Trial Outcomes & Findings for Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) (NCT NCT03834870)
NCT ID: NCT03834870
Last Updated: 2023-04-20
Results Overview
Participation will be determined by the ratio of participants who are successfully enrolled to the total number of eligible patients. The numerator, denominator, frequencies and 95% confidence intervals will be reported.
COMPLETED
EARLY_PHASE1
1012 participants
up to 16 months
2023-04-20
Participant Flow
Participant milestones
| Measure |
Elder Adults in Emergency Department Setting
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Overall Study
STARTED
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1012
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Overall Study
COMPLETED
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1002
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Baseline characteristics by cohort
| Measure |
Elder Adults in Emergency Department Setting
n=1002 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Age, Continuous
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73.5 years
STANDARD_DEVIATION 9.04 • n=5 Participants
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Age, Customized
60-69
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392 Participants
n=5 Participants
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Age, Customized
70-79
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370 Participants
n=5 Participants
|
|
Age, Customized
80-89
|
177 Participants
n=5 Participants
|
|
Age, Customized
90+
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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594 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
408 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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49 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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938 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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298 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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673 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
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Region of Enrollment
United States
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1002 participants
n=5 Participants
|
|
Education
Associate's Degree
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46 Participants
n=5 Participants
|
|
Education
Undergraduate Degree (Bachelor's program or equivalent)
|
192 Participants
n=5 Participants
|
|
Education
Professional Degree (Master's program or equivalent)
|
138 Participants
n=5 Participants
|
|
Education
High School Graduate or GED
|
290 Participants
n=5 Participants
|
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Education
High School Not Completed
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92 Participants
n=5 Participants
|
|
Education
Refused/Unknown
|
4 Participants
n=5 Participants
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|
Education
Some college
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240 Participants
n=5 Participants
|
|
Household Income
Less than 25k
|
291 Participants
n=5 Participants
|
|
Household Income
Between 25k to 34k
|
122 Participants
n=5 Participants
|
|
Household Income
Between 35k to 49k
|
111 Participants
n=5 Participants
|
|
Household Income
Between 50k to 74k
|
116 Participants
n=5 Participants
|
|
Household Income
Between 75k to 99k
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63 Participants
n=5 Participants
|
|
Household Income
Between 100k to 149k
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53 Participants
n=5 Participants
|
|
Household Income
More than 150k
|
42 Participants
n=5 Participants
|
|
Household Income
Refused/Unknown
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204 Participants
n=5 Participants
|
|
Marital Status
Single or Never Married
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233 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
221 Participants
n=5 Participants
|
|
Marital Status
Married or Co-habituating
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360 Participants
n=5 Participants
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Marital Status
Divorced
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157 Participants
n=5 Participants
|
|
Marital Status
Separated
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19 Participants
n=5 Participants
|
|
Marital Status
Other
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7 Participants
n=5 Participants
|
|
Marital Status
Refused/Unknown
|
5 Participants
n=5 Participants
|
|
Employment Status
Full Time
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103 Participants
n=5 Participants
|
|
Employment Status
Not Employed/Retired
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840 Participants
n=5 Participants
|
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Employment Status
Part Time
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56 Participants
n=5 Participants
|
|
Employment Status
Refused/Unknown
|
3 Participants
n=5 Participants
|
|
Living Arrangement
In Their Own Home
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936 Participants
n=5 Participants
|
|
Living Arrangement
In Someone Else's Home
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42 Participants
n=5 Participants
|
|
Living Arrangement
Assisted Living
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24 Participants
n=5 Participants
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Number of Household Members
|
2 persons
STANDARD_DEVIATION 1.1 • n=5 Participants
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Internet Usage
Every Day
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530 Participants
n=5 Participants
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Internet Usage
1-2 Times a Week
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157 Participants
n=5 Participants
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Internet Usage
1-2 Times a Month
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32 Participants
n=5 Participants
|
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Internet Usage
Rarely
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280 Participants
n=5 Participants
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Internet Usage
Refused/Unknown
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3 Participants
n=5 Participants
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Confidence in Using Technology
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6.9 units on a scale
STANDARD_DEVIATION 2.91 • n=5 Participants
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PRIMARY outcome
Timeframe: up to 16 monthsPopulation: The total number of eligible participants.
Participation will be determined by the ratio of participants who are successfully enrolled to the total number of eligible patients. The numerator, denominator, frequencies and 95% confidence intervals will be reported.
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=1204 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Implementation in Terms of Participation
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1012 Participants
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PRIMARY outcome
Timeframe: up to 16 monthsPopulation: The number of participants who were enrolled in the study (n=1,012)/
Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=1012 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Implementation in Terms of Usage
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1002 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 16 monthsPopulation: The number of participants who successfully used VOICES to completion.
Participant satisfaction will be measured along multiple dimensions using post-use satisfaction survey with two 5-point Likert response set scales, developed by the research team. Scale 1: Likert scale 1-5, where 1= Very Dissatisfied, and 5= Very Satisfied Scale 2: Likert scale 1-5, where 1= Strongly Disagree, and 5= Strongly Agree
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=1002 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Acceptability
Level of confidentiality and privacy provided while using this tool (Scale 1)
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4.57 units on a scale
Standard Deviation 0.76
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Acceptability
The time it took to complete using the VOICES tool (Scale 1)
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4.44 units on a scale
Standard Deviation 0.81
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Acceptability
Your ability to complete the VOICES tool on your own on the iPad, without any staff (Scale 1)
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4.5 units on a scale
Standard Deviation 0.81
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Acceptability
Time to complete the tool on the iPad was short (Scale 2)
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4.11 units on a scale
Standard Deviation 0.98
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Acceptability
I felt engaged in the tool throughout the process (Scale 2)
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4.29 units on a scale
Standard Deviation 0.81
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Acceptability
Audio and visual aids of the tool were helpful (Scale 2)
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4.41 units on a scale
Standard Deviation 0.75
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Acceptability
I felt the fonts, size and the colors of the text in the tool were appropriate and readable (Scale2)
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4.53 units on a scale
Standard Deviation 0.68
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Acceptability
Using this tool on the iPad was very easy (Scale 2)
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4.53 units on a scale
Standard Deviation 0.67
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Acceptability
I was comfortable answering questions on the iPad (Scale 2)
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4.56 units on a scale
Standard Deviation 0.65
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Acceptability
Using the iPad and the headphones provided more privacy (Scale 2)
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4.5 units on a scale
Standard Deviation 0.70
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Acceptability
I feel comfortable discussing mistreatment with a doctor or medical professional (Scale 2)
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4.4 units on a scale
Standard Deviation 0.80
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Acceptability
This tool is appropriate for learning about mistreatment (Scale 2)
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4.54 units on a scale
Standard Deviation 0.66
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Acceptability
This tool is appropriate to be used in the emergency department (Scale 2)
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4.41 units on a scale
Standard Deviation 0.73
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Acceptability
I was able to complete VOICES on the iPad on my own (Scale 2)
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4.40 units on a scale
Standard Deviation 0.80
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Acceptability
Using VOICES on the iPad was a frustrating experience (Scale 2)
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1.87 units on a scale
Standard Deviation 1.30
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Acceptability
The instructions provided by Vicky were clear and easy to follow (Scale 2)
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4.59 units on a scale
Standard Deviation 0.61
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Acceptability
I feel more confident about understanding EM/resources in case I/someone else I know is mistreated
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4.50 units on a scale
Standard Deviation 0.67
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Acceptability
I feel safer after using VOICES on the iPad (Scale 2)
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4.21 units on a scale
Standard Deviation 0.89
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Acceptability
I learned new, useful things about elder mistreatment (Scale 2)
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4.34 units on a scale
Standard Deviation 0.68
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Acceptability
I would like to see this used by other older adults in the community such as the doctor's office (2)
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4.52 units on a scale
Standard Deviation 0.68
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 16 monthsPopulation: The number of participants who successfully used VOICES to completion.
Demand will be assessed 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 % of the patients who self-identified with elder mistreatment and the % who receive the Brief Negotiation Interview (BNI) portion of VOICES.
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=1002 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Demand
Participants who received the BNI
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71 Participants
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Demand
Participants who self-identified with elder mistreatment
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67 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 16 monthsPopulation: The number of participants who successfully used VOICES to completion.
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 |
Elder Adults in Emergency Department Setting
n=1002 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Practicality
Actual Consent Duration
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14.9 minutes
Standard Deviation 5.9
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Practicality
Participant Estimated Time to Completion
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12.2 minutes
Standard Deviation 9.1
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Practicality
Actual VOICES Duration
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8.8 minutes
Standard Deviation 5.4
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 16 monthsPopulation: The number of participants who successfully used VOICES to completion.
To understand the efficacy of VOICES in this pilot, we will look at how many participants changed their self-identification response after completing the educational component.
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=1002 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Efficacy of the Educational Material
Overall participants who changed their self-identification response
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40 Participants
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Efficacy of the Educational Material
"Yes" (does self-identify) response changed to "No" (does not self-identify) response
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21 Participants
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Efficacy of the Educational Material
"No" (does not self-identify) response changed to "Yes" (does self-identify) response
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19 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 16 monthsPopulation: The number of participants who successfully used VOICES to completion and accessed the self-disclosure Brief Negotiation Interview (N=18).
We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=18 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Efficacy of the Brief Negotiation Interview
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3 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 16 monthsPopulation: The number of participants who self-identified with elder mistreatment.
We will explore whether self-identification impacts likelihood of self-disclosure. Effect-size estimation measured by change in the % of patients who disclose among those who self-identified.
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=67 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Efficacy of Self-Identification on Self-Disclosure
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49 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: up to 16 monthsPopulation: The number of participants who used VOICES to completion and screened positive for suspicion of elder mistreatment (n=112).
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 positive based on social worker assessment, and those referred to Adult Protective Services (APS). The percent correct classification will be reported.
Outcome measures
| Measure |
Elder Adults in Emergency Department Setting
n=112 Participants
Elder mistreatment in an Emergency Department setting.
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.
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|---|---|
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Accuracy
Participants substantiated for elder mistreatment
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49 Participants
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Accuracy
Of the substantiated participants, participants referred to Adult Protective Services (APS)
|
11 Participants
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Accuracy
Referred APS cases accepted and opened by APS
|
11 Participants
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Adverse Events
Elder Adults in Emergency Department Setting
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