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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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The aim of this study is to assess the feasibility of the VOICES Elder Abuse Intervention among older adults with cognitive impairment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elder adults in emergency department setting with cognitive impairment | Experimental | Elder mistreatment in an Emergency Department setting with cognitive impairment. |
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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 with cognitive impairment 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 |
|---|---|---|---|---|---|---|
| St. Raphael Emergency Department | New Haven | Connecticut | 06511 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Elder Adults Enrolled in the Study | Elder adults with cognitive impairments who were enrolled in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 with cognitive impairment 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) up to 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 | 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. |
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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 emergency department 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 | Jan 26, 2022 | Jun 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2023 | Jun 14, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 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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| 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 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. | 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. |
| 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. | 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 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 | Number of household members for those who do not live alone (N=53). | This is based off of those who do not live alone (N=53) out of the 101 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 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. | 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) | 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). | Posted | Count of Participants | Participants | Measure collected 5-10 minutes directly following VOICES intervention. |
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| 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. | 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). | 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 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=16). | Posted | Count of Participants | Participants | Measure collected up to directly following VOICES intervention to 1 week following VOICES intervention. |
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| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
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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 the emergency department (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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| Title | Measurements |
|---|---|
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| Cases referred to APS that were substantiated and opened |
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