Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)

Elder Abuse Clinical Trial

— VOICES-PC  

Official title:

The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05224843
• Other study ID #: 2000023799_b
• Secondary ID: 1R01AG060084-01
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2021
• Est. completion date: June 22, 2022

Study information

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

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 22, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age 60 years or older

• Alert and oriented to person and place

• Abbreviated Mental Test (AMT-4) score of 4

• Able to consent and communicate in English

• Agrees and able to use the iPad

Exclusion Criteria:

• subjects who live in nursing homes or other long-term care sitting and do not reside in community setting

• patients will be excluded if they cannot safely undergo the studies required for participation

• subjects with clear signs of EM

• Patient or clinician refusal to participate

• severe hearing and vision impairment

• COVID-19 positive

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	Yale Internal Medicine Associates	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 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.
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	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.
Primary	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.
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.