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Trial record 1 of 1 for:    NCT00428181
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Multidisciplinary Approach to Reduce Injury and Alcohol

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ClinicalTrials.gov Identifier: NCT00428181
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : April 6, 2012
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Craig Field, Ph.D., University of Texas at Austin

Tracking Information
First Submitted Date  ICMJE January 25, 2007
First Posted Date  ICMJE January 29, 2007
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
  • Reduction in injury recidivism [ Time Frame: August 2011 ]
  • Reduction in alcohol intake [ Time Frame: August 2011 ]
  • Reduction in alcohol problems [ Time Frame: August 2011 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2007)
  • Reduction in injury recidivism
  • Reduction in alcohol intake
  • Reduction in alcohol problems
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2007)
  • Increase in treatment utilization
  • Decrease in injury related risk behavior
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multidisciplinary Approach to Reduce Injury and Alcohol
Official Title  ICMJE Multidisciplinary Approach to Reduce Injury and Alcohol
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Drinking Behavior
  • Injury Recidivism
Intervention  ICMJE
  • Behavioral: Brief alcohol intervention
    Brief alcohol intervention
  • Behavioral: Brief alcohol intervention plus booster
    Brief alcohol intervention plus booster in a later session
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Brief alcohol intervention plus booster
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2012)
605
Original Enrollment  ICMJE
 (submitted: January 25, 2007)
1500
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00428181
Other Study ID Numbers  ICMJE NIAAA_FIE_015439
R01AA015439 ( U.S. NIH Grant/Contract )
NIH Grant 1R01 AA015439
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Craig Field, Ph.D., University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Craig A. Field, PhD UT Austin School of Social Work
PRS Account University of Texas at Austin
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP