An Early Phase 1 interventional study of Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) in Elder Abuse, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Yale University · Early Phase 1, Interventional, and Screening
To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency Department (ED) to promote self-disclosure.
To develop and refine the interactive VOICES tool, which will promote self-identification and self-disclosure to increase reporting of EM at point-of-care in the Emergency Department (ED) setting. Prior to conducting a feasibility study, focus groups will be conducted to inform the process and to develop a tool to evaluate the use of VOICES.
Feasibility Study: To conduct a feasibility study (N= 800) examining the use of VOICES in a busy ED.
Exploratory Aim: To perform 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).
Yale University is the lead sponsor of 1,763 studies on the registry; 290 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 129 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elder mistreatment in an Emergency Department setting.
Behavioral: 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.
Implementation in Terms of Participation
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.
Time frame: up to 16 months
Implementation in Terms of Usage
Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.
Time frame: up to 16 months
Acceptability
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
Time frame: up to 16 months
Demand
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.
Time frame: up to 16 months
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: up to 16 months
Efficacy of the Educational Material
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.
Time frame: up to 16 months
Efficacy of the Brief Negotiation Interview
We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).
Time frame: up to 16 months
Efficacy of Self-Identification on Self-Disclosure
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.
Time frame: up to 16 months
Accuracy
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.
Time frame: up to 16 months
| Milestone | Elder Adults in Emergency Department Setting |
|---|---|
| Started | 1012 |
| Completed | 1002 |
| Not completed | 10 |
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.
| Participants | Elder Adults in Emergency Department Setting |
|---|---|
| Implementation in Terms of Participation | 1012 |
Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.
| Participants | Elder Adults in Emergency Department Setting |
|---|---|
| Implementation in Terms of Usage | 1002 |
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
| units on a scale | Elder Adults in Emergency Department Setting |
|---|---|
| Level of confidentiality and privacy provided while using this tool (Scale 1) | 4.57 ± 0.76 |
| The time it took to complete using the VOICES tool (Scale 1) | 4.44 ± 0.81 |
| Your ability to complete the VOICES tool on your own on the iPad, without any staff (Scale 1) | 4.5 ± 0.81 |
| Time to complete the tool on the iPad was short (Scale 2) | 4.11 ± 0.98 |
| I felt engaged in the tool throughout the process (Scale 2) | 4.29 ± 0.81 |
| Audio and visual aids of the tool were helpful (Scale 2) | 4.41 ± 0.75 |
| I felt the fonts, size and the colors of the text in the tool were appropriate and readable (Scale2) | 4.53 ± 0.68 |
| Using this tool on the iPad was very easy (Scale 2) | 4.53 ± 0.67 |
| I was comfortable answering questions on the iPad (Scale 2) | 4.56 ± 0.65 |
| Using the iPad and the headphones provided more privacy (Scale 2) | 4.5 ± 0.70 |
| I feel comfortable discussing mistreatment with a doctor or medical professional (Scale 2) | 4.4 ± 0.80 |
| This tool is appropriate for learning about mistreatment (Scale 2) | 4.54 ± 0.66 |
| This tool is appropriate to be used in the emergency department (Scale 2) | 4.41 ± 0.73 |
| I was able to complete VOICES on the iPad on my own (Scale 2) | 4.40 ± 0.80 |
| Using VOICES on the iPad was a frustrating experience (Scale 2) | 1.87 ± 1.30 |
| The instructions provided by Vicky were clear and easy to follow (Scale 2) | 4.59 ± 0.61 |
| I feel more confident about understanding EM/resources in case I/someone else I know is mistreated | 4.50 ± 0.67 |
| I feel safer after using VOICES on the iPad (Scale 2) | 4.21 ± 0.89 |
| I learned new, useful things about elder mistreatment (Scale 2) | 4.34 ± 0.68 |
| I would like to see this used by other older adults in the community such as the doctor's office (2) | 4.52 ± 0.68 |
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.
| Participants | Elder Adults in Emergency Department Setting |
|---|---|
| Participants who received the BNI | 71 |
| Participants who self-identified with elder mistreatment | 67 |
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.
| minutes | Elder Adults in Emergency Department Setting |
|---|---|
| Actual VOICES Duration | 8.8 ± 5.4 |
| Actual Consent Duration | 14.9 ± 5.9 |
| Participant Estimated Time to Completion | 12.2 ± 9.1 |
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.
| Participants | Elder Adults in Emergency Department Setting |
|---|---|
| Overall participants who changed their self-identification response | 40 |
| "Yes" (does self-identify) response changed to "No" (does not self-identify) response | 21 |
| "No" (does not self-identify) response changed to "Yes" (does self-identify) response | 19 |
We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).
| Participants | Participants Who Accessed Self-disclosure Brief Negotiation Interview |
|---|---|
| Efficacy of the Brief Negotiation Interview | 3 |
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.
| Participants | Elder Adults in Emergency Department Setting |
|---|---|
| Efficacy of Self-Identification on Self-Disclosure | 49 |
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.
| Participants | Participant Group Who Screened Positive for Suspicion of Elder Mistreatment |
|---|---|
| Participants substantiated for elder mistreatment | 49 |
| Of the substantiated participants, participants referred to Adult Protective Services (APS) | 11 |
| Referred APS cases accepted and opened by APS | 11 |
Collected over Up to 16 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Elder Adults in Emergency Department Setting | 0/1,012 (0%) | 0/1,012 (0%) | 0/1,012 (0%) |
| Age, Continuous(years) | Elder Adults in Emergency Department Setting |
|---|---|
| Mean | 73.5 ± 9.04 |
| Age, Customized(Participants) | Elder Adults in Emergency Department Setting |
|---|---|
| 60-69 | 392 |
| 70-79 | 370 |
| 80-89 | 177 |
| 90+ | 63 |
| Sex: Female, Male(Participants) | Elder Adults in Emergency Department Setting |
|---|---|
| Female | 594 |
| Male | 408 |
| Ethnicity (NIH/OMB)(Participants) | Elder Adults in Emergency Department Setting |
|---|---|
| Hispanic or Latino | 49 |
| Not Hispanic or Latino | 938 |
| Unknown or Not Reported | 15 |
| Race (NIH/OMB)(Participants) | Elder Adults in Emergency Department Setting |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 298 |
| White | 673 |
| More than one race | 16 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Elder Adults in Emergency Department Setting |
|---|---|
| United States | 1002 |
| Education(Participants) | Elder Adults in Emergency Department Setting |
|---|---|
| Associate's Degree | 46 |
| Undergraduate Degree (Bachelor's program or equivalent) | 192 |
| Professional Degree (Master's program or equivalent) | 138 |
| High School Graduate or GED | 290 |
| High School Not Completed | 92 |
| Refused/Unknown | 4 |
| Some college | 240 |
| Household Income(Participants) | Elder Adults in Emergency Department Setting |
|---|---|
| Less than 25k | 291 |
| Between 25k to 34k | 122 |
| Between 35k to 49k | 111 |
| Between 50k to 74k | 116 |
| Between 75k to 99k | 63 |
| Between 100k to 149k | 53 |
| More than 150k | 42 |
| Refused/Unknown | 204 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.