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

The Utility of the Computerized Assessment and Referral System (CARS) Screener for Mental Health Evaluations in the Emergency Setting

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.

Study Overview

• Status: Completed
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener; Behavioral: CARS-SA Summary Results

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.

• Study Type: Interventional
• Enrollment (Actual): 451
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CARS-SA Report; Emergency care providers for subjects in this group will receive a copy of the subject's CARS-SA summary results.	Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener; Subjects will take the CARS-SA Screener.; Other Names: CARS-SA Screener; Behavioral: CARS-SA Summary Results; Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.; Other Names: CARS-SA Report
OTHER: No CARS-SA Report; Emergency care providers for subjects in this group will not receive a copy of the subject's CARS-SA summary results.	Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener; Subjects will take the CARS-SA Screener.; Other Names: CARS-SA Screener

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 hours

Collaborators and Investigators

• Sponsor: University of Arkansas

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2017
• Primary Completion (ACTUAL): December 21, 2019
• Study Completion (ACTUAL): December 21, 2019

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (ACTUAL): October 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 206914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No