Emergency Physician Brief Interventions for Alcohol

Hazardous Drinking Clinical Trial

Official title:

Emergency Physician Brief Interventions for Alcohol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443183
• Other study ID #: 9906010726
• Secondary ID: 5R01AA012417-03
• Status: Completed
• Phase: N/A
• Start date: May 2002
• Est. completion date: November 2004

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Harmful Drinking
• Hazardous Drinking

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Drinks Consumed Daily for the Past 30 Days		Baseline (Before Intervention)
Primary	Number of Drinks Consumed Per Week		After 6 Months
Primary	Number of Drinks Consumed Per Week		After 12 Months
Primary	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
Primary	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	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
Secondary	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
Secondary	Short Form Health Survey	Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.	After 6 Months
Secondary	Short Form Health Survey	Assess health status in 2 domains, physical and mental, including summary measures and overall general health perceptions.	After 12 Months