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CompletedNCT00428181Updated Apr 6, 2012

Multidisciplinary Approach to Reduce Injury and Alcohol

A Phase 3 interventional study of Brief alcohol intervention and Brief alcohol intervention plus booster in Drinking Behavior and Injury Recidivism, sponsored by University of Texas at Austin. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-06.

Sponsored by University of Texas at Austin · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
605
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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. The primary outcomes of interest in the proposed trial are injury recidivism, alcohol intake, and alcohol problems. Because brief alcohol interventions with injured patients are opportunistic in nature, the patient's motivation to change or stage of change likely influences their response to brief intervention as well as the need for additional intervention. Therefore, the primary hypothesis of the proposed research is that patients presenting for treatment of an alcohol related injury who are in the precontemplation or contemplation stages of change require brief intervention with booster while patients in the preparation or action stages of change benefit equally from brief intervention alone or brief intervention plus booster. That is, an interaction between the patient's stage of change (Precontemplation and Contemplation or Action) at enrollment and treatment type (Brief Intervention, Brief Intervention with Booster and Treatment as Usual) is hypothesized to influence treatment effect at follow up. In addition, the impact of intervention on the patient's motivation to change at follow up will be assessed.

02

Conditions studied

  • Drinking Behavior
  • Injury Recidivism

Keywords

  • Brief alcohol intervention
  • Booster session
  • Personalized feedback
  • Motivational interview
  • Injury recidivism
  • Psychological Interview
  • Risk Reduction Behaviors
03

In context

Drinking Behavior

50 studies on the registry are indexed under Drinking Behavior; 6 are open to participants now.

This study's enrollment of 605 is above the median of 124 across 45 interventional studies indexed under Drinking Behavior.

Browse Drinking Behavior studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who are treated for an intentional or unintentional injury associated with motor vehicle collisions involving driver (i.e., passenger or pedestrian) will be eligible for inclusion in the study.
  • Patients who are treated for an intentional or unintentional injury associated with violence-related injuries including gunshot wounds, stab wounds, or other injuries related to assaults and falls will be eligible for inclusion in the study.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
605 participants (actual)

Study arms

  • Active comparator
    1 Brief Intervention

    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

  • Active comparator
    2) Booster

    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

  • BehavioralBrief alcohol intervention

    Brief alcohol intervention

  • BehavioralBrief alcohol intervention plus booster

    Brief alcohol intervention plus booster in a later session

06

What researchers measure

Primary outcomes

  1. Reduction in injury recidivism

    Time frame: August 2011

  2. Reduction in alcohol intake

    Time frame: August 2011

  3. Reduction in alcohol problems

    Time frame: August 2011

07

Study locations

3 sites
  • Brackenridge University Medical Center
    Austin, Texas 78701, United States
  • Methodist Health System
    Dallas, Texas 75203, United States
  • Baylor University Medical Center at Dallas
    Dallas, Texas 75390, United States
08

References and documents

Publications

  • 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. PubMed 26124071 ↗
  • 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. PubMed 24263324 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2007, a primary completion of Sep 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2007
First posted
Jan 29, 2007
Start
Sep 2007
Primary completionActual
Sep 2011
CompletionActual
Oct 2011
Last update
Apr 6, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00428181
Responsible party
Craig Field, Ph.D. (Principal Investigator, University of Texas at Austin) — Principal investigator
First posted
Jan 29, 2007
Start date
Sep 2007
Primary completion
Sep 2011
Completion
Oct 2011
Last update
Apr 6, 2012

Study contacts

Craig A. Field, PhD
principal investigator · UT Austin School of Social Work

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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