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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03323853
Other study ID # 206914
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 30, 2017
Est. completion date December 21, 2019

Study information

Verified date June 2021
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 451
Est. completion date December 21, 2019
Est. primary completion date December 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Computerized Assessment and Referral System (CARS) Self-Assessment Screener
Subjects will take the CARS-SA Screener.
CARS-SA Summary Results
Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.

Locations

Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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