Emergency Physician Brief Interventions for Alcohol

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00443183
First received: March 1, 2007
Last updated: July 31, 2012
Last verified: July 2012

March 1, 2007
July 31, 2012
May 2002
November 2004   (final data collection date for primary outcome measure)
  • Number of Drinks Consumed Daily for the Past 30 Days [ Time Frame: Baseline (Before Intervention) ] [ Designated as safety issue: No ]
  • Number of Drinks Consumed Per Week [ Time Frame: After 6 Months ] [ Designated as safety issue: No ]
  • Number of Drinks Consumed Per Week [ Time Frame: After 12 Months ] [ Designated as safety issue: No ]
  • Number of Binge Episodes in the Past 30 Days [ Time Frame: After 6 Months ] [ Designated as safety issue: No ]
    Greater than 4 drinks for women and greater than 5 drinks for men
  • Number of Binge Episodes in the Past 30 Days [ Time Frame: After 12 Months ] [ Designated as safety issue: No ]
    Greater than 4 drinks for women and greater than 5 drinks for men
Efficacy of BNI
Complete list of historical versions of study NCT00443183 on ClinicalTrials.gov Archive Site
  • Contemplation Ladder Scores [ Time Frame: After 6 Months ] [ Designated as safety issue: No ]
    A brief measure of motivation or readiness to change, allowing patients to indicate their motivation to change their drinking from 1 to 10, in which 2 is least motivated and 10 is most motivated.
  • Contemplation Ladder Scores [ Time Frame: After 12 Months ] [ Designated as safety issue: No ]
    A brief measure of motivation or readiness to change, allowing patients to indicate their motivation to change their drinking from 1 to 10, in which 2 is least motivated and 10 is most motivated.
  • Short Form Health Survey [ Time Frame: After 6 Months ] [ Designated as safety issue: No ]
    Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.
  • Short Form Health Survey [ Time Frame: After 12 Months ] [ Designated as safety issue: No ]
    Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.
Not Provided
Not Provided
Not Provided
 
Emergency Physician Brief Interventions for Alcohol
Emergency Physician Brief Interventions for Alcohol

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Harmful Drinking
  • Hazardous Drinking
Behavioral: Brief Negotiation Interview (BNI)
  • Experimental: Brief Negotiation Interview
    The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes.
    Intervention: Behavioral: Brief Negotiation Interview (BNI)
  • Placebo Comparator: Discharge Instructions
    Scripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
November 2004
November 2004   (final data collection date for primary outcome measure)

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;
  • In police custody; and
  • Inability to provide 2 contact numbers for follow-up.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00443183
5 R01 AA12417-03
Not Provided
Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Gail D'Onofrio, MD, MS Yale University
Yale University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP