Trial Outcomes & Findings for Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility) (NCT NCT05224843)
NCT ID: NCT05224843
Last Updated: 2023-07-17
Results Overview
Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80).
COMPLETED
PHASE1
80 participants
5-10 minutes before VOICES intervention use.
2023-07-17
Participant Flow
Participant milestones
| Measure |
Older Adults Enrolled in the Study
The number of eligible older adults who were enrolled in the VOICES study.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
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 80 participants who completed VOICES.
Baseline characteristics by cohort
| Measure |
Older Adults in Primary Care Setting
n=80 Participants
The number of eligible older adults enrolled in the Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) study in the primary care setting.
|
|---|---|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 7.87 • n=80 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=80 Participants
|
|
Education
High School not Completed
|
3 Participants
n=80 Participants
|
|
Education
High School Graduate or GED
|
10 Participants
n=80 Participants
|
|
Education
Some college or associate's degree program
|
14 Participants
n=80 Participants
|
|
Education
Associate's Degree
|
7 Participants
n=80 Participants
|
|
Education
College degree (bachelor's program)
|
9 Participants
n=80 Participants
|
|
Education
Graduate degree (master's program)
|
26 Participants
n=80 Participants
|
|
Education
Doctorate or professional degree
|
11 Participants
n=80 Participants
|
|
Household Income
Less than 25k
|
11 Participants
n=80 Participants
|
|
Household Income
Between 25k to 34k
|
3 Participants
n=80 Participants
|
|
Household Income
Between 35k to 49k
|
3 Participants
n=80 Participants
|
|
Household Income
Between 50k to 74k
|
15 Participants
n=80 Participants
|
|
Household Income
Between 75k to 99k
|
6 Participants
n=80 Participants
|
|
Household Income
Between 100k to 149k
|
14 Participants
n=80 Participants
|
|
Household Income
More than 150k
|
15 Participants
n=80 Participants
|
|
Household Income
Refused/Unknown
|
13 Participants
n=80 Participants
|
|
Marital Status
Single or Never Married
|
11 Participants
n=80 Participants
|
|
Marital Status
Widowed
|
8 Participants
n=80 Participants
|
|
Marital Status
Married or Co-habituating
|
45 Participants
n=80 Participants
|
|
Marital Status
Divorced
|
13 Participants
n=80 Participants
|
|
Marital Status
Separated
|
3 Participants
n=80 Participants
|
|
Marital Status
Other
|
0 Participants
n=80 Participants
|
|
Marital Status
Refused/Unknown
|
0 Participants
n=80 Participants
|
|
Employment Status
Retired/Not Employed
|
61 Participants
n=80 Participants
|
|
Employment Status
Part-time
|
6 Participants
n=80 Participants
|
|
Employment Status
Full-time
|
13 Participants
n=80 Participants
|
|
Living Arrangement
In my home
|
74 Participants
n=80 Participants
|
|
Living Arrangement
In someone else's home
|
2 Participants
n=80 Participants
|
|
Living Arrangement
Assisted living
|
4 Participants
n=80 Participants
|
|
Number of Household Members
|
2 persons
STANDARD_DEVIATION 0.84 • n=53 Participants • This is based off of those who do not live alone (N=53) out of the 80 participants who completed VOICES.
|
|
Internet Usage
Every Day
|
63 Participants
n=80 Participants
|
|
Internet Usage
1-2 Times a Week
|
4 Participants
n=80 Participants
|
|
Internet Usage
1-2 Times a Month
|
2 Participants
n=80 Participants
|
|
Internet Usage
Rarely
|
11 Participants
n=80 Participants
|
|
Confidence in Using Technology
|
6.74 units on a scale
STANDARD_DEVIATION 2.83 • n=80 Participants
|
|
Has Living Will
Yes
|
45 Participants
n=80 Participants
|
|
Has Living Will
No
|
30 Participants
n=80 Participants
|
|
Has Living Will
Unknown
|
5 Participants
n=80 Participants
|
|
Veteran Status
Yes
|
10 Participants
n=80 Participants
|
|
Veteran Status
No
|
70 Participants
n=80 Participants
|
|
Has Health Care Assistant
Yes
|
71 Participants
n=80 Participants
|
|
Has Health Care Assistant
No
|
6 Participants
n=80 Participants
|
|
Has Health Care Assistant
Unknown
|
3 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 5-10 minutes before VOICES intervention use.Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80).
Outcome measures
| Measure |
Older Adults Approached for the Study
n=97 Participants
The number of older adults approached for the study in the primary care setting.
|
|---|---|
|
Participation
|
80 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=80 Participants
The number of older adults approached for the study in the primary care setting.
|
|---|---|
|
Usage
|
80 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=80 Participants
The number of older adults approached for the study in the primary care setting.
|
|---|---|
|
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)
|
4.67 units on a scale
Standard Deviation 0.69
|
|
Acceptability
Ability to complete VOICES on their own on the iPad, without staff assistance (Scale 1)
|
4.60 units on a scale
Standard Deviation 0.74
|
|
Acceptability
Time to complete the tool on the iPad was short (Scale 2)
|
4.42 units on a scale
Standard Deviation 0.82
|
|
Acceptability
Participant felt engaged in the tool throughout the process (Scale 2)
|
4.29 units on a scale
Standard Deviation 0.96
|
|
Acceptability
Audio and visual aids of the tool were helpful (Scale 2)
|
4.15 units on a scale
Standard Deviation 0.98
|
|
Acceptability
Participant felt fonts, size and colors of text in the tool were appropriate and readable (Scale 2)
|
4.64 units on a scale
Standard Deviation 0.72
|
|
Acceptability
Using this tool on the iPad was very easy (Scale 2)
|
4.71 units on a scale
Standard Deviation 0.66
|
|
Acceptability
I was comfortable answering questions on the iPad (Scale 2)
|
4.75 units on a scale
Standard Deviation 0.61
|
|
Acceptability
Using the iPad and the headphones provided more privacy (Scale 2)
|
4.41 units on a scale
Standard Deviation 0.84
|
|
Acceptability
Participant feels comfortable discussing mistreatment with a doctor or medical professional (Scale2)
|
4.46 units on a scale
Standard Deviation 0.78
|
|
Acceptability
VOICES is appropriate for learning about mistreatment (Scale 2)
|
4.54 units on a scale
Standard Deviation 0.67
|
|
Acceptability
VOICES is appropriate to be used in primary care setting (Scale 2)
|
4.11 units on a scale
Standard Deviation 1.06
|
|
Acceptability
The participant was able to complete VOICES on the iPad on their own (Scale 2)
|
4.54 units on a scale
Standard Deviation 0.83
|
|
Acceptability
Using VOICES on the iPad was a frustrating experience (Scale 2)
|
1.74 units on a scale
Standard Deviation 1.10
|
|
Acceptability
The instructions provided by VOICES digital coach were clear and easy to follow (Scale 2)
|
4.70 units on a scale
Standard Deviation 0.56
|
|
Acceptability
Participant confidence understanding mistreatment and resources after using VOICES (Scale 2)
|
4.41 units on a scale
Standard Deviation 0.85
|
|
Acceptability
Participant feels safer after using VOICES on the iPad (Scale 2)
|
3.80 units on a scale
Standard Deviation 1.08
|
|
Acceptability
The participant learned new, useful things about elder mistreatment (Scale 2)
|
4.05 units on a scale
Standard Deviation 0.98
|
|
Acceptability
Participant would like to see VOICES used by others in the community (ie. doctor's office) (Scale 2)
|
4.47 units on a scale
Standard Deviation 0.76
|
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 elder mistreatment (EM) victims in the Primary Care setting will be measured by the percent who screen positive for EM and the percent who receive the Brief Negotiation Interview (BNI) portion of VOICES. The BNI is a method designed to enhance identifying EM among older adults-- the process intends to encourage reflection of the user with their behaviors and whether they are willing to seek change by identifying with and reporting their abuse.
Outcome measures
| Measure |
Older Adults Approached for the Study
n=80 Participants
The number of older adults approached for the study in the primary care setting.
|
|---|---|
|
Demand
Participants who screened positive for suspicion of elder mistreatment
|
6 Participants
|
|
Demand
Participants who self-identified with elder mistreatment
|
3 Participants
|
|
Demand
Participants who self-reported elder mistreatment
|
3 Participants
|
|
Demand
Participants who received the Brief Negotiated Interview (BNI) pathway
|
4 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=80 Participants
The number of older adults approached for the study in the primary care setting.
|
|---|---|
|
Practicality
Actual VOICES Duration
|
9.31 minutes
Standard Deviation 4.33
|
|
Practicality
Actual Consent Duration
|
14.09 minutes
Standard Deviation 4.54
|
|
Practicality
Participant estimated time to completion
|
18.38 minutes
Standard Deviation 11.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measure collected 5-10 minutes directly following VOICES intervention.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=4 Participants
The number of older adults approached for the study in the primary care setting.
|
|---|---|
|
Efficacy of the Brief Negotiation Interview
|
1 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=6).
To understand the accuracy of the VOICES tool, a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying elder mistreatment (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=6 Participants
The number of older adults approached for the study in the primary care setting.
|
|---|---|
|
Accuracy
Participants substantiated for elder mistreatment by the social worker
|
6 Participants
|
|
Accuracy
Participants referred to APS by the social worker
|
1 Participants
|
|
Accuracy
Cases referred to APS that were substantiated and opened
|
1 Participants
|
Adverse Events
Older Adults in Primary Care 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