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

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

Study Overview

• Status: Completed
• Conditions: Elder Abuse
• Intervention / Treatment: Behavioral: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 1012
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • St. Raphael Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elder adults in emergency department setting; Elder mistreatment in an Emergency Department setting.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Fuad Abujarad, PhD,MSc, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2000023799; 5R01AG060084-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No