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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00865774
Other study ID # IRB00006734
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2009
Est. completion date December 2011

Study information

Verified date August 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The American College of Surgeons now requires screening for alcohol use in trauma centers. The purpose of this research study is to provide information about the best screening and treatment methods. The investigators hope the findings will provide information that will improve healthcare by reducing problems related to risky alcohol use. The trauma team is conducting a comparison of two different ways of talking about alcohol use. Participants will be randomized into one of the two study groups.


Description:

The goal of this study is to guide further policy development regarding effective alcohol screening by: (a) comparing the effectiveness of two new, shorter screening tools for risky drinking patterns with the longer screening tool in current use; (b) assessing the outcomes of two different brief counseling interventions (BIs) with trauma patients screened to have risky drinking behaviors; and (c) examining the impact of the implementation of this new policy in a Level I Trauma Center.

The Specific Aims will be accomplished by:

1. Screening patients who are admitted to the Trauma Center, and conducting BIs for all who screen positive;

2. Collecting formative qualitative data regarding participants' perceptions of benefits of drunken states, their individual risks, and perceived healthier alternatives;

3. Collecting quantitative data (injury severity score and hospital length of stay) and correlating these data with patient demographics and responses on the different screening methods;

4. Collecting follow-up data by telephone on self-reported alcohol use and trauma recidivism, using an interviewer-administered assessment;

5. Collecting data on trauma recidivism from ED data, publicly available records, and patient self-report at 6-month telephone follow-up;

6. Surveying trauma staff and physicians at three intervals regarding the process of implementing the new ACS policy, any perceived difficulties, and the perceived impact


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date December 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Inpatient on trauma service

- 18 years or older

- Speaks either English or Spanish

One or more of the following:

- Patient answered yes to either admission screening question

- Patient has a positive BAL of less than or equal to 79 and also has a positive Audit score (men greater than or equal to 8; women greater than or equal to 4)

- Patient has a BAL of 80 or higher

- patient has no record of a BAL on file and they have a positive Audit score

Exclusion Criteria:

- Patient unable or unwilling to provide informed consent

- Patient refusal contact at six months

- Patient has a positive BAL of less than or equal to 79 and negative AUDIT score

- Patient deemed unable to complete a BI

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Quantity Frequency Model
The quantitative intervention involves emphasis on tracking and measuring the number of drinks on a weekly basis.
Targets Subjective Drunkenness
Explores factors leading to drunkenness and alternative coping strategies for healthier function.

Locations

Country Name City State
United States Wake Forest University Baptist Medical Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (25)

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Anderson JA, Coscia RL, Cryer HG, et al. Injury does not occur by accident. Resources for the optimal care of the injured patient 2006. Chicago, IL: 2006. p. 115-20.

Collett D. Modeling Survival Data in Medical Research 2003.

Cox DR, Oakes DO. Analysis of Survival Data. London: Chapman & Hall; 1984.

Crawford MJ, Patton R, Touquet R, Drummond C, Byford S, Barrett B, Reece B, Brown A, Henry JA. Screening and referral for brief intervention of alcohol-misusing patients in an emergency department: a pragmatic randomised controlled trial. Lancet. 2004 Oct 9-15;364(9442):1334-9. — View Citation

Cunningham RM, Maio RF, Hill EM, Zink BJ. The effects of alcohol on head injury in the motor vehicle crash victim. Alcohol Alcohol. 2002 May-Jun;37(3):236-40. — View Citation

Dunn C, Ostafin B. Brief interventions for hospitalized trauma patients. J Trauma. 2005 Sep;59(3 Suppl):S88-93; discussion S94-100. — View Citation

Feuer EJ, Kessler LG. Test statistic and sample size for a two-sample McNemar test. Biometrics. 1989 Jun;45(2):629-36. Erratum in: Biometrics 1989 Sep;45(3):1039. — View Citation

Fitzgerald DJ, Radek KA, Chaar M, Faunce DE, DiPietro LA, Kovacs EJ. Effects of acute ethanol exposure on the early inflammatory response after excisional injury. Alcohol Clin Exp Res. 2007 Feb;31(2):317-23. — View Citation

Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982 Apr-Jun;1(2):121-9. — View Citation

Gentilello LM, Ebel BE, Wickizer TM, Salkever DS, Rivara FP. Alcohol interventions for trauma patients treated in emergency departments and hospitals: a cost benefit analysis. Ann Surg. 2005 Apr;241(4):541-50. — 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. — View Citation

Kaufmann CR, Branas CC, Brawley ML. A population-based study of trauma recidivism. J Trauma. 1998 Aug;45(2):325-31; discussion 331-2. — View Citation

McDonald AJ 3rd, Wang N, Camargo CA Jr. US emergency department visits for alcohol-related diseases and injuries between 1992 and 2000. Arch Intern Med. 2004 Mar 8;164(5):531-7. — View Citation

National Highway Safety Traffic Administration. National Communications Plan 2006. http://www.nhtsa.dot.gov/people/injury/NewmediaForum Web/images/NHTS-1689%20Comm%20Plan.pdf Accessed March 18, 2008.

O'Brien MC, McCoy TP, Champion H, Mitra A, Robbins A, Teuschlser H, Wolfson M, DuRant RH. Single question about drunkenness to detect college students at risk for injury. Acad Emerg Med. 2006 Jun;13(6):629-36. Epub 2006 Apr 13. — View Citation

Reboussin BA, Song EY, Shrestha A, Lohman KK, Wolfson M. A latent class analysis of underage problem drinking: evidence from a community sample of 16-20 year olds. Drug Alcohol Depend. 2006 Jul 27;83(3):199-209. Epub 2005 Dec 15. — View Citation

Rollnick S. Health Behavior Change: A Guide for paracticioners. New York: Churchill Livingstone; 1999.

Saitz R. Clinical practice. Unhealthy alcohol use. N Engl J Med. 2005 Feb 10;352(6):596-607. Review. — View Citation

Schermer CR, Moyers TB, Miller WR, Bloomfield LA. Trauma center brief interventions for alcohol disorders decrease subsequent driving under the influence arrests. J Trauma. 2006 Jan;60(1):29-34. — View Citation

Schermer CR. Feasibility of alcohol screening and brief intervention. J Trauma. 2005 Sep;59(3 Suppl):S119-23; discussion S124-33. — View Citation

Sims DW, Bivins BA, Obeid FN, Horst HM, Sorensen VJ, Fath JJ. Urban trauma: a chronic recurrent disease. J Trauma. 1989 Jul;29(7):940-6; discussion 946-7. — View Citation

Tanner MA, Wong WH. Data-based nonparametric estimation of the hazard function with applications to model diagnostics and exploratory analysis. J Am Stat Assoc. 1984; 79:174-182.

Wechsler H, Davenport A, Dowdall G, Moeykens B, Castillo S. Health and behavioral consequences of binge drinking in college. A national survey of students at 140 campuses. JAMA. 1994 Dec 7;272(21):1672-7. — View Citation

Zambell KL, Phelan H, Vande Stouwe C, Zhang P, Shellito JE, Molina PE. Acute alcohol intoxication during hemorrhagic shock: impact on host defense from infection. Alcohol Clin Exp Res. 2004 Apr;28(4):635-42. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Trauma recidivism after discharge as measured by a review of computerized ED records,NC Trauma database,the Forsyth County EMS registry,NC EMS registry and self-reports at a 6-month telephone follow-up of alcohol-related injuries and changes in alcohol 6 months
Secondary Patient satisfaction ratings of the BI,the response to the BI as rated by the interviewer,reported citations for driving under the influence(to be obtained from the NC State Department of Motor Vehicles) and 3 surveys of trauma service staff 6 months
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