Elder Abuse
Conditions
Brief summary
To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency Department (ED) to promote self-disclosure.
Detailed description
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).
Interventions
BEHAVIORALVirtual 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.
Sponsors
National Institute on Aging (NIA)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 60 years or older * Non-full trauma track * Alert and oriented to person and place * AMT-4 score of 4 * Able to consent and communicate in English * Agrees and able to use the iPad * Not in police custody
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 * presenting with active psychotic symptoms * presenting with acute intoxication * COVID-19 positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementation in Terms of Participation | up to 16 months | 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. |
| Implementation in Terms of Usage | up to 16 months | Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | up to 16 months | 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. |
| Acceptability | up to 16 months | 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 |
| Efficacy of the Brief Negotiation Interview | up to 16 months | We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI). |
| Practicality | up to 16 months | 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. |
| Efficacy of the Educational Material | up to 16 months | 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. |
| Demand | up to 16 months | 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. |
| Efficacy of Self-Identification on Self-Disclosure | up to 16 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,002 |
| Total | 1,002 |
Baseline characteristics
| Characteristic | Elder Adults in Emergency Department Setting |
|---|---|
| Age, Continuous | 73.5 years STANDARD_DEVIATION 9.04 |
| Age, Customized 60-69 | 392 Participants |
| Age, Customized 70-79 | 370 Participants |
| Age, Customized 80-89 | 177 Participants |
| Age, Customized 90+ | 63 Participants |
| Confidence in Using Technology | 6.9 units on a scale STANDARD_DEVIATION 2.91 |
| Education Associate's Degree | 46 Participants |
| Education High School Graduate or GED | 290 Participants |
| Education High School Not Completed | 92 Participants |
| Education Professional Degree (Master's program or equivalent) | 138 Participants |
| Education Refused/Unknown | 4 Participants |
| Education Some college | 240 Participants |
| Education Undergraduate Degree (Bachelor's program or equivalent) | 192 Participants |
| Employment Status Full Time | 103 Participants |
| Employment Status Not Employed/Retired | 840 Participants |
| Employment Status Part Time | 56 Participants |
| Employment Status Refused/Unknown | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 938 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Household Income Between 100k to 149k | 53 Participants |
| Household Income Between 25k to 34k | 122 Participants |
| Household Income Between 35k to 49k | 111 Participants |
| Household Income Between 50k to 74k | 116 Participants |
| Household Income Between 75k to 99k | 63 Participants |
| Household Income Less than 25k | 291 Participants |
| Household Income More than 150k | 42 Participants |
| Household Income Refused/Unknown | 204 Participants |
| Internet Usage 1-2 Times a Month | 32 Participants |
| Internet Usage 1-2 Times a Week | 157 Participants |
| Internet Usage Every Day | 530 Participants |
| Internet Usage Rarely | 280 Participants |
| Internet Usage Refused/Unknown | 3 Participants |
| Living Arrangement Assisted Living | 24 Participants |
| Living Arrangement In Someone Else's Home | 42 Participants |
| Living Arrangement In Their Own Home | 936 Participants |
| Marital Status Divorced | 157 Participants |
| Marital Status Married or Co-habituating | 360 Participants |
| Marital Status Other | 7 Participants |
| Marital Status Refused/Unknown | 5 Participants |
| Marital Status Separated | 19 Participants |
| Marital Status Single or Never Married | 233 Participants |
| Marital Status Widowed | 221 Participants |
| Number of Household Members | 2 persons STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 298 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 673 Participants |
| Region of Enrollment United States | 1002 participants |
| Sex: Female, Male Female | 594 Participants |
| Sex: Female, Male Male | 408 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,012 |
| other Total, other adverse events | 0 / 1,012 |
| serious Total, serious adverse events | 0 / 1,012 |
Outcome results
Primary
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
Population: The total number of eligible participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elder Adults in Emergency Department Setting | Implementation in Terms of Participation | 1012 Participants |
95% CI: [81.98, 86.1]
Primary
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
Population: The number of participants who were enrolled in the study (n=1,012)/
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elder Adults in Emergency Department Setting | Implementation in Terms of Usage | 1002 Participants |
95% CI: [98.4, 99.6]
Other Pre-specified
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
Population: The number of participants who successfully used VOICES to completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elder Adults in Emergency Department Setting | Acceptability | Level of confidentiality and privacy provided while using this tool (Scale 1) | 4.57 units on a scale | Standard Deviation 0.76 |
| Elder Adults in Emergency Department Setting | Acceptability | The time it took to complete using the VOICES tool (Scale 1) | 4.44 units on a scale | Standard Deviation 0.81 |
| Elder Adults in Emergency Department Setting | Acceptability | Your ability to complete the VOICES tool on your own on the iPad, without any staff (Scale 1) | 4.5 units on a scale | Standard Deviation 0.81 |
| Elder Adults in Emergency Department Setting | Acceptability | Time to complete the tool on the iPad was short (Scale 2) | 4.11 units on a scale | Standard Deviation 0.98 |
| Elder Adults in Emergency Department Setting | Acceptability | I felt the fonts, size and the colors of the text in the tool were appropriate and readable (Scale2) | 4.53 units on a scale | Standard Deviation 0.68 |
| Elder Adults in Emergency Department Setting | Acceptability | Using this tool on the iPad was very easy (Scale 2) | 4.53 units on a scale | Standard Deviation 0.67 |
| Elder Adults in Emergency Department Setting | Acceptability | I was comfortable answering questions on the iPad (Scale 2) | 4.56 units on a scale | Standard Deviation 0.65 |
| Elder Adults in Emergency Department Setting | Acceptability | Using the iPad and the headphones provided more privacy (Scale 2) | 4.5 units on a scale | Standard Deviation 0.7 |
| Elder Adults in Emergency Department Setting | Acceptability | I feel comfortable discussing mistreatment with a doctor or medical professional (Scale 2) | 4.4 units on a scale | Standard Deviation 0.8 |
| Elder Adults in Emergency Department Setting | Acceptability | This tool is appropriate for learning about mistreatment (Scale 2) | 4.54 units on a scale | Standard Deviation 0.66 |
| Elder Adults in Emergency Department Setting | Acceptability | The instructions provided by Vicky were clear and easy to follow (Scale 2) | 4.59 units on a scale | Standard Deviation 0.61 |
| Elder Adults in Emergency Department Setting | Acceptability | I feel more confident about understanding EM/resources in case I/someone else I know is mistreated | 4.50 units on a scale | Standard Deviation 0.67 |
| Elder Adults in Emergency Department Setting | Acceptability | I felt engaged in the tool throughout the process (Scale 2) | 4.29 units on a scale | Standard Deviation 0.81 |
| Elder Adults in Emergency Department Setting | Acceptability | Audio and visual aids of the tool were helpful (Scale 2) | 4.41 units on a scale | Standard Deviation 0.75 |
| Elder Adults in Emergency Department Setting | Acceptability | This tool is appropriate to be used in the emergency department (Scale 2) | 4.41 units on a scale | Standard Deviation 0.73 |
| Elder Adults in Emergency Department Setting | Acceptability | I was able to complete VOICES on the iPad on my own (Scale 2) | 4.40 units on a scale | Standard Deviation 0.8 |
| Elder Adults in Emergency Department Setting | Acceptability | Using VOICES on the iPad was a frustrating experience (Scale 2) | 1.87 units on a scale | Standard Deviation 1.3 |
| Elder Adults in Emergency Department Setting | Acceptability | I feel safer after using VOICES on the iPad (Scale 2) | 4.21 units on a scale | Standard Deviation 0.89 |
| Elder Adults in Emergency Department Setting | Acceptability | I learned new, useful things about elder mistreatment (Scale 2) | 4.34 units on a scale | Standard Deviation 0.68 |
| Elder Adults in Emergency Department Setting | Acceptability | I would like to see this used by other older adults in the community such as the doctor's office (2) | 4.52 units on a scale | Standard Deviation 0.68 |
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 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
Population: The number of participants who used VOICES to completion and screened positive for suspicion of elder mistreatment (n=112).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elder Adults in Emergency Department Setting | Accuracy | Participants substantiated for elder mistreatment | 49 Participants |
| Elder Adults in Emergency Department Setting | Accuracy | Of the substantiated participants, participants referred to Adult Protective Services (APS) | 11 Participants |
| Elder Adults in Emergency Department Setting | Accuracy | Referred APS cases accepted and opened by APS | 11 Participants |
Other Pre-specified
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
Population: The number of participants who successfully used VOICES to completion.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elder Adults in Emergency Department Setting | Demand | Participants who received the BNI | 71 Participants |
| Elder Adults in Emergency Department Setting | Demand | Participants who self-identified with elder mistreatment | 67 Participants |
Other Pre-specified
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
Population: The number of participants who self-identified with elder mistreatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elder Adults in Emergency Department Setting | Efficacy of Self-Identification on Self-Disclosure | 49 Participants |
Other Pre-specified
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
Population: The number of participants who successfully used VOICES to completion and accessed the self-disclosure Brief Negotiation Interview (N=18).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elder Adults in Emergency Department Setting | Efficacy of the Brief Negotiation Interview | 3 Participants |
Other Pre-specified
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
Population: The number of participants who successfully used VOICES to completion.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Elder Adults in Emergency Department Setting | Efficacy of the Educational Material | Overall participants who changed their self-identification response | 40 Participants |
| Elder Adults in Emergency Department Setting | Efficacy of the Educational Material | Yes (does self-identify) response changed to No (does not self-identify) response | 21 Participants |
| Elder Adults in Emergency Department Setting | Efficacy of the Educational Material | No (does not self-identify) response changed to Yes (does self-identify) response | 19 Participants |
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: up to 16 months
Population: The number of participants who successfully used VOICES to completion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elder Adults in Emergency Department Setting | Practicality | Actual VOICES Duration | 8.8 minutes | Standard Deviation 5.4 |
| Elder Adults in Emergency Department Setting | Practicality | Actual Consent Duration | 14.9 minutes | Standard Deviation 5.9 |
| Elder Adults in Emergency Department Setting | Practicality | Participant Estimated Time to Completion | 12.2 minutes | Standard Deviation 9.1 |