Enhancing Emergency Practitioner (EP)-Performed Alcohol Interventions in the Emergency Department (ED)

NCT ID: NCT00261859

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 900 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2009-11-30

Brief Summary

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).

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).

Conditions

Harmful Drinking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

SCA

Standard Care with Assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

SCNA

Standard Care No Assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

BNI

Brief Negotiated Interview

Group Type: EXPERIMENTAL

BNI

Intervention Type: BEHAVIORAL

behavioral- brief intervention

EBNI

Enhanced Brief Negotiated Interview

Group Type: EXPERIMENTAL

BNI

Intervention Type: BEHAVIORAL

behavioral- brief intervention

Interventions

BNI

behavioral- brief intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail D'Onofrio, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital (Adult Emergency Department)

New Haven, Connecticut, United States

Countries

United States

References

D'Onofrio G, Fiellin DA, Pantalon MV, Chawarski MC, Owens PH, Degutis LC, Busch SH, Bernstein SL, O'Connor PG. A brief intervention reduces hazardous and harmful drinking in emergency department patients. Ann Emerg Med. 2012 Aug;60(2):181-92. doi: 10.1016/j.annemergmed.2012.02.006. Epub 2012 Mar 28.

Reference Type: BACKGROUND

PMID: 22459448 (View on PubMed)

Other Identifiers

R01AA014963-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0303025116

Identifier Type: -

Identifier Source: org_study_id