Automated Bilingual Computerized Alcohol Screening and Intervention in Latinos (AB-CASI)

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

Detailed Description
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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.

Official Title
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Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Behavioral: Computerized Alcohol Screening
* Behavioral: Brief Negotiated Interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB-CASI<br>Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention | Behavioral: Computerized Alcohol Screening<br>* iPad based automated alcohol screening<br>Behavioral: Brief Negotiated Interview<br>* iPad based automated brief negotiated interview (BNI)<br>* Other names: BNI;|
| No Intervention: Standard Care<br>Standard Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reported Binge Drinking Episodes | Self reported number of binge drinking episodes over the previous 28 days assessed using the 28 day timeline follow back at 12 months. This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver | Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school) | 12 months post enrollment | 
| Alcohol-Related Negative Health Behaviors and Consequences: number of injuries | Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school) | 12 months post enrollment | 
| Alcohol-Related Negative Health Behaviors and Consequences: number of arrests | Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school) | 12 months post enrollment | 
| Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school | Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school) | 12 months post enrollment | 
| Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school | Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school) | 12 months post enrollment | 
| Mean Number of Weekly Drinks | Self reported mean number of weekly drinks as measured by a 28 day timeline follow back. This outcome was corrected 3/2020 to accurately reflect the time frame from the original protocol. It was also moved to the secondary outcome measure section as was the original intent. | 12 months post enrollment | 
| Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin | Self reported alcohol-related negative health behaviors and consequences based on the Brief Event Data survey (includes episodes of impaired driving, riding with an impaired driver, injuries, arrests, tardiness and days absent from work/school) | 12 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Alcoholism, AB-CASI, Emergency Department