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Disseminating Organizational SBI Services at Trauma Centers (DO-SBIS)

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ClinicalTrials.gov Identifier: NCT00607620
Recruitment Status : Unknown
Verified November 2009 by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Recruitment status was:  Recruiting
First Posted : February 6, 2008
Last Update Posted : November 23, 2009
University of Washington
Harborview Injury Prevention and Research Center
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
The goal of the Disseminating Organizational Screening and Brief Interventions Services (DO-SBIS) investigation is to capitalize on the unique opportunity afforded by the American College of Surgeons' mandate by taking early steps to insure high quality, evidence-based SBI services are implemented and outcomes are assessed. In the first phase of the investigation, SBI services will be assessed for all 190 level I trauma centers in the United States. In the second phase of the investigation, 20 level I trauma centers will be selected for randomization to intervention or control conditions.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Alcohol Dependence Behavioral: Brief Intervention Phase 2

Detailed Description:

Each year in the United States approximately 2.5 million individuals are so severely injured that they require inpatient hospital admission. The integration of screening and brief interventions (SBI) into acute injury care has the potential to markedly increase the number of patients who receive needed services and has been a longstanding public health objective. In January of 2005 the American College of Surgeons, the primary agency responsible for developing trauma center requirements, passed a landmark resolution mandating that level I trauma centers must screen injured patients for an alcohol use disorder, and provide an intervention to those who screen positive. Preliminary studies suggest that there is a substantial risk that the SBI mandate will be implemented with marked variability and that low quality SBI procedures could become the default standard of trauma center care.

Providers at each intervention trauma center will receive workshop training and ongoing telephone coaching in the delivery of evidence-based motivational interviewing (MI) intervention; MI training will be embedded within evidence-based organizational development activities that aim to facilitate the integration of SBI services into routine trauma center care. Control trauma centers will implement SBI care as usual. The investigation hypothesizes that intervention trauma centers, when compared to control trauma centers, will demonstrate higher quality SBI, as evidenced by greater provider proficiency in SBI delivery, significant reductions in 6- and 12-month post-injury alcohol use in patients receiving SBI, and enhanced organizational acceptance of SBI services. Without DO-SBIS baseline data on SBI services and follow-up RCT data on patient, provider, and organizational outcomes, a critical opportunity to provide empiric support of a historic policy decision to require alcohol services at level I trauma centers could be lost. The DO-SBIS interdisciplinary research group includes trauma surgery opinion leaders who are dedicated to implementing future policy mandates that derive from the DO-SBIS research program. Future mandates will aim to strengthen and refine trauma center delivery of evidence-based SBI services. The dissemination of high quality SBI services at level I trauma centers has the potential to influence alcohol policy in other health care settings nationwide.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disseminating Organizational SBI Services (DO-SBIS) at Trauma Centers
Study Start Date : September 2008
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention
Providers receive training in brief interventions from study staff
Behavioral: Brief Intervention
Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
Other Name: Motivational Interviewing

Primary Outcome Measures :
  1. Whether the training provided by the study impacts the ability of providers to give effective care. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • For provider subjects: staff at trauma centers selected by study
  • For patient subjects: admitted to trauma centers selected by study, positive blood alcohol levels, able to provide two follow-up contacts

Exclusion Criteria:

  • For Providers: Once a trauma center is selected for participation, providers will be selected from existing hospital staff.
  • For Patients: Patients so severely injured that they cannot participate in study procedures will be excluded;
  • Patients who are admitted after self-inflicted injury, or are psychotic and therefore require more intensive acute interventions, will not be included in the study;
  • Injured hospitalized prisoners are excluded.
  • Children under the age of 18 are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607620

Contact: Jennifer Stubbs, BS 206-744-1756 jens2@u.washington.edu

United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: DOUGLAS ZATZICK    206-744-1756 ext 0    DZATZICK@U.WASHINGTON.EDU   
Contact: JENNIFER M STUBBS    206.744.1756 ext 0    JENS2@U.WASHINGTON.EDU   
Principal Investigator: DOUGLAS F ZATZICK         
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
Harborview Injury Prevention and Research Center
Principal Investigator: Douglas F Zatzick, MD University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Zatzick, MD, University of Washington School of Medicine
ClinicalTrials.gov Identifier: NCT00607620     History of Changes
Other Study ID Numbers: NIAAA-ZATZICK_AA016102
1R01AA016102-01 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcohol Abuse
Alcohol Dependence
Alcohol Use Disorder
Brief Intervention
Motivational Interviewing

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders