NCT00261859

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

4.1 years

First QC Date

December 2, 2005

Last Update Submit

March 4, 2020

Conditions

Harmful Drinking

Keywords

hazardous drinking

Outcome Measures

Primary Outcomes (1)

  • efficacy of brief intervention

    12 months

Study Arms (4)

SCA

NO INTERVENTION

Standard Care with Assessment

SCNA

NO INTERVENTION

Standard Care No Assessment

BNI

EXPERIMENTAL

Brief Negotiated Interview

Behavioral: BNI

EBNI

EXPERIMENTAL

Enhanced Brief Negotiated Interview

Behavioral: BNI

Interventions

BNIBEHAVIORAL

behavioral- brief intervention

BNIEBNI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital (Adult Emergency Department)

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 22459448BACKGROUND

Study Officials

  • Gail D'Onofrio, MD, MS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 5, 2005

Study Start

October 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

US(1)