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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00183183
Other study ID # NIAAAASE15123
Secondary ID R21AA015123NIH 5
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated May 21, 2010
Start date April 2004
Est. completion date December 2005

Study information

Verified date May 2010
Source University of Connecticut Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Alcohol abuse is associated with injury, chronic illness, absenteeism from work, and social costs to families and communities. The goal of this project is to translate motivational interventions successful in the primary care setting to the Emergency Department (ED) environment by implementing screening, brief intervention and referral to treatment (SBIRT) in order to reduce at-risk drinking among ED patients.


Description:

To evaluate the effectiveness of SBIRT in the emergency room setting, ED patients meeting NIAAA criteria for high risk drinking were recruited from 14 sites nationwide (control group-Spring, 2004; intervention group-Summer, 2004). 26% of screened ED patients met inclusion criteria. All enrollees received a list of local referral resources. Intervention group patients also participated in a 15 minute negotiated interview and ED staff referred them directly for treatment if indicated. Enrollees completed 3-month follow-up surveys with a telephone Interactive Voice Response (IVR) system. A total of 1137 patients were enrolled across 14 sites (561 intervention, 576 control), with 62% male, 37% Black, and 38% White, and a mean age of 37. At baseline intervention-i and control-c groups were similar in demographic characteristics and number of drinks on a typical day (mean-i 5.00, mean-c 5.12) and maximum drinks on a given day in the past month (mean-i 7.51, mean-c 7.33). The 3 month follow-up rate was 62% (n=687); the 6 month follow-up rate was 52% (n=567). The 12 month follow up is currently underway.


Recruitment information / eligibility

Status Completed
Enrollment 1137
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age 18+

- Communication in English or Spanish

- Met NIAAA criteria for "at-risk drinking":

- for Men: 15 or more drinks/week, or 5 or more drinks on a single occasion

- for Women: 8 or more drinks/week, or 4 or more drinks on a single occasion

- Age 65 or over: 8 or more drinks/week or more than 1 drink per day

Exclusion Criteria:

- Requests detox or already in alcohol treatment program

- Abnormal mental status

- Too ill to give consent

- Unable to provide consent for other reasons

- Suicidal

- Employee or student of site institution (where required)

- Prisoner

- Inability to follow up

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Screening and Brief Intervention


Locations

Country Name City State
United States The University of New Mexico Hospital/Health Sciences Center Albuquerque New Mexico
United States University of Michigan Hospital and Health System / Department of Emergency Medicine Ann Arbor Michigan
United States Department of Emergency Medicine Emory University School of Medicine / Emergency Care Center of the Grady Memorial Hospital Atlanta Georgia
United States Boston University Medical Center Boston Massachusetts
United States Tufts-New England Medical Center Hospital/Tufts University Boston Massachusetts
United States Cooper Health/Department of Emergency Medicine at UMNDJ-RWJMS Camden New Jersey
United States University of Virginia Health System, University Hospital Charlottesville Virginia
United States University of Denver/Denver Health Medical Center Denver Colorado
United States University of Connecticut Health Center Farmington Connecticut
United States Charles R. Drew University of Medicine and Science/Matrin Luther King Hospital Los Angeles California
United States University of Southern California Keck School of Medicine / Los Angeles County+University of Southern California Medical Center Los Angeles California
United States Section of Emergency Medicine/Yale University School of Medicine New Haven Connecticut
United States Rhode Island Hospital / Brown University / Department of EM and Injury Prevention Center Providence Rhode Island
United States University of California San Diego Medical Center - Hillcrest San Diego California
United States Howard University/College of Medicine/Department of Pharmacology and Emergency Medicine Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut Health Center National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantity of drinks per day
Primary Frequency of drinking days per week
Secondary Completing alcohol related treatment
Secondary Reporting negative alcohol related events
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