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

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ClinicalTrials.gov Identifier: NCT00261859
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : August 5, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

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).

Condition or disease Intervention/treatment Phase
Harmful Drinking Behavioral: BNI Phase 2 Phase 3

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Enhancing EP-Performed Alcohol Interventions in the ED
Study Start Date : October 2005
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. efficacy of brief intervention [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261859


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

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00261859     History of Changes
Other Study ID Numbers: 25116
NIH 1 R01 AA14963-01A1
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016

Keywords provided by Yale University:
hazardous drinking