Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

Elder Abuse Clinical Trial

— VOICES  

Official title:

Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834870
• Other study ID #: 2000023799
• Secondary ID: 5R01AG060084-04
• Status: Completed
• Phase: Early Phase 1
• Start date: July 20, 2020
• Est. completion date: March 1, 2022

Study information

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

Clinical Trial Summary

To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency Department (ED) to promote self-disclosure.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age 60 years or older

• Non-full trauma track

• Alert and oriented to person and place

• AMT-4 score of 4

• Able to consent and communicate in English

• Agrees and able to use the iPad

• Not in police custody

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

• presenting with active psychotic symptoms

• presenting with acute intoxication

• 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	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 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
Other	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
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.	up to 16 months
Other	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
Other	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
Other	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
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 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
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.	up to 16 months
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.	up to 16 months