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

March 2, 2018 updated by: Douglas Zatzick, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

878

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • Motivational Interviewing
No Intervention: Usual Care
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The investigators will assess at baseline, 6-month and 12-month.
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.
The investigators will assess at baseline, 6-month and 12-month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The investigators will assess at 6- and 12-month.
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
The investigators will assess at 6-month and 12-month.
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.
The investigators will assess at 6-month and 12-month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Harborview Injury Prevention and Research Center

Investigators

  • Principal Investigator: Douglas F Zatzick, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30660
  • 1R01AA016102-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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