Trial Outcomes & Findings for Feasibility of Elder Mistreatment VOICES-CI Screening Tool (NCT NCT05216081)
NCT ID: NCT05216081
Last Updated: 2023-09-22
Results Overview
Participation will be determined by the number of patients with cognitive impairment enrolled in VOICES. Successful enrollment of 80 older adults (N=80).
COMPLETED
NA
102 participants
5-10 minutes before VOICES intervention use.
2023-09-22
Participant Flow
Participant milestones
| Measure |
Elder Adults Enrolled in the Study
Elder adults with cognitive impairments who were enrolled in the study.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This is based off of those who do not live alone (N=53) out of the 101 participants who completed VOICES.
Baseline characteristics by cohort
| Measure |
Elder Adults in Emergency Department Setting With Cognitive Impairment
n=101 Participants
Elder mistreatment in an Emergency Department setting with cognitive impairment.
Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES): Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.
|
|---|---|
|
Age, Continuous
|
76.9 years
STANDARD_DEVIATION 7.83 • n=101 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=101 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=101 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=101 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=101 Participants
|
|
Education
High School not Completed
|
15 Participants
n=101 Participants
|
|
Education
High School Graduate or GED
|
28 Participants
n=101 Participants
|
|
Education
Some college or associate's degree program
|
20 Participants
n=101 Participants
|
|
Education
Associate's Degree
|
7 Participants
n=101 Participants
|
|
Education
College degree (bachelor's program)
|
13 Participants
n=101 Participants
|
|
Education
Graduate degree (master's program)
|
15 Participants
n=101 Participants
|
|
Education
Doctorate or professional degree
|
3 Participants
n=101 Participants
|
|
Household Income
Less than 25k
|
31 Participants
n=101 Participants
|
|
Household Income
Between 25k to 34k
|
5 Participants
n=101 Participants
|
|
Household Income
Between 35k to 49k
|
7 Participants
n=101 Participants
|
|
Household Income
Between 50k to 74k
|
8 Participants
n=101 Participants
|
|
Household Income
Between 75k to 99k
|
7 Participants
n=101 Participants
|
|
Household Income
Between 100k to 149k
|
12 Participants
n=101 Participants
|
|
Household Income
More than 150k
|
6 Participants
n=101 Participants
|
|
Household Income
Refused/Unknown
|
25 Participants
n=101 Participants
|
|
Marital Status
Single or Never Married
|
28 Participants
n=101 Participants
|
|
Marital Status
Widowed
|
21 Participants
n=101 Participants
|
|
Marital Status
Married or Co-habituating
|
31 Participants
n=101 Participants
|
|
Marital Status
Divorced
|
18 Participants
n=101 Participants
|
|
Marital Status
Separated
|
1 Participants
n=101 Participants
|
|
Marital Status
Other
|
2 Participants
n=101 Participants
|
|
Marital Status
Refused/Unknown
|
0 Participants
n=101 Participants
|
|
Employment Status
Retired/Not Employed
|
85 Participants
n=101 Participants
|
|
Employment Status
Part-time
|
11 Participants
n=101 Participants
|
|
Employment Status
Full-time
|
5 Participants
n=101 Participants
|
|
Living Arrangement
In my home
|
92 Participants
n=101 Participants
|
|
Living Arrangement
In someone else's home
|
6 Participants
n=101 Participants
|
|
Living Arrangement
Assisted living
|
3 Participants
n=101 Participants
|
|
Number of Household Members
|
2 persons
STANDARD_DEVIATION 0.96 • n=53 Participants • This is based off of those who do not live alone (N=53) out of the 101 participants who completed VOICES.
|
|
Internet Usage
Every Day
|
61 Participants
n=101 Participants
|
|
Internet Usage
1-2 Times a Week
|
12 Participants
n=101 Participants
|
|
Internet Usage
1-2 Times a Month
|
4 Participants
n=101 Participants
|
|
Internet Usage
Rarely
|
24 Participants
n=101 Participants
|
|
Confidence in Using Technology
|
6.2 units on a scale
STANDARD_DEVIATION 2.74 • n=101 Participants
|
|
Has Living Will
Yes
|
55 Participants
n=101 Participants
|
|
Has Living Will
Unknown
|
4 Participants
n=101 Participants
|
|
Has Living Will
No
|
42 Participants
n=101 Participants
|
|
Veteran Status
Yes
|
15 Participants
n=101 Participants
|
|
Veteran Status
No
|
86 Participants
n=101 Participants
|
|
Has Health Care Assistant
Yes
|
84 Participants
n=101 Participants
|
|
Has Health Care Assistant
Unknown
|
3 Participants
n=101 Participants
|
|
Has Health Care Assistant
No
|
14 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: 5-10 minutes before VOICES intervention use.Participation will be determined by the number of patients with cognitive impairment enrolled in VOICES. Successful enrollment of 80 older adults (N=80).
Outcome measures
| Measure |
Older Adults Approached for the Study
n=147 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Participation
|
102 Participants
|
PRIMARY outcome
Timeframe: 5-10 minutes directly following VOICES intervention.Usage will be determined by the number of patients enrolled in the study that complete the VOICES tool. Our target is to enroll 80 older adults (N=80).
Outcome measures
| Measure |
Older Adults Approached for the Study
n=102 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Usage
|
101 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5-10 minutes directly following VOICES intervention use.Participant satisfaction will be measured using post-use satisfaction survey. Responses will be measured via two 5-point Likert scales where generally higher values represent better outcomes: Scale 1- Satisfaction: Where 1= "Very Dissatisfied", 2= "Dissatisfied", 3= "Neutral", 4= "Satisfied", and 5= "Very Satisfied". Scale 2- Agreement: Where 1= "Strongly Disagree", 2= "Disagree", 3= "Neutral", 4= "Agree", and and 5= "Strongly Agree".
Outcome measures
| Measure |
Older Adults Approached for the Study
n=101 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Acceptability
Level of confidentiality and privacy provided while using VOICES (Scale 1)
|
4.45 units on a scale
Standard Deviation 0.96
|
|
Acceptability
The time it took to complete using the VOICES tool (Scale 1)
|
4.12 units on a scale
Standard Deviation 1.08
|
|
Acceptability
Ability to complete VOICES on their own on the iPad, without staff assistance (Scale 1)
|
4.28 units on a scale
Standard Deviation 0.93
|
|
Acceptability
Time to complete the tool on the iPad was short (Scale 2)
|
3.72 units on a scale
Standard Deviation 1.06
|
|
Acceptability
Participant felt engaged in the tool throughout the process (Scale 2)
|
4.07 units on a scale
Standard Deviation 0.73
|
|
Acceptability
Audio and visual aids of the tool were helpful (Scale 2)
|
4.46 units on a scale
Standard Deviation 0.70
|
|
Acceptability
Participant felt fonts, size and colors of text in the tool were appropriate and readable (Scale 2)
|
4.55 units on a scale
Standard Deviation 0.61
|
|
Acceptability
Using this tool on the iPad was very easy (Scale 2)
|
4.52 units on a scale
Standard Deviation 0.64
|
|
Acceptability
I was comfortable answering questions on the iPad (Scale 2)
|
4.56 units on a scale
Standard Deviation 0.67
|
|
Acceptability
Using the iPad and the headphones provided more privacy (Scale 2)
|
4.36 units on a scale
Standard Deviation 0.84
|
|
Acceptability
Participant feels comfortable discussing mistreatment with a doctor or medical professional (Scale2)
|
4.31 units on a scale
Standard Deviation 0.86
|
|
Acceptability
VOICES is appropriate for learning about mistreatment (Scale 2)
|
4.40 units on a scale
Standard Deviation 0.86
|
|
Acceptability
VOICES is appropriate to be used in the emergency department (Scale 2)
|
4.19 units on a scale
Standard Deviation 0.85
|
|
Acceptability
The participant was able to complete VOICES on the iPad on their own (Scale 2)
|
4.19 units on a scale
Standard Deviation 0.90
|
|
Acceptability
Using VOICES on the iPad was a frustrating experience (Scale 2)
|
1.95 units on a scale
Standard Deviation 1.05
|
|
Acceptability
The instructions provided by VOICES digital coach were clear and easy to follow (Scale 2)
|
4.53 units on a scale
Standard Deviation 0.58
|
|
Acceptability
Participant confidence understanding mistreatment and resources after using VOICES (Scale 2)
|
4.40 units on a scale
Standard Deviation 0.70
|
|
Acceptability
Participant feels safer after using VOICES on the iPad (Scale 2)
|
4.19 units on a scale
Standard Deviation 0.87
|
|
Acceptability
The participant learned new, useful things about elder mistreatment (Scale 2)
|
4.18 units on a scale
Standard Deviation 0.87
|
|
Acceptability
Participant would like to see VOICES used by others in the community (ie. doctor's office) (Scale 2)
|
4.31 units on a scale
Standard Deviation 0.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5-10 minutes directly following VOICES intervention use.Demand will be assess through examining how likely will VOICES be used by patients. To do this, the size of target population of EM victims in the ED will be measured by the percent who screen positive for EM and the percent who receive the Brief Negotiation Interview (BNI) portion of VOICES.
Outcome measures
| Measure |
Older Adults Approached for the Study
n=101 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Demand
Participants who screened positive for elder mistreatment
|
16 Participants
|
|
Demand
Participants who received the BNI
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Actual time duration is assessed during VOICES use by the computer program (the actual duration of the patient's time using VOICES). Estimation of completed time is completed 5-10 minutes directly following VOICES intervention use.Practicality will be assessed by observing the ease of VOICES use by patients. To do this, a series of steps will be watched to determine the 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 Research Assistant; and (3) patients perceived time of VOICES as measured on post-survey. Each of these will be reported as part of the overall outcome.
Outcome measures
| Measure |
Older Adults Approached for the Study
n=101 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Practicality
Actual VOICES Duration
|
9.51 minutes
Standard Deviation 5.05
|
|
Practicality
Actual Consent Duration
|
19.08 minutes
Standard Deviation 5.20
|
|
Practicality
Participant Estimated Time to Completion
|
24.20 minutes
Standard Deviation 18.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measure collected 5-10 minutes directly following VOICES intervention.Population: The number of older adults who accessed the customized Brief Negotiation Interview (BNI) section of the VOICES program (N=5) out of the enrolled older adults who completed the study (N=101).
To look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI)
Outcome measures
| Measure |
Older Adults Approached for the Study
n=5 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Efficacy of the Brief Negotiation Interview
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measure collected 5-10 minutes directly following VOICES intervention.Population: The number of older adults who self-identified with elder mistreatment through the VOICES program (N=14) out of the enrolled older adults who completed the study (N=101).
To explore whether self-identification impacts likelihood of self-disclosure for participants who first self-identified with elder mistreatment. Effect-size estimation measured by change in the percent of patients who disclose.
Outcome measures
| Measure |
Older Adults Approached for the Study
n=14 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Number of Participants for Which Self-Identification of Elder Mistreatment Impacted Likelihood of Self-Disclosure
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measure collected up to directly following VOICES intervention to 1 week following VOICES intervention.Population: The number of participants who used VOICES to completion and screened positive for suspicion of elder mistreatment (n=16).
To understand the accuracy of the VOICES tool, a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were referred to Adult Protective Services (APS). The percent correct classification will be reported.
Outcome measures
| Measure |
Older Adults Approached for the Study
n=16 Participants
The number of older adults approached for the study in the emergency department setting with cognitive impairments following initial screening criteria.
|
|---|---|
|
Accuracy
Participants referred to APS by the social worker
|
1 Participants
|
|
Accuracy
Participants substantiated for elder mistreatment or other services by the social worker
|
10 Participants
|
|
Accuracy
Cases referred to APS that were substantiated and opened
|
1 Participants
|
Adverse Events
Elder Adults in Emergency Department Setting With Cognitive Impairment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place