NCT05224843: VOICES-PC

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

Completed Phase 1 Results posted Last updated 17 July 2023

What this trial tests

Phase 1 trial testing Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) in Elder Abuse in 80 participants. Completed in 22 June 2022.

Timeline

17 December 2021

Primary endpoint
22 June 2022

22 June 2022

Quick facts

Lead sponsor	Yale University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	80
Start date	17 December 2021
Primary completion	22 June 2022
Estimated completion	22 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

Conditions studied

• Elder Abuse — all drugs for Elder Abuse →

Sponsor

Yale University

Who can join

60 and older, any sex, with Elder Abuse. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participation Primary · 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).

Group	Value	95% CI
Older Adults Approached for the Study	80

Usage Primary · 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).

Group	Value	95% CI
Older Adults Enrolled in the Study	80

Acceptability Secondary · 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".

Level of confidentiality and privacy provided while using VOICES (Scale 1)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.45	± 0.96

The time it took to complete using the VOICES tool (Scale 1)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.67	± 0.69

Ability to complete VOICES on their own on the iPad, without staff assistance (Scale 1)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.60	± 0.74

Time to complete the tool on the iPad was short (Scale 2)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.42	± 0.82

Participant felt engaged in the tool throughout the process (Scale 2)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.29	± 0.96

Audio and visual aids of the tool were helpful (Scale 2)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.15	± 0.98

Participant felt fonts, size and colors of text in the tool were appropriate and readable (Scale 2)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.64	± 0.72

Using this tool on the iPad was very easy (Scale 2)

Group	Value	95% CI
Older Adults in Primary Care Setting	4.71	± 0.66

Demand Secondary · 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.

Participants who screened positive for suspicion of elder mistreatment

Group	Value	95% CI
Older Adults in Primary Care Setting	6

Participants who self-identified with elder mistreatment

Group	Value	95% CI
Older Adults in Primary Care Setting	3

Participants who self-reported elder mistreatment

Group	Value	95% CI
Older Adults in Primary Care Setting	3

Participants who received the Brief Negotiated Interview (BNI) pathway

Group	Value	95% CI
Older Adults in Primary Care Setting	4

Practicality Secondary · 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.

Actual VOICES Duration

Group	Value	95% CI
Older Adults in Primary Care Setting	9.31	± 4.33

Actual Consent Duration

Group	Value	95% CI
Older Adults in Primary Care Setting	14.09	± 4.54

Participant estimated time to completion

Group	Value	95% CI
Older Adults in Primary Care Setting	18.38	± 11.55

Efficacy of the Brief Negotiation Interview Secondary · 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)

Group	Value	95% CI
Older Adults Who Accessed Brief Negotiation Interview (BNI)	1

Accuracy Secondary · Measure 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.

Participants substantiated for elder mistreatment by the social worker

Group	Value	95% CI
Older Adults in Primary Care Setting	6

Participants referred to APS by the social worker

Group	Value	95% CI
Older Adults in Primary Care Setting	1

Cases referred to APS that were substantiated and opened

Group	Value	95% CI
Older Adults in Primary Care Setting	1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.