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

• Sponsor: University of Arkansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03323853
• Collaborator: (none)
• Enrollment: 451
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.7
• Patients Per Site Per Month: 19

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health	Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener; Behavioral: CARS-SA Summary Results	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 451 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: The Utility of the Computerized Assessment and Referral System (CARS) Screener for Mental Health Evaluations in the Emergency Setting
• Actual Study Start Date: Dec 30, 2017
• Actual Primary Completion Date: Dec 21, 2019
• Actual Study Completion Date: Dec 21, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [Up to 12 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

• University of Arkansas

Investigators

• Principal Investigator: Michael P Wilson, M.D., Ph.D., University of Arkansas

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 28, 2019

More Information

Publications

None provided.

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT03323853
• Other Study ID Numbers: 206914
• First Posted: Oct 27, 2017
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Emergencies

Study Results

Participant Flow

Arm/Group Title	CARS Report	No CARS Report
Arm/Group Description	CARS Report: Patients will be evaluated by emergency providers using the CARS report	No CARS Report: Patients will be evaluated by emergency providers without using the CARS report
Period Title: Overall Study
STARTED	213	238
COMPLETED	213	238
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	CARS Report	No CARS Report	Total
Arm/Group Description	CARS Report: Patients will be evaluated by emergency providers using the CARS report	No CARS Report: Patients will be evaluated by emergency providers without using the CARS report	Total of all reporting groups
Overall Participants	213	238	451
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.28 (16.23)	40.79 (15.45)	40.55 (15.81)
Sex: Female, Male (Count of Participants)
Female	121 56.8%	145 60.9%	266 59%
Male	92 43.2%	93 39.1%	185 41%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CARS Report	No CARS Report
Arm/Group Description	CARS Report: Patients will be evaluated by emergency providers using the CARS report	No CARS Report: Patients will be evaluated by emergency providers without using the CARS report
Measure Participants	213	238
Count of Participants [Participants]	1 0.5%	1 0.4%

Adverse Events

Time Frame	Duration of ED visit (typically 2 hours)
Arm/Group Title	CARS Report		No CARS Report
Arm/Group Description	CARS Report: Patients will be evaluated by emergency providers using the CARS report		No CARS Report: Patients will be evaluated by emergency providers without using the CARS report
All Cause Mortality
	CARS Report		No CARS Report
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/213 (0%)		0/238 (0%)
Serious Adverse Events
	CARS Report		No CARS Report
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/213 (0%)		0/238 (0%)
Other (Not Including Serious) Adverse Events
	CARS Report		No CARS Report
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/213 (0%)		0/238 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.