Multidisciplinary Approach to Reduce Injury and Alcohol

Drinking Behavior Clinical Trial

Official title:

Multidisciplinary Approach to Reduce Injury and Alcohol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428181
• Other study ID #: NIAAA_FIE_015439
• Secondary ID: R01AA015439NIH G
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2007
• Last updated: April 5, 2012
• Start date: September 2007
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drinking Behavior
• Injury Recidivism

Intervention

Behavioral:
• Brief alcohol intervention
Brief alcohol intervention
• Brief alcohol intervention plus booster
Brief alcohol intervention plus booster in a later session

Locations

Country	Name	City	State
United States	Brackenridge University Medical Center	Austin	Texas
United States	Baylor University Medical Center at Dallas	Dallas	Texas
United States	Methodist Health System	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in injury recidivism		August 2011	No
Primary	Reduction in alcohol intake		August 2011	No
Primary	Reduction in alcohol problems		August 2011	No