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Multidisciplinary Approach to Reduce Injury and Alcohol
This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), October 2007
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00428181
  Purpose

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.


Condition Intervention Phase
Drinking Behavior
Injury Recidivism
Behavioral: Brief alcohol intervention
Phase III

Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Multidisciplinary Approach to Reduce Injury and Alcohol

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Reduction in injury recidivism
  • Reduction in alcohol intake
  • Reduction in alcohol problems

Secondary Outcome Measures:
  • Increase in treatment utilization
  • Decrease in injury related risk behavior

Estimated Enrollment: 1500
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428181

Contacts
Contact: Carla Pezzia, MPH 214-648-1094 Carla.Pezzia@utsouthwestern.edu
Contact: Craig A. Field, PhD 214-648-1343 craig.field@utsouthwestern.edu

Locations
United States, Texas
Baylor University Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Carla Pezzia, MPH     214-648-1094     Carla.Pezzia@utsouthwestern.edu    
Contact: Craig A. Field, PhD     214-648-1343     craig.field@utsouthwestern.edu    
Principal Investigator: Craig A. Field, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Craig A. Field, PhD UT Houston-Dallas Regional Campus
  More Information

Study ID Numbers: NIAAA_FIE_015439, NIH Grant 1R01 AA015439
Study First Received: January 25, 2007
Last Updated: October 5, 2007
ClinicalTrials.gov Identifier: NCT00428181  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Brief alcohol intervention
Booster session
Personalized feedback
Motivational interview
Injury recidivism
Psychological Interview
Risk Reduction Behaviors

Study placed in the following topic categories:
Drinking Behavior
Ethanol

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 06, 2009