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Clinical Trials/NCT00443183
NCT00443183
Completed
Not Applicable

Emergency Physician Brief Interventions for Alcohol

Yale University1 site in 1 country500 target enrollmentMay 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Harmful Drinking
Sponsor
Yale University
Enrollment
500
Locations
1
Primary Endpoint
Number of Binge Episodes in the Past 30 Days
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Patients with hazardous and harmful alcohol consumption are at increased risk for adverse health consequences and have frequent visits to the Emergency Department(ED). Despite research that has demonstrated the prevalence of alcohol problems in ED patients, there are limited data on the effectiveness of brief intervention (BI) strategies for patients in this setting. The purpose of the current study is to evaluate the effectiveness of a brief intervention, termed Brief Negotiation Interview (BNI), provided by emergency practitioners (EPs-emergency physicians and physician assistants), in reducing alcohol consumption in ED patients with hazardous and harmful drinking. In a controlled randomized clinical trial of 500 patients with hazardous and harmful drinking, BNI will be compared to scripted discharge instructions (DI). Three hypotheses will be tested: BNI is superior to DI in: 1) reducing alcohol consumption; 2) reducing the number of binge drinking episodes; and 3) increasing utilization of primary care or alcohol-related services. Alcohol consumption and utilization of primary care or alcohol-related services will be measured by self-report at 1,6 and 12 months. An additional benefit to changing patterns of consumption and utilization of health services may be decreased ED visits and alcohol-related hospitalizations. These will be assessed utilizing a statewide database. In order to facilitate real-world application of BNI in the ED, the project will result in a BNI manual for EPs and an adherence and competence scale. Unique features of the current project as compared to earlier studies include: 1)use of a credible control condition; 2) enrollment of a heterogeneous population; 3)use of a manual-guided intervention by existing ED staff; 4)systematic assessment of adherence and competence to ensure quality administration and discriminability of interventions; 5)monitoring of use of ancillary treatments; and 6)monitoring of repeat ED visits and alcohol-related hospitalizations.

Registry
clinicaltrials.gov
Start Date
May 2002
End Date
November 2004
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients, 18 years or older who present to the adult ED at Yale-New Haven Hospital will be screened for the NIAAA criteria for at risk drinking( ) namely:
  • Men: \> 14 drinks per week or \> 4 drinks per occasion
  • Women \&: \> 7 drinks per week or (all \>65) \> 3 drinks per occasion
  • or will be considered to screen positive for harmful drinking, if they exhibit any current injury or medical condition occurring in the setting of acute alcohol ingestion as determined by a) self-report; b)serum or breathalyzer test with a blood alcohol concentration (BAC) \> 0.02mg%;( , , ) or c) a history of any injury or medical condition involving the use of alcohol within the past year.

Exclusion Criteria

  • Patients will be excluded for the following:
  • Non-English speaking;
  • Pregnancy;
  • Alcohol dependence;
  • Current enrollment in substance abuse treatment program;
  • Current cocaine or illicit opiate use;
  • Current ED visit for acute psychiatric complaint;
  • History of neuroleptic prescription;
  • Hospitalization for psychiatric problem in the past year;
  • Condition that precludes interview i.e., life threatening injury/illness;

Outcomes

Primary Outcomes

Number of Binge Episodes in the Past 30 Days

Time Frame: After 12 Months

Greater than 4 drinks for women and greater than 5 drinks for men

Number of Drinks Consumed Per Week

Time Frame: After 12 Months

Number of Drinks Consumed Daily for the Past 30 Days

Time Frame: Baseline (Before Intervention)

Secondary Outcomes

  • Short Form Health Survey(After 12 Months)
  • Contemplation Ladder Scores(After 12 Months)

Study Sites (1)

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