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.

Study Overview

• Status: Completed
• Conditions: Hazardous Drinking; Harmful Drinking
• Intervention / Treatment: Behavioral: Brief Negotiation Interview (BNI); Behavioral: Discharge Instructions

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
Placebo Comparator: Discharge Instructions; Scripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length.	Behavioral: Discharge Instructions; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Drinks Consumed Daily for the Past 30 Days		Baseline (Before Intervention)
Number of Drinks Consumed Per Week		After 6 Months
Number of Drinks Consumed Per Week		After 12 Months
Number of Binge Episodes in the Past 30 Days	Greater than 4 drinks for women and greater than 5 drinks for men	After 6 Months
Number of Binge Episodes in the Past 30 Days	Greater than 4 drinks for women and greater than 5 drinks for men	After 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contemplation Ladder Scores	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.	After 6 Months
Contemplation Ladder Scores	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.	After 12 Months
Short Form Health Survey	Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.	After 6 Months
Short Form Health Survey	Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.	After 12 Months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Gail D'Onofrio, MD, MS, Yale University

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): November 1, 2004

Study Registration Dates

• First Submitted: March 1, 2007
• First Submitted That Met QC Criteria: March 2, 2007
• First Posted (Estimate): March 5, 2007

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 9906010726; 5R01AA012417-03 (U.S. NIH Grant/Contract)