Mental HealthCARS-SANCT03323853
Computerized Assessment and Referral System Screener for Mental Health Evaluations in the Emergency Setting
A study testing Computerized Assessment and Referral System (CARS) Self-Assessment Screener and CARS-SA Summary Results in people with Mental Health, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Computerized Assessment and Referral System (CARS) Self-Assessment Screener and CARS-SA Summary Results
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2017to 21 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
- Not incarcerated
- English-speaking and English-writing (as translators will not be available for this study)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- Computerized Assessment and Referral System (CARS) Self-Assessment Screener, CARS-SA Summary Results
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Assessment and Referral System (CARS) Self-Assessment ScreenerBehavioural
Also called CARS-SA Screener
Subjects will take the CARS-SA Screener.
CARS-SA Summary ResultsBehavioural
Also called CARS-SA Report
Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.
| Study group | Role | What they receive |
|---|---|---|
| CARS-SA Report | Experimental | Emergency care providers for subjects in this group will receive a copy of the subject's CARS-SA summary results. Receives: Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener; Behavioral: 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. Receives: Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start30 Dec 2017
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael P Wilson, M.D., Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323853
- Sponsor's protocol ID
- 206914
- Acronym
- CARS-SA
- Status last verified
- Jun 2021
- First submitted
- 17 Oct 2017
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37161345
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of the Computerized Assessment and Referral System (CARS) Screener for Mental Health Evaluations in the Emergency Setting
- ClinicalTrials.gov ID
- NCT03323853
- Acronym / sponsor ID
- CARS-SA / 206914
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARS-SA Report | Experimental | Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment Screener, Behavioral: CARS-SA Summary ResultsEmergency care providers for subjects in this group will receive a copy of the subject's CARS-SA summary results. |
| No CARS-SA Report | Other | Behavioral: Computerized Assessment and Referral System (CARS) Self-Assessment ScreenerEmergency care providers for subjects in this group will not receive a copy of the subject's CARS-SA summary results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years of age
- Not incarcerated
- English-speaking and English-writing (as translators will not be available for this study)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Assessment and Referral System (CARS) Self-Assessment ScreenerAlso: CARS-SA ScreenerSubjects will take the CARS-SA Screener. | Behavioural | CARS-SA Report, No CARS-SA Report |
| CARS-SA Summary ResultsAlso: CARS-SA ReportSubjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report. | Behavioural | CARS-SA Report |
Primary outcome
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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37161345Thompson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Wilson, M.D., Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Assessment and Referral System (CARS) Self-Assessment Screener and CARS-SA Summary Results in people with Mental Health, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.