Emergency Physician Brief Interventions for Alcohol

Study Overview
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Brief Summary
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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.

Official Title
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Emergency Physician Brief Interventions for Alcohol

Conditions
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Harmful Drinking, Hazardous Drinking

Intervention / Treatment
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* Behavioral: Brief Negotiation Interview (BNI)
* Behavioral: Discharge Instructions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief Negotiation Interview<br>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)<br>* 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.<br>|
| Placebo Comparator: Discharge Instructions<br>Scripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length. | Behavioral: Discharge Instructions<br>* 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.<br>|

What is the study measuring?
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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 |