Enhancing Emergency Practitioner (EP)-Performed Alcohol Interventions in the Emergency Department (ED)
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Purpose
The purpose of this study is to evaluate the effectiveness of an enhanced emergency practitioner (EP) performed brief intervention (BI), namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 hazardous and harmful (HH) drinkers will be randomly assigned to one of the 4 conditions. We, the researchers at Yale University, will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).
| Condition | Intervention | Phase |
|---|---|---|
|
Harmful Drinking |
Behavioral: BNI |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
| Official Title: | Enhancing EP-Performed Alcohol Interventions in the ED |
- efficacy of brief intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 900 |
| Study Start Date: | October 2005 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: SCA
Standard Care with Assessment
|
|
|
No Intervention: SCNA
Standard Care No Assessment
|
|
|
Experimental: BNI
Brief Negotiated Interview
|
Behavioral: BNI
behavioral- brief intervention
|
|
Experimental: EBNI
Enhanced Brief Negotiated Interview
|
Behavioral: BNI
behavioral- brief intervention
|
Detailed Description:
A critical need exists to refine and test brief interventions (BI) for Emergency Department (ED) populations with hazardous and harmful (HH) drinking that can be translated into real-world settings; and to enhance the effects of these BIs so they can be maintained over time. The ED is an ideal setting for BIs, as many ED patients who exceed low-risk recommendations do not have contact with either alcohol treatment specialists or visit primary care medical practitioners. This includes a large segment of young adults ages 18-30 whose only contact with the health care system is often an ED visit. The purpose of this study is to evaluate the effectiveness of an enhanced Emergency Practitioner (EP) performed BI, namely, the Enhanced Brief Negotiation Interview (E-BNI). This includes a basic BNI performed in the ED with referral to a primary care provider, followed by a telephone booster intervention performed by trained nurses 1-month post ED visit. The E-BNI will be compared to the basic BNI (without booster), and standard care with assessments (SC-A) and without (SC-NA). In a randomized, controlled clinical trial 900 HH drinkers will be randomly assigned to one of the 4 conditions. We will conduct cost benefit analysis of the interventions. Follow-up assessments, at 6 and 12-months, will be obtained via interactive voice response (IVR).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients, 18 years or older, who present to the adult ED at Yale-New Haven Hospital will be screened for exceeding the NIAAA criteria for low-risk drinking
- Patients may be hazardous "at-risk" drinkers who screen over the limits, but do not currently exhibit medical, social or legal problems as a result of their drinking, or they may be harmful drinkers, presenting with an alcohol associated injury or illness.
Exclusion Criteria:
Patients will be excluded for the following reasons:
- Non-English speaking;
- Alcohol dependence;
- Current enrollment in a substance abuse treatment program;
- Current ED visit for acute psychiatric complaint;
- Condition that precludes interview i.e., life threatening injury/illness;
- In police custody; or
- Inability to provide two contact numbers for follow-up.
Contacts and Locations| United States, Connecticut | |
| Yale New Haven Hospital (Adult Emergency Department) | |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: | Gail D'Onofrio, MD, MS | Yale University |
More Information
Publications:
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00261859 History of Changes |
| Other Study ID Numbers: | 25116, NIH 1 R01 AA14963-01A1 |
| Study First Received: | December 2, 2005 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
hazardous drinking |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013