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Completed

NCT Number: NCT05216081

Feasibility of Elder Mistreatment VOICES-CI Screening Tool

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

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Key information

Conditions

Elder Abuse Elder Mistreatment

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Raphael Emergency Department

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age 60 or above
  • Montreal Cognitive Assessment (MoCA) score between 14-25
  • Not in police custody
  • Non-full trauma track upon arrival
  • 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 settings
  • At the discretion of the clinician, patient will be excluded if they cannot safely undergo the studies required for participation
  • Subject refusal to participate
  • Subjects with clear signs of elder mistreatment
  • Severe hearing and vision impairment
  • Presenting with acute intoxication
  • Presenting with active psychotic symptoms
  • Presenting with COVID-19 diagnosis and/or severe COVID-19 symptoms

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. Participation

    Time frame: 5-10 minutes before VOICES intervention use.

    Participation will be determined by the number of patients with cognitive impairment enrolled in VOICES. Successful enrollment of 80 older adults (N=80).

  2. Usage

    Time frame: 5-10 minutes directly following VOICES intervention.

    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).

Other outcomes

  1. Acceptability

    Time frame: 5-10 minutes directly following VOICES intervention use.

    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".

  2. Demand

    Time frame: 5-10 minutes directly following VOICES intervention use.

    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.

  3. Practicality

    Time frame: 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.

    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 Brief Negotiation Interview

    Time frame: Measure collected 5-10 minutes directly following VOICES intervention.

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

  5. Number of Participants for Which Self-Identification of Elder Mistreatment Impacted Likelihood of Self-Disclosure

    Time frame: Measure collected 5-10 minutes directly following VOICES intervention.

    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.

  6. Accuracy

    Time frame: Measure collected up to directly following VOICES intervention to 1 week following VOICES intervention.

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: VOICES-CI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2022
Registry last updated
Sep 22, 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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