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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA022083-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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To study the efficacy of AB-CASI against standard of care in a randomized controlled trial in the Emergency Department.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB-CASI | Experimental | Automated Bilingual Computerized Alcohol Screening and Brief Negotiated Interview(BNI) Intervention |
|
| Standard Care | No Intervention | Standard Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Alcohol Screening | Behavioral | iPad based automated alcohol screening |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Day Treatment Engagement | Engagement in alcohol treatment program based on Treatment Services Review at 30 day phone follow up | 30 days post enrollment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federico Vaca, MD, MPH | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32777381 | Background | 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. | |
| 37219901 | Derived | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Brief Negotiated Interview |
| Behavioral |
iPad based automated brief negotiated interview (BNI) |
|
|
| 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 |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006306 |
| Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |