NCT03323853

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 24, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

October 17, 2017

Results QC Date

May 3, 2021

Last Update Submit

June 2, 2021

Conditions

Mental Health

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CARS-SA Report

EXPERIMENTAL

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 ScreenerBehavioral: CARS-SA Summary Results

No CARS-SA Report

OTHER

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

Interventions

Computerized Assessment and Referral System (CARS) Self-Assessment ScreenerBEHAVIORAL

Subjects will take the CARS-SA Screener.

Also known as: CARS-SA Screener
CARS-SA ReportNo CARS-SA Report
CARS-SA Summary ResultsBEHAVIORAL

Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.

Also known as: CARS-SA Report
CARS-SA Report

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • Thompson RG Jr, Mullinax S, De Monte R, McBain S, Porter A, Eastin C, Landes SJ, Wilson MP. Effectiveness of a Self-Administered Computerized Mental Health Screening Tool in the Emergency Department. Psychiatr Serv. 2023 Nov 1;74(11):1180-1184. doi: 10.1176/appi.ps.20220523. Epub 2023 May 10.

    PMID: 37161345DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Automobiles

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Motor VehiclesTransportationTechnology, Industry, and Agriculture

Results Point of Contact

Title
Dr. Michael Wilson
Organization
University of Arkansas for Medical Sciences
MPWilson@uams.edu
501-686-5515

Study Officials

  • Michael P Wilson, M.D., Ph.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 27, 2017

Study Start

December 30, 2017

Primary Completion

December 21, 2019

Study Completion

December 21, 2019

Last Updated

June 24, 2021

Results First Posted

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)