Feasibility of Elder Mistreatment VOICES-CI Screening Tool

Elder Abuse Clinical Trial

— VOICES-CI  

Official title:

Feasibility of Elder Mistreatment VOICES Screening Tool for Older Adults With Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05216081
• Other study ID #: 2000023799_a
• Secondary ID: 1R01AG060084-01
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the feasibility of the VOICES Elder Abuse Intervention among older adults with cognitive impairment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elder Abuse

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	St. Raphael Emergency Department	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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".	5-10 minutes directly following VOICES intervention use.
Other	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.
Other	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.
Other	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.
Other	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.
Other	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.
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).	5-10 minutes before VOICES intervention use.
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).	5-10 minutes directly following VOICES intervention.