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Multidisciplinary Approach to Reduce Injury and Alcohol

Primary Purpose

Drinking Behavior, Injury Recidivism

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Brief alcohol intervention

Brief alcohol intervention plus booster

About this trial

This is an interventional treatment trial for Drinking Behavior focused on measuring Brief alcohol intervention, Booster session, Personalized feedback, Motivational interview, Injury recidivism, Psychological Interview, Risk Reduction Behaviors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Brackenridge University Medical Center
Methodist Health System
Baylor University Medical Center at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1 Brief Intervention

2) Booster

Arm Description

Outcomes

Primary Outcome Measures

Reduction in injury recidivism

Reduction in alcohol intake

Reduction in alcohol problems

Secondary Outcome Measures

Full Information

NCT ID

NCT00428181

First Posted

January 25, 2007

Last Updated

April 5, 2012

Sponsor

University of Texas at Austin

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00428181

Brief Title

Multidisciplinary Approach to Reduce Injury and Alcohol

Official Title

Multidisciplinary Approach to Reduce Injury and Alcohol

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas at Austin

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drinking Behavior, Injury Recidivism

Keywords

Brief alcohol intervention, Booster session, Personalized feedback, Motivational interview, Injury recidivism, Psychological Interview, Risk Reduction Behaviors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

605 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Brief Intervention

Arm Type

Active Comparator

Arm Description

Arm Title

2) Booster

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Brief alcohol intervention

Intervention Description

Brief alcohol intervention

Intervention Type

Behavioral

Intervention Name(s)

Brief alcohol intervention plus booster

Intervention Description

Brief alcohol intervention plus booster in a later session

Primary Outcome Measure Information:

Title

Reduction in injury recidivism

Time Frame

August 2011

Title

Reduction in alcohol intake

Time Frame

August 2011

Title

Reduction in alcohol problems

Time Frame

August 2011

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig A. Field, PhD

Organizational Affiliation

UT Austin School of Social Work

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brackenridge University Medical Center

City

Austin

State/Province

Texas

ZIP/Postal Code

78701

Country

United States

Facility Name

Methodist Health System

City

Dallas

State/Province

Texas

ZIP/Postal Code

75203

Country

United States

Facility Name

Baylor University Medical Center at Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26124071

Citation

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.

Results Reference

derived

PubMed Identifier

24263324

Citation

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.

Results Reference

derived

Learn more about this trial

Multidisciplinary Approach to Reduce Injury and Alcohol

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