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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
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Active Comparator

Arm Label

1 Brief Intervention

2) Booster

Arm 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 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.

Outcomes

Primary Outcome Measures

Reduction in injury recidivism
Reduction in alcohol intake
Reduction in alcohol problems

Secondary Outcome Measures

Full Information

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)
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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
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.
Arm Title
2) Booster
Arm Type
Active Comparator
Arm 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.
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
No
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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