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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG060084-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elder adults in emergency department setting | Experimental | Elder mistreatment in an Emergency Department 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 |
|---|---|---|
| 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. | 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. | up to 16 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 16 months |
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 |
|---|---|---|---|---|---|---|
| St. Raphael Emergency Department | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | The total number of eligible participants. | Posted | Count of Participants | Participants | up to 16 months |
|
Up to 16 months
Adverse event data were collected over the entire enrollment period, from 7/20/2020 to 12/01/2021.
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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 | 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. |
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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 emergency department staff were not included in the study and outcomes only extend to older adult patients in the emergency department.
| 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 | Jul 16, 2020 | Mar 1, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2023 | Mar 3, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2020 | Mar 1, 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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| 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. | 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. | 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. | 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). | 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. | 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. | up to 16 months |
| years |
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| Age, Customized | Count of Participants | Participants |
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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 | 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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| Units | Counts |
|---|
| Participants |
|
|
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| 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. | The number of participants who were enrolled in the study (n=1,012)/ | Posted | Count of Participants | Participants | up to 16 months |
|
|
|
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| 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 | The number of participants who successfully used VOICES to completion. | Posted | Mean | Standard Deviation | units on a scale | up to 16 months |
|
|
|
| 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. | The number of participants who successfully used VOICES to completion. | Posted | Count of Participants | Participants | up to 16 months |
|
|
|
| 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. | The number of participants who successfully used VOICES to completion. | Posted | Mean | Standard Deviation | minutes | up to 16 months |
|
|
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| 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. | The number of participants who successfully used VOICES to completion. | Posted | Count of Participants | Participants | up to 16 months |
|
|
|
| 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). | The number of participants who successfully used VOICES to completion and accessed the self-disclosure Brief Negotiation Interview (N=18). | Posted | Count of Participants | Participants | up to 16 months |
|
|
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| 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. | The number of participants who self-identified with elder mistreatment. | Posted | Count of Participants | Participants | up to 16 months |
|
|
|
| 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. | The number of participants who used VOICES to completion and screened positive for suspicion of elder mistreatment (n=112). | Posted | Count of Participants | Participants | up to 16 months |
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|
|
| 0 |
| 1,012 |
| 0 |
| 1,012 |
| 0 |
| 1,012 |
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| Time to complete the tool on the iPad was short (Scale 2) |
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| I 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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| I felt the fonts, size and the colors of the text in the tool were appropriate and readable (Scale2) |
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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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| I feel comfortable discussing mistreatment with a doctor or medical professional (Scale 2) |
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| This tool is appropriate for learning about mistreatment (Scale 2) |
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| This tool is appropriate to be used in the emergency department (Scale 2) |
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| I was able to complete VOICES on the iPad on my 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 Vicky were clear and easy to follow (Scale 2) |
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| I feel more confident about understanding EM/resources in case I/someone else I know is mistreated |
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| I feel safer after using VOICES on the iPad (Scale 2) |
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| I learned new, useful things about elder mistreatment (Scale 2) |
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| I would like to see this used by other older adults in the community such as the doctor's office (2) |
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| Title | Measurements |
|---|---|
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| Referred APS cases accepted and opened by APS |
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