Clinical trial NCT00443183: Emergency Physician Brief Interventions for Alcohol
Official title: Emergency Physician Brief Interventions for Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Harmful Drinking
Hazardous Drinking
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2007-03-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Drinks Consumed Daily for the Past 30 Days
timeFrame: Baseline (Before Intervention)
measure: Number of Drinks Consumed Per Week
timeFrame: After 6 Months
measure: Number of Drinks Consumed Per Week
timeFrame: After 12 Months
measure: Number of Binge Episodes in the Past 30 Days
timeFrame: After 6 Months
measure: Number of Binge Episodes in the Past 30 Days
timeFrame: After 12 Months
Secondary outcomes:
measure: Contemplation Ladder Scores
timeFrame: After 6 Months
measure: Contemplation Ladder Scores
timeFrame: After 12 Months
measure: Short Form Health Survey
timeFrame: After 6 Months
measure: Short Form Health Survey
timeFrame: After 12 Months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Gail D'Onofrio, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: