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Multidisciplinary Approach to Reduce Injury and Alcohol

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Craig Field, Ph.D., University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT00428181
First received: January 25, 2007
Last updated: April 5, 2012
Last verified: April 2012

January 25, 2007
April 5, 2012
September 2007
September 2011   (final data collection date for primary outcome measure)
  • Reduction in injury recidivism [ Time Frame: August 2011 ] [ Designated as safety issue: No ]
  • Reduction in alcohol intake [ Time Frame: August 2011 ] [ Designated as safety issue: No ]
  • Reduction in alcohol problems [ Time Frame: August 2011 ] [ Designated as safety issue: No ]
  • Reduction in injury recidivism
  • Reduction in alcohol intake
  • Reduction in alcohol problems
Complete list of historical versions of study NCT00428181 on ClinicalTrials.gov Archive Site
Not Provided
  • Increase in treatment utilization
  • Decrease in injury related risk behavior
Not Provided
Not Provided
 
Multidisciplinary Approach to Reduce Injury and Alcohol
Multidisciplinary Approach to Reduce Injury and Alcohol

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Drinking Behavior
  • Injury Recidivism
  • Behavioral: Brief alcohol intervention
    Brief alcohol intervention
  • Behavioral: Brief alcohol intervention plus booster
    Brief alcohol intervention plus booster in a later session
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
605
October 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00428181
NIAAA_FIE_015439, R01AA015439, NIH Grant 1R01 AA015439
Yes
Craig Field, Ph.D., University of Texas at Austin
University of Texas at Austin
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Craig A. Field, PhD UT Austin School of Social Work
University of Texas at Austin
April 2012

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