Feasibility of Elder Mistreatment VOICES-CI Screening Tool (VOICES-CI)

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

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

Study Overview

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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

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:

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

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 with cognitive impairment; Elder mistreatment in an Emergency Department setting with cognitive impairment.	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
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.
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.

Other Outcome Measures

Outcome Measure	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".	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.
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.
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.

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): February 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Digital Health
• Other Study ID Numbers: 2000023799_a; 1R01AG060084-01 (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