Feasibility of Elder Mistreatment VOICES Screening Tool for Older Adults With Cognitive Impairment
Phase: NA
Conditions: Elder Abuse, Elder Mistreatment
Sponsor: Yale University

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Feasibility of Elder Mistreatment VOICES 
Screening Tool for Older Adults with 
Cognitive Impairment
 Protocol Number
2000030574
Protocol Version
01/20/2022
 Version #1
IDE Number: N/A
IDE Holder: N/A
PRINCIPAL INVESTIGATOR:
Fuad Abujarad
Yale School of Medicine
Department of Emergency Medicine
(203)928-9259
Fuad.abujarad@yale.edu
Confidentiality Statement:
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REVISION HISTORY:
Revision #
Version Date
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Synopsis
Primary Objective
The primary objective of this study is to conduct a study with eighty (N=80) participants in order 
to evaluate the feasibility of implementing the new and enhanced VOICES tool (HIC#: 
2000023799) for older adults with cognitive impairment (CI) into the emergency Department (ED).
Secondary Objective (if applicable)
Study Duration
Eight months. 
Study Design 
This is a feasibility study of tablet-based screening tool to identify suspicion of elder 
mistreatment for older adults with cognitive impairment.
Number of Study Sites
1: Yale-New Haven Hospital Emergency Department at the Saint Raphael's Campus (YNHH-ED-
SRC)
Study Population
Older adults (age 60+) seen at the SRC ED.
Number of Participants
80
Primary Outcome Variables
Acceptability, Demand, Implementation, and Practicality 
Secondary and Exploratory Outcome Variables (if applicable)
N/A
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Abbreviations
Abbreviation 
Explanation
CI
Cognitive Impairment
EM
Elder Mistreatment 
YNHH
Yale-New Haven Hospital
SRC ED
Saint Raphael’s Campus Emergency 
Department
ED
Emergency Department
EPS
Elder Protective Services 
RA
Research assistant
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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
The VOICES tool has been developed and tested with more than 1000 patients at Yale 
Emergency Department (IRB Protocol ID:2000023799 and Submission ID:CR00008317). 
2.1.2
Device Clinical Experience
In a prior clinical study at Yale Emergency Department (IRB Protocol ID:2000023799 and 
Submission ID:CR00008317), we developed an innovative digital health tool that runs on 
tablets called VOICES that screens, educates, and motivates older adults to make an 
informed decision about self-reporting of elder mistreatment. VOICES is a digital health 
intervention to screen and identify suspicion of elder mistreatment when there are no 
recognized signs and symptoms of abuse. The VOICES tool is currently being evaluated 
with older adults in emergency department settings. 1000 subjects have used the 
VOICES tool so far without any issues. Study participants have demonstrated signs of 
feasibility, acceptance, demand, and full completion of the tool for those who consented to 
participate. There is an opportunity to expand VOICES to more vulnerable older adult 
populations, such as older adults with cognitive impairment.
2.2
Background/Prevalence of Research Topic
Elder mistreatment (EM) is a major public health problem with estimated prevalence in the 
United State ranges from 27.9% to 62.3% for emotional abuse and 3.5%–23.1% for physical 
abuse among older adults with cognitive impairment (CI). EM consists of physical, 
emotional, sexual and financial abuse as well as neglect committed by a person in a position 
of trust to the older adult. It causes serious adverse outcomes for its victims including injury, 
increased service utilization, mental distress and the risk of mortality. A major barrier in 
overcoming EM is the inability to accurately identify EM victims. It is estimated that only 1 in 
24 cases become known to authorities.
Adults with CI are at even greater risk of elder mistreatment compared to those without. This 
is problematic as they are not likely to report that they are being mistreated, despite some of 
them having a general understanding of what constitutes EM. There are several perceived 
barriers to self-disclosure (informing others about the EM experiences) that limit help-
seeking behaviors, including fear of nursing home placement, of losing autonomy or a 
caregiver, and of getting an abusive family member in legal trouble. As a result, reporting of 
EM remains low and providers often miss the opportunity to identify EM at point-of-care.
In our parent project, we used Digital Health frameworks to develop the Virtual cOaching in 
making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) tool. This is a 
new and innovative digital health tool that screens, educates, and motivates older adults to 
make an informed decision about self-identification (recognizing that they themselves are 
victims) and self-disclosure of elder mistreatment.
3 Rationale/Significance
3.1
Problem Statement
Is the VOICES tool, currently developed for older adults without cognitive impairment, feasible 
for older adults with cognitive impairment?
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3.2
Purpose of Study/Potential Impact
Our aim is to assess the feasibility (N= 80) of the VOICES screening tool among older adults 
with cognitive impairment. If VOICES is feasible for identifying suspicion of EM with older 
adults with cognitive impairment, then we will be able to connect more victims of EM to 
necessary services and potentially prevent a multitude of poor EM outcomes.
3.2.1
Potential Risks
There are no medical interventions in this study, and direct medical risks are minimal. 
However, identification of potential EM without adequate safeguards could increase the risk 
of physical harm, emotional harm, risk of neglect, and financial loss to the victim. In addition, 
EM identification can potentially lead to adverse events including: 

retaliation of a family member or caregiver, 

an older adult may lose the caregiver or be abandoned by a caregiver, and a 
family member or paid caregiver may be arrested / incarcerated,

discharge of a patient to a long-term care or skilled nursing facility, which they 
may not be able to afford,

distress/anxiety during and/or after using the VOICES tool is a potential risk 
given the complex emotions typically associated with this phenomenon.

there is a risk of compromised security of personal information.
Many of these adverse events would likely occur as a result of the mandatory report to 
Connecticut Protective Services for the Elderly (PSE) that the attending clinician would 
make with help of the care team (attending, clinician, nurses, and social worker). 
However, during this study the care team is expected to discover information that will 
require them to make a report to PSE even if the patient does not want them to do so. 
Minimizing Risks:
Risks will be minimized through appropriate participant exclusions and close medical 
supervision throughout the protocol.  We will inform all participants that there is a 
chance that they may experience adverse events due to the identification of EM by 
participating in the study and that their participation is voluntary. We will also remind 
participants that they can discontinue participation at any time. 
In Summary: VOICES’ goal is to help identify cases of EM when there are no 
recognized signs and symptoms of mistreatment. The subsequent procedures for the 
EM identification are important but are similar to the case when a provider identify 
suspicion of EM during normal clinical care: 

all patients who screen positive with the VOICES tool will be reviewed and 
assessed by the attending to evaluate if the tool’s suspicion of mistreatment 
will either be confirmed (necessitating a report to authorities) or rejected (no 
report necessary).

while the research team recognizes that the EM identified through the VOICES 
tool may lead to adverse events for patients associated with EM identification, 
we anticipate that the attending clinician response will minimize the possible 
adverse events due to the EM identification. 

We will train all RAs to detect common signs of distress and anxiety. If any are 
even suspected of being observed, the attending clinician at SRC ED will be 
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contacted immediately for consultation and next steps, which could include 
counseling, referrals, or a psychiatric evaluation.

If the older adult screens positive on the VOICES for EM or the older adult 
wants to self-disclose EM, the RA will notify the attending physician at the 
SRC ED if there is suspicion of EM. Also, if the tool fails to identify EM but the 
patient would like to disclose EM, the RA will notify the attending clinician. 
The RA will stay with the participant until the attending clinician arrives and 
implements existing protocols for handling EM identification. 

The attending clinician and care team can address each patient's concerns 
around reporting, immediate safety concerns, and any concerns for retaliation 
or abandonment. If the assessment indicates suspicion of abuse, and the case 
gets reported to PSE, usually PSE will arrive within 12 hours to take care of 
the case. While waiting for PSE, the health care team members will discuss 
safety issues with the patient. If the older adult feels s/he is in immediate 
danger or does not feel safe going home, the care team will create a safe 
disposition plan that can include safety admission to the hospital until PSE can 
implement a more permanent solution.

We will protect against psychological distress by informing all participants that 
there is a chance that they may experience some negative emotions while 
completing the surveys, after completing survey, or when they leave the 
hospital, but that they do not have to answer questions that they find 
distressing. We will also remind participants that they can discontinue 
participation at any time. We will also provide all older adults that we approach 
with the brochure on resources for aging well that also include free referral 
line. These options will be discussed with participants during initial recruitment.  

Although privacy and confidentiality will be preserved to the utmost extent 
possible, participants will be informed that, should EM be identified, the RA will 
report this to the attending at the SRC ED. For example, if in the course of 
research procedures, a participant reveals elder abuse to the RA, the RA will 
discuss with the participant his/her responsibility to report the abuse to the 
attending. The attending will coordinate with the care team to do an EM 
assessment and if they find suspicion of abuse, they will intervene to ensure 
patient safety.  Also, if the participant divulges suicidality, the RA must report 
this to the attending and notify the PI.

We will follow standard hospital operating procedures to guard against the 
possibility of study coercion, loss of confidentiality, psychological distress, and 
escalation of abuse, acknowledging that awareness or suspicion of reporting 
may anger the abuser but can also empower the patients and ultimately, make 
them safer. 

Our intent is to conduct a VOICES study session without the presence of the 
caregiver. From our experience, family members usually volunteer to leave the 
room, when they usually do so. 
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
We will ask the caregivers to leave the room before engaging the older adults 
in using the VOICES tool and after the consent. If the older adult wants the 
caregiver to remain, we will respect their wishes, but that patient will be 
excluded from the study and no study information will be presented. 

If a participant reveals depression, the research assistant will provide a referral 
to a mental health agency accessible to the subject.  If a participant reveals 
severe depression or suicidality, or requests immediate psychiatric care for 
any reason, the RA will alert the patient’s clinician to initiate an immediate 
psychiatric evaluation. 

Since the VOICES tool is a web-based application in nature, no information 
will be stored on the tablet. If the tablet gets lost or stolen, the patient’s data 
will not be compromised. All iPads contain encryption software, per University 
Policy 5100.  
3.2.2
Potential Benefits
Although there are risks to the subjects, the benefits outweigh the risks. EM can have 
profound medical consequences for victims, significantly increasing their risk for mortality, 
exacerbations of chronic illnesses, and depression. EM is very seldom identified, and low 
rates of identification and reporting have likely led to much of the associated morbidity and 
mortality. Therefore, by increasing identification of this morbid and mortal phenomenon, the 
VOICES tool may offer significant benefits to patients. A potential benefit for the participants 
is that they will gain better self-awareness, enhance and support self-disclosure, and 
improve reporting of EM at the point-of-care setting, which may result in, better emotional 
and physical health, increased safety, and quality of care
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4 Study Objectives
4.1
Hypothesis
The hypothesis of this study is: the VOICES tool, developed for older adults without cognitive 
impairment, applicable and feasible for older adults with cognitive impairment? 
o
To what extent is VOICES satisfying to end-users?
o
To what extent is VOICES likely to be used?
o
To what extent can VOICES be delivered to participants in the ED with   
cognitive impairment?
o
To what extent can VOICES be carried out with older adults with cognitive 
impairment without outside intervention?
4.2
Primary Objective
The primary aim and objective of this study is to determine whether VOICES tool is feasibility 
for identifying suspicion of elder mistreatment among older adults with cognitive impairment.  
4.3
Secondary Objectives (if applicable)
N/A.
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5 Study Design
5.1
General Design Description
Overview and Rationale: We will conduct a study with eighty (N=80) participants to evaluate 
the feasibility of implementing VOICES for older adults with cognitive impairment. The objective 
of this study is to evaluate markers of feasibility rather than to determine the efficacy of VOICES. 
Settings: Participants for the feasibility study will be recruited from the large and diverse patient 
population of Yale-New Haven Hospital Emergency Department at the Saint Raphael's 
Campus(YNHH-ED-SRC). This is the same ED where we conducted the parent project.
Sample Size Justification: The sample size was determined based on the practical 
considerations of time and availability of subjects and the precision by which the targeted 
feasibility parameters will be estimated. For dichotomous outcomes (e.g. demand, 
implementation) a sample size of (N=80) will be a sufficient size to estimate a 95% confidence 
interval around a proportion with a width of no greater than 0.228. For continuous outcomes (e.g. 
acceptability, time to completion) a sample size of 80 produces a two-sided 95% confidence 
interval with a distance from the mean to the limits that is equal to 22% of the measure’s 
standard deviation.
Recruitment: In the YNHH-ED-SRC setting we will seek to enroll eligible older adults with CI. 
This ED sees approximately 550 persons age 60 or older each week. To meet our recruitment 
goal of N=80, over the 4-month study period we will need to enroll approximately 5 participants 
each week. As such, we are confident we can meet our sample size. We will develop a rotating 
schedule for the RA that varies shifts by time to get a representative ED sample. For details on 
eligibility please see the (Protection of Human Subjects) section.
5.1.1
Study Date Range and Duration
The expected length of the study is 8 months, enrollment will be for 4 months and there is no 
follow-up.
5.1.2
Number of Study Sites
This study will be performed at one study site, the Yale-New Haven Hospital Emergency 
Department at the Saint Raphael's Campus(YNHH-ED-SRC).
5.2
Outcome Variables
5.2.1
Primary Outcome Variables
The primary outcome variables include the areas of acceptability, demand, 
implementation, and practicality of the VOICES tool. 
o
Acceptability: To what extent is VOICES satisfying to end-users?
o
Demand: To what extent is VOICES likely to be used?
o
Implementation: To what extent can VOICES be delivered to participants 
with cognitive impairment in the ED?
o
Practicality: To what extent can VOICES be carried out with older adults with 
cognitive impairment without outside intervention?
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5.2.2
Secondary and Exploratory Outcome Variables (if applicable)
N/A
5.3
Study Population
Participants aged 60 and older seen at YNHH-SRC-ED.
5.3.1
Number of Participants
The number participants to be recruited is 80 participants.
5.3.2
Eligibility Criteria/Vulnerable Populations
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria:
1.
Provision of signed and dated informed consent form
2.
Stated willingness to comply with all study procedures and availability for the duration 
of the study 
3.
Age 60 or above
4.
MoCA score between 14-25
5.
Not in police custody
6.
Non-full trauma track upon arrival
7.
Able to consent and communicate in English
8.
Agrees and able to use the iPad 
An individual who meets any of the following criteria will be excluded from participation in 
this study:
1.
Subjects who live in nursing homes or other long-term care settings
2.
At the discretion of the clinician, patient will be excluded if they cannot safely undergo 
the studies required for participation
3.
Subject refusal to participate
4.
Subjects with clear signs of elder mistreatment
5.
Severe hearing and vision impairment
6.
Presenting with acute intoxication
7.
Presenting with active psychotic symptoms
8.
Presenting with COVID-19 diagnosis and/or severe COVID-19 symptoms
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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)
The VOICES tool goal includes:
1) Educate older adults on Elder Abuse and the type of help available for victims.
2) Screen for elder abuse to detect suspicion of elder abuse.
3) Motivate older adults (with suspicion of elder abuse) to self-identify and self-disclose abuse.
The ultimate goal of VOICES to identify older adults with high suspicion of being victims of abuse and 
encourage them to seek help.  
The goal of our current study is to identify markers of feasibility and not to test the efficacy of 
VOICES. However, during the feasibility testing if the tool identifies a suspicion of abuse, then the RA 
will contact the attending clinician to coordinate with the care team at the ED to conduct an Elder 
Abuse Assessment to confirm or reject the findings from VOICES.
In practice, VOICES will identify “suspicion of elder abuse”, if:
1)
An older adult screened positive 
2)
An older adult indicated that they want to report abuse to their provider
A subject will be considered positive for suspicion of abuse if:
If the subject answers “Yes” to questions 2-4 of the 5-question mistreatment screener (Elder Abuse 
Suspicion Index, EASI-sa), AND/OR answers “Yes” to “Do you feel you have been mistreated in the 
last 12 months?”
Suspected Mistreatment Protocol
The VOICES tool only determines whether there is a suspicion of abuse, leaving the confirmation of 
legitimate abuse to the existing protocols in place at the ED. If the RA sees that the tool has identified 
suspicion of abuse, the RA will contact the attending to coordinate with the care team to perform a 
formal elder mistreatment assessment to confirm or reject the suspicion. 
6.1.2
Device Administration and Schedule
The VOICES tool will be provided on an iPad to the eligible participant and self-
administrated by the participant. The research assistant will provide technical assistance if 
necessary, but otherwise the participant is expected to go through the tool independently, 
guided by the tool’s virtual coach.
We will assess the patient ability to consent by checking if the patient can:

articulate a choice regarding study participation

understand its purpose

comprehend that participation does not constitute medical treatment
If the patient has the capacity to consent, then he/she will complete the consent process on 
their own.
If patient does not have the capacity to consent, he/she will be excluded from the study.
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We will normalize the study approach to the patient and caregiver as much as possible to 
mitigate potential risk of the caregiver being the eligible participant’s abuser. We will include 
in our introduction of the study that we are asking all individuals over 60 that meet the 
requirements in the ED to participate in the study, and that the patient has not specifically 
been flagged for mistreatment of any kind. We will initially open the topic by describing our 
study as inquiring about “safety at home”, and follow-up with more detail if the caregiver or 
subject are interested.
On average, we anticipate the time needed to complete the consent may range from 15-20 
minutes. The patient will be given as much time as needed to consider their participation in 
the study. The consent process will be completed without the presence of the caregiver.
If the caregiver did not leave the room, or if the patient wanted them to be present, then the 
patient will not be eligible for the study and cannot participate. 
6.1.3
Method of Assignment/Randomization (if applicable)
N/A
6.1.4
Device Calibration 
N/A
6.1.5
Storage Conditions
All tablets will be secured in a locked cabinet when not in use.
6.1.6
Concomitant therapy
NA
6.1.7
Restrictions
N/A
6.2
Assessments
6.2.1
Efficacy
Questionnaires to be administered:

Demographics questionnaire

Post-Use Survey questionnaire
Demographics will be used to confirm the recruitment of a diverse population, as well as 
identify any patterns in outcomes with certain populations. The post-use survey will be used 
to determine some measures in practicality (perceived time to complete tool), 
implementation (success of execution), and acceptability (5-point Likert scale response 
questions). 
6.2.2
Safety
All data will be entered into databases that are protected with appropriate passwords and 
routine backups of all data will be carried out. All data collected on the subjects will be coded 
with numbers to maintain confidentiality. Access to the files will be restricted to the 
investigators and study personnel on this protocol. Clinical data will be stored with specific 
patient identifiers, (de-identification of samples), and maintained in a locked file, separate 
from any other clinical records with limited access, to assure patient confidentiality. Results 
will be assembled with confidential clinical research records, but will be unidentifiable without 
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these files, to assure confidentiality. The only data that will be used in this study is the 
information directly obtained from the subjects.
6.2.3
Adverse Events Definition and Reporting
An adverse event that must be reported to the IRB because it is one of the following: 
1. Serious or life-threatening; AND 
2. Unanticipated (unexpected) OR anticipated but occurring with a greater frequency 
than expected; AND 
3. Possibly, probably or definitely related to the intervention.
This section describes the procedures and timelines for adverse events (AE) and serious 
adverse events (SAE), collection and reporting.

No SAEs are expected from the direct use of VOICES tool on the iPad, but when 
SAEs occur as result of EM identification and disclosure that are related to the 
VOICES tool, they will be reported to the NIA Program Officer, Yale IRB, and to the 
research team within 48 hours of study’s knowledge of the SAE. 

AEs will be reported per Yale IRB policies. They will also be reported to the NIA 
Program Officer and the study’s team at frequency requested by NIA. At minimum, 
included in semi-annual reports.

In the unlikely event that such events occur, Reportable Events (which are events 
that are serious or life-threatening and unanticipated and possibly related)or 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) that may 
require a temporary or permanent interruption of study activities will be reported 
immediately to the NIA Program Officer, Yale IRB, and to the research team, 
followed by a written report within 5 calendar days of the Principal Investigator 
becoming aware of the event to the IRB and any appropriate funding and regulatory 
agencies. 

The PI will apprise fellow investigators and study personnel of all UPIRSOs and 
adverse events that occur during the conduct of this research project through regular 
study meetings and via email as they are reviewed by the PI. 

All deaths will be reported within 24 hours of study’s knowledge of death. 

The report of death will be submitted to NIA Program Officer, Yale IRB, and to the 
research team.

Since the VOICES tool is a web-based application in nature, no information will be 
stored on the tablet. Data will be stored on Yale’s secure servers. If the tablet 
becomes lost or stolen, the patient’s data will not be compromised. All iPads contain 
encryption software, per University Policy 5100. 
6.2.4
Pharmacokinetics (if applicable)
N/A
6.2.5
Biomarkers (if applicable)
N/A
6.3
Study Procedures
6.3.1
Study Schedule
Only one visit and no follow-up. The study will be carried out in one session, during the 
duration of the participant’s visit in the ED. There will be no follow-up with the participant, 
and the expected time to perform the study is around 45-60 minutes, including consent and 
post-use survey. Consent is estimated to take between 15-20 minutes on average, and the 
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post-survey is estimated to take between 5-7 minutes on average. If a follow-up evaluation is 
necessary due to suspicion of mistreatment, the evaluation may take an additional 60 
minutes performed by the care team.
6.3.2
Informed Consent
We will pay special attention to the ethical issues and the unique challenges of EM research 
as well as to consenting and enrolling older persons with cognitive impairments in our study. 
The consent process informs a volunteer about the study and fully explains the purpose of 
the research, that this is a research study, that participation is voluntary, and that the 
participant has the right to stop at any time. Our consent includes all of the eight basic 
elements of informed consent as articulated by 45 CFR §46.116,21 CFR §50 and Yale IRB 
Policy 200 Informed Consent for Human Research) and the additional elements of informed 
consent. Before agreeing to participate in VOICES, potential subjects will be made aware of 
and understand the risks of participation. They are the following:

A statement that the study involves research. This includes:
o
An explanation of the purposes of the research, stressing that this is not an 
intervention
o
The expected duration of the subject’s participation
o
A description of the procedures to be followed
o
A description of any foreseeable risks or discomforts to the subject. 
o
A description of any expected benefits to the subject or to others
o
When applicable, a disclosure of appropriate alternative offered
o
A statement explaining how confidentiality of data will be managed
o
An explanation of the risk of injury 
o
List of whom to contact with questions about the research, research subjects’ 
rights, or in the event of a research-related injury to the subject, that include: 
Principal Investigator’s contact information and IRB Administrator’s contact 
information

A statement that:
o
Participation is voluntary
o
Refusal to participate will involve no penalty or loss of benefits to which the 
subject is otherwise entitled
o
The subject may discontinue participation at any time without penalty or loss 
of benefits to which the subject is otherwise entitled.

In addition to the eight required elements of informed consent, additional elements 
are added to the consent. They include:
o
A statement that VOICES may involve risks to the subject which are currently 
unforeseeable;
o
Anticipated circumstances in which the subject’s participation may be 
terminated by the PI;
o
Any additional costs to the subject that may result from participation in the 
research;
o
The consequences of a subject’s decision to withdraw from the research and 
procedures for orderly termination of participation by the subject;
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o
The approximate number of subjects involved in the study;
o
An explanation of what will be done with the participant information, in the 
presenting case as well as long-term.
We designed a detailed process on how to evaluate capacity and obtain informed consent 
from older adult with cognitive impairments.
First: We will use the Montreal Cognitive Assessment (MoCA) to evaluate the severity of CI 
at the time of enrolment.72  From our pilot at the Adler Center, we  found MoCA scores 
between 14 and 25 will mainly correspond to MCI or mild dementia. This was also confirmed 
by our preliminary findings when we piloted VOICES at a dementia clinic (N=30)  where we 
found that VOICES use is feasible to patients with 14  MoCA  25. Subjects who score out 
side this range will be excluded.
Second: During our digital informed consent process, we will use the criteria from 
“Evaluation to Sign Consent” to determine if the potential participant is capable of providing 
consent and by asking the questions (below ). This approach is derived from the Evaluation 
to Sign Consent [DeRenzo EG, et al. J Health Care Law Polic 1998;1:66-87]. Factors to be 
considered include the ability to articulate a choice regarding study participation, understand 
the study’s purpose, and comprehend that participation does not constitute medical 
treatment.  In addition, the digital informed consent process will introduce “teach-back” 
questions throughout the duration of the consent process to gauge the participant’s 
understanding to the content of the consent process. 
Understand Its Purpose: What is the study about?
Q: “Why are we asking you to take part in this study?
Articulate a Choice Regarding Study Participation : Can you stop the study at any time?
Q: “True or False: If you do not want to participate, can you stop at any time?”
Comprehend That Participation Does Not Constitute Medical Treatment
Q: “True or False: This study will not interfere with your medical treatment at the 
center.”
The RA will have access to the subject’s responses and the RA will not enroll the subject if 
capacity to consent is not gained from the subject.
Third: Members of the study team who are responsible for participant recruitment and 
consent will be highly trained in obtaining informed consent and evaluating the capacity of 
the participants to understand the purpose, risks, benefits, confidentiality, and privacy 
associated with study is vital for valid informed consent. At the end of the consent process, 
the RA will review the subject’s understanding of the study by asking the following questions:

What are you being asked to do?

What questions is this study trying to answer?

What are the potential risks and benefits of participating in this study?

Can you withdraw from the study, and what should you do if you 
decide to withdraw?
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
Do you understand that participation in this study is voluntary and is 
not part of your medical treatment?
Individuals consenting will be given as much time as they need to comprehend the informed 
consent content.
6.3.3
Screening
The anticipated process for the screening and data collection is described below and is 
expected to take 45-60 minutes. The RA will be stationed in the ED and will work with 
designated nurses to identify potential participants. 
We will have the RA perform the MoCA during the screening process to determine eligibility. 
No pre-existing or previously documented scores will be used to assess eligibility to maintain 
consistency with screening. The MoCA test on average can be conducted within 10 minutes. 
All team members will be certified and trained to perform the MoCA. 
A MoCA score between 14-25 is associated with Mild cognitive impairment and Mild dementia. 
Our pilot study findings show that patients with 14-25 MoCA score can safely use the VOICES 
intervention to completion.
We are requesting a HIPPA waiver for recruitment purposes only. The RA will review 
the EPIC screen and will then check the demographics for patients 60 years or older. 
The care team will help the RA approach the patients to ask additional screening 
questions. We don’t have resources and staffing to approach every patient and 
ascertain eligibility. Using Epic is more efficient for the RAs. The RA will track and 
document each EHR that the RA accesses using the VOICES tool screening log.
6.3.4
Enrollment 
The research assistants will enroll subjects in the study, after they have consented and meet 
all eligibility criteria.
6.3.5
On Study Visits
There will be only one study visit necessary, which will be approximately a 45–60-minute 
session including:

Introduction of study by research assistant

Consent

VOICES Tool self-administered by the eligible subject

Post-use survey

Incentive and resources to be given at end of study

If the patient is eligible and would like to participate in the study, the RA will conduct the 
consent process in a private room used by the patient. Participants must be able to 
consent and communicate in English. For all patients participating in this study, the 
consent will be requested from the patient. Participants must be able and agree to use a 
tablet computer.

Important considerations 
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
At the end of the consent process, the RA will review the subject’s understanding 
of the study by asking the following question:
o
What are you being asked to do?
o
What questions is this study trying to answer?
o
What are the potential risks and benefits of participating in this study?
o
Can you withdraw from the study, and what should you do if you decide to 
withdraw?
o
Do you understand that participation in this study is voluntary and is not 
part of your medical treatment?

The caregiver will be asked to step out of the room and go wait in the waiting room. 
The patient will undergo the study procedures on their own without the presence of 
the caregiver. If the caregiver did not leave the room, or if the patient wanted them 
to be present then the patient will not be eligible for the study and cannot 
participate.

Participants will be given a description of the study and that they are testing the 
feasibility of VOICES and that the evaluation is not a measure of their individual 
performance but measure of the tool performance.

The RA will collect the participant demographics to gather background information on 
the participants.

Participants will be asked to go through the VOICES tool to completion. The RA will 
be monitoring the use of VOICES and documenting issues of interest that are 
observed. 

The RA will collect the post study survey from participants after using VOICES.

Each participant will be given $75 Bank of America debit card as compensation for 
their time and participation.

If a participant screens positive or wants to self-report EM, the RA will notify the 
attending physician.

The RA will stay with the older adult until the social worker arrives.
6.3.6
End of Study and Follow-up
Participants will be given a $75 incentive upon completion of the post-use survey, as well as 
a brochure on resources from the CT Protective Services for the Elderly. 
6.3.7
Removal of subjects
Since this study is a one-time study, if a participant decides to withdraw, the participant’s 
withdrawal will be documented in the study record and the study will not continue from the 
point of their withdrawal. Also, participant will be told that they can quit the study at any time.
6.4
Statistical Method
6.4.1
Statistical Design
The purpose of this objective is to understand important areas of feasibility, including 
acceptability, demand, implementation, and practicality (Table 1). Data for the completion of 
this objective comes from the following sources: (1) Participant demographic data obtained 
on pre-survey, (2) participant responses given to questions during VOICES (EM screener, 
self-identification, self-disclosure), (3) participant responses on participant satisfaction given 
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to questions on post-survey, and (4) observations made by the RA on enrollment, VOICES 
administration, and data collection for each participant.
6.4.2
Sample Size Considerations
Sample Size Justification: The sample size was determined based on the practical 
considerations of time and availability of subjects and the precision by which the targeted 
feasibility parameters will be estimated. For dichotomous outcomes (e.g. demand, 
implementation) a sample size of (N=80) will be a sufficient size to estimate a 95% 
confidence interval around a proportion with a width of no greater than 0.228. For continuous 
outcomes (e.g. acceptability, time to completion) a sample size of 80 produces a two-sided 
95% confidence interval with a distance from the mean to the limits that is equal to 22% of 
the measure’s standard deviation.
6.4.3
Planned Analysis
6.4.3.1
Primary Analyses
Data analysis will be performed using SAS v9.4 (SAS Institute, Cary, NC). Analysis of 
feasibility will be primarily descriptive. Numeric summaries including frequencies for 
categorical outcomes and means, medians, standard deviations and interquartile ranges for 
continuous outcomes will be presented. Graphical summaries will be used to describe 
distributions of outcomes and relations with baseline characteristics. 95% confidence intervals 
for means and proportions will be estimated to describe uncertainty from sampling variation 
for feasibility outcomes.
6.4.3.2
Secondary Objectives Analyses
N/A
6.4.3.3
Safety
N/A
6.4.3.4
Analysis of Subject Characteristics
N/A
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
N/A
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7  Trial Administration
7.1
 Ethical Considerations: Informed Consent/Assent and HIPAA Authorization
We pay special attention to the ethical issues and the unique challenges of EM research and 
to consenting and enrolling older adults with cognitive impairment in our study. We designed 
a detailed process on how to evaluate capacity, and obtain informed consent form older 
adults. Evaluating the capacity of the participants to understand the purpose, risks, benefits, 
confidentiality, and privacy associated with the study is vital for valid informed consent. We 
will use standardized criteria to determine if the potential participant is capable of providing 
consent and by asking 2 questions: “What is the study about?” and “Can you stop the study 
at any time?”. This approach is derived from the Evaluation to Sign Consent. 
Members of the study team who are responsible for participant recruitment and consent will 
be highly trained in obtaining informed consent. Additionally, we will employ evidence-based 
practices from the geriatrics to correctly address these challenges. Evaluating the capacity of 
the participants to understand the purpose, risks, benefits, confidentiality, and privacy 
associated with study is vital for valid informed consent. Participants must be able to consent 
and communicate in English. Patients who lack the ability to provide informed consent will be 
excluded from the study.
We are requesting a HIPPA waiver for recruitment purposes only. The RA will review 
the ED Track Board in EPIC and will then check the demographic and chief complaint 
for patient 60 years or older. They will then approach the patients identified as EMR 
screening eligible to ask additional screening questions. We don’t have resources and 
staffing to approach every ED patient and ascertain eligibility. Using Epic is more 
efficient for the RAs.
The RA will track and document each EHR that the RA accesses using the VOICES 
tool screening log.
1.
What protected health information (medical information along with the HIPAA 
identifiers) about subjects will be collected and used for the research? Medical 
records will be reviewed to collect the following variables: MRN, DOB, Able to 
communicate in English, Living in community dwelling, any severe hearing/vision 
impairment, and Abbreviated Mental Test 4 (AMT-4) score (which asks the patient to 
report their age, date of birth, current location, and year).
2.
How will the research data be collected, recorded and stored? We will have access-
restricted files on each subject. Data of the study will be entered into a secure database. 
In this study, the following materials will be collected from human subjects: 
questionnaire, study subject’s study ID, and signature. All paper documents will be 
maintained in a locked file, separate from other clinical records to assure confidentiality. 
All electronically stored data will be encrypted and password-protected. Only the 
primary investigator, co-investigators, study coordinator and programmers will have 
access to subjects’ data. All datasets will be de-identified and only known to study 
investigators involved in consent and data acquisition. All information relating to 
participating subjects will be deidentified.
3.
How will the digital data be stored? On secure database server.
4.
What methods and procedures will be used to safeguard the confidentiality and security 
of the identifiable study data and the storage media indicated above during and after 
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the subject’s participation in the study?
The VOICES system will be designed to ensure compliance with good research 
practice regarding the management of research data containing Protected Health 
Information (PHI). VOICES will adopt comprehensive security strategies that will 
assure the confidentiality and privacy of the patient and clinical information. Only 
authorized users will have access to patient PHI, which will help assuage concerns 
participants may have regarding the privacy and security of their data. The guidelines 
contained in the Common Framework give a detailed specification of technical 
architecture, privacy safeguards, and several approaches to health information 
exchange. We will utilize this framework to protect patient privacy and keep PHI 
under strict local control. We will continuously evaluate our security practices in order 
to quickly identify any new vulnerabilities that could compromise VOICES integrity 
and privacy. We will utilize the Yale Information Technology Services (ITS) existing 
privacy and security practices and technology, and incorporate Yale ITS-consistent 
policies into VOICES development and implementation. In addition to tier separation 
and firewall protection, the three-tiered architecture maintains VOICES security, 
confidentiality, and privacy. VOICES will maintain data security with appropriate 
encryption, system controls and audit trails. Paper surveys will be stored in a locked 
area. All electronic data will be de-identified and stored in secure database.
5.
What will be done with the data when the research is completed? Are there plans to 
destroy the identifiable data? If yes, describe how, by whom and when identifiers will 
be destroyed. If no, describe how the data and/or identifiers will be secured.
Data will be stored in safe secure server.
6.
If appropriate, has a Certificate of Confidentiality been obtained? YES
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.  
The IRB will conduct continuing review at intervals appropriate to the degree of risk, but not 
less than once per year.
A study closure report will be submitted to the IRB after all research activities have been 
completed.   
Other study events (e.g. data breaches, protocol deviations) will be submitted per Yale IRB's 
policies.
7.3
Subject Confidentiality
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Subject confidentiality is held in strict trust by the research team.  Subject medical record 
review will be limited to the just the elements needed to complete the study.  Only authorized 
HIPAA and GCP trained study team members will be allowed to extract research data from 
medical records and enter it into VOICES database. No direct subject identifiers will be 
entered into VOICES data analysis database.
Each subject will be assigned a unique study number. A master list linking the unique study 
number to the human subject will be maintained in a secure database file. 
7.4
Deviations/Unanticipated Problems
If the study team becomes aware of an anticipated problem (e.g. data breach, protocol 
deviation), the event will be reported to the IRB by e-mail.
7.5
Data Collection
Data of the study will be entered into a secure database on a secure server. In this study, 
the following materials will be collected from human subjects: questionnaire, study subject’s 
study ID, and signature. All paper documents will be maintained in a locked file, separate 
from other clinical records to assure confidentiality. All electronically stored data will be 
encrypted and password-protected. Only the primary investigator, co-investigators, study 
coordinator and programmers will have access to subjects’ data. All datasets will be de-
identified and only known to study investigators involved in consent and data acquisition. All 
information relating to participating subjects will be deidentified.
7.6
Data Quality Assurance
The VOICES system will be designed to ensure compliance with good research practice 
regarding the management of research data containing Protected Health Information (PHI). 
VOICES will adopt comprehensive security strategies that will assure the confidentiality and 
privacy of the patient and clinical information. Only authorized users will have access to 
patient PHI, which will help assuage concerns participants may have regarding the privacy 
and security of their data. The guidelines contained in the Common Framework give a 
detailed specification of technical architecture, privacy safeguards, and several approaches 
to health information exchange. We will utilize this framework to protect patient privacy and 
keep PHI under strict local control. We will continuously evaluate our security practices in 
order to quickly identify any new vulnerabilities that could compromise VOICES integrity and 
privacy. We will utilize the Yale Information Technology Services (ITS) existing privacy and 
security practices and technology, and incorporate Yale ITS-consistent policies into VOICES 
development and implementation. In addition to tier separation and firewall protection, the 
three-tiered architecture maintains VOICES security, confidentiality, and privacy. VOICES 
will maintain data security with appropriate encryption, system controls and audit trails.
7.7
Study Records
Documents that will be considered study records for this study are consent forms, 
demographics and post-use surveys.
7.8
Access to Source
All documents will be collected electronically for the purpose of this study. All electronically 
stored data will be encrypted and password-protected. Only the primary investigator, co-
investigators, study coordinator and programmers will have access to subjects’ data. All 
datasets will be de-identified and only known to study investigators involved in consent and 
data acquisition.
7.9
Data or Specimen Storage/Security
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Data will be collected and stored digitally and maintained on a securely encrypted database 
server with password protection.
7.10 Retention of Records
Data will be retained based on Yale IRB policy.
7.11 Study Monitoring
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a daily 
basis.
7.12 Data Safety Monitoring Plan
The DSMP will be monitored by the study team. The Principal Investigator (PI) will be 
responsible for ensuring participants’ safety on a daily basis. To ensure that we are 
identifying both the adverse events that we might anticipate as well as those that we might 
not, the PI will review each case where either: (1) a report was made to PSE or (2) a patient 
was admitted to the hospital for safety to assess for any potential adverse events. The Data 
and Safety Monitoring Team (DSMT) will consist of Drs. Abujarad, Hwang, and Marottoli; this 
team will monitor participant safety, evaluate the progress of the study, and review 
procedures for maintaining the confidentiality of data, the quality of data collection, 
management, and analyses. They will monitor the study for reports of any adverse or 
unexpected events. Study participants will be advised to contact the study team to report 
any adverse events or concerns. VOICES will only be administrated for the intervention 
group, and there will be no control groups. The PI and the investigative team will monitor 
data and safety at the monthly study team meetings. 
The following will be reviewed:

Cumulative accrual

Enrollment of subjects who meet the study eligibility criteria only 

Recruitment is proceeding as planned

The informed consent process is conducted appropriately; informed consent is 
obtained

Evaluate the progress of the trial, including periodic assessments of data quality and 
timeliness, recruitment, accrual and retention, participant risk versus benefit, and 
other factors that can affect study outcome

Consider factors external to the study when relevant information becomes available, 
such as scientific or therapeutic developments that may have an impact on the safety 
of the participants or the ethics of the trial

Review study performance, make recommendations, and assist in the resolution of 
problems reported by the PI

Evaluate data completeness and quality and as specified in the protocol 
Prior to proceeding with any study procedures:

Review the research protocol, informed consent documents and plans for data safety 
and monitoring

Protect the safety of the study participants

Ensure the confidentiality of the study data and the results of monitoring

Review procedures for the privacy and confidentiality of subjects 

Review cumulative attrition and attrition by gender and race/ethnicity

Review dropouts and ensure reason for withdrawal from the study are documented
The principal investigator will be responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews. During the review process the principal 
investigator will evaluate whether the study should continue unchanged, require 
modification/amendment, or close enrollment. The principal investigator and the 
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Institutional Review Board (IRB) and the NIA have the authority to stop or suspend the 
study or require modifications.
7.13 Study Modification
For any study modifications, we will update this study protocol. Then we will submit the 
updated protocol to Yale IRB for approval. Once approved the changes can be implemented 
in the study.
7.14 Study Discontinuation
N/A
7.15 Study Completion
The study will be completed by March 30th 2022. The PI will notify Yale IRB of the study 
completion.
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 
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.
 All investigators will follow the applicable conflict of interest policies.
7.17 Funding Source
The study is funded by the National Institute on Aging award number 3R01AG060084-04S1.
7.18 Publication Plan
At the completion of this study and the feasibility study for older adults with cognitive 
impairment, we expect to enhance the VOICES tool and create all related and necessary 
user guides. We anticipate that if feasible, VOICES will inform development of national Elder 
Mistreatment (EM)intervention and screening guidelines on a generalizable scale that will 
broaden the base for EM identification and intervention while closing health disparity gaps 
and respecting the autonomy of older adults. Yale University is committed to open and timely 
dissemination of research outcomes and is aware of and agrees to abide by the principles 
for sharing research resources. 
As a Clinical and Translational Science Awards (CTSA) site, Yale will share the study results 
with other CTSA institutions and academic or healthcare institutions that would find them 
useful. In addition, the research team will seek to broadly disseminate through publication in 
peer-reviewed journals and presentations at national meetings to share and demonstrate the 
findings and the lessons learned from this project.  We will seek to present at conferences 
such as the Gerontological Society of America annual meeting, the American Geriatrics 
Society annual meeting and the National Association of Adult Protective Services annual 
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meeting.  We will share the de-identified research data and results developed from this study 
so that other institutions can benefit from the improvements to current elder abuse and 
neglect interventions. With additional funding, our future plan is to disseminate the findings 
and further enhance VOICES to accommodate its use as a tool in the clinical setting at Yale 
New Haven Hospital, making it a standard of care and rollout within the Yale New Haven 
Hospital system. 
In accordance with the National Institutes of Health (NIH) policy to promote broad and 
responsible dissemination of information from NIH-funded clinical trials, we registered the 
VOICES trial on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03834870).  In 
addition, we will submit the VOICES trial results information to ClinicalTrials.gov. The results 
information will be submitted to ClinicalTrials.gov as outlined in the policy and according to 
the specific timelines stated in the policy (i.e. not later than 21 calendar days after the 
enrollment of the first participant).
The informed consent documents for the VOICES trial will include a specific statement 
relating to posting of clinical trial information at ClinicalTrials.gov and the trial number. 
Yale has an internal policy and mechanism in place to ensure that clinical trials registration 
and results reporting occur incompliance with the NIH policy requirements. Since 2012, the 
Yale ClinicalTrials.gov (CTgov) team has been housed at the Yale Center for Analytical 
Sciences (YCAS).  Through direct support from the Yale Center for Clinical Investigations 
(YCCI), the team assists researchers in all facets of using the ClinicalTrials.gov database. In 
addition, the Yale CTgov team provides guidance to Yale University with respect to clinical 
research study registration and results reporting as it pertains to regulatory compliance. For 
more information on the Yale ClinicalTrials.gov (CTgov) please visit their website at: 
(https://publichealth.yale.edu/ycas/clinical_trials_gov/).
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8 Appendices
Appendix #
Title
Section
Topic
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9 List of Tables
9.1.1.1
Table 1. Planned Data Analyses and Interpretation
Concept 
Question 
Outcomes of Interest 
Acceptability 
To what extent is VOICES 
satisfying to end-users?  
Participant satisfaction measured using post-use satisfaction survey with a 5-
point Likert response set. 
Demand 
To what extent is VOICES likely 
to be used? 
Size of target population of older adults in the YIMA measured by the number 
of subjects who were approached compared to the number of subjects enrolled.  
Implementation 
To what extent can VOICES be 
delivered to participants with CI 
in the ED?  
Degree of execution measured by % of potential participants approached who 
consent to participate in the feasibility study 
Success of execution measured by # of participants who used the tool to 
completion and reasons for not completing it as reported on post-survey 
Practicality 
To what extent can VOICES be 
carried out with older adults with 
CI without outside intervention? 
Efficiency of implementation measured by the average time (1) to consent & 
orient participants to the tool and (2) needed to complete VOICES documented 
by the RA; and (3) patients perceived time of VOICES as measured on post-
survey
Factors affecting implementation measured by the number and source of 
interruptions during participation documented by the RA; The number of 
participants who want their caregiver/family member present during study as 
documented by the RA 
Positive/Negative effects of VOICES measured by participants’ perceptions of 
safety concerns vs. benefits and the degree of engagement as reported on post-
survey
APPROVED BY THE YALE UNIVERSITY IRB 1/26/2022