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Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)

The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05224843
Acronym
VOICES-PC
Enrollment
80
Registered
2022-02-04
Start date
2021-12-17
Completion date
2022-06-22
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elder Abuse

Brief summary

To test an interactive intervention to screen for Elder Abuse and Mistreatment (EM) in the Primary Care (PC) setting to promote self-identification and self-disclosure of EM.

Detailed description

The aim of this study is to perform a feasibility evaluation (N=80) of the VOICES screening tool among older adults in the primary care setting. If VOICES is feasible for identifying suspicion of EM in primary care setting, then it will be able to connect more victims of EM to necessary services and potentially prevent a multitude of poor EM outcomes

Interventions

Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

VOICES Elder Abuse Intervention

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 60 years or older * Alert and oriented to person and place * Abbreviated Mental Test (AMT-4) score of 4 * Able to consent and communicate in English * Agrees and able to use the iPad

Exclusion criteria

* subjects who live in nursing homes or other long-term care sitting and do not reside in community setting * patients will be excluded if they cannot safely undergo the studies required for participation * subjects with clear signs of EM * Patient or clinician refusal to participate * severe hearing and vision impairment * COVID-19 positive

Design outcomes

Primary

MeasureTime frameDescription
Participation5-10 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).
Usage5-10 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).

Other

MeasureTime frameDescription
PracticalityActual 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.
Acceptability5-10 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.
AccuracyMeasure collected up to directly following VOICES intervention to 1 week following VOICES intervention.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.
Efficacy of the Brief Negotiation InterviewMeasure 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)
Demand5-10 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Older Adults in Primary Care Setting
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.
80
Total80

Baseline characteristics

CharacteristicOlder Adults in Primary Care Setting
Age, Continuous75.1 years
STANDARD_DEVIATION 7.87
Confidence in Using Technology6.74 units on a scale
STANDARD_DEVIATION 2.83
Education
Associate's Degree
7 Participants
Education
College degree (bachelor's program)
9 Participants
Education
Doctorate or professional degree
11 Participants
Education
Graduate degree (master's program)
26 Participants
Education
High School Graduate or GED
10 Participants
Education
High School not Completed
3 Participants
Education
Some college or associate's degree program
14 Participants
Employment Status
Full-time
13 Participants
Employment Status
Part-time
6 Participants
Employment Status
Retired/Not Employed
61 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
76 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Has Health Care Assistant
No
6 Participants
Has Health Care Assistant
Unknown
3 Participants
Has Health Care Assistant
Yes
71 Participants
Has Living Will
No
30 Participants
Has Living Will
Unknown
5 Participants
Has Living Will
Yes
45 Participants
Household Income
Between 100k to 149k
14 Participants
Household Income
Between 25k to 34k
3 Participants
Household Income
Between 35k to 49k
3 Participants
Household Income
Between 50k to 74k
15 Participants
Household Income
Between 75k to 99k
6 Participants
Household Income
Less than 25k
11 Participants
Household Income
More than 150k
15 Participants
Household Income
Refused/Unknown
13 Participants
Internet Usage
1-2 Times a Month
2 Participants
Internet Usage
1-2 Times a Week
4 Participants
Internet Usage
Every Day
63 Participants
Internet Usage
Rarely
11 Participants
Living Arrangement
Assisted living
4 Participants
Living Arrangement
In my home
74 Participants
Living Arrangement
In someone else's home
2 Participants
Marital Status
Divorced
13 Participants
Marital Status
Married or Co-habituating
45 Participants
Marital Status
Other
0 Participants
Marital Status
Refused/Unknown
0 Participants
Marital Status
Separated
3 Participants
Marital Status
Single or Never Married
11 Participants
Marital Status
Widowed
8 Participants
Number of Household Members2 persons
STANDARD_DEVIATION 0.84
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
13 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
66 Participants
Region of Enrollment
United States
80 participants
Sex: Female, Male
Female
49 Participants
Sex: Female, Male
Male
31 Participants
Veteran Status
No
70 Participants
Veteran Status
Yes
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 80
other
Total, other adverse events
0 / 80
serious
Total, serious adverse events
0 / 80

Outcome results

Primary

Participation

Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80).

Time frame: 5-10 minutes before VOICES intervention use.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Older Adults Approached for the StudyParticipation80 Participants
95% CI: [73.7, 88.8]
Primary

Usage

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).

Time frame: 5-10 minutes directly following VOICES intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Older Adults Approached for the StudyUsage80 Participants
95% CI: [95.4, 100]
Other Pre-specified

Acceptability

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.

Time frame: 5-10 minutes directly following VOICES intervention use.

ArmMeasureGroupValue (MEAN)Dispersion
Older Adults Approached for the StudyAcceptabilityLevel of confidentiality and privacy provided while using VOICES (Scale 1)4.45 units on a scaleStandard Deviation 0.96
Older Adults Approached for the StudyAcceptabilityThe time it took to complete using the VOICES tool (Scale 1)4.67 units on a scaleStandard Deviation 0.69
Older Adults Approached for the StudyAcceptabilityAbility to complete VOICES on their own on the iPad, without staff assistance (Scale 1)4.60 units on a scaleStandard Deviation 0.74
Older Adults Approached for the StudyAcceptabilityTime to complete the tool on the iPad was short (Scale 2)4.42 units on a scaleStandard Deviation 0.82
Older Adults Approached for the StudyAcceptabilityParticipant felt engaged in the tool throughout the process (Scale 2)4.29 units on a scaleStandard Deviation 0.96
Older Adults Approached for the StudyAcceptabilityAudio and visual aids of the tool were helpful (Scale 2)4.15 units on a scaleStandard Deviation 0.98
Older Adults Approached for the StudyAcceptabilityParticipant felt fonts, size and colors of text in the tool were appropriate and readable (Scale 2)4.64 units on a scaleStandard Deviation 0.72
Older Adults Approached for the StudyAcceptabilityUsing this tool on the iPad was very easy (Scale 2)4.71 units on a scaleStandard Deviation 0.66
Older Adults Approached for the StudyAcceptabilityI was comfortable answering questions on the iPad (Scale 2)4.75 units on a scaleStandard Deviation 0.61
Older Adults Approached for the StudyAcceptabilityUsing the iPad and the headphones provided more privacy (Scale 2)4.41 units on a scaleStandard Deviation 0.84
Older Adults Approached for the StudyAcceptabilityParticipant feels comfortable discussing mistreatment with a doctor or medical professional (Scale2)4.46 units on a scaleStandard Deviation 0.78
Older Adults Approached for the StudyAcceptabilityVOICES is appropriate for learning about mistreatment (Scale 2)4.54 units on a scaleStandard Deviation 0.67
Older Adults Approached for the StudyAcceptabilityVOICES is appropriate to be used in primary care setting (Scale 2)4.11 units on a scaleStandard Deviation 1.06
Older Adults Approached for the StudyAcceptabilityThe participant was able to complete VOICES on the iPad on their own (Scale 2)4.54 units on a scaleStandard Deviation 0.83
Older Adults Approached for the StudyAcceptabilityUsing VOICES on the iPad was a frustrating experience (Scale 2)1.74 units on a scaleStandard Deviation 1.1
Older Adults Approached for the StudyAcceptabilityThe instructions provided by VOICES digital coach were clear and easy to follow (Scale 2)4.70 units on a scaleStandard Deviation 0.56
Older Adults Approached for the StudyAcceptabilityParticipant confidence understanding mistreatment and resources after using VOICES (Scale 2)4.41 units on a scaleStandard Deviation 0.85
Older Adults Approached for the StudyAcceptabilityParticipant feels safer after using VOICES on the iPad (Scale 2)3.80 units on a scaleStandard Deviation 1.08
Older Adults Approached for the StudyAcceptabilityThe participant learned new, useful things about elder mistreatment (Scale 2)4.05 units on a scaleStandard Deviation 0.98
Older Adults Approached for the StudyAcceptabilityParticipant would like to see VOICES used by others in the community (ie. doctor's office) (Scale 2)4.47 units on a scaleStandard Deviation 0.76
Other Pre-specified

Accuracy

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.

Time frame: 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).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Older Adults Approached for the StudyAccuracyParticipants substantiated for elder mistreatment by the social worker6 Participants
Older Adults Approached for the StudyAccuracyParticipants referred to APS by the social worker1 Participants
Older Adults Approached for the StudyAccuracyCases referred to APS that were substantiated and opened1 Participants
95% CI: [3.6, 62.4]
Other Pre-specified

Demand

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.

Time frame: 5-10 minutes directly following VOICES intervention use.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Older Adults Approached for the StudyDemandParticipants who screened positive for suspicion of elder mistreatment6 Participants
Older Adults Approached for the StudyDemandParticipants who self-identified with elder mistreatment3 Participants
Older Adults Approached for the StudyDemandParticipants who self-reported elder mistreatment3 Participants
Older Adults Approached for the StudyDemandParticipants who received the Brief Negotiated Interview (BNI) pathway4 Participants
95% CI: [3.5, 15.4]
Other Pre-specified

Efficacy of the Brief Negotiation Interview

To look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI)

Time frame: Measure collected 5-10 minutes directly following VOICES intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Older Adults Approached for the StudyEfficacy of the Brief Negotiation Interview1 Participants
95% CI: [4.6, 69.9]
Other Pre-specified

Practicality

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Older Adults Approached for the StudyPracticalityActual VOICES Duration9.31 minutesStandard Deviation 4.33
Older Adults Approached for the StudyPracticalityActual Consent Duration14.09 minutesStandard Deviation 4.54
Older Adults Approached for the StudyPracticalityParticipant estimated time to completion18.38 minutesStandard Deviation 11.55

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026