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

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ClinicalTrials.gov Identifier: NCT00607620
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Harborview Injury Prevention and Research Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington

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 Not Applicable

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)
Actual Enrollment : 878 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
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention
Providers receive training in alcohol screening and brief interventions from study staff in compliance with American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
Behavioral: Brief Intervention
Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
Other Name: Motivational Interviewing
No Intervention: Usual Care
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate



Primary Outcome Measures :
  1. Number of Participants With Hazardous Drinking [ Time Frame: The investigators will assess at baseline, 6-month and 12-month. ]
    The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a dichotomous measure. AUDIT Scores of ≥8 for men and ≥5 for women indicate hazardous drinking.

  2. Alcohol Use Problems [ Time Frame: The investigators will assess at baseline, 6-month and 12-month. ]
    The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.


Secondary Outcome Measures :
  1. Number of Abstinent Days [ Time Frame: The investigators will assess at 6- and 12-month. ]
    The investigators will use the Form 90 to assess the number of days within the last 90 days in which a patient did not consume alcohol.

  2. Number of Binge Drinking Days [ Time Frame: The investigators will assess at 6-month and 12-month. ]
    The investigators will use the Form 90 to assess the number of days in which a male participants consumed ≥5 alcoholic drinks and female participants consumed ≥4 alcoholic drinks

  3. Alcohol Use Problems [ Time Frame: The investigators will assess at 6-month and 12-month. ]
    The investigators will use the Short Inventory of Problems (SIP) as a continuous measure. The 16-item scale score ranges from 0-48 with higher scores indicating worse outcomes.



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

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


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Harborview Injury Prevention and Research Center
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Douglas F Zatzick, MD University of Washington

Publications of Results:
Responsible Party: Douglas Zatzick, Professor, Psychiatry & Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT00607620     History of Changes
Other Study ID Numbers: 30660
1R01AA016102-01 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2008    Key Record Dates
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018
Last Verified: March 2018

Keywords provided by Douglas Zatzick, University of Washington:
Alcohol Abuse
Alcohol Dependence
Alcohol Use Disorder
Screening
Brief Intervention
Motivational Interviewing

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs