Elder Abuse, Elder Mistreatment
Conditions
Keywords
Digital Health
Brief summary
The aim of this study is to assess the feasibility of the VOICES Elder Abuse Intervention among older adults with cognitive impairment.
Detailed description
The VOICES Elder Abuse Intervention was developed and refined to promote self-identification and self-disclosure to increase reporting of elder abuse and elder mistreatment at the point-of-care in the Emergency Department (ED) setting. A study (N= 1000) examining the use of VOICES in a busy ED with cognitively intact older adults was completed. The purpose of this study is to to assess the feasibility (N= 80) of the VOICES screening tool among older adults with cognitive impairment.
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
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age 60 or above 4. Montreal Cognitive Assessment (MoCA) score between 14-25 5. Not in police custody 6. Non-full trauma track upon arrival 7. Able to consent and communicate in English 8. Agrees and able to use the iPad
Exclusion criteria
1. Subjects who live in nursing homes or other long-term care settings 2. At the discretion of the clinician, patient will be excluded if they cannot safely undergo the studies required for participation 3. Subject refusal to participate 4. Subjects with clear signs of elder mistreatment 5. Severe hearing and vision impairment 6. Presenting with acute intoxication 7. Presenting with active psychotic symptoms 8. Presenting with COVID-19 diagnosis and/or severe COVID-19 symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage | 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). |
| Participation | 5-10 minutes before VOICES intervention use. | Participation will be determined by the number of patients with cognitive impairment enrolled in VOICES. Successful enrollment of 80 older adults (N=80). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Practicality | 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. |
| Efficacy of the Brief Negotiation Interview | 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) |
| Acceptability | 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. |
| Accuracy | 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 EM cases that were referred to Adult Protective Services (APS). The percent correct classification will be reported. |
| Number of Participants for Which Self-Identification of Elder Mistreatment Impacted Likelihood of Self-Disclosure | Measure collected 5-10 minutes directly following VOICES intervention. | To explore whether self-identification impacts likelihood of self-disclosure for participants who first self-identified with elder mistreatment. Effect-size estimation measured by change in the percent of patients who disclose. |
| Demand | 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 EM victims in the ED will be measured by the percent who screen positive for EM and the percent who receive the Brief Negotiation Interview (BNI) portion of VOICES. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Elder Adults in Emergency Department Setting With Cognitive Impairment Elder mistreatment in an Emergency Department setting with cognitive impairment.
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. | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | Elder Adults in Emergency Department Setting With Cognitive Impairment |
|---|---|
| Age, Continuous | 76.9 years STANDARD_DEVIATION 7.83 |
| Confidence in Using Technology | 6.2 units on a scale STANDARD_DEVIATION 2.74 |
| Education Associate's Degree | 7 Participants |
| Education College degree (bachelor's program) | 13 Participants |
| Education Doctorate or professional degree | 3 Participants |
| Education Graduate degree (master's program) | 15 Participants |
| Education High School Graduate or GED | 28 Participants |
| Education High School not Completed | 15 Participants |
| Education Some college or associate's degree program | 20 Participants |
| Employment Status Full-time | 5 Participants |
| Employment Status Part-time | 11 Participants |
| Employment Status Retired/Not Employed | 85 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Has Health Care Assistant No | 14 Participants |
| Has Health Care Assistant Unknown | 3 Participants |
| Has Health Care Assistant Yes | 84 Participants |
| Has Living Will No | 42 Participants |
| Has Living Will Unknown | 4 Participants |
| Has Living Will Yes | 55 Participants |
| Household Income Between 100k to 149k | 12 Participants |
| Household Income Between 25k to 34k | 5 Participants |
| Household Income Between 35k to 49k | 7 Participants |
| Household Income Between 50k to 74k | 8 Participants |
| Household Income Between 75k to 99k | 7 Participants |
| Household Income Less than 25k | 31 Participants |
| Household Income More than 150k | 6 Participants |
| Household Income Refused/Unknown | 25 Participants |
| Internet Usage 1-2 Times a Month | 4 Participants |
| Internet Usage 1-2 Times a Week | 12 Participants |
| Internet Usage Every Day | 61 Participants |
| Internet Usage Rarely | 24 Participants |
| Living Arrangement Assisted living | 3 Participants |
| Living Arrangement In my home | 92 Participants |
| Living Arrangement In someone else's home | 6 Participants |
| Marital Status Divorced | 18 Participants |
| Marital Status Married or Co-habituating | 31 Participants |
| Marital Status Other | 2 Participants |
| Marital Status Refused/Unknown | 0 Participants |
| Marital Status Separated | 1 Participants |
| Marital Status Single or Never Married | 28 Participants |
| Marital Status Widowed | 21 Participants |
| Number of Household Members | 2 persons STANDARD_DEVIATION 0.96 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 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 | 1 Participants |
| Race (NIH/OMB) White | 71 Participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 42 Participants |
| Veteran Status No | 86 Participants |
| Veteran Status Yes | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
Primary
Participation
Participation will be determined by the number of patients with cognitive impairment enrolled in VOICES. Successful enrollment of 80 older adults (N=80).
Time frame: 5-10 minutes before VOICES intervention use.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Older Adults Approached for the Study | Participation | 102 Participants |
95% CI: [61.5, 76.2]
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Older Adults Approached for the Study | Usage | 101 Participants |
95% CI: [94.7, 99.8]
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Older Adults Approached for the Study | Acceptability | Level of confidentiality and privacy provided while using VOICES (Scale 1) | 4.45 units on a scale | Standard Deviation 0.96 |
| Older Adults Approached for the Study | Acceptability | The time it took to complete using the VOICES tool (Scale 1) | 4.12 units on a scale | Standard Deviation 1.08 |
| Older Adults Approached for the Study | Acceptability | Ability to complete VOICES on their own on the iPad, without staff assistance (Scale 1) | 4.28 units on a scale | Standard Deviation 0.93 |
| Older Adults Approached for the Study | Acceptability | Time to complete the tool on the iPad was short (Scale 2) | 3.72 units on a scale | Standard Deviation 1.06 |
| Older Adults Approached for the Study | Acceptability | Participant felt engaged in the tool throughout the process (Scale 2) | 4.07 units on a scale | Standard Deviation 0.73 |
| Older Adults Approached for the Study | Acceptability | Audio and visual aids of the tool were helpful (Scale 2) | 4.46 units on a scale | Standard Deviation 0.7 |
| Older Adults Approached for the Study | Acceptability | Participant felt fonts, size and colors of text in the tool were appropriate and readable (Scale 2) | 4.55 units on a scale | Standard Deviation 0.61 |
| Older Adults Approached for the Study | Acceptability | Using this tool on the iPad was very easy (Scale 2) | 4.52 units on a scale | Standard Deviation 0.64 |
| Older Adults Approached for the Study | Acceptability | I was comfortable answering questions on the iPad (Scale 2) | 4.56 units on a scale | Standard Deviation 0.67 |
| Older Adults Approached for the Study | Acceptability | Using the iPad and the headphones provided more privacy (Scale 2) | 4.36 units on a scale | Standard Deviation 0.84 |
| Older Adults Approached for the Study | Acceptability | Participant feels comfortable discussing mistreatment with a doctor or medical professional (Scale2) | 4.31 units on a scale | Standard Deviation 0.86 |
| Older Adults Approached for the Study | Acceptability | VOICES is appropriate for learning about mistreatment (Scale 2) | 4.40 units on a scale | Standard Deviation 0.86 |
| Older Adults Approached for the Study | Acceptability | VOICES is appropriate to be used in the emergency department (Scale 2) | 4.19 units on a scale | Standard Deviation 0.85 |
| Older Adults Approached for the Study | Acceptability | The participant was able to complete VOICES on the iPad on their own (Scale 2) | 4.19 units on a scale | Standard Deviation 0.9 |
| Older Adults Approached for the Study | Acceptability | Using VOICES on the iPad was a frustrating experience (Scale 2) | 1.95 units on a scale | Standard Deviation 1.05 |
| Older Adults Approached for the Study | Acceptability | The instructions provided by VOICES digital coach were clear and easy to follow (Scale 2) | 4.53 units on a scale | Standard Deviation 0.58 |
| Older Adults Approached for the Study | Acceptability | Participant confidence understanding mistreatment and resources after using VOICES (Scale 2) | 4.40 units on a scale | Standard Deviation 0.7 |
| Older Adults Approached for the Study | Acceptability | Participant feels safer after using VOICES on the iPad (Scale 2) | 4.19 units on a scale | Standard Deviation 0.87 |
| Older Adults Approached for the Study | Acceptability | The participant learned new, useful things about elder mistreatment (Scale 2) | 4.18 units on a scale | Standard Deviation 0.87 |
| Older Adults Approached for the Study | Acceptability | Participant would like to see VOICES used by others in the community (ie. doctor's office) (Scale 2) | 4.31 units on a scale | Standard Deviation 0.82 |
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 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=16).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Older Adults Approached for the Study | Accuracy | Participants substantiated for elder mistreatment or other services by the social worker | 10 Participants |
| Older Adults Approached for the Study | Accuracy | Participants referred to APS by the social worker | 1 Participants |
| Older Adults Approached for the Study | Accuracy | Cases referred to APS that were substantiated and opened | 1 Participants |
95% CI: [50.5, 89.8]
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 EM victims in the ED will be measured by the percent who screen positive for EM and the percent who receive the Brief Negotiation Interview (BNI) portion of VOICES.
Time frame: 5-10 minutes directly following VOICES intervention use.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Older Adults Approached for the Study | Demand | Participants who screened positive for elder mistreatment | 16 Participants |
| Older Adults Approached for the Study | Demand | Participants who received the BNI | 9 Participants |
95% CI: [10, 24.2]
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.
Population: The number of older adults who accessed the customized Brief Negotiation Interview (BNI) section of the VOICES program (N=5) out of the enrolled older adults who completed the study (N=101).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Older Adults Approached for the Study | Efficacy of the Brief Negotiation Interview | 0 Participants |
Other Pre-specified
Number of Participants for Which Self-Identification of Elder Mistreatment Impacted Likelihood of Self-Disclosure
To explore whether self-identification impacts likelihood of self-disclosure for participants who first self-identified with elder mistreatment. Effect-size estimation measured by change in the percent of patients who disclose.
Time frame: Measure collected 5-10 minutes directly following VOICES intervention.
Population: The number of older adults who self-identified with elder mistreatment through the VOICES program (N=14) out of the enrolled older adults who completed the study (N=101).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Older Adults Approached for the Study | Number of Participants for Which Self-Identification of Elder Mistreatment Impacted Likelihood of Self-Disclosure | 8 Participants |
95% CI: [32.6, 78.6]
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Older Adults Approached for the Study | Practicality | Actual VOICES Duration | 9.51 minutes | Standard Deviation 5.05 |
| Older Adults Approached for the Study | Practicality | Actual Consent Duration | 19.08 minutes | Standard Deviation 5.2 |
| Older Adults Approached for the Study | Practicality | Participant Estimated Time to Completion | 24.20 minutes | Standard Deviation 18.79 |