NCT02247388

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

5.6 years

First QC Date

September 16, 2014

Last Update Submit

April 21, 2022

Conditions

Alcohol Dependence

Keywords

Alcohol DependenceAlcoholismAB-CASIEmergency Department

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Mean Number of Weekly Drinks

    12 months post enrollment

  • Alcohol-Related Negative Health Behaviors and Consequences: episodes of impaired drivin

    12 months post enrollment

  • Alcohol-Related Negative Health Behaviors and Consequences: episodes riding with an impaired driver

    12 months post enrollment

  • Alcohol-Related Negative Health Behaviors and Consequences: number of injuries

    12 months post enrollment

  • Alcohol-Related Negative Health Behaviors and Consequences: number of arrests

    12 months post enrollment

  • +2 more secondary outcomes

Other Outcomes (1)

  • 30 Day Treatment Engagement

    30 days post enrollment

Study Arms (2)

AB-CASI

EXPERIMENTAL

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

Behavioral: Computerized Alcohol ScreeningBehavioral: Brief Negotiated Interview

Standard Care

NO INTERVENTION

Standard Care

Interventions

Computerized Alcohol ScreeningBEHAVIORAL

iPad based automated alcohol screening

AB-CASI
Brief Negotiated InterviewBEHAVIORAL

iPad based automated brief negotiated interview (BNI)

Also known as: BNI
AB-CASI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Related Publications (2)

  • 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.

    PMID: 32777381BACKGROUND

  • Vaca FE, Dziura J, Abujarad F, Pantalon M, Hsiao A, Reynolds J, Maciejewski KR, Field CA, D'Onofrio G. Use of an Automated Bilingual Digital Health Tool to Reduce Unhealthy Alcohol Use Among Latino Emergency Department Patients: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2314848. doi: 10.1001/jamanetworkopen.2023.14848.

    PMID: 37219901DERIVED

MeSH Terms

Conditions

AlcoholismEmergencies

Interventions

EthanolMass Screening

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsDiagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Federico Vaca, MD, MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 25, 2014

Study Start

October 1, 2014

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

US(1)