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
  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
Behavioral: Brief alcohol intervention plus booster
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multidisciplinary Approach to Reduce Injury and Alcohol

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • 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 ]

Enrollment: 605
Study Start Date: September 2007
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Brief alcohol intervention plus booster in a later session

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Brackenridge University Medical Center
Austin, Texas, United States, 78701
Baylor University Medical Center at Dallas
Dallas, Texas, United States, 75390
Methodist Health System
Dallas, Texas, United States, 75203
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Craig A. Field, PhD UT Austin School of Social Work
  More Information

No publications provided by University of Texas at Austin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Craig Field, Ph.D., Principal Investigator, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT00428181     History of Changes
Other Study ID Numbers: NIAAA_FIE_015439, R01AA015439, NIH Grant 1R01 AA015439
Study First Received: January 25, 2007
Last Updated: April 5, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Texas at Austin:
Brief alcohol intervention
Booster session
Personalized feedback
Motivational interview
Injury recidivism
Psychological Interview
Risk Reduction Behaviors

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

ClinicalTrials.gov processed this record on October 22, 2014