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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00261859
First received: December 2, 2005
Last updated: July 19, 2012
Last verified: July 2012
  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

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261859

Locations
United States, Connecticut
Yale New Haven Hospital (Adult Emergency Department)
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Gail D'Onofrio, MD, MS Yale University
  More Information

Publications:
D'Onofrio G, Fiellin DA, Pantalon M, 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 (e pub date).

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

ClinicalTrials.gov processed this record on October 22, 2014