol, baseline comparability of treatment 
groups, data quality, and uptake of the assigned intervention. A set of monitoring tables will be generated for 
this purpose. Because this is a minimal risk trial and the follow-up period is relatively short (18 months), no 
monitoring for efficacy or futility is being proposed.  
9. DATA COLLECTION AND MANAGEMENT 
9.1 Data Collection  
All data collection and data entry will be performed by site research staff, using tools and standard operating 
procedures (SOPs) provided jointly by the Central Project Management (CPM) and by the Data Coordinating 
Center (DCC). The primary mode of data collection will be directly onto electronic forms, through a device that 
is encrypted and secured according to site institutional standards for information security. The DCC will also 
provide equivalent paper forms, for use in situations where a suitably secure, internet-connected device is 
unavailable (e.g., a telephone interview conducted after hours at home). Access to all data collection and data 
entry services will be through a study portal website Patient dashboard, described below. Staff will be trained in 
the proper handling of paper forms (i.e., storage in secured participant jackets, no identifying information, all 
notations in permanent ink, all modifications initialed and dated in red ink).  
 
9.1.1 D-CARE Study Portal Website  
Most of the DCC data management services will be organized and delivered through the D-CARE Study Portal 
Website, a secure web tool that will be available to study staff. Role-based access to DCC services will require 
login through Yale's Central Authentication Service (CAS), using Yale Research Affiliate user accounts (netids) 
that will be issued to staff as required. The portal website will be hosted by Yale Information Technology 
Services (ITS) and certified as HIPAA-compliant by the Yale Information Security Office (ISO). ISO will scan 
the portal website for vulnerabilities throughout the study period. 
9.1.2 REDCap  
All data collection systems and services will be based on REDCap, the CTSA-supported data management 
tool (http://project-redcap.org). While REDCap provides many essential features, its main strength is its open 
architecture and support for user-designed extensions ("plugins" and "hooks"). Many of the services described 
below are highly customized REDCap extensions that appear to the user as stand-alone web applications. 
Through these extensions, we can customize the interface of any REDCap-based web tool to match the 
workflow of the study activity. 
9.1.3 Site Management Services  
The portal website will be the means for disseminating site metrics such as accrual progress; interviewer 
performance; error rates; error closure statistics; and other performance measures. Detailed reports will be 

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distributed to sites and comparative reports and charts ("site report cards") will be available on an "all sites" 
page. We will post relevant administrative forms on the study portal website, as well as important study 
documents such as the MOP, and study forms. 
9.1.4 Staff Management Services  
DCC will provide, through the D-CARE portal website, tools for managing site study staff. Basic information 
such as role on study, email address, and active status will be editable by site coordinators, but staff training 
will be a particular focus of this module. The DCC will work with CPM to develop training certification standards 
and curricula for site staff involved in data collection and will provide means for accessing tutorials and signing 
up for training webinars. Training certificates will be issued, sent to staff by email, and tracked. Only certified 
staff will have access to the REDCap-based data collection tools. Interview staff will be monitored on key 
performance factors such as refusal rate, data completion rate, adherence to rules for contacting patients (e.g., 
at least one weekend, one evening attempt), adherence to interview windows, and metrics assessing the 
measurement of key outcomes. Staff will be re-trained as indicated by monitoring results. 
9.1.5 Data Quality Control 
9.1.5.1 Preventive Data Quality Control  
Clear, unambiguous, and uniform procedures that all study personnel can follow are essential to maintaining 
data quality.37 DCC will provide DCS site staff with SOPs and standardized training, and all staff will follow 
identical procedures for data collection. Staff will be continuously monitored according to interview 
performance and measurement metrics, and interviewers showing significant departures from group medians 
will be evaluated for additional training or other action. 
 
Interview design will be partly guided by two principles that have large effects on data quality: parsimony and 
specification completeness. Keeping the number of data elements to the minimum required to accomplish 
study goals reduces the overall participant, site staff, and data management burden in terms of time and efforts 
necessary to process data for analysis. Wherever possible, responses that are open to interpretation (e.g., free 
text responses, non-exhaustive choice sets) will be avoided. 
9.1.5.2 Proactive Data Quality Control  
Comprehensive point-of-entry error checks will be built into the electronic forms. REDCap provides for range 
checks and branching logic enforcement and has limited support for higher-dimension data pattern actions. For 
example, branching logic may be defined based on data "piped in" from other forms. 
9.1.5.3 Batch Error Checks and Error Resolution   
Batch error processing is a necessary component of data quality control. It has been reported that batch data 
cleaning can reduce the median transcription data entry error rate by as much as seven-fold.38 A substantial 
portion of D-CARE data will be entered via transcription from paper forms (e.g., after hours assessments), so 
batch error checks problematic data patterns will be a vital component of the QC system. Finally, by design, 
real-time errors can be overridden by interviewers (e.g., a lab value outside the range allowed). These 
(apparent) errors must still be resolved.  
 
The D-CARE tool for daily batch error detection, tracking and resolution will be a web-based tool under 
development by DCC that is based on the "Data Quality Control Query" (DQCQ) utility implemented in the 
SILVER-AMI study: http://medicine.yale.edu/intmed/geriatrics/silver_ami/about/. DQCQ is a REDCap-based 
web tool that manages a database of error conditions detected by SAS programs that use a standard DQCQ 
code (macro) library. All errors are viewable and tracked by DCC staff, and can be conditionally exposed to site 
staff for resolution. Site staff can correct most errors through "mini forms" rendered directly on the DQCQ 

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interface using REDCap metadata, or they may use the normal REDCap interface. Site staff can also declare 
errors as "unrecoverable" or "resolved as an outlier," in which cases explanations are required. DQCQ errors 
can only be closed by DCC staff. DQCQ works with built-in REDCap QA/QC features, such as explanatory 
"field notes" that can be entered onto any REDCap form. Updates are audited through the normal REDCap 
logging feature. Site staff are incentivized to address open DQCQ queries though performance summaries 
(open queries, 30-day resolution rate, etc) displayed on the portal website dashboards, and on comparative 
reports that rank sites on these important metrics. 
9.2 Intervention Support   
HSDC Management Services The primary tool for HSDC intervention workflow and task management will be a 
specialized software application developed by a third-party vendor (High5LA) working with the DCC.  This 
application is a modification of the software system, also developed by High5LA, in use by the UCLA dementia 
care team. The workflow/task management software will be integrated with a REDCap-based electronic data 
capture module (EDC), following methods worked out for STRIDE. 
 
DCC will work with CPM and CTS’s to develop and maintain training standards for software and will provide 
means for accessing tutorial and training webinars.  The DCC, High5LA (the software vendor), and CPM will 
coordinate user support efforts for the software.   
CBDC Management Services The study will use existing BRI Care Consultation Information System software 
and relevant data will be exported. This software tracks all contacts, action steps, assessment domains, direct 
and indirect time, and other processes completed as part of the program. Built in reports are generated by 
Care Consultants, supervisors, and administrators that provide results for these data in aggregate form, which 
can be exported as individual case-level data to statistical software for analyses. 
9.2 The Data Mart  
DCC will maintain a read-only snapshot or "data mart" for use by DCC data managers and statisticians for 
analyses, batch error checks and study conduct reports. The data mart will be regenerated each night and will 
be in SAS format. The data mart will include all assessment and outcome data, as well as fidelity measures 
from the HSDC and CBDC systems. Specific data mart snapshots used for DSMB reports, interim analyses, 
manuscripts and other specialized purposes will be permanently saved. 
10. SAFETY AND ADVERSE EVENTS  
10.1 Background 
This section describes the requirements and processes for reporting adverse events (AE), serious AE (SAE) 
and unanticipated problems to the Institutional Review Board (IRB) of record and DSMB. It incorporates 
guidelines provided by the Office of Human Research Protections (OHRP) of the Department of Health and 
Human Services (DHHS) and Food and Drug Administration (FDA) reporting requirements. NIH is obligated to 
ensure that researchers comply with their approved reporting procedures. Because this is a minimal risk trial, 
we will ascertain self-report (by caregiver) of SAEs of death and hospitalizations at each outcome assessment 
time point, which will be monitored by the DSMB.  At the end of the follow-up, we will confirm any between-
group differences in SAEs by examining data on mortality and hospitalizations from CMS data files and site-
obtained utilization data. 
10.2 Definitions 
Adverse Event: Because 45 CFR 46 does not provide a specific definition for an adverse event (AE), the 
definition of an AE will conform to the International Conference on Harmonization (ICH) Good Clinical Practice 
(GCP) Guidelines. The same definition is used by the U.S. Food and Drug Administration (FDA) except that 

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“drug” is typically used instead of the term “intervention.” An AE is defined as any untoward medical 
occurrence in a patient or clinical investigation subject administered an intervention and which does not 
necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with 
the use of an investigational intervention, whether or not related to the intervention. 
Serious Adverse Event (SAE): Any AE that: 
• 
Results in death; 
• 
Is life threatening, or places the participant at immediate risk of death from the event as it occurred;  
• 
Requires or prolongs hospitalization; 
• 
Causes persistent or significant disability or incapacity; 
• 
Results in congenital anomalies or birth defects; 
• 
Is another condition, which the investigators judge to represent significant hazards. 
Unanticipated Problem: any incident, experience, or outcome that meets all of the following criteria: 
• 
unexpected, in terms of nature, severity, or frequency, given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and informed 
consent document; and (b) the characteristics of the study population;  
• 
related or possibly related to participation in the research; in this guidance document, possibly related 
means there is a reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research;  
• 
suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
Adverse Event Reporting Period: The study period during which adverse events must be reported is 
normally defined as the period from the initiation of any study procedures to the end of the study treatment 
follow-up. 
Preexisting Condition: A preexisting condition is one that is present at the time of providing the consent for 
the study.  A preexisting condition is considered an adverse event if the frequency, intensity, or the character of 
the condition worsens during the study period. 
10.3 Responsibilities 
Investigators conducting clinical research are responsible for: 
• 
Assurance that their procedures are conducted in compliance with these guidelines. 
• 
Creating a DSMP that describes the plans for adverse events, serious adverse events, and 
unanticipated problems commensurate with the nature and complexity of the study. 
- 
Recipients of Serious Adverse Event and Unanticipated Problem reports must include the IRB  
and DSMB 
- 
Adherence to the DSMP with respect to timely submission of adverse events, serious adverse 
events, and unanticipated problems. 
10.4 Level of Monitoring in this Study  
Data and Safety Monitoring Board The study will convene a Data and Safety Monitoring Board (DSMB) that will 
meet once in year 1 and twice a year thereafter. The DSMB will monitor participants’ safety and study 

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progress, and make recommendations to the project team regarding participants’ safety and continuation of the 
trial. The DSMB will include experts in dementia care (including investigators), clinical trials and statistics. 
General Description/Overview: This pragmatic trial differs from a typical randomized, controlled trial (RCT) in 
important ways. First, no experimental interventions are used. All interventions are standard of care and not 
research. Indeed, the consent form does not include language for consent to an intervention, only for collecting 
data. Thus, the definitions of research and therefore AE, SAE, Unanticipated Problems and Pre-existing 
conditions do not apply to the intervention. However, this appraisal does not preclude the need to monitor the 
study and its impact on participant safety. There are no in-person study visits other than the baselines 
conducted prior to the 2020 COVID-19 pandemic; the only data collection methodologies are questionnaires 
and examination of claims data. Therefore, our safety monitoring procedures focus on data collection via the 
methodologies available in the protocol design. Our plan is based upon the following principles:  
 
1) It is not feasible or necessary for participant safety to monitor AEs as the definitions above do not apply 
because the intervention is not research. 
2) Limited monitoring is justified for serious adverse events (SAEs) as many of these will not occur in our study 
population (e.g. congenital anomalies) AND this is not a trial that has implications for FDA approval. Thus, only 
Good Clinical Practice (GCP) need dictate the level of monitoring in accordance with Federal Registry Title 21.  
3) It is not necessary to assign monitored SAEs as “related” or “unrelated” to the study protocol because there 
is inherent bias in this assessment, attribution of “relatedness” would be a tremendous burden, and whether a 
difference in SAE burden is considered “related” or not, a significant difference between groups would be 
treated with similar concern by the DSMB.  
4) Mechanisms for timely reporting after SAE ascertainment are important, but collective totals of monitored 
SAEs at assigned intervals will meet “timeliness” for the purposes of this study.  
5) The primary and secondary study outcomes will not require additional SAE reporting.  
10.5 Ascertainment of AE, Unanticipated Problems (UP), and SAE 
10.5.1 Adverse events  
As noted in 10.4, AEs will not be collected in this trial since “any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the intervention” will be 
occurring in the course of routine care, not research. Limited SAEs will be collected and reported as outlined in 
11.5.3. 
10.5.1 Unanticipated Problems (UP) 
Investigator institutions must have written procedures for ensuring prompt reporting to the IRB and others as 
appropriate, of any Unanticipated Problem involving risks to study participants or others (45 CFR 46.103(b)(5)).  
As shown in Table 6, if the site PI or study coordinator has an individual concern, they will be required to 
contact the Medical Safety Officer (MSO) within 48 hours of first knowledge of the event.  An UP form must be 
completed by the site investigator and faxed to the PI/Study Director (SD) within 48 hours.  The site PI will 
keep a copy of this UP form on file at the study site.  The SD will confirm that the UP is an anticipated event 
and, if confirmed, report the UP to the DSMB within 48 hours of its notification. An UP will result in corrective 
plans and measures to prevent reoccurrence.  An electronic record of such concerns and the action plan will 
be filed by the SD with the DCC so that concerns can be tabulated and reported as outlined below. 
Table 6. Methods to ascertain safety concerns and SAEs 

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10.5.2 Ascertainment of SAEs and Deaths 
Given the principles in 10.2, our plan focuses on a limited set of SAEs. Only hospitalizations and deaths will be 
collected, which will ensure the protection of participants from potential harm but remain feasible within the 
study design. The vast majority of SAE ascertainment will occur from telephone interviews per the outcomes 
assessment schedule. Self-reported hospitalizations and death will be reviewed by the SD by the SD on 
schedule determined by DSMB (e.g., every 6 months). 
Participants who die within the participating health care systems will be verified CMS Master Beneficiary 
Summary File at the end of the study.  
As outlined in the safety plan below, SAEs will be reported to the DSMB, and the IRB of record in accordance 
with NIH and local regulations, and in conformity with the Data and Safety Monitoring Plan developed by the 
DSMB and approved by NIA and PCORI.  
10.6 Safety Personnel 
Study Director (SD): The SD will coordinate reporting of the safety data. The SD will monitor and evaluate all 
collected UPs and SAEs from all sites efficiently and effectively by regular review/monitoring of reports of 
monitored SAEs or UP reported directly by site PIs/personnel. The SD may suggest measures to the PIs to 
improve monitoring or prevent risk to participants. Upon approval by the DSMB, these modifications may be 
submitted as protocol modifications to the IRB of record. The SD will review reports of UPs and SAEs (in total, 
but not segregated by treatment assignment) and submit these to the DSMB, the IRB of record and the DCC 
for distribution to Reporting of Unanticipated Problems and Serious Adverse Events 
Deaths learned by the Clinical Trial Site, Dementia Care Specialists and Care Consultants are to be reported 
to Central Project Management (CPM) as soon as learning of it.  CPM is responsible for notifying the DSMB 
Chair and NIA via email with death details (Dyad ID #, date of death and classified as related or unrelated to 
research participation or intervention related. 
 
Each CTS is required to maintain a log of deaths that occur at their site. Information on the log should include: 
• 
Date learned of death  
• 
Dyad ID 
• 
Date of Death 
• 
Cause of death (if known) 
• 
Related or Unrelated to study participation or intervention 
Similarly, hospitalizations should only be reported to the cIRB if they are related or possibly related to research 
participation.  If the hospitalization is unexpected, and related or possibly related to research participation, it 
• Site PI has specific concern → contact SD directly; 
• Outcomes telephone interview reported hospitalizations or deaths confirmed by CMS Master Beneficiary 
file for patients 
 

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should be submitted to the IRB within 3 working days. The CTS should report the unexpected, and related or 
possibly related hospitalizations to CPM immediately upon knowledge of it. 
Determination of reporting hospitalizations to CPM will be made by the Clinical Trial Site. The Clinical Trial Site 
will ONLY report hospitalizations that are directly related to research participation or intervention of the study. 
CPM is responsible for notifying the appropriate entity.  
CPM will also maintain an on-going log of hospitalizations for each CTS with the abovementioned information 
and will be responsible for communicating the information to the DSMB, NIA, and IRB, as appropriate. 
A summary report of the UP and SAE collected by all methods of ascertainment will be prepared by the SD 
and DCC for submission to the DSMB and IRB of record in accordance with the Safety Monitoring Plan. 
 
11. ETHICAL AND REGULATORY CONSIDERATIONS 
11.1 Good Clinical Practice Statement 
The trial will be conducted in accordance with the ethical principles that have their origin in the Declaration of 
Helsinki, and that are consistent with the ICH guidelines for Good Clinical Practice (GCP) and all federal as 
well as local regulatory requirements. 
11.2 Informed Consent 
The principles of informed consent are described in ICH guidelines for GCP (ICH E6[R1]). The ICH used by the 
investigators at the trial sites will be reviewed and approved by the Trial’s DSMB prior to submission to the IRB 
and Informed Consent. 
As noted previously in the screening procedures outlined above, potential participants and their identified 
caregivers, referred by physicians will be contacted by telephone if they do not otherwise opt out. Informed 
consent will be obtained by trained study personnel with all caregivers and participants who are able to 
consent. At the time of the COVID-19 pandemic, consenting and baseline interviews were switched to 
telephonic. Initially, each site differed with respect to the Legally Authorized Representative consenting. 
Currently, all four clinical trial sites have approval to obtain verbal consents from care recipients (who have the 
ability to consent), caregivers, and Legally Authorized Representatives (LAR) using an electronic consent 
process (through RedCap). In the event that the caregiver is not the LAR, verbal consent from the LAR will be 
obtained prior to the baseline interview being conducted.  
 
After consenting, they will receive a general description of the study, including the baseline and surveillance 
evaluations, along with the study specific evaluations. The IRB agreed that consent for the interventions is not 
considered necessary since these are facilitating standard of care in a consistent fashion, not providing an 
experimental intervention. Of course, data collection does require consent and thus will be the primary focus of 
the consenting process.  
 
Decisional capacity and proxy consent:  For all potential participants who score 8 or higher on the short version 
of the MOCA, cognitive status will be assessed by administration of the full 22-item telephone MOCA prior to 
consenting and those scoring < 16 will be considered incapable of consenting for participating in the study and 
providing patient-reported outcomes.39 Those unable to consent will be asked for assent using the question 
“We would to ask your [caregiver relationship or name] some questions. Would that be ok?”  If the person with 
dementia says “no”, then the patient and caregiver will not be enrolled in the study. All caregivers will be 
consented for providing caregiver-reported outcomes and for obtaining caregiver utilization data (for spouses 
only). 

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11.3 Institutional Review Board 
11.3.1 IRB of Record 
All identified participating sites have agreed to rely on the review of the IRB at the primary site, UCLA.  Any 
sites added after the study has begun will be required to rely on the same IRB.  This application is a multi-site 
study involving non-exempt human subjects research. Therefore, all sites confirm compliance with the NIH 
Policy on the Use of a Single Institutional Review Board of Record for Multi-Site Research consistent with 45 
CFR Part 46.114. 
As required by 45 CFR 46 Part E, all UCLA IRBs are registered with the federal Office for Human Research 
Protections.  The IRB that will review this study has appropriate membership, including the professional 
competence necessary to review the proposed research.  
11.3.2 Authorization/Reliance Agreement 
The participating sites are all signatories to the SMART IRB agreement (NIH’s National Center for Advancing 
Translational Sciences (NCATS) Streamlined, Multi-site, Accelerated Resource for Trials (SMART) IRB 
Reliance Platform). This means that an agreement is already in place and related documentation (including 
joinder agreements and general standard operating procedures) is centrally available to all sites.  All sites also 
have access to the SMART IRB platform to properly document their acceptance of the arrangement for this 
particular proposal and track the status of the reliance.  The UCLA IRB office will download and maintain a 
local copy of such documentation.  
Any sites added after award will be expected to sign on to SMART IRB if they have not already done so.  If 
such sites are ineligible to sign on to SMART IRB, an appropriate agreement will be negotiated.  
11.3.3 Communication Plan 
The UCLA Principal Investigator will designate a central point of contact on the UCLA study team, the Study 
Director, to: 
• 
Coordinate communications with reliance sites 
• 
Request and receive information and documentation from relying sites 
• 
Develop template materials for review by the UCLA IRB and for limited modification by relying sites 
• 
Submit materials from all sites to the UCLA IRB and coordinate responses to any IRB queries 
• 
Provide documentation to relying sites 
Reliance sites will follow local procedures to coordinate, collect and verify information such as: 
• 
Local context 
• 
Site variations in areas such as recruiting, informed consent, HIPAA, populations 
• 
Conflict of Interest disclosure and management 
• 
Completion of ancillary reviews 
• 
Training and qualifications of study team 
• 
Continuing Review or Closure information 
• 
Reportable Events 
Reliance sites will provide necessary information or assurances to the UCLA study team for submission to the 
UCLA IRB.  The UCLA IRB office will communicate directly with the UCLA study team as the proxy for all 
relying sites. 
UCLA has dedicated reliance points of contact within its IRB office.  Sections of UCLA’s web-based IRB 
system are designed for submissions, reviews and documentation related to relying sites.  When appropriate, 

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the UCLA IRB office will communicate directly with relying site Human Research Protection Program offices. 
Relying sites will follow their local procedures for dissemination of information and documentation (e.g., if the 
local IRB office or ancillary services require copies of the UCLA IRB approval).  
11.4 Protocol Changes 
Any change in the study protocol must be approved by the DSMB, PCORI, and the Project’s Study Advisory 
Committee and approved by the cIRB and trial sites’ before it can be implemented. 
11.5 Risks to Human Subjects 
The risks associated with participation in the study intervention itself are deemed to be minimal because: 1) the 
intervention is aimed at maximizing participation in components of current standard of care; and 2) the 
intervention is being implemented by trained professionals in the care setting in which they typically provide 
care. Our assessment of minimal risk does not, however, preclude the possibility that adverse events, and 
serious adverse events could occur. Therefore, a comprehensive data safety monitoring plan is outlined in the 
following sections. Authority for monitoring the safety of the protocol will reside in an independent DSMB 
responsible for holding the PIs accountable for data quality and completeness and assessing the ongoing 
safety of the trial participants through periodic meetings/review. Ongoing participant safety monitoring is the 
responsibility of site PIs who will report adverse events to the SD. The SD has the authority to directly report 
concerns to the DSMB if they arise. 
There are potential risks associated with data collection and information management and, in fact, these risks 
are the major reason consent will be required in this trial. These include inadvertent disclosure of personal 
health information or research data collected. Every effort will be made to inform the participant of this potential 
and minimize the risks as outlined below.  
11.5.1 Protection Against Risks 
Minimizing Risks: The study protocol will be implemented at each clinic only after the PI, and study 
coordinator have undergone rigorous protocol training. The training and monitoring of performance in 
accordance with the Manual of Procedures for the study will be the responsibility of the study PI and SD. All 
efforts will be made to minimize risks and participant inconvenience and mitigate interruptions of therapy. Risks 
will be minimized by: 1) adequate training of all staff with proficiency testing; 2) frequently encouraging 
participant questions throughout the interventions; and 4) Serious Adverse Event (SAE) Reporting and 
monitoring overall study safety by a DSMB as outlined below. 
11.5.2 Potential Benefits of the Proposed Research to Human Participants and Others 
There are a number of potential benefits of the study for the participants including: 1) enhanced care by 
receiving one of two effective dementia care interventions, 2) receiving close monitoring of the participant 
during the trial, and 3) preventing or reducing caregiver stress and depression. 
There are also potential societal benefits from the proposed research. Optimizing models of care for providing 
effective comprehensive dementia care has the potential to greatly enhance patient care – including the 
potential to reduce morbidity both for the patient and caregiver as well as reduce costs.  
11.5.3 Importance of the Knowledge to be Gained 
The knowledge to be gained from this trial is substantial. It addresses a critically important clinical question, the 
care of the burgeoning population of persons afflicted with dementia. It also is a head-to-head comparison of 

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two evidence-based approaches to determine comparative effectiveness using a pragmatic design in clinical 
practice settings representing diverse geography and patient populations. 
11.6 Safety Monitoring Protocol 
Safety monitoring will be accomplished in accordance with the Safety Monitoring Plan included in the Manual 
of Procedures (MOP) to be approved by the DSMB. 
11.7 Inclusion of Women and Minorities 
As shown in Table 8, women are expected to constitute 67% of the overall sample, consistent with higher life 
expectancy of women than men. Also, women are more likely to participate in clinical trials than men. Table 8 
also summarizes the racial and ethnic background of the potential participants at each of the 4 trial sites.  
Table 8: Estimated Final Racial/Ethnic and Gender Enrollment Table: 
 
Ethnic Categories 
 
Not Hispanic 
Hispanic or Latino 
Total 
Racial Categories 
Male 
Female 
Male 
Female 
 
American Indian/Alaska Native 
7 
14 
0 
0 
21 
Asian 
22 
44 
0 
0 
66 
Black/African American 
102 
208 
15 
30 
355 
Hawaiian/Pacific Islander 
10 
21 
0 
0 
31 
White 
473 
979 
71 
151 
1674 
More than one race 
1 
1 
 
1 
3 
Total 
615 
1267 
86 
182 
2150 
 
12. STUDY DOCUMENTS 
12.1 Retention of Records 
The site PI will retain all study-related documents for at least seven years (7) following the completion or 
discontinuation of the study. If the site PI’s personal situation is such that such archiving can no longer be 
ensured, the PI will inform the Central Project Management and the relevant records will be transferred to a 
central secure location for storage. 
13. PUBLICATION AND DISSEMINATION POLICY 
The project PIs in discussion with the Study Advisory Committee will establish a Publication and Dissemination 
Committee, which will set the rules for publication of the data and authorship in conformity with PCORI policies.  
In accordance with PCORI’s legislative mandate on public dissemination, we will make the study’s findings 
available to clinicians, patients, and the general public not later than 90 days after the completion of the study 
on September 30, 2024. 
13.1 Dissemination 
The findings of this trial have important implications for public health and policy, requiring wide dissemination; 
additionally, several aspects of this trial’s approach and implementation will shape clinical practice and form 
the basis for dissemination after the trial. First, the screening methods will be built to interface with major EHR 

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vendor software and will be readily transferable to any site using similar software. Second, instruments used 
for risk assessment and intervention management by the DCS can be used in any health system. Third, patient 
materials will be adapted and used in the program and will be exportable after the trial. Fourth, training 
materials and procedures will be available for propagating “train the trainer” programs. 
A Publication and Dissemination Committee (PDC) will be established to oversee the dissemination of the 
study’s findings. The PDC will include members of the National Patients and Stakeholders Council (NPSC) and 
investigators with content expertise. This structure will allow the stakeholders and investigators to jointly 
address how to disseminate study findings to influence clinicians, patients, policy makers, communities, CMS 
and other third-party payers. Also, local councils will work with investigators from the trial site to plan 
dissemination and implementation in local communities.  
Dissemination of study results will be accomplished through traditional routes (e.g. scientific meeting 
presentations, publications), but also through novel routes felt to be most effective by our patients and other 
stakeholder partners using the PCORI Dissemination and Implementation Action Plan begun through a recent 
roundtable. 
A particularly valuable asset for dissemination of this project is the Pepper Older Americans Independence 
Centers, which form a network of fourteen key academic institutions and thought leaders who are likely to be 
early adopters of this program if proven effective. Three other potential resources for dissemination will be the 
Health Care Systems Research Network (HCSRN), PCORI Patient Powered Research Network (PPRN) and 
the Clinical Data Research Network (CDRN).  
14. ORGANIZATIONAL FRAMEWORK OF AN INTERDISCIPLINARY TEAM OF INVESTIGATORS, 
PATIENTS, AND STAKEHOLDERS 
The research will have four major partners: Patients and Stakeholders, Clinical Trial Sites (CTS) Central 
Project Management (CPM), and the Data Coordinating Center (DCC) and will be overseen by a Study 
Advisory Committee (SAC). The SAC will advise the study before it goes into the field and will monitor all 
progress to ensure that patient and other stakeholder views are continually integrated into the research.  The 
tasks and responsibilities of each of CPM, CTS, and DCC are presented in Table 9. 
Table 9: Tasks and responsibilities (all tasks will be guided by the SAC)  
Task 
Lead Responsibility 
 
CPM 
CTS 
DCC 
Convene Study Advisory Committee 
X 
 
 
Convene national Patient and Stakeholder council 
X 
 
 
Convene local Patient and Stakeholder councils 
 
X 
 
Coordinate IRB 
X 
 
 
Convene DSMB 
X 
 
 
Develop HSDC and CBDC 
X 
X 
 
Adapt and implement HSDC and CBDC 
 
X 
 
Train DCS’ and DCS Assistants 
X 
 
X 
Develop randomization procedures 
 
 
X 
Create data collection instruments and standardize collection of outcomes 
 
 
X 
Recruit participants 
 
X 
 
Collect baseline and outcome measures and data entry 
 
X 
 
Ongoing reporting of recruitment and patients seen 
 
 
X 
Prepare materials for DSMB 
 
 
X 
Data analysis 
 
 
X 

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An Operations Committee will include the study PI (Reuben), the project director, a CTS PI, the DCC PI 
(Peduzzi), and Co-I (Gill) and will meet weekly to make decisions about the day-to-day conduct of the study, 
prepare for SAC and DSMB meetings.  
The Operations Committee is responsible for overall operational management and coordination of the entire 
project, synthesizing information from various committees, preparing and executing operational plans, 
identifying problems and disseminating information to the other Committees. 
In addition, the following committees will be convened during Year 1 and maintained for the duration of the 
study: Local Patient and Stakeholders, National Patient and Stakeholder, Clinical Trial Sites, Recruitment and 
Retention, Interventions and Training, and Assessment and Outcomes.  
Table 10 displays the functions of the current committees. The committees include scientific chairs, other 
highly regarded experts in the area of dementia, and patient and stakeholder representatives.  The 
Committees conduct their business through regularly scheduled conference calls; their approved minutes are 
posted on the study’s internal website/ portal. 
14.1 Reporting Structure 
The various committees, DCC, and IT Management Group report to the Operations Committee, which in turn 
reports to the Study Advisory Committee and to the National Institute on Aging Program Officer. The PCORI 
program officers interface with the study leadership through the SAC and directly with the PI on a monthly call.  
Table 10:  Functions of the Committees  
Committee 
Committee Function  
 
Study Advisory 
Advises the study before it goes into the field and monitors all progress to ensure that 
patient and other stakeholder views are continually integrated into the research.   
Operations  
Includes the study PI (Reuben), the Study Director, a CTS PI, the DCC PI (Peduzzi), and 
Co-I (Gill) meets weekly to make decisions about the day-to-day conduct of the study, 
prepare for SAC and DSMB meetings.  
Clinical Trial Sites  
Provides a venue for bidirectional flow of information between site PIs and the study’s 
leadership. It includes all site PIs and provides high-level guidance for the trial’s 
implementation at the trial sites. 
Recruitment and Retention 
Responsible for high-level guidance on recruitment and retention activities. 
Intervention  
 
Responsible for developing the protocols for the intervention. It has two distinct sub-
committees focusing on the separate intervention arms and overseeing the 
implementation of the intervention at the trial sites. 
Health Systems-based 
Dementia care 
Responsible for developing the protocols and implementation, including DCS training, of 
the HSDC arm  
Community-based Dementia 
care 
Responsible for developing the protocols and implementation for the CBDC arm of the 
study.  
National Patient Stakeholders 
Council  
Responsible for developing protocols for patient and stakeholder engagement, 
overseeing the formation and training of local patient and stakeholder councils, providing 
input into protocol development and all aspects of trial’s implementation. 
Assessment and Outcomes  
Responsible for selection of measures and protocols for collecting data, sample size 
estimation, power calculation, and data analyses. 
Data Management and 
Operations Support 
Responsible for building the IT infrastructure for data collection and management, staff 
training in data recording, building appropriate interfaces with the EHRs at sites to allow 
data collection, creating data forms, ensuring data security, and overseeing FCM 
software development. Also responsible for providing web tools for workflow 
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Ancillary Studies  
Reviews ancillary studies proposals and make recommendations to the investigators on 
the approval of ancillary studies to the trial. 
Publications and Presentations  To review and coordinate publications and major presentations from the study. 
14.2 Meeting Schedule and Functions of the Leadership 
The Operations Committee holds a conference call weekly to review progress, establish work objectives, and 
discuss operational problems.  Other committees meet monthly or more often, if needed. In addition, all 
investigators meet monthly during the planning year to monitor progress and provide additional input. The SAC 
meets twice yearly in person. We plan to hold an investigators’ meeting once yearly.  
14.3 Integration of Patient and Stakeholders in the Trial’s Planning, Implementation, Analyses and 
Dissemination  
In accordance with the model set forth by Curtis et al,40 patient engagement will occur at two levels – locally, at 
the clinical trial sites, and nationally, at the central project management level. To provide integration between 
the local and national patient and stakeholder councils, the local councils at the 4 trial sites have chosen 
representatives to serve on the National Patient and Stakeholder Council (NPSC).  
Year 1 will focus on 1) development of local patient and stakeholder councils; 2) development of national 
patient and stakeholder council (NPSC); 3) training of investigators and stakeholders to work in partnership; 4) 
refining methods for eliciting patients’ and stakeholders’ voices, and 5) setting up structures to assure patients 
and stakeholders engagement with investigators to: (a) formulate the final research questions; (b) finalize study 
design with attention to recruitment of participants, the planned intervention, the comparators, and the 
outcomes; (c) monitor study’s progress and interim results; and (d) help disseminate the results of the study.   
14.3.1 Local Patient and Stakeholder Councils 
The LPSCs are comprised of 7 persons drawn from the constituencies described in Table 11.  
Table 11. Composition of Local Patient and Stakeholder Committees 
LPSC Role 
Description 
Chair 
Facilitate the group and provide linkages with the investigative team (e.g. 
engagement professional) and NPSC. The facilitator should have expertise in 
engaging patients and other stakeholders in research.  This is essential to promote 
timely communication, interaction and connections among scientists and the local 
stakeholders. The Chair should be able to translate between research language and 
lay language for effective communication between investigative team and LPSC.   
Trial key 
personnel 
Dementia Care Specialist providing Health System-based Dementia Care (HSDC 
intervention 
Social Worker or Case/Care Manager Consultant providing Community-based 
Dementia Care (CBDC) 
Patient and 
Caregiver 
stakeholders 
Patient/caregiver stakeholders (personal experience with dementia): consider 
diversity of representation for dementia stages, male/female, and communication 
preferences (computer/email vs. phone/mail).   
Community 
stakeholders 
Volunteers or representatives from sites where the community-based interventions 
will be in place such as local community centers, adult day cares, respite programs, 
churches or senior centers that provide resources for dementia care 
Area Agency on 
Aging 
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Alzheimer’s 
Association 
The Alzheimer’s Association or equivalent 
Primary health 
provider 
stakeholder 
Primary Care Physician who has patients including those with dementia 
Other health 
provider 
stakeholder 
A home health agency who has experience receiving referrals for patients with 
dementia  
14.3.2 National Patient and Stakeholder Council  
The NPSC is comprised of 6 persons, 2 Co-chairs and a representative from each LPSC. The NPSC: 1) 
serves in a consultative capacity to local councils and site PIs, various work group committees and study 
leadership; 2) integrates the input from the 4 local councils and communicates that to the trial’s PI and 
committees; and; 3) coordinates activities initially for a) formulating the final research questions; b) finalizing 
study design; c) monitors study progress, and suggests changes and edits of all participant-facing print 
materials and d) provides recommendations for disseminating the results. 
14.3.3 Training patients, stakeholders, and investigators  
During Year 1, investigators, patients and stakeholders will undergo training, focusing on communicating what 
it means to be partners in patient-centered research. The training emphasized an authentic communication 
paradigm that builds and maintains trust, respect, and mutual understanding.   
14.3.4 Engaging patients and other stakeholders as partners in all phases of the research 
The bidirectional process of engaging patients and other stakeholders will take place in local councils and the 
NPSC throughout the duration of the project. The local councils will meet 4 times a year during years 1-4 and 
twice during year 5. The NPSC will continue to meet monthly throughout the duration of the study. 
After year 1, the local councils will focus on refining their trial sites’ local resources that support screening and 
recruitment strategies, the intervention(s), assessment and outcomes, and strategies for disseminating the 
trial’s findings. These local councils will provide recommendations to the NPSC and to site PIs and continually 
support the local Dementia Care Specialists and Care Consultants. The NPSC will collate the information from 
all local councils and provide guidance to the PI and various committees. 
14.3.5 Monitoring the study’s progress 
During recruitment, the Operations Committee will review the accrual of participants weekly and after 
recruitment, the collection of outcomes at its weekly meeting. The SAC and DSMB will also review the study’s 
progress. In addition, each committee will review progress of its responsibilities at the monthly meetings.   
14.3.6 Dissemination and implementation of study findings 
The project team will prepare a summary of findings that will be sent by mail to all study participants, including 
their caregivers. This summary will be reviewed and vetted by the National and Local Patient/Family 
Stakeholder Committees to ensure that the reading level, formatting, and content of the material are 
appropriate for the target group of participants. The project team has had experience providing updates of 
findings about improved dementia care through the UCLA ADC newsletters. This summary of findings will be 

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translated into Spanish and, if appropriate, adapted to suit the population of a specific region. In addition to an 
individual mailing to each participant/caregiver, this information will be conveyed through the project’s website. 
A Publications Committee will be established to oversee the dissemination of the study findings. It will include 
members of the NPSC and investigators with content expertise. This structure will allow the stakeholders and 
investigators to jointly address 1) how to disseminate the study findings to impact clinicians, patients, policy 
makers, communities, CMS and other payers; and 2) how study interventions can be scaled up for wider 
implementation. Also, LPSCs will work with site investigators to plan dissemination in their local communities. 
The patients and stakeholders can be effective particularly in influencing the policies of CMS and other payers, 
which can facilitate the adoption of the intervention. In addition to publications in scientific journals, the 
Publications Committee will plan presentations at scientific meetings, and orchestrate presentations to 
stakeholders, the media, payers, and policymakers.    
 
If HSDC proves to be superior, dissemination will be less of an issue for systems that serve high percentages 
of capitated patients (i.e. Medicare Advantage), since the program would achieve cost savings if it is as 
effective as the original UCLA demonstration ($2100 per year cost savings, CMS unpublished data).  However, 
an initial upfront investment will be required. Work on disseminating HSDC, funded by the Commonwealth 
Fund, will create business cases for adopting organizations to determine how soon they will be able to 
recapture their investment. In addition, some healthcare systems that have strong cultures of team care may 
want to adapt the intervention by using BSN registered nurses as Dementia Care Specialists, thereby reducing 
staffing costs and addressing access in areas that may lack advance practice nurses. If major departures 
occur (e.g., substituting a BSN registered nurse for a nurse practitioner DCS), then the model would need to be 
evaluated for fidelity to ensure that similar care is provided. In fee-for-service environments, under the current 
reimbursement structure, HSBC would likely not generate revenue after costs of the intervention are 
considered. Nevertheless, there are new and emerging cost reimbursement mechanisms (e.g. 99483 cognitive 
assessment code, Chronic Care Management) that can be used to offset significant costs. Other obstacles to 
disseminating HSDC include the lack of a trained workforce and the availability of nurse practitioners who can 
fill the Dementia Care Specialist role. A grant under consideration by the John A. Hartford foundation for their 
December 2018 Board meeting would fund the development of a hands-on, in-person skill-building sessions to 
train nurse practitioners to become Dementia Care Specialists. 
 
If CBDC proves to be superior, health systems that serve high percentages of capitated patients may opt to 
contract with community-based organizations to provide this service as a member benefit. Systems that largely 
care for fee-for-service patients will likely have financial obstacles to implement this program. Nevertheless, if 
CBDC confers clinical advantages, other mechanisms through the Agency for Community Living (ACL) or new 
Medicare mechanisms might be created to support this program. 
If either HSDC or CBDC is superior, diffusion will need to be planned and an organization will need to assume 
responsibility for ensuring the fidelity within adopting health systems. Such an organization will need to be 
identified or created. 
 
 
 
 
 

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