Multidisciplinary Approach to Reduce Injury and Alcohol
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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 |
- 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 |
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| 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 | |
| Principal Investigator: | Craig A. Field, PhD | UT Austin School of Social Work |
More Information
No publications provided
| 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, Local Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013