Brief Intervention for Alcohol Use Among Injured Patients
| Tracking Information | |||||
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| First Received Date ICMJE | January 13, 2006 | ||||
| Last Updated Date | October 26, 2012 | ||||
| Start Date ICMJE | March 2006 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Hospital re-admissions [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Hospital re-admissions | ||||
| Change History | Complete list of historical versions of study NCT00278785 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Brief Intervention for Alcohol Use Among Injured Patients | ||||
| Official Title ICMJE | Brief Intervention for Alcohol Use Among Injured Patients: A Prospective, Randomized Trial | ||||
| 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:
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Brief Motivational Interview
10-20 minute brief motivational interview
Other Names:
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 830 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00278785 | ||||
| Other Study ID Numbers ICMJE | 200513815-1, Office of Traffic Safety, Grant Number AL0584 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Garth Utter, University of California, Davis | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | California Office of Traffic Safety | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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