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

Alcohol Dependence Clinical Trial

— AB-CASI  

Official title:

Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247388
• Other study ID #: 1211011052
• Secondary ID: R01AA022083-01A1
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 840
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Computerized Alcohol Screening
iPad based automated alcohol screening
• Brief Negotiated Interview
iPad based automated brief negotiated interview (BNI)

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Corrected and republished in: Contemp Clin Trials. 2020 Sep 16;:106128. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	30 Day Treatment Engagement	Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up	30 days post enrollment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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