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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00278785
Other study ID # 237217
Secondary ID Office of Traffi
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 2006
Est. completion date January 24, 2027

Study information

Verified date December 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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: 1. Reduce the number of re-admissions and deaths due to injuries associated with alcohol consumption 2. Reduce the number of driving under the influence (DUI) arrests 3. Reduce harmful drinking behavior


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 830
Est. completion date January 24, 2027
Est. primary completion date January 24, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief Motivational Interview
10-20 minute brief motivational interview

Locations

Country Name City State
United States University of California, Davis, Medical Center Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis California Office of Traffic Safety

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital re-admissions number of hospital re-admissions 2 years
Secondary 12 month AUDIT Results Score on self administered questionnaire 12 months
Secondary Moving violations/DUI number of moving violations/DUI 2 years
Secondary Self referral for counselling/treatment number of self referrals for counseling/treatment 12 months
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