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Computerized Assessment and Referral System Screener for Mental Health Evaluations in the Emergency Setting (CARS-SA)

Primary Purpose

Mental Health

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Assessment and Referral System (CARS) Self-Assessment Screener
CARS-SA Summary Results
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • >18 years of age
  • Not incarcerated
  • English-speaking and English-writing (as translators will not be available for this study)

Exclusion Criteria:

  • Unable or unwilling to complete CARS screener
  • Unable or unwilling to provide any history of alcohol abuse
  • Currently presenting with a chief complaint of a psychiatric symptom
  • Currently presenting with a substance use complaint
  • History of a known psychiatric condition
  • Patients taking psychiatric medication

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CARS-SA Report

No CARS-SA Report

Arm Description

Emergency care providers for subjects in this group will receive a copy of the subject's CARS-SA summary results.

Emergency care providers for subjects in this group will not receive a copy of the subject's CARS-SA summary results.

Outcomes

Primary Outcome Measures

Number of Participants With CARS Mental Health Diagnoses Made in the ED; the Number of Psychiatry Evaluations in the Emergency Department (ED); and the Number of Mental Health Referrals Made From the ED
The composite measure includes: the number of CARS mental health diagnoses made in the ED; the number of psychiatry evaluations in the emergency department (ED); and the number of mental health referrals made from the ED.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2017
Last Updated
June 2, 2021
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT03323853
Brief Title
Computerized Assessment and Referral System Screener for Mental Health Evaluations in the Emergency Setting
Acronym
CARS-SA
Official Title
The Utility of the Computerized Assessment and Referral System (CARS) Screener for Mental Health Evaluations in the Emergency Setting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 30, 2017 (Actual)
Primary Completion Date
December 21, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a hybrid effectiveness-implementation randomized controlled trial which will be conducted at the emergency department (ED) at the University of Arkansas for Medical Sciences (UAMS) in Little Rock, Arkansas. The hypothesis of this study is that use of the CARS (a computerized mental health screener) will modify emergency department treatment of patients with previously undiagnosed mental illness.
Detailed Description
This pragmatic mixed methods clinical trial will compare the intervention of providing a CARS screener report to emergency providers to not providing the report. It will also collect qualitative data regarding implementation of the CARS screener and report. Consecutive patients presenting when a research associate is available will be approached to participate. Patients will be approached after evaluation by an emergency physician. The Computerized Assessment and Referral System (CARS) is based on the Composite International Diagnostic Interview (CIDI), a validated instrument for assessing mental health diagnoses.CARS was piloted at 6 different sites in 2016, all in DUI populations. As CARS has not been specifically validated on non-DUI populations, investigators will collect alcohol history (see below). The CARS self-assessment version (CARS-SA) will be utilized in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CARS-SA Report
Arm Type
Experimental
Arm Description
Emergency care providers for subjects in this group will receive a copy of the subject's CARS-SA summary results.
Arm Title
No CARS-SA Report
Arm Type
Other
Arm Description
Emergency care providers for subjects in this group will not receive a copy of the subject's CARS-SA summary results.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Assessment and Referral System (CARS) Self-Assessment Screener
Other Intervention Name(s)
CARS-SA Screener
Intervention Description
Subjects will take the CARS-SA Screener.
Intervention Type
Behavioral
Intervention Name(s)
CARS-SA Summary Results
Other Intervention Name(s)
CARS-SA Report
Intervention Description
Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.
Primary Outcome Measure Information:
Title
Number of Participants With CARS Mental Health Diagnoses Made in the ED; the Number of Psychiatry Evaluations in the Emergency Department (ED); and the Number of Mental Health Referrals Made From the ED
Description
The composite measure includes: the number of CARS mental health diagnoses made in the ED; the number of psychiatry evaluations in the emergency department (ED); and the number of mental health referrals made from the ED.
Time Frame
Up to 12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: >18 years of age Not incarcerated English-speaking and English-writing (as translators will not be available for this study) Exclusion Criteria: Unable or unwilling to complete CARS screener Unable or unwilling to provide any history of alcohol abuse Currently presenting with a chief complaint of a psychiatric symptom Currently presenting with a substance use complaint History of a known psychiatric condition Patients taking psychiatric medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Wilson, M.D., Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Computerized Assessment and Referral System Screener for Mental Health Evaluations in the Emergency Setting

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