NCT00428181

Brief Summary

The purpose of this study is to determine whether a booster session is needed after a brief intervention upon initial admission to the emergency room (ER) in order to reduce the rate of alcohol-related injury recidivism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
605

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2007

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

4 years

First QC Date

January 25, 2007

Last Update Submit

April 5, 2012

Conditions

Drinking BehaviorInjury Recidivism

Keywords

Brief alcohol interventionBooster sessionPersonalized feedbackMotivational interviewInjury recidivismPsychological InterviewRisk Reduction Behaviors

Outcome Measures

Primary Outcomes (3)

  • Reduction in injury recidivism

    August 2011

  • Reduction in alcohol intake

    August 2011

  • Reduction in alcohol problems

    August 2011

Study Arms (2)

1 Brief Intervention

ACTIVE COMPARATOR

The primary purpose of the proposed research is to compare the effectiveness of brief intervention, brief intervention plus a booster and treatment as usual for adult patients with an alcohol related injury.

Behavioral: Brief alcohol intervention

2) Booster

ACTIVE COMPARATOR

The primary purpose of the proposed research is to compare the effectiveness of brief intervention, brief intervention plus a booster and treatment as usual for adult patients with an alcohol related injury.

Behavioral: Brief alcohol intervention plus booster

Interventions

Brief alcohol interventionBEHAVIORAL

Brief alcohol intervention

1 Brief Intervention
Brief alcohol intervention plus boosterBEHAVIORAL

Brief alcohol intervention plus booster in a later session

2) Booster

Eligibility Criteria

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

You may qualify if:

  • Patients must be eighteen years of age or older.
  • Study clinicians actively monitor these patients on a daily basis and the patient's ability to participate is determined through the use of hospital medical records, daily contact with the emergency department nursing staff and hospital personnel as well as direct contact with the patient.
  • Currently, patients who are intoxicated at the time of admission to the emergency room are maintained in an observation area or admitted for twenty-three hour observation in order to rule out severe injury. They will be monitored by study personnel on an hourly basis and approached to participate in the study after evidence of acute intoxication has subsided.
  • Admitted patients who are intoxicated will be approached during their hospital stay after they are medically stable.

You may not qualify if:

  • Patients with other penetrating trauma not related to motor vehicle collisions, violence or falls, such as poisoning, bites, contusions, concussions, strains and sprains are excluded.
  • Patients with traumatic brain injury, or a Glasgow Coma Scale (GCS) score of less than 15, are also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Brackenridge University Medical Center

Austin, Texas, 78701, United States

Location

Methodist Health System

Dallas, Texas, 75203, United States

Location

Baylor University Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Cochran G, Field C, Foreman M, Ylioja T, Brown CV. Effects of brief intervention on subgroups of injured patients who drink at risk levels. Inj Prev. 2016 Jun;22(3):221-5. doi: 10.1136/injuryprev-2015-041596. Epub 2015 Jun 29.

    PMID: 26124071DERIVED

  • Field C, Walters S, Marti CN, Jun J, Foreman M, Brown C. A multisite randomized controlled trial of brief intervention to reduce drinking in the trauma care setting: how brief is brief? Ann Surg. 2014 May;259(5):873-80. doi: 10.1097/SLA.0000000000000339.

    PMID: 24263324DERIVED

MeSH Terms

Conditions

Drinking BehaviorRisk Reduction Behavior

Interventions

EthanolMethodsImmunization, Secondary

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative TechniquesImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic Techniques

Study Officials

  • Craig A. Field, PhD

    UT Austin School of Social Work

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

US(3)