Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03834870
Other study ID # 2000023799
Secondary ID 5R01AG060084-04
Status Completed
Phase Early Phase 1
First received
Last updated
Start date July 20, 2020
Est. completion date March 1, 2022

Study information

Verified date March 2023
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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).


Recruitment information / eligibility

Status Completed
Enrollment 1012
Est. completion date March 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States St. Raphael Emergency Department New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Acceptability 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
up to 16 months
Other Demand 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. up to 16 months
Other 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. up to 16 months
Other Efficacy of the Educational Material 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. up to 16 months
Other Efficacy of the Brief Negotiation Interview We will look at how many patients changed their readiness to disclose after completing the Brief Negotiation Interview (BNI). up to 16 months
Other Efficacy of Self-Identification on Self-Disclosure 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.
up to 16 months
Other 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 positive based on social worker assessment, and those referred to Adult Protective Services (APS). The percent correct classification will be reported. up to 16 months
Primary Implementation in Terms of Participation 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. up to 16 months
Primary Implementation in Terms of Usage Usage will be determined by the number of consented participants enrolled in the study who used VOICES to completion. up to 16 months
See also
  Status Clinical Trial Phase
Recruiting NCT06039930 - Tele-PROTECT Therapy: Effectiveness, Empowerment, and Implementation N/A
Terminated NCT04563728 - Use Surveillance Technology to Reduce Elder Abuse Recidivism N/A
Active, not recruiting NCT05783102 - Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER): Pilot Study N/A
Completed NCT04258579 - Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults N/A
Completed NCT05216081 - Feasibility of Elder Mistreatment VOICES-CI Screening Tool N/A
Completed NCT05224843 - Feasibility of VOICES Elder Abuse Intervention in Primary Care Setting (VOICES-PC Feasibility) Phase 1
Terminated NCT03593564 - Knowledge and Interpersonal Skills to Develop Exemplary Relationships N/A
Not yet recruiting NCT05958654 - DETECT-RPC Universal EM Screening N/A
Recruiting NCT05807568 - MIStreatment Screening in Elders Before Discharge N/A