Clinical trial NCT02247388: Automated Bilingual Computerized Alcohol Screening and Intervention in Latinos (AB-CASI)
Official title: Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Alcohol Dependence
Alcoholism
AB-CASI
Emergency Department
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-09-25
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in the Emergency Department.

Detailed description: The research team will rigorously test the efficacy of AB-CASI, against a standard condition (SC) in a first-of-a-kind ED randomized controlled trial. Studying an urban adult (≥ 18 y/o) Latino ED population, the objectives are to demonstrate the superiority of AB-CASI compared to SC in: 1) reduction of alcohol consumption (Aims 1), 2) reduction of negative health behaviors and consequences (Aim 2), and 3) increasing 30-day treatment engagement (Aim 3). The investigators will also explore variation of the AB-CASI intervention on alcohol consumption, alcohol-related negative health behaviors and consequences, and 30-day treatment engagement by Latino subpopulations (Puerto-Rican, Mexican-American, Cuban-American, South/Central American) as well as other potential modifiers (age, birthplace, gender, preferred language, reason for ED visit, and smoking status). English and Spanish speaking Latino adults presenting to the Bridgeport Hospital ED will be screened using the study inclusion and exclusion criteria.

In March 2020, the primary and secondary outcomes were corrected to reflect the protocol as it was written initially. The citations section of this study registration also includes the citation for the published protocol manuscript.

Eligibility criteria: Inclusion Criteria:

* English and Spanish speaking adult
* ≥ 18 y/o
* Latino patients who present to the Bridgeport Hospital's ED
* Drink over the NIAAA low-risk limits.

Exclusion Criteria:

* Primary language other than English or Spanish
* Current enrollment in an alcohol or substance abuse treatment program
* Current ED visit for acute psychosis
* Condition that precludes interview or AB-CASI use i.e., life threatening injury/illness
* In police custody
* Inability to provide two contact numbers for follow-up

Primary outcomes:
measure: Self Reported Binge Drinking Episodes
timeFrame: 12 months
Secondary outcomes:
measure: Mean Number of Weekly Drinks
timeFrame: 12 months post enrollment
measure: Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin
timeFrame: 12 months post enrollment
measure: Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver
timeFrame: 12 months post enrollment
measure: Alcohol-Related Negative Health Behaviors and Consequences: number of injuries
timeFrame: 12 months post enrollment
measure: Alcohol-Related Negative Health Behaviors and Consequences: number of arrests
timeFrame: 12 months post enrollment
measure: Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school
timeFrame: 12 months post enrollment
measure: Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school
timeFrame: 12 months post enrollment
Other outcomes:
measure: 30 Day Treatment Engagement
timeFrame: 30 days post enrollment
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Federico Vaca, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaca FE, Dziura J, Abujarad F, Pantalon MV, Hsiao A, Field CA, D'Onofrio G. Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients. Contemp Clin Trials. 2020 Sep;96:106104. doi: 10.1016/j.cct.2020.106104. Epub 2020 Aug 7.