Multidisciplinary Approach to Reduce Injury and Alcohol

NCT ID: NCT00428181

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 605 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-10-31

Brief 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.

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.

Conditions

Drinking Behavior; Injury Recidivism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Brief alcohol intervention

Intervention Type: BEHAVIORAL

Brief alcohol intervention

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.

Group Type: ACTIVE_COMPARATOR

Brief alcohol intervention plus booster

Intervention Type: BEHAVIORAL

Brief alcohol intervention plus booster in a later session

Interventions

Brief alcohol intervention

Brief alcohol intervention

Intervention Type: BEHAVIORAL

Brief alcohol intervention plus booster

Brief alcohol intervention plus booster in a later session

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Craig Field, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig A. Field, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Austin School of Social Work

Locations

Brackenridge University Medical Center

Austin, Texas, United States

Methodist Health System

Dallas, Texas, United States

Baylor University Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

References

Cochran G, Field C, Foreman M, Ylioja T, Brown CV. Effects of brief intervention on subgroups of injured patients who drink at risk levels. Inj Prev. 2016 Jun;22(3):221-5. doi: 10.1136/injuryprev-2015-041596. Epub 2015 Jun 29.

Reference Type: DERIVED

PMID: 26124071 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24263324 (View on PubMed)

Other Identifiers

R01AA015439

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant 1R01 AA015439

Identifier Type: -

Identifier Source: secondary_id

NIAAA_FIE_015439

Identifier Type: -

Identifier Source: org_study_id