NCT00865774

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

2.4 years

First QC Date

March 17, 2009

Last Update Submit

August 7, 2018

Conditions

Alcoholism

Keywords

TraumaAlcoholBrief Intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Arm number 1 focuses on the traditional quantity frequency model.

Behavioral: Quantity Frequency Model

2

EXPERIMENTAL

Arm number 2 targets subjective drunkenness.

Behavioral: Targets Subjective Drunkenness

Interventions

Quantity Frequency ModelBEHAVIORAL

The quantitative intervention involves emphasis on tracking and measuring the number of drinks on a weekly basis.

1
Targets Subjective DrunkennessBEHAVIORAL

Explores factors leading to drunkenness and alternative coping strategies for healthier function.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient on trauma service
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (25)

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    PMID: 17250625BACKGROUND

  • 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. doi: 10.1097/01.alc.0000122104.85971.55.

    PMID: 15100616BACKGROUND

  • 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. doi: 10.1093/alcalc/37.3.236.

    PMID: 12003910BACKGROUND

  • Saitz R. Clinical practice. Unhealthy alcohol use. N Engl J Med. 2005 Feb 10;352(6):596-607. doi: 10.1056/NEJMcp042262. No abstract available.

    PMID: 15703424BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1097/01.ta.0000199420.12322.5d.

    PMID: 16456433BACKGROUND

  • 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. doi: 10.1016/S0140-6736(04)17190-0.

    PMID: 15474136BACKGROUND

  • 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.

    PMID: 10522717BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1001/archinte.164.5.531.

    PMID: 15006830BACKGROUND

  • 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. doi: 10.1097/01.sla.0000157133.80396.1c.

    PMID: 15798453BACKGROUND

  • 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.

    PMID: 7966895BACKGROUND

  • Dunn C, Ostafin B. Brief interventions for hospitalized trauma patients. J Trauma. 2005 Sep;59(3 Suppl):S88-93; discussion S94-100. doi: 10.1097/01.ta.0000174682.13138.a3.

    PMID: 16355072BACKGROUND

  • Schermer CR. Feasibility of alcohol screening and brief intervention. J Trauma. 2005 Sep;59(3 Suppl):S119-23; discussion S124-33. doi: 10.1097/01.ta.0000174679.12567.7c.

    PMID: 16355047BACKGROUND

  • 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. doi: 10.1016/j.drugalcdep.2005.11.013. Epub 2005 Dec 15.

    PMID: 16359829BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

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  • Andersen P, Gill R. Cox regression model for counting processes: a large sample study. Ann Stat. 1982; 10:1100-1120.

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  • 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.

    PMID: 2746704BACKGROUND

  • Kaufmann CR, Branas CC, Brawley ML. A population-based study of trauma recidivism. J Trauma. 1998 Aug;45(2):325-31; discussion 331-2. doi: 10.1097/00005373-199808000-00019.

    PMID: 9715190BACKGROUND

  • Feuer EJ, Kessler LG. Test statistic and sample size for a two-sample McNemar test. Biometrics. 1989 Jun;45(2):629-36.

    PMID: 2765642BACKGROUND

  • 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. doi: 10.1002/sim.4780010204.

    PMID: 7187087BACKGROUND

  • Collett D. Modeling Survival Data in Medical Research 2003.

    BACKGROUND

  • 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. doi: 10.1197/j.aem.2005.12.023. Epub 2006 Apr 13.

    PMID: 16614453BACKGROUND

MeSH Terms

Conditions

AlcoholismWounds and Injuries

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mary Claire O'Brien, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

August 9, 2018

Record last verified: 2018-08

Locations

US(1)