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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Alcohol Screening
Brief Negotiated Interview
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Alcohol Dependence, Alcoholism, AB-CASI, Emergency Department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bridgeport Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AB-CASI

Standard Care

Arm Description

Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention

Standard Care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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)
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)
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)
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)
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)

Full Information

First Posted
September 16, 2014
Last Updated
April 21, 2022
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02247388
Brief Title
Automated Bilingual Computerized Alcohol Screening and Intervention in Latinos (AB-CASI)
Acronym
AB-CASI
Official Title
Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Alcohol Dependence, Alcoholism, AB-CASI, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AB-CASI
Arm Type
Experimental
Arm Description
Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard Care
Intervention Type
Behavioral
Intervention Name(s)
Computerized Alcohol Screening
Intervention Description
iPad based automated alcohol screening
Intervention Type
Behavioral
Intervention Name(s)
Brief Negotiated Interview
Other Intervention Name(s)
BNI
Intervention Description
iPad based automated brief negotiated interview (BNI)
Primary Outcome Measure Information:
Title
Self Reported Binge Drinking Episodes
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean Number of Weekly Drinks
Description
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.
Time Frame
12 months post enrollment
Title
Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin
Description
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)
Time Frame
12 months post enrollment
Title
Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver
Description
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)
Time Frame
12 months post enrollment
Title
Alcohol-Related Negative Health Behaviors and Consequences: number of injuries
Description
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)
Time Frame
12 months post enrollment
Title
Alcohol-Related Negative Health Behaviors and Consequences: number of arrests
Description
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)
Time Frame
12 months post enrollment
Title
Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school
Description
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)
Time Frame
12 months post enrollment
Title
Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school
Description
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)
Time Frame
12 months post enrollment
Other Pre-specified Outcome Measures:
Title
30 Day Treatment Engagement
Description
Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up
Time Frame
30 days post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Vaca, MD, MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32777381
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.
Results Reference
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Automated Bilingual Computerized Alcohol Screening and Intervention in Latinos (AB-CASI)

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