Artificial Intelligence + Care Coach Intervention for Persons Living With Dementia and Caregivers
Phase: NA
Conditions: Dementia, Caregiver, Emergency Department, Artificial Intelligence, Care Transition
Sponsor: Yale University

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ED-to-community care transitions for 
persons living with dementia and care 
partners: development, implementation, 
and pilot testing of a novel artificial 
intelligence + care coach intervention
 Protocol Number
2000032226
Protocol Version
05/31/2023
#4
PRINCIPAL INVESTIGATOR:
Name: Cameron Gettel MD MHS
Department: Emergency Medicine
Telephone Number: 203 737-4842
Email Address: Cameron.gettel@yale.edu
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NCT05352399

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Protocol Number
05/31/2023, Version #4
2
REVISION HISTORY:
Revision #
Version Date
1
02/19/2022
2
03/31/2022
3
04/15/2022
4
05/31/2023
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3
Synopsis
Primary Objective
The primary objective is develop and test NeuViCare AI + care coach as an intervention for ED-
to-community care transitions for PLWD and their care partners, offering a potential solution to 
the lack of existing ED care transition interventions.
Secondary Objective (if applicable)
N/A
Study Duration
August 2022 – February 2024
Study Design 
Overall, we will use a sequential exploratory mixed-methods approach with integration of 
Specific Aims at the study design level. We will use a two-phase qualitative approach within 
Specific Aim 1, including: 1) semi-structured interviews with stakeholders, and 2) AI design 
optimization through a design thinking workshop. Specific Aim 2 will use a quantitative 
approach to assess implementation and patient-centered outcomes in a quantitative survey-
based fashion through a one-arm open-labeled trial to primarily assess functionality and 
usability.
Number of Study Sites
EDs at York St. Campus, Saint Raphael Campus, Shoreline Campus, and Bridgeport Campus
Study Population
For the older adult participants, the inclusion criteria will be: 1) age ≥65 years with a diagnosis 
of ADRD or dementia within the electronic health record OR new cognitive impairment 
identified during an ED visit, 2) be fluent in English or Spanish, 3) discharge to the community 
setting after an ED visit, and 4) be willing to engage in discussions regarding the 
implementation of a novel AI technology. Primary care partners of PLWD must possess a smart 
device (either a phone, tablet, or computer) that has internet access to utilize and interact with 
NeuViCare AI services.
Number of Participants
55
Primary Outcome Variables
After in-ED enrollment, we will collect baseline measurements of PLWD and their care 
partners. Particularly, at time 0 this will include domain assessments of validated tools 
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addressing dementia knowledge, PLWD self-efficacy, psychological well-being, social 
connectedness, and caregiver experience. After ED- or hospital-community care transition, a 
virtual session led by the care coach will build upon discharge instructions by developing a 
comprehensive transdisciplinary care plan and integrating the use of NeuViCare AI 
technology. Subsequent sessions with the PLWD and their care partner will assess knowledge 
translation of NeuviCare AI, follow through with care plan, and the development of sustainable 
skills for preventing crisis and recidivism. At follow-up time points of 7 days, 30 days, and 3 
months, participants will be contacted to reassess responses to above domains of interest 
(primary outcome). 
Secondary and Exploratory Outcome Variables (if applicable)
Participants will be measured regarding their healthcare utilization, including ED visits, 
hospitalizations and care plan adherence with follow-up in the outpatient setting (secondary 
outcome). Finally, implementation outcomes of the NeuViCare AI technology will be assessed 
through validated surveys of acceptability, appropriateness, feasibility, and usability (secondary 
outcome).
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Abbreviations
Abbreviation 
Explanation
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Glossary of Terms
Glossary
Explanation
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Table of Contents
Preface.....................................................................................................................................2
Synopsis ..................................................................................................................................4
Primary Objective.................................................................................................................4
Secondary Objective (if applicable)......................................................................................4
Study Duration......................................................................................................................4
Study Design........................................................................................................................4
Number of Study Sites .........................................................................................................4
Study Population ..................................................................................................................5
Number of Participants.........................................................................................................5
Primary Outcome Variables .................................................................................................5
Secondary and Exploratory Outcome Variables (if applicable)............................................5
Abbreviations ...........................................................................................................................6
Glossary of Terms....................................................................................................................7
1
Introduction.....................................................................................................................11
1.1
Introductory Statement ............................................................................................11
2
Background.....................................................................................................................12
2.1.1
Device Preclinical Experience..........................................................................12
2.1.2
Device Clinical Experience...............................................................................12
2.2
Background/prevalence of research topic ...............................................................12
3
Rationale/Significance ....................................................................................................13
3.1
Problem Statement..................................................................................................13
3.2
Purpose of Study/Potential Impact ..........................................................................13
3.2.1
Potential Risks..................................................................................................13
3.2.2
Potential Benefits .............................................................................................13
4
Study Objectives.............................................................................................................14
4.1
Hypothesis...............................................................................................................14
4.2
Primary Objective ....................................................................................................14
4.3
Secondary Objectives (if applicable) .......................................................................14
5
Study Design ..................................................................................................................15
5.1
General Design Description.....................................................................................15
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5.1.1
Study Date Range and Duration ......................................................................15
5.1.2
Number of Study Sites .....................................................................................15
5.2
Outcome Variables..................................................................................................15
5.2.1
Primary Outcome Variables .............................................................................15
5.2.2
Secondary and Exploratory Outcome Variables (if applicable)........................15
5.3
Study Population .....................................................................................................15
5.3.1
Number of Participants.....................................................................................16
5.3.2
Eligibility Criteria/Vulnerable Populations.........................................................16
6
Methods..........................................................................................................................19
6.1
Treatment – Device .................................................................................................19
6.1.1
Intended Use for Device  (provide the following information for each device 
being investigated in the study) ......................................................................................19
6.1.2
Device Administration and Schedule................................................................19
6.1.3
Method of Assignment/Randomization (if applicable) ......................................19
6.1.4
Device Calibration ............................................................................................19
6.1.5
Storage Conditions...........................................................................................19
6.1.6
Concomitant therapy ........................................................................................19
6.1.7
Restrictions.......................................................................................................19
6.2
Assessments ...........................................................................................................20
6.2.1
Efficacy.............................................................................................................20
6.2.2
Safety ...............................................................................................................20
6.2.3
Adverse Events Definition and Reporting.........................................................21
6.2.4
Pharmacokinetics (if applicable).......................................................................21
6.2.5
Biomarkers (if applicable).................................................................................21
6.3
Study Procedures....................................................................................................21
6.3.1
Study Schedule ................................................................................................22
6.3.2
Informed Consent.............................................................................................22
6.3.3
Screening .........................................................................................................22
6.3.4
Enrollment ........................................................................................................22
6.3.5
On Study Visits.................................................................................................22
6.3.6
End of Study and Follow-up .............................................................................23
6.3.7
Removal of subjects.........................................................................................23
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6.4
Statistical Method ....................................................................................................23
6.4.1
Statistical Design..............................................................................................23
6.4.2
Sample Size Considerations ............................................................................23
6.4.3
Planned Analysis..............................................................................................23
6.4.4
Subsets and Covariates ...................................................................................24
6.4.5
Handling of Missing Data .................................................................................24
7
Trial Administration.........................................................................................................25
7.1
 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization ........25
7.2
Institutional Review Board (IRB) Review.................................................................25
7.3
Subject Confidentiality.............................................................................................25
7.4
Deviations/Unanticipated Problems.........................................................................26
7.5
Data Collection ........................................................................................................26
7.6
Data Quality Assurance...........................................................................................26
7.7
Study Records.........................................................................................................26
7.8
Access to Source.....................................................................................................26
7.9
Data or Specimen Storage/Security ........................................................................27
7.10
Retention of Records...............................................................................................27
7.11
Study Monitoring......................................................................................................27
7.12
Data Safety Monitoring Plan....................................................................................27
7.13
Study Modification ...................................................................................................27
7.14
Study Discontinuation..............................................................................................27
7.15
Study Completion ....................................................................................................28
7.16
Conflict of Interest Policy.........................................................................................28
7.17
Funding Source .......................................................................................................28
7.18
Publication Plan.......................................................................................................28
8
Appendices.....................................................................................................................29
9
List of Tables ..................................................................................................................30
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1 Introduction
1.1
Introductory Statement
This document is a protocol for a human research study. The purpose of this protocol is to 
ensure that this study is to be conducted according to ICH GCP guidelines, and according to 
CFR 21 Part 812, other applicable government regulations, and Institutional research 
policies and procedures.
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2 Background
2.1.1
Device Preclinical Experience
As a way to address many of these unmet caregivers' needs and poor patient outcomes, 
Amicus Brain Innovations, Inc. a technology start-up company, has created NeuViCare, 
which is a soon-to-be commercially available AI-led, assistive and decision support online 
service application that can be accessed from a smart phone, tablet or computer by 
clinicians, patients and caregivers. It was designed to reduce caregiver load and increase 
patient adherence rates for better quality of life. 
NeuViCare's multifunctional platform services are designed to impact caregiver load, while 
addressing their unmet needs and patients' quality of life through AI-led technology. 
NeuViCare Task-Support Service will increase care plan adherence rates and allow for more 
timely diagnoses by providing an interactive, appointment reminder service. NeuViCare 
Resource Advisor will educate caregivers about available resources and reduce their time 
spent on this task by providing context-sensitive, task-support services to reliable community 
resources. NeuViCare Community will provide a secure, online forum that will provide peer-
support and increase caregivers knowledge on challenging behaviors by administering 
weekly educational series and just-in time answers provided by AI. Amicus Brain will provide 
technical support and troubleshoot any issues with the community software.
2.1.2
Device Clinical Experience
Given the potential impact of NeuViCare in improving quality of care, Amicus Brain and Yale 
Memory Clinic have previously partnered together to successfully pilot test NeuViCare’s 
impact on patient care in the outpatient Neurology setting.
2.2
Background/prevalence of research topic
As the nation’s older adult population grows, Alzheimer’s Disease and Alzheimer’s Disease-
Related Dementias (AD/ADRD) is projected to affect an estimated 12.7 million people by 
2050. Attention has been drawn to the growing population of persons living with dementia 
(PLWD) and their care partners through the National Plan to Address AD, yet physical, 
psychological, and financial burdens have persisted for the estimated 21.6 million unpaid 
informal care partners (e.g. family, friends). Often at considerable personal cost, care 
partners play an integral role in ensuring success of care transitions across healthcare 
settings, particularly involving the emergency department (ED). With the majority of PLWDs 
being discharged from the ED, care partners subsequently provide a significant amount of 
hands-on care and navigation of health-related and social needs within this vulnerable time 
period. Highlighting the inadequacies of current care transition efforts, PLWDs visit the ED at 
a higher rate and also have higher ED return and mortality rates after an initial ED visit in 
comparison to their non-cognitively impaired counterparts. The prioritization of ED dementia 
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care research by the American Geriatrics Society, the widespread dissemination of the 2014 
consensus geriatric ED guidelines, and the 2018 launch of a geriatric ED accreditation 
program have highlighted the need for evidence with best practices for PLWD and their care 
partners. All prioritize the importance of ED-to-community care transitions, yet effective 
interventions focusing on patient- and care partner-centered outcomes are largely lacking. 
With uncertainty regarding treatment options for PLWD, there is an urgent need and 
opportunity to develop interventions addressing ED-to-community care transitions.
To date, little data exist on effective interventions to improve ED-to-community care 
transitions for older adults with ADRD or cognitive impairment. Attempts have primarily 
focused on cognitively intact older adults and considered the use of comprehensive geriatric 
assessments, enhanced discharge planning, referrals to specialist services, or community 
paramedics with variable impact on ED revisits and overall limited attention to patient-
centered outcomes. Traditionally, some of these ‘high touch’ modalities involve frequent 
check-ins by healthcare personnel to ensure care plan adherence, but are resource-
intensive, and therefore may have limitations in the way of scalability and affordability. 
Technology, including artificial intelligence (AI), has been shown to be a ‘high tech’ 
advancement that offers the potential to benefit older adults by promoting self-service and 
independence. AI has proven to be acceptable and used by older adults and care partners in 
relation to healthcare needs, but has been incorporated less within ED populations. 
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3 Rationale/Significance
3.1
Problem Statement
As the nation’s older adult population grows, Alzheimer’s Disease and Alzheimer’s Disease-
Related Dementias (AD/ADRD) is projected to affect an estimated 12.7 million people by 
2050. With the majority of PLWDs being discharged from the ED,14 care partners 
subsequently provide a significant amount of hands-on care and navigation of health-related 
and social needs within this vulnerable time period. To date, little data exist on effective 
interventions to improve ED-to-community care transitions for older adults with ADRD or 
cognitive impairment. Technology, including artificial intelligence (AI), has been shown to be 
a ‘high tech’ advancement that offers the potential to benefit older adults by promoting self-
service and independence. AI has proven to be acceptable and used by older adults and 
care partners in relation to healthcare needs, but has been incorporated less within ED 
populations.
3.2
Purpose of Study/Potential Impact
Incorporation of AI-led technology among PLWD and their care partners will provide new 
insights into ways in which the ED discharge process can be improved. Additionally, this 
work will provide information regarding the optimal interaction between AI + care coaching to 
support this essential population during ED-to-community care transitions. Together, the 
proposed research will provide high-quality evidence regarding the design optimization and 
feasibility of implementing a novel ‘high tech – high touch’ ED-to-community care transition 
intervention among PLWD and their care partners.
3.2.1
Potential Risks
This risks to human subjects in the proposed research are minimal. Specific Aim 1 involves 
qualitative interviews and a design thinking workshop with various stakeholders regarding 
the role of AI + care coaching during ED-to-home community care transitions. Specific Aim 2 
involves the pilot testing of the NeuViCare AI. Psychologically, there is a risk that participants 
will find the interviews and engagement with the AI + care coach burdensome or distressing. 
There is also a risk of inadvertent release of potentially identifying information. Other 
physical, social, cultural, financial, and legal risks are minimal. Data collection, management, 
and analytic processes outlined in the proposal are designed to ensure that participant 
privacy and confidentiality will be maintained.
3.2.2
Potential Benefits
Results from this study will help us learn more about ED-to-community care transitions of 
PLWD and their care partners. We believe that the possible benefits for clinical care 
outweigh the minimal risks of the proposed research. A small incentive will be provided, and 
the participants may benefit directly from the AI + care coach intervention, particularly if the 
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hypothesis is proven correct. This could be due to increased access to support and manifest 
in the way of increased engagement in the care plan, reduced care partner burden, and 
reduced health utilization in the following 30 days. 
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4 Study Objectives
4.1
Hypothesis
Specific Aim 1: We will optimize the NeuViCare AI + care coach intervention, for subsequent 
pilot testing.
Specific Aim 2: We will demonstrate: 1) feasible and acceptable implementation of 
NeuViCare AI + care coach intervention, 2) care plan adherence and NeuViCare AI 
engagement, and 3) reduced 30-day care partner burden and PLWD healthcare utilization.
4.2
Primary Objective
The primary objective is develop and test NeuViCare AI + care coach as an intervention for 
ED-to-community care transitions for PLWD and their care partners, offering a potential 
solution to the lack of existing ED care transition interventions.
4.3
Secondary Objectives (if applicable)
N/A
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5 Study Design
5.1
General Design Description
Overall, we will use a sequential exploratory mixed-methods approach with integration of 
Specific Aims at the study design level. The rationale for the use of this approach is based 
on evidence that has shown the mixed-methods approach to be well-suited for the 
investigation of novel technology incorporation within healthcare settings by linking 
stakeholder’s perspectives (qualitative) with implementation and patient-centered outcomes 
(quantitative). As performed by other user-centered design approaches, we will use a two-
phase qualitative approach within Specific Aim 1, including: 1) semi-structured interviews 
with stakeholders, and 2) AI design optimization through a design thinking workshop. 
Specific Aim 2 will use a quantitative approach to assess implementation and patient-
centered outcomes in a quantitative survey-based fashion.
5.1.1
Study Date Range and Duration
August 2022 – February 2024
5.1.2
Number of Study Sites
EDs at York St. Campus, Saint Raphael Campus, Shoreline Campus, and Bridgeport 
Campus
5.2
Outcome Variables
5.2.1
Primary Outcome Variables
After in-ED enrollment, we will collect baseline measurements of PLWD and their care 
partners. Particularly, at time 0 this will include domain assessments of validated tools 
addressing dementia knowledge, PLWD self-efficacy, psychological well-being, social 
connectedness, and caregiver experience. After ED- or hospital-community care transition, a 
virtual session led by the care coach will build upon discharge instructions by developing a 
comprehensive transdisciplinary care plan and integrating the use of NeuViCare AI 
technology. Subsequent sessions with the PLWD and their care partner will assess 
knowledge translation of NeuviCare AI, follow through with care plan, and the development 
of sustainable skills for preventing crisis and recidivism. At follow-up time points of 7 days, 
30 days, and 3 months, participants will be contacted to reassess responses to above 
domains of interest (primary outcome). 
5.2.2
Secondary and Exploratory Outcome Variables (if applicable)
Participants will be measured regarding their healthcare utilization, including ED visits, 
hospitalizations and care plan adherence with follow-up in the outpatient setting (secondary 
outcome). Finally, implementation outcomes of the NeuViCare AI technology will be 
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assessed through validated surveys of acceptability, appropriateness, feasibility, and 
usability (secondary outcome).
5.3
Study Population
For the older adult participants, the inclusion criteria will be: 1) age ≥65 years with a 
diagnosis of ADRD or dementia within the electronic health record OR new cognitive 
impairment identified during an ED visit, 2) be fluent in English or Spanish, 3) discharge to 
the community setting after an ED visit, and 4) be willing to engage in discussions regarding 
the implementation of a novel AI technology. Primary care partners of PLWD must possess 
a smart device (either a phone, tablet, or computer) that has internet access to utilize and 
interact with NeuViCare AI services.
5.3.1
Number of Participants
Phase 1 (qualitative interviews) – approximately 15
Phase 2 (Design Thinking Workshop) – approximately 15
Pilot Implementation – approximately 25
5.3.2
Eligibility Criteria/Vulnerable Populations
For the older adult participants, the inclusion criteria will be: 1) age ≥65 years with a 
diagnosis of ADRD or dementia within the electronic health record OR new cognitive 
impairment identified during an ED visit, 2) be fluent in English or Spanish, 3) discharge to 
the community setting after an ED visit, and 4) be willing to engage in discussions regarding 
the implementation of a novel AI technology. Primary care partners of PLWD must possess 
a smart device (either a phone, tablet, or computer) that has internet access to utilize and 
interact with NeuViCare AI services.
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6 Methods
6.1
Treatment – Device 
6.1.1
Intended Use for Device  (provide the following information for each device 
being investigated in the study)
Building upon prior work in the outpatient Neurology setting, NeuViCare AI will include 
variations of its 5 components: 1) NeuViCare Planner - enables review of ordered tests and 
external resources recommended by the care provider; 2) NeuViCare Task-Support Service 
- provides context-sensitive, personalized SMS text-based assistance to help patients’ 
complete care plan captured in the NeuViCare Planner;  3) NeuViCare Resource Advisor - 
presents trusted, unbiased advice to locate nearby resources listed within their care plan; 4) 
NeuViCare Advisor - educates and trains PLWD and their care partners at the moment of 
need; and 5) NeuViCare Community Hub - a safe virtual space which enables care partners 
to interact with other peer care partners to gain their experiential knowledge and emotional 
support.
6.1.2
Device Administration and Schedule
If interested and consented to joint the study, the PLWD and/or care partner will be given 
introductory instructions regarding the use of NeuViCare by the RA in the ED prior to 
discharge. Post-ED education will be performed by occupational therapy care coaches who 
will focus on incorporating NeuViCare AI technology to problem solve and build skills to 
empower PLWD and their care partners with knowledge and capacity to reduce severity of 
crisis escalations that result in healthcare utilization. 
6.1.3
Method of Assignment/Randomization (if applicable)
N/A
6.1.4
Device Calibration 
N/A
6.1.5
Storage Conditions
N/A
6.1.6
Concomitant therapy
N/A
6.1.7
Restrictions
There are no restrictions.
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6.2
Assessments
6.2.1
Efficacy
Implementation outcomes of the NeuViCare AI technology 
will be assessed through validated surveys of 
acceptability, appropriateness, feasibility, and usability. 
Acceptability is defined as the perception that a given 
innovation is agreeable, palatable, or satisfactory. 
Acceptability will be measured by the Acceptability of 
Intervention Measure (AIM). Appropriateness is defined 
as the perceived fit, relevance, or compatibility of the 
innovation for a given setting or consumer, and/or 
perceived fit of the innovation to address a particular issue 
or problem. Appropriateness will be measured by the 
Intervention Appropriateness Measure (IAM). Feasibility is 
defined as the extent to which a new innovation can be 
successfully used or carried out within a given setting, and 
will be measured by the Feasibility of Intervention 
Measure (FIM). Finally, usability encapsulates several 
aspects including subjective assessments of effectiveness, efficiency, and satisfaction, and 
will be measured using the System Usability Scale (SUS). All measures identified are 
psychometrically valid and readable (Table).
6.2.2
Safety
N/A
6.2.3
Adverse Events Definition and Reporting
The PI will take all possible measures to minimize any risks that may occur as a 
consequence of participation in this investigation. Adverse events will be recorded and noted 
by the PI, and reported to the Yale University Human Research Protection Program. While 
we feel that such events are very unlikely, we will follow all until resolution if adverse events 
occur.
6.2.4
Pharmacokinetics (if applicable)
N/A
6.2.5
Biomarkers (if applicable)
N/A
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6.3
Study Procedures
6.3.1
Study Schedule
6.3.2
Informed Consent
Both Specific Aims 1 and 2 will prospectively enroll participants identified and recruited by 
the trained Research Assistant (RA). For Specific Aim 1, the RA will be present in real-time 
within the ED and evaluate all ED older adults by electronic medical record screening. Those 
with identified dementia in the electronic medical record will be candidates for inclusion, 
among others described further below. Prior to participation the RA will then approach the 
treating clinician and ask for their approval to speak with the patient and caregiver prior to 
engagement. Informed consent will be obtained by personnel with up-to-date Yale HIC-
required human subject’s protection and HIPAA trainings. Written informed consent will be 
targeted, but verbal informed consent by telephone may need to be used given several 
present care partner/visitor restriction policies in the ED. Participants will be informed of the 
purpose of the study, the likely length of the qualitative interview or design thinking 
workshop, and the possible risks and benefits of participation. In addition, procedures to 
protect confidentiality will be reviewed. Participants will be reminded that inclusion is 
voluntary and that they are free to end the interaction at any point they wish. There will be no 
coercion or undue influence to participate in the research. The semi-structured interview 
guide will be developed, refined, and then reviewed and approved by the Yale University 
Human Research Protection Program prior to the start of the study, as will recruitment and 
written informed consent procedures.
Specifically, the RA will first assess the potential participant’s capacity given that this work 
will prioritize PLWD and their care partners. The goal will be to determine their genuine 
comprehension of the study, not their mere ability to read and repeat the consent text. This 
will be completed by first approaching the candidate patient participant using the validated 
UBACC Capacity 10 questions. A score of ≥14 will be required to denote capacity, and a 
‘best response’ will be required to be noted for at least one item in the domains of 
understanding, appreciation, reasoning and choice. For those without capacity, we will 
operate under the premise of ‘obtaining assent and respecting dissent’. The RA will ask the 
patient if they agree to participate in the research. Assent can be expressed or indicated 
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verbally (e.g., saying “yes”), behaviorally (e.g., acting agreeably), or emotionally (e.g., having 
a positive facial expression). Furthermore, the separate assent form will be presented to the 
candidate patient participant, requesting their signature. Conversely, dissent will be noted by 
a ‘verbal or non-verbal indication of unwillingness to participate in study procedures. This will 
be noted and the participant will not be questioned further. When the patient lacks capacity 
but provides assent, the RA will then reach out by telephone to the contact listed in the 
electronic medical record to obtain proxy informed consent, going through the separate 
caregiver consent form. The relation of the contact will be described and reported in terms of 
family member (relation), designated care partner, legally authorized representative, 
surrogate decision maker to ensure they have authority to provide consent. 
In the case of older adults with proxy-informed consent or among those that have capacity 
and also provided consent/assent, the RA will perform the 4AT. The 4AT is scored from 0-12 
and tests for delirium and cognitive impairment. A score of ≥4 suggests possible delirium, 
with these people to be excluded from our study. A score of 1-3 suggests possible cognitive 
impairment. A score of 0 suggests delirium or severe cognitive impairment is unlikely. 
Additionally, the RA will then perform the AD8 with the older adult as well as their care 
partner by telephone. The AD8 is more focused on dementia specifically for screening. As a 
gold standard, a score of ≥2 on the care partner-completed AD8 will be noted to suggest 
cognitive impairment. In cases where AD8 scores differ between patient and care partner, 
the care partner score will be the one that dictates the ‘true’ AD8 score and therefore 
whether the patient is concerning for cognitive impairment or not. 
For Specific Aim 2 (pilot testing), similar in-ED recruitment strategies will be used as above 
for identification, consent, cognitive screening, follow-up scheduling, and nominal gift card 
incentivization, but an additional method of recruitment will also be employed in this phase of 
the research. To broaden our potential participant pool (particularly when the RA is not in the 
ED), we will work with the JDAT team to obtain a Dashboard/list of ED patients that meet 
inclusion criteria. The JDAT team will query the electronic medical record to identify patients 
with a problem list diagnosis of ‘dementia’ that were discharged from the ED sites. The 
Dashboard/list of patients will be securely provided to the research team’s RA. The research 
team’s RA will then use EPIC In-Basket function to contact one of three clinicians with a 
recent and/or longitudinal relationship with the patient and/or caregiver, outside of the 
treating ED physician. Clinician #1 is the patient’s PCP, clinician #2 is the ED case manager, 
and clinician #3 is the ED follow-up nurse. The ED case manager, if involved in the patient’s 
care, has a longitudinal relationship that lasts up to 72 hours beyond emergency care, in 
which the patient or caregiver is able to contact them to address issues. In their current role, 
the ED follow-up nurse already contacts all patients >65 years of age discharged from the 
ED within 24-48 hours. If the enrolling RA is not present in the ED, the ED case manager or 
ED follow-up nurse during their interaction will briefly mention the study goals and inquire if 
the research team’s RA can contact them by telephone to further discuss the study. If for 
some reason, the case manager or follow-up nurse did not meet with a patient with dementia 
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identified through the JDAT Dashboard, then we will ask the patient’s PCP through EPIC In-
Basket if acceptable to contact the patient and caregiver. The research team’s RA will then 
contact the patient and/or caregiver, first informing them that one of the 3 listed clinicians 
stated it was acceptable for the RA to contact them, followed then by describing the study, 
identifying interest, and consenting the patient and/or caregiver as described previously 
(similar to in-ED enrollment from here forward).
6.3.3
Screening
See 6.3.2.
6.3.4
Enrollment 
See 6.3.2.
6.3.5
On Study Visits
Qualitative interviews will be conducted in Specific Aim 1, Phase 1, and will take 
approximately 30-45 minutes. A Design Thinking Workshop will be convened during Specific 
Aim 1, Phase 2 and will take approximately 2-4 hours. Pilot implementation in Specific Aim 2 
will follow the PLWD and care partners for 3 months post-ED visit.
6.3.6
End of Study and Follow-up
Participants will be assessed up to 3 months post-ED visit regarding outcomes through 
surveys built into the AI platform. There is no in-person follow-up.
6.3.7
Removal of subjects
Engagement with the study is voluntary. If a participant wishes to withdraw, they will stop 
using the NeuViCare AI software and not complete follow-up surveys.
6.4
Statistical Method
6.4.1
Statistical Design
Recorded interviews will be professionally transcribed. We will perform coding throughout 
the study using a qualitative descriptive approach with thematic analysis. A draft code key 
will be generated through an inductive coding process. Interviews and coding will occur 
concurrently, and coding disagreements will be resolved by group consensus. We will use 
the final code key to analyze the remaining transcripts, and will then produce code reports 
and identify themes while maintaining an audit trail of coding decisions. NVivo, a specialized 
software package for qualitative research, will be used to facilitate data organization and 
theme identification. 
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Additionally, we will use a primarily inductive approach to content analysis whereby 
theoretical insights will be developed from the design thinking workshop data. Similar to prior 
qualitative work within design thinking workshops, themes and subthemes will be generated 
and grouped by common words, phrases, or ideas.
Regarding the DKAS and Zarit Caregiver burden scale, we will compare baseline and 30-
day mean scores of the pilot group using the paired t-test.Given the proposal’s pilot nature, 
descriptive statistics will be used to assess ED and hospitalization outcomes as well as 
survey data regarding implementation outcomes. A mean score of ≥4 using the FIM will be 
indicative of NeuviCare AI’s feasibility. A mean score of ≥4 using the AIM will be indicative of 
NeuviCare AI’s acceptability. A mean score of ≥4 (using the IAM will be indicative of 
NeuviCare AI’s appropriateness. In analyzing usability data, the 10-item SUS has a possible 
original score of 0-40. After multiplication by 2.5 and conversion to a 0-100 scale, prior 
research suggests that above average usability are interventions with a score ≥68.
6.4.2
Sample Size Considerations
N/A
6.4.3
Planned Analysis
6.4.3.1
Primary Analyses
See 6.4.1.
6.4.3.2
Secondary Objectives Analyses
See 6.4.1.
6.4.3.3
Safety
N/A
6.4.3.4
Analysis of Subject Characteristics
We will present descriptive characteristics of cognition screening (to identify degree of 
ADRD), health literacy, chronic conditions, sociodemographic factors, and ED chief 
complaint.
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6.4.3.5
Interim Analysis (if applicable)
N/A
6.4.3.6
Health economic evaluation
N/A
6.4.3.7
Other
N/A
6.4.4
Subsets and Covariates
N/A
6.4.5
Handling of Missing Data
Missing data will be considered missing at random and will not be imputed.
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7  Trial Administration
7.1
 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization
Information sheets will be Institutional Review Board (IRB)-approved and the 
participant/legally authorized representative (LAR)/surrogate decision-maker will have the 
document read to them. The RA will explain the research study to the participant and answer 
any questions that may arise. This conversation will take place in a private room or via 
telephone if the caregiver is not present in the ED.
Participants/LAR/surrogate decision-makers will have the opportunity to carefully review the 
information sheet and ask questions. The participants/LAR should have the opportunity to 
discuss the study with their family or surrogates, or think about it prior to agreeing to 
participate. Participants/LAR must be informed that participation is voluntary and that they 
may withdraw from the study at any time, without prejudice. A copy of information sheet will 
be given to the participants/LAR/surrogate decision-makers for their records.
See additional information in 6.3.2.
7.2
Institutional Review Board (IRB) Review
The protocol will be submitted to the IRB for review and approval. Approval of the protocol 
must be obtained before initiating any research activity. Any change to the protocol or study 
team will require an approved IRB amendment before implementation. The IRB will 
determine whether informed consent and HIPAA authorization are required.
A study closure report will be submitted to the IRB after all research activities have been 
completed.
7.3
Subject Confidentiality
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor(s) and their interventions. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party 
without prior written approval of the sponsor.
All research activities will be conducted in as private a setting as possible.
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The study monitor, representatives of the Institutional Review Board (IRB), or regulatory 
agencies may inspect all documents and records required to be maintained by the 
investigator, including but not limited to, medical records (office, clinic, or hospital) for the 
participants in this study. The clinical study site will permit access to such records.
The study participant's contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept in a 
secure location for as long a period as dictated by the reviewing IRB, Institutional policies, 
or, if applicable, sponsor requirements.
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at the [insert location]. This will not include the 
participant's contact or identifying information. Rather, individual participants and their 
research data will be identified by a unique study identification number. The study data entry 
and study management systems used will be secured and password protected. At the end of 
the study, all study databases will be de-identified and archived at the Yale School of 
Medicine.
7.4
Deviations/Unanticipated Problems
A protocol deviation is any noncompliance with the study protocol. The noncompliance may 
be either on the part of the participant, the investigator, or the study site staff. As a result of 
deviations, corrective actions are to be developed by the site and implemented promptly.
It is the responsibility of the site investigator to identify and report deviations within 5 working 
days of identification of the protocol deviation. All deviations must be addressed in study 
source documents, reported to the study sponsor, and the reviewing Institutional Review 
Board (IRB) per their policies.
Unanticipated problems involving risks to participants or others include, in general, 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 
Institutional Review Board (IRB)-approved research protocol and informed consent 
document; and (b) the characteristics of the participant population being studied;

Related or possibly related to participation in the research (“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); and

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.
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The investigator will report unanticipated problems (UPs) to the reviewing Institutional 
Review Board (IRB) and to the study sponsor. The UP report will include the following 
information: 

Protocol identifying information: protocol title and number, PI's name, and the IRB 
project number;

A detailed description of the event, incident, experience, or outcome;

An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP;

A description of any changes to the protocol or other corrective actions that have 
been taken or are proposed in response to the UP.
To satisfy the requirement for prompt reporting, UPs will be reported using the following 
timeline:

UPs that are serious adverse events (SAEs) will be reported to the IRB and study 
sponsor, if applicable within 5 days in accordance with of the investigator becoming 
aware of the event.

Any other UP will be reported to the IRB and study sponsor within 10 days of the 
investigator becoming aware of the problem.

All UPs should be reported to appropriate institutional officials (as required by an 
institution's written reporting procedures), the supporting agency head (or designee), 
and the Office for Human Research Protections (OHRP) within & 10 days of the 
IRB's receipt of the report of the problem from the investigator.
7.5
Data Collection
Data will be collected using the NeuViCare AI app.
7.6
Data Quality Assurance
Participant Safeguards: For Specific Aim 1, telephone qualitative interviews and cognitive 
debriefing processes will be conducted by personnel with interview experience among 
PLWD and their care partners. In the unlikely event that a participant experiences distress, 
study personnel will be instructed to terminate the interview, listen to the concerns of the 
participants, and provide reflective statements so that the participant knows that his or her 
concerns were heard. Such events will also be documented by Dr Gettel as part of the audit 
trail standard in qualitative research.
NeuViCare AI: The application is implemented on the HIPAA compliant Google Compute 
Platform (GCP), also called Google Cloud. Hence, NeuViCare’s computing, network, and 
data storage services are all on the cloud. All data collected and stored by the NeuViCare 
application is guaranteed to be only stored on the Cloud, encrypted at rest. For more 
information, you can visit the following website: 
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https://cloud.google.com/security/compliance/hipaa-compliance/. Amicus Brain has secured 
HIPAA Business Associate Agreement (BAA) from Google; thus, ensuring that all parties 
maintain HIPAA security and overall HIPAA compliance. Additional data safety measures 
include the following:
Use of HTTPS 128-bit encryption for all data transfers using Secure Socket Layer 
transmission
All data stored in Google Cloud is encrypted at the storage level using AES256 (a 
256-bit key) file encryption
Ensuring study data is only accessible to authorized users
Using only servers in a secure private, HIPAA-compliant cloud environment 
provisioned from GCP
Amicus Brain has instituted physical safeguards and cyber security safeguards 
including separation of environments and separation of roles to protect the 
Production cloud environment where the NeuViCare application is hosted. 
Confidentiality and Data Safeguards: To minimize the risks to data confidentiality, data will 
be stored and accessed on secure servers, and access will be limited to members of the 
research team. For the step involving chart review, minimal personnel will be used, and no 
sections of the chart will be printed. Once variables that require access to protected health 
information have been constructed, a deidentified data set will be created for analysis, with 
each participant assigned a unique random number. Additionally, recorded interviews will 
not contain any identifying information. Access to the deidentified data set and qualitative 
interview transcripts will be limited and maintained on password protected computer systems 
in locked offices. 
Adverse Events: The PI will take all possible measures to minimize any risks that may 
occur as a consequence of participation in this investigation. Adverse events will be 
recorded and noted by the PI, and reported to the Yale University Human Research 
Protection Program. While we feel that such events are very unlikely, we will follow all until 
resolution if adverse events occur.
7.7
Study Records
Interviews records, surveys completed.
7.8
Access to Source
Source data will be maintained per Medical Records policy in a password protected, secure, 
Health Insurance Portability and Accountability Act (HIPAA) compliant, web-based electronic 
database with a built-in audit trail.
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Only Institutional Review Board (IRB) approved research team members who have current 
HIPAA and Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) 
and human subjects protection training will be authorized to access records.
7.9
Data or Specimen Storage/Security
To minimize the risks to data confidentiality, data will be stored and accessed on secure 
servers, and access will be limited to members of the research team. For the step involving 
chart review, minimal personnel will be used, and no sections of the chart will be printed. 
Once variables that require access to protected health information have been constructed, a 
deidentified data set will be created for analysis, with each participant assigned a unique 
random number. Additionally, recorded interviews will not contain any identifying information. 
Access to the deidentified data set and qualitative interview transcripts will be limited and 
maintained on password protected computer systems in locked offices.
7.10 Retention of Records
Study records retained for 1 year, then destroyed.
7.11 Study Monitoring
As stated in the NIH Resource Sharing Plan guideline, our plan will disseminate project 
results to the wider scientific and healthcare community and thereby ‘expedite the 
translation of the research results into knowledge, products, and procedures to 
improve human health.’ Research resources generated with funds from this grant will be 
freely distributed, as available, to qualified academic investigators for non-commercial 
research. Yale University and the PI will adhere to the NIH Grants Policy on Sharing of 
Unique Research Resources including the “Sharing of Biomedical Research Resources: 
Principles and Guidelines for Recipients of NIH Grants and Contracts” issued in December 
1999. We recognize that the public dissemination of our scientific results facilitates the 
creation of collaborative efforts, with outside investigators playing an important role in the 
ultimate development of additional original research. These critical objectives will be 
achieved by disclosing our research findings and conclusions in oral or poster 
presentations at national and international meetings and in publications in refereed 
scientific journals. We also respect the rights of our collaborators in this regard. Published 
manuscripts will be deposited to the NIH manuscript service as required. Should any 
intellectual property arise which requires a patent, we would ensure that the technology 
remains widely available to the research community in accordance with the NIH Principles 
and Guidelines document. Moreover, we plan to share resources with broad availability of 
policies, practices, materials, and tools to facilitate collaboration, reuse, and replication. 
Making project materials, databases, results, and algorithms available will facilitate 
collaboration and reuse and allow for verification or replication by other researchers.
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7.12 Data Safety Monitoring Plan
The principal investigator is responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews quarterly.  During the review process the 
principal investigator will evaluate whether the study should continue unchanged, require 
modification/amendment, or close to enrollment.
The principal investigator and the Institutional Review Board (IRB) have the authority to stop 
or suspend the study or require modifications.
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving 
Risks to Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the 
unlikely event that such events occur, Reportable Events (which are events that are serious 
or life-threatening and unanticipated (or anticipated but occurring with a greater frequency 
than expected) and possibly, probably, or definitely related) or Unanticipated Problems 
Involving Risks to Subjects or Others that may require a temporary or permanent interruption 
of study activities will be reported immediately (if possible), followed by a written report within 
5 calendar days of the Principal Investigator becoming aware of the event to the IRB (using 
the appropriate forms from the website) and any appropriate funding and regulatory 
agencies. The investigator will apprise fellow investigators and study personnel of all 
UPIRSOs and adverse events that occur during the conduct of this research project via 
email as they are reviewed by the principal investigator. The protocol’s research monitor(s), 
e.g., study sponsors, funding and regulatory agencies, and regulatory and decision-making 
bodies will be informed of adverse events within 5 days of the event becoming known to the 
principal investigator.
7.13 Study Modification
Study will be modified as needed and reported through the IRB as needs arise.
7.14 Study Discontinuation
Study will be discontinued if significant adverse events are noted to participants.
7.15 Study Completion
February 2024
7.16 Conflict of Interest Policy
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical. Therefore, any actual conflict of interest of persons who 
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have a role in the design, conduct, analysis, publication, or any aspect of this trial will be 
disclosed and managed. Furthermore, persons who have a perceived conflict of interest will 
be required to have such conflicts managed in a way that is appropriate to their participation 
in the trial. The study leadership in conjunction with the appropriate conflict of interest review 
committee has established policies and procedures for all study group members to disclose 
all conflicts of interest and will establish a mechanism for the management of all reported 
dualities of interest.
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or 
financial gain greater than the minimum allowable by their institution, etc.) must have the 
conflict reviewed by the Yale Provost’s Committee on Conflict of Interest with a Committee-
sanctioned conflict management plan that has been reviewed and approved by the study 
sponsor prior to participation in this study.  All investigators will follow the applicable conflict 
of interest policies.
7.17 Funding Source
Geriatric Emergency care Applied Research Network 2.0  / Emergency Medicine Foundation 
/ West Health Institute
7.18 Publication Plan
The PI hold primary responsibility for publishing the results, which will be targeted after 
research study completion. The PI will adhere to the publication guide provided by funding 
sponsors.
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8 Appendices
Appendix #
Title
Section
Topic
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9 List of Tables
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