Mental Health
Conditions
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.
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.
Interventions
BEHAVIORALComputerized Assessment and Referral System (CARS) Self-Assessment Screener
Subjects will take the CARS-SA Screener.
BEHAVIORALCARS-SA Summary Results
Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CARS Report CARS Report: Patients will be evaluated by emergency providers using the CARS report | 213 |
| No CARS Report No CARS Report: Patients will be evaluated by emergency providers without using the CARS report | 238 |
| Total | 451 |
Baseline characteristics
| Characteristic | CARS Report | No CARS Report | Total |
|---|---|---|---|
| Age, Continuous | 40.28 years STANDARD_DEVIATION 16.23 | 40.79 years STANDARD_DEVIATION 15.45 | 40.55 years STANDARD_DEVIATION 15.81 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 121 Participants | 145 Participants | 266 Participants |
| Sex: Female, Male Male | 92 Participants | 93 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 213 | 0 / 238 |
| other Total, other adverse events | 0 / 213 | 0 / 238 |
| serious Total, serious adverse events | 0 / 213 | 0 / 238 |
Outcome results
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.
Time frame: Up to 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CARS Report | 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 | 1 Participants |
| No CARS Report | 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 | 1 Participants |