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Emergency Physician Brief Interventions for Alcohol

Primary Purpose

Harmful Drinking, Hazardous Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Negotiation Interview (BNI)
Discharge Instructions
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Harmful Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brief Negotiation Interview

Discharge Instructions

Arm Description

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.

Scripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length.

Outcomes

Primary Outcome Measures

Number of Drinks Consumed Daily for the Past 30 Days
Number of Drinks Consumed Per Week
Number of Drinks Consumed Per Week
Number of Binge Episodes in the Past 30 Days
Greater than 4 drinks for women and greater than 5 drinks for men
Number of Binge Episodes in the Past 30 Days
Greater than 4 drinks for women and greater than 5 drinks for men

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2007
Last Updated
March 27, 2020
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00443183
Brief Title
Emergency Physician Brief Interventions for Alcohol
Official Title
Emergency Physician Brief Interventions for Alcohol
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Harmful Drinking, Hazardous Drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Negotiation Interview
Arm Type
Experimental
Arm Description
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.
Arm Title
Discharge Instructions
Arm Type
Placebo Comparator
Arm Description
Scripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length.
Intervention Type
Behavioral
Intervention Name(s)
Brief Negotiation Interview (BNI)
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Discharge Instructions
Intervention Description
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 Outcome Measure Information:
Title
Number of Drinks Consumed Daily for the Past 30 Days
Time Frame
Baseline (Before Intervention)
Title
Number of Drinks Consumed Per Week
Time Frame
After 6 Months
Title
Number of Drinks Consumed Per Week
Time Frame
After 12 Months
Title
Number of Binge Episodes in the Past 30 Days
Description
Greater than 4 drinks for women and greater than 5 drinks for men
Time Frame
After 6 Months
Title
Number of Binge Episodes in the Past 30 Days
Description
Greater than 4 drinks for women and greater than 5 drinks for men
Time Frame
After 12 Months
Secondary Outcome Measure Information:
Title
Contemplation Ladder Scores
Description
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.
Time Frame
After 6 Months
Title
Contemplation Ladder Scores
Description
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.
Time Frame
After 12 Months
Title
Short Form Health Survey
Description
Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.
Time Frame
After 6 Months
Title
Short Form Health Survey
Description
Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.
Time Frame
After 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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; In police custody; and Inability to provide 2 contact numbers for follow-up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail D'Onofrio, MD, MS
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Emergency Physician Brief Interventions for Alcohol

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