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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG060084-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older adults in Primary Care setting | Experimental | Elder mistreatment in the Primary Care setting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) | Behavioral | Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool. |
| Measure | Description | Time Frame |
|---|---|---|
| Participation | Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80). | 5-10 minutes before VOICES intervention use. |
| 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). | 5-10 minutes directly following VOICES intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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". |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fuad Abujarad, PhD,MSc | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Internal Medicine Associates | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Older Adults Enrolled in the Study | The number of eligible older adults who were enrolled in the VOICES study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participation | Participation will be determined by the number of patients enrolled in VOICES. Successful enrollment of 80 older adults (N=80). | Posted | Count of Participants | Participants | 5-10 minutes before VOICES intervention use. |
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Adverse event data for each participant was collected immediately upon occurrence during their study session (approximately 5-15 minutes including post-survey activities). Overall data were collected over the entire enrollment period, from 12/15/2022 to 6/22/2022, a period of 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This study was limited to English-speaking older adults, leading to less representation with the Hispanic/Latino population.
Providers, nurses and other clinical staff were not included in the study and outcomes only extend to older adult patients in the primary care setting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fuad Abujarad | Yale University | +1 (203) 737-5088 | fuad.abujarad@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2022 | Jun 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2023 | Jun 8, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2022 | Jun 7, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014831 | Voice |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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VOICES Elder Abuse Intervention
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| 5-10 minutes directly following VOICES intervention use. |
| 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. | 5-10 minutes directly following VOICES intervention use. |
| 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. | 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. |
| Efficacy of the Brief Negotiation Interview | To look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI) | Measure collected 5-10 minutes directly following VOICES intervention. |
| 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. | Measure collected up to directly following VOICES intervention to 1 week following VOICES intervention. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Household Income | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Living Arrangement | Count of Participants | Participants |
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| Number of Household Members | This is based off of those who do not live alone (N=53) out of the 80 participants who completed VOICES. | Median | Standard Deviation | persons |
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| Internet Usage | Count of Participants | Participants |
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| Confidence in Using Technology | Confidence in Using Technology is measured by a question that uses a scale of 1-10 (0= Not confident at all, 10= Very confident), where a higher score indicates greater confidence. | Mean | Standard Deviation | units on a scale |
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| Has Living Will | Count of Participants | Participants |
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| Veteran Status | Count of Participants | Participants |
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| Has Health Care Assistant | Count of Participants | Participants |
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| 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). | Posted | Count of Participants | Participants | 5-10 minutes directly following VOICES intervention. |
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| 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". | Posted | Mean | Standard Deviation | units on a scale | 5-10 minutes directly following VOICES intervention use. |
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| 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. | Posted | Count of Participants | Participants | 5-10 minutes directly following VOICES intervention use. |
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| 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. | Posted | Mean | Standard Deviation | minutes | 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. |
|
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| 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) | Posted | Count of Participants | Participants | Measure collected 5-10 minutes directly following VOICES intervention. |
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| 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. | The number of participants who used VOICES to completion and screened positive for suspicion of elder mistreatment (n=6). | Posted | Count of Participants | Participants | Measure collected up to directly following VOICES intervention to 1 week following VOICES intervention. |
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| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
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| Time to complete the tool on the iPad was short (Scale 2) |
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| Participant felt engaged in the tool throughout the process (Scale 2) |
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| Audio and visual aids of the tool were helpful (Scale 2) |
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| Participant felt fonts, size and colors of text in the tool were appropriate and readable (Scale 2) |
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| Using this tool on the iPad was very easy (Scale 2) |
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| I was comfortable answering questions on the iPad (Scale 2) |
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| Using the iPad and the headphones provided more privacy (Scale 2) |
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| Participant feels comfortable discussing mistreatment with a doctor or medical professional (Scale2) |
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| VOICES is appropriate for learning about mistreatment (Scale 2) |
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| VOICES is appropriate to be used in primary care setting (Scale 2) |
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| The participant was able to complete VOICES on the iPad on their own (Scale 2) |
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| Using VOICES on the iPad was a frustrating experience (Scale 2) |
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| The instructions provided by VOICES digital coach were clear and easy to follow (Scale 2) |
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| Participant confidence understanding mistreatment and resources after using VOICES (Scale 2) |
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| Participant feels safer after using VOICES on the iPad (Scale 2) |
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| The participant learned new, useful things about elder mistreatment (Scale 2) |
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| Participant would like to see VOICES used by others in the community (ie. doctor's office) (Scale 2) |
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| Participants who received the Brief Negotiated Interview (BNI) pathway |
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| Title | Measurements |
|---|---|
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| Cases referred to APS that were substantiated and opened |
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