NCT00443183

Brief Summary

Patients with hazardous and harmful alcohol consumption are at increased risk for adverse health consequences and have frequent visits to the Emergency Department(ED). Despite research that has demonstrated the prevalence of alcohol problems in ED patients, there are limited data on the effectiveness of brief intervention (BI) strategies for patients in this setting. The purpose of the current study is to evaluate the effectiveness of a brief intervention, termed Brief Negotiation Interview (BNI), provided by emergency practitioners (EPs-emergency physicians and physician assistants), in reducing alcohol consumption in ED patients with hazardous and harmful drinking. In a controlled randomized clinical trial of 500 patients with hazardous and harmful drinking, BNI will be compared to scripted discharge instructions (DI). Three hypotheses will be tested: BNI is superior to DI in: 1) reducing alcohol consumption; 2) reducing the number of binge drinking episodes; and 3) increasing utilization of primary care or alcohol-related services. Alcohol consumption and utilization of primary care or alcohol-related services will be measured by self-report at 1,6 and 12 months. An additional benefit to changing patterns of consumption and utilization of health services may be decreased ED visits and alcohol-related hospitalizations. These will be assessed utilizing a statewide database. In order to facilitate real-world application of BNI in the ED, the project will result in a BNI manual for EPs and an adherence and competence scale. Unique features of the current project as compared to earlier studies include: 1)use of a credible control condition; 2) enrollment of a heterogeneous population; 3)use of a manual-guided intervention by existing ED staff; 4)systematic assessment of adherence and competence to ensure quality administration and discriminability of interventions; 5)monitoring of use of ancillary treatments; and 6)monitoring of repeat ED visits and alcohol-related hospitalizations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2002

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2007

Completed
Last Updated

March 30, 2020

Status Verified

August 1, 2016

Enrollment Period

2.5 years

First QC Date

March 1, 2007

Last Update Submit

March 27, 2020

Conditions

Harmful DrinkingHazardous Drinking

Outcome Measures

Primary Outcomes (5)

  • Number of Drinks Consumed Daily for the Past 30 Days

    Baseline (Before Intervention)

  • Number of Drinks Consumed Per Week

    After 6 Months

  • Number of Drinks Consumed Per Week

    After 12 Months

  • Number of Binge Episodes in the Past 30 Days

    Greater than 4 drinks for women and greater than 5 drinks for men

    After 6 Months

  • Number of Binge Episodes in the Past 30 Days

    Greater than 4 drinks for women and greater than 5 drinks for men

    After 12 Months

Secondary Outcomes (4)

  • Contemplation Ladder Scores

    After 6 Months

  • Contemplation Ladder Scores

    After 12 Months

  • Short Form Health Survey

    After 6 Months

  • Short Form Health Survey

    After 12 Months

Study Arms (2)

Brief Negotiation Interview

EXPERIMENTAL

The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes.

Behavioral: Brief Negotiation Interview (BNI)

Discharge Instructions

PLACEBO COMPARATOR

Scripted discharge instructions to be read by emergency practitioner and designed to be less than 1 minute in length.

Behavioral: Discharge Instructions

Interventions

Brief Negotiation Interview (BNI)BEHAVIORAL

The Brief Negotiation Interview is a manual guided intervention using techniques based on motivational interviewing, brief advice, and behavioral contracting and is designed to be delivered in less than 10 minutes.

Brief Negotiation Interview
Discharge InstructionsBEHAVIORAL

Used as a placebo comparator, scripted discharge instructions are to be read by emergency practitioner and designed to be less than 1 minute in length.

Discharge Instructions

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 the NIAAA criteria for at risk drinking( ) namely:
  • Men: \> 14 drinks per week or \> 4 drinks per occasion
  • Women \&: \> 7 drinks per week or (all \>65) \> 3 drinks per occasion
  • or will be considered to screen positive for harmful drinking, if they exhibit any current injury or medical condition occurring in the setting of acute alcohol ingestion as determined by a) self-report; b)serum or breathalyzer test with a blood alcohol concentration (BAC) \> 0.02mg%;( , , ) or c) a history of any injury or medical condition involving the use of alcohol within the past year.

You may not qualify if:

  • Patients will be excluded for the following:
  • Non-English speaking;
  • Pregnancy;
  • Alcohol dependence;
  • Current enrollment in substance abuse treatment program;
  • Current cocaine or illicit opiate use;
  • Current ED visit for acute psychiatric complaint;
  • History of neuroleptic prescription;
  • Hospitalization for psychiatric problem in the past year;
  • Condition that precludes interview i.e., life threatening injury/illness;
  • In police custody; and
  • Inability to provide 2 contact numbers for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Study Officials

  • Gail D'Onofrio, MD, MS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2007

First Posted

March 5, 2007

Study Start

May 1, 2002

Primary Completion

November 1, 2004

Study Completion

November 1, 2004

Last Updated

March 30, 2020

Record last verified: 2016-08

Locations

US(1)