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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05224843
Collaborator
National Institute on Aging (NIA) (NIH)
80
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9.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
VOICES Elder Abuse InterventionVOICES Elder Abuse Intervention
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Feasibility of the VOICES Digital Health Tool for Elder Mistreatment Screening in the Primary Care Setting (VOICES-PC Feasibility)
Actual Study Start Date :
Dec 17, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Older adults in Primary Care setting

Elder mistreatment in the Primary Care 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.

Outcome Measures

Primary Outcome Measures

  1. Participation [up to 4months]

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

  2. Usage [up to 4 months]

    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 Outcome Measures

  1. Acceptability [up to 4 months]

    Participant satisfaction will be measured using post-use satisfaction survey. Responses will be measured on a 5-point Likert scale where 1= "Strongly Disagree/Very Dissatisfied", and 5= "Strongly Agree or Very Satisfied".

  2. International Positive And Negative Affect Schedule Short-Form (I-PANAS-SF) [up to 4 months]

    Participant satisfaction will be measured using I-PANAS-SF survey. Responses will be measured on a 5-Point Likert scale where 1= "Very slightly or not at all" and 5= "Extremely".

  3. Demand [up to 4months]

    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 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.

  4. Implementation [up to 4 months]

    Implementation will be measured by understanding to what extent can VOICES be used in the ED. To do this, the degree of execution will be measured by the percent of potential participants approached who consent to participate in the pilot study and of those, the number that achieve success of execution measured by number of participants who used the tool to completion. Anecdotal reasons for not completing the tool will be collected to inform process.

  5. Practicality [up to 4 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.

  6. Efficacy of the Educational Material [up to 4 months]

    To understand the efficacy of VOICES in this study, and look at how many participants changed their self-identification response after completing the educational component.

  7. Efficacy of the Brief Negotiation Interview [up to 4 months]

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

  8. Efficacy of Self-Identification on Self-Disclosure [up to 4 months]

    To explore whether self-identification impacts likelihood of self-disclosure. Effect-size estimation measured by change in the percent of patients who disclose. Potential sources of bias measured by (1) sample representativeness & (2) observed group differences of participants measured by demographic data determine through t-tests and chi-square analyses.

  9. Accuracy [up to 4 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 referred to Adult Protective Services (APS). The percent correct classification will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age 60 years or older

  • 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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale Internal Medicine Associates New Haven Connecticut United States 06511

Sponsors and Collaborators

  • Yale University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Fuad Abujarad, PhD,MSc, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT05224843
Other Study ID Numbers:
  • 2000023799_b
  • 1R01AG060084-01
First Posted:
Feb 4, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 31, 2022