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Completed

NCT Number: NCT05224843

Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility)

To test an interactive intervention to screen for Elder Abuse and Mistreatment (EM) in the Primary Care (PC) setting to promote self-identification and self-disclosure of EM.

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Key information

Conditions

Elder Abuse

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale Internal Medicine Associates

New Haven, Connecticut, 06511, United States

About this study

The aim of this study is to perform a feasibility evaluation (N=80) of the VOICES screening tool among older adults in the primary care setting. If VOICES is feasible for identifying suspicion of EM in primary care setting, then it will be able to connect more victims of EM to necessary services and potentially prevent a multitude of poor EM outcomes

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
  • Alert and oriented to person and place
  • Abbreviated Mental Test (AMT-4) score of 4
  • 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 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
  • 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. Participation

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

    Participation will be determined by the number of patients 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 elder mistreatment (EM) victims in the Primary Care setting will be measured by the percent who screen positive for EM and the percent who receive the Brief Negotiation Interview (BNI) portion of VOICES. The BNI is a method designed to enhance identifying EM among older adults-- the process intends to encourage reflection of the user with their behaviors and whether they are willing to seek change by identifying with and reporting their abuse.

  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. 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 elder mistreatment (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

The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)

Acronym: VOICES-PC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2022
Registry last updated
Jul 17, 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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