- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00278785
Brief Intervention for Alcohol Use Among Injured Patients
Brief Intervention for Alcohol Use Among Injured Patients: A Prospective, Randomized Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- University of California, Davis, Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 1
Control group to receive informational pamphlet on alcohol use and list of self referral agencies
|
|
|
Experimental: 2
Intervention group receives pamphlet on alcohol and self referral information in addition to brief motivational interview
|
10-20 minute brief motivational interview
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital re-admissions
Time Frame: 2 years
|
number of hospital re-admissions
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12 month AUDIT Results
Time Frame: 12 months
|
Score on self administered questionnaire
|
12 months
|
|
Moving violations/DUI
Time Frame: 2 years
|
number of moving violations/DUI
|
2 years
|
|
Self referral for counselling/treatment
Time Frame: 12 months
|
number of self referrals for counseling/treatment
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Garth H. Utter, MD, MSc, University of California, Davis
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 237217
- Office of Traffic Safety (Other Identifier: UC Davis)
- Grant Number AL0584 (Other Grant/Funding Number: UC Davis)
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