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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247388
Recruitment Status : Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Alcohol Dependence Behavioral: Computerized Alcohol Screening Behavioral: Brief Negotiated Interview Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Automated Bilingual Computerized Alcohol Screen and Intervention in Latinos
Study Start Date : October 2014
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AB-CASI
Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention
Behavioral: Computerized Alcohol Screening
iPad based automated alcohol screening

Behavioral: Brief Negotiated Interview
iPad based automated brief negotiated interview (BNI)
Other Name: BNI

No Intervention: Standard Care
Standard Care



Primary Outcome Measures :
  1. Self Reported Binge Drinking Episodes [ Time Frame: 12 months ]
    Self reported number of binge drinking episodes over the previous 28 days assessed using the 28 day timeline follow back at 12 months.


Secondary Outcome Measures :
  1. Mean Number of Weekly Drinks [ Time Frame: 12 months post enrollment ]
    Self reported mean number of weekly drinks as measured by a 28 day timeline follow back

  2. Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin [ Time Frame: 12 months post enrollment ]
    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)

  3. Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver [ Time Frame: 12 months post enrollment ]
    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)

  4. Alcohol-Related Negative Health Behaviors and Consequences: number of injuries [ Time Frame: 12 months post enrollment ]
    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)

  5. Alcohol-Related Negative Health Behaviors and Consequences: number of arrests [ Time Frame: 12 months post enrollment ]
    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)

  6. Alcohol-Related Negative Health Behaviors and Consequences: episodes of tardiness from work/school [ Time Frame: 12 months post enrollment ]
    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)

  7. Alcohol-Related Negative Health Behaviors and Consequences: days absent from work/school [ Time Frame: 12 months post enrollment ]
    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)


Other Outcome Measures:
  1. 30 Day Treatment Engagement [ Time Frame: 30 days post enrollment ]
    Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247388


Locations
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United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Federico Vaca, MD, MPH Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02247388    
Other Study ID Numbers: 1211011052
R01AA022083-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Keywords provided by Yale University:
Alcohol Dependence
Alcoholism
AB-CASI
Emergency Department
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs