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
  Purpose

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.


Condition Intervention
Harmful Drinking
Hazardous Drinking
Behavioral: Brief Negotiation Interview (BNI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Emergency Physician Brief Interventions for Alcohol

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 500
Study Start Date: May 2002
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  • In police custody; and
  • Inability to provide 2 contact numbers for follow-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443183

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Gail D'Onofrio, MD, MS Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00443183     History of Changes
Other Study ID Numbers: 5 R01 AA12417-03
Study First Received: March 1, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014