Skip to main content
OpenTrials
Completed

NCT Number: NCT00443183

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Harmful Drinking Hazardous Drinking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Negotiation Interview (BNI)

Behavioral

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.

Discharge Instructions

Behavioral

Used as a placebo comparator, scripted discharge instructions are to be read by emergency practitioner and designed to be less than 1 minute in length.

Primary outcomes

  1. Number of Drinks Consumed Daily for the Past 30 Days

    Time frame: Baseline (Before Intervention)

  2. Number of Drinks Consumed Per Week

    Time frame: After 6 Months

  3. Number of Drinks Consumed Per Week

    Time frame: After 12 Months

  4. Number of Binge Episodes in the Past 30 Days

    Time frame: After 6 Months

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

  5. 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

Secondary outcomes

  1. Contemplation Ladder Scores

    Time frame: After 6 Months

    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.

  2. Contemplation Ladder Scores

    Time frame: After 12 Months

    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.

  3. Short Form Health Survey

    Time frame: After 6 Months

    Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.

  4. Short Form Health Survey

    Time frame: After 12 Months

    Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Mar 5, 2007
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.