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Completed

NCT Number: NCT03834870

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

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

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Key information

Conditions

Elder Abuse

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

St. Raphael Emergency Department

New Haven, Connecticut, 06511, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.

Primary outcomes

  1. Implementation in Terms of Participation

    Time frame: up to 16 months

    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.

  2. Implementation in Terms of Usage

    Time frame: up to 16 months

    Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion.

Other outcomes

  1. Acceptability

    Time frame: up to 16 months

    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

  2. Demand

    Time frame: up to 16 months

    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.

  3. Practicality

    Time frame: up to 16 months

    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.

  4. Efficacy of the Educational Material

    Time frame: up to 16 months

    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.

  5. Efficacy of the Brief Negotiation Interview

    Time frame: up to 16 months

    We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI).

  6. Efficacy of Self-Identification on Self-Disclosure

    Time frame: up to 16 months

    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.

  7. Accuracy

    Time frame: up to 16 months

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: VOICES

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 8, 2019
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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