Brief Intervention for Alcohol Use Among Injured Patients
Primary Purpose
Alcohol Drinking, Wounds and Injuries
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Interview
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Drinking focused on measuring interviews, brief intervention, drinking, alcohol, injuries, wounds, intervention studies
Eligibility Criteria
Inclusion Criteria: >=18 yrs old English or Spanish Speaking Mentally and physically able to provide consent and participate in the intervention Admission to the trauma ward or ICU Exclusion Criteria: <18 yrs old Non-English or Non-Spanish Speaking Severe Psychiatric illness incarcerated
Sites / Locations
- University of California, Davis, Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
Control group to receive informational pamphlet on alcohol use and list of self referral agencies
Intervention group receives pamphlet on alcohol and self referral information in addition to brief motivational interview
Outcomes
Primary Outcome Measures
Hospital re-admissions
number of hospital re-admissions
Secondary Outcome Measures
12 month AUDIT Results
Score on self administered questionnaire
Moving violations/DUI
number of moving violations/DUI
Self referral for counselling/treatment
number of self referrals for counseling/treatment
Full Information
NCT ID
NCT00278785
First Posted
January 13, 2006
Last Updated
September 29, 2022
Sponsor
University of California, Davis
Collaborators
California Office of Traffic Safety
1. Study Identification
Unique Protocol Identification Number
NCT00278785
Brief Title
Brief Intervention for Alcohol Use Among Injured Patients
Official Title
Brief Intervention for Alcohol Use Among Injured Patients: A Prospective, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 24, 2027 (Anticipated)
Study Completion Date
January 24, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
California Office of Traffic Safety
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The underlying hypothesis that providing brief interventions to individuals who engage in potentially harmful patterns of alcohol use will alter their drinking behavior and therefore avoid negative consequences. Specifically, this study aims to determine if brief interventions will:
Reduce the number of re-admissions and deaths due to injuries associated with alcohol consumption
Reduce the number of driving under the influence (DUI) arrests
Reduce harmful drinking behavior
Detailed Description
Alcohol use is the most common underlying cause of injuries in the United States. There is a growing body of literature suggesting that brief interventions (BI), in the form of a short (10-60 minute) counseling session, may decrease alcohol consumption and its harmful consequences. In contrast to the abundant literature on the effectiveness of BI in the outpatient setting, only 3 randomized controlled trials have been performed an adults specifically in the setting of acute trauma, and have had inconclusive results. All three studies used highly trained persons to perform the BI, and all were greater than 30 minutes in duration, a situation that may not necessarily reflect the practicalities of routine medical care. This raises the question of whether the benefits seen in these studies reflect the expertise of a small number of individuals or whether the effects correlate with the amount of time spent with the patient. Highly trained personnel and time are valuable commodities in a busy trauma center and may not be feasible given the competing clinical demands. We propose to investigate whether BI are effective in a setting that is more likely to reflect "real world" of clinical medicine rather than an idealized setting, utilizing trauma nurse practitioners to perform brief (5-10 minute) interviews.
We will identify all patients admitted with trauma who test positive on a blood alcohol test. These patients will be consented and randomized to either a brief intervention group, or a standard medical care group. All patients will receive an AUDIT questionnaire to identify patterns of drinking behavior and an alcohol information pamphlet. After discharge, patients will be telephoned at 1,6, and 12 months. The first 2 contacts will be to see how the patient is doing and to verify the contact information. The AUDIT questionnaire will be re-administered during the 12 month interview.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Wounds and Injuries
Keywords
interviews, brief intervention, drinking, alcohol, injuries, wounds, intervention studies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
830 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Control group to receive informational pamphlet on alcohol use and list of self referral agencies
Arm Title
2
Arm Type
Experimental
Arm Description
Intervention group receives pamphlet on alcohol and self referral information in addition to brief motivational interview
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Interview
Other Intervention Name(s)
Brief intervention, Motivational interview
Intervention Description
10-20 minute brief motivational interview
Primary Outcome Measure Information:
Title
Hospital re-admissions
Description
number of hospital re-admissions
Time Frame
2 years
Secondary Outcome Measure Information:
Title
12 month AUDIT Results
Description
Score on self administered questionnaire
Time Frame
12 months
Title
Moving violations/DUI
Description
number of moving violations/DUI
Time Frame
2 years
Title
Self referral for counselling/treatment
Description
number of self referrals for counseling/treatment
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>=18 yrs old
English or Spanish Speaking
Mentally and physically able to provide consent and participate in the intervention
Admission to the trauma ward or ICU
Exclusion Criteria:
<18 yrs old
Non-English or Non-Spanish Speaking
Severe Psychiatric illness
incarcerated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garth H. Utter, MD, MSc
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis, Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7563455
Citation
Gentilello LM, Donovan DM, Dunn CW, Rivara FP. Alcohol interventions in trauma centers. Current practice and future directions. JAMA. 1995 Oct 4;274(13):1043-8.
Results Reference
background
PubMed Identifier
9178789
Citation
Soderstrom CA, Smith GS, Dischinger PC, McDuff DR, Hebel JR, Gorelick DA, Kerns TJ, Ho SM, Read KM. Psychoactive substance use disorders among seriously injured trauma center patients. JAMA. 1997 Jun 11;277(22):1769-74.
Results Reference
background
PubMed Identifier
8105114
Citation
Rivara FP, Koepsell TD, Jurkovich GJ, Gurney JG, Soderberg R. The effects of alcohol abuse on readmission for trauma. JAMA. 1993 Oct 27;270(16):1962-4.
Results Reference
background
PubMed Identifier
10522717
Citation
Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
Results Reference
background
PubMed Identifier
10527297
Citation
Ockene JK, Adams A, Hurley TG, Wheeler EV, Hebert JR. Brief physician- and nurse practitioner-delivered counseling for high-risk drinkers: does it work? Arch Intern Med. 1999 Oct 11;159(18):2198-205. doi: 10.1001/archinte.159.18.2198.
Results Reference
background
PubMed Identifier
12492754
Citation
Smith AJ, Hodgson RJ, Bridgeman K, Shepherd JP. A randomized controlled trial of a brief intervention after alcohol-related facial injury. Addiction. 2003 Jan;98(1):43-52. doi: 10.1046/j.1360-0443.2003.00251.x.
Results Reference
background
PubMed Identifier
15343198
Citation
Spirito A, Monti PM, Barnett NP, Colby SM, Sindelar H, Rohsenow DJ, Lewander W, Myers M. A randomized clinical trial of a brief motivational intervention for alcohol-positive adolescents treated in an emergency department. J Pediatr. 2004 Sep;145(3):396-402. doi: 10.1016/j.jpeds.2004.04.057.
Results Reference
background
PubMed Identifier
10596521
Citation
Monti PM, Colby SM, Barnett NP, Spirito A, Rohsenow DJ, Myers M, Woolard R, Lewander W. Brief intervention for harm reduction with alcohol-positive older adolescents in a hospital emergency department. J Consult Clin Psychol. 1999 Dec;67(6):989-94. doi: 10.1037//0022-006x.67.6.989.
Results Reference
background
PubMed Identifier
11838918
Citation
Longabaugh R, Woolard RE, Nirenberg TD, Minugh AP, Becker B, Clifford PR, Carty K, Licsw, Sparadeo F, Gogineni A. Evaluating the effects of a brief motivational intervention for injured drinkers in the emergency department. J Stud Alcohol. 2001 Nov;62(6):806-16. doi: 10.15288/jsa.2001.62.806.
Results Reference
background
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Brief Intervention for Alcohol Use Among Injured Patients
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