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

Primary Purpose

Alcohol Abuse, Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder, Screening, Brief Intervention, Motivational Interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

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

Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate

Outcomes

Primary Outcome Measures

Number of Participants With Hazardous Drinking
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.
Alcohol Use Problems
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

Number of Abstinent Days
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.
Number of Binge Drinking Days
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
Alcohol Use Problems
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.

Full Information

First Posted
January 29, 2008
Last Updated
March 2, 2018
Sponsor
University of Washington
Collaborators
Harborview Injury Prevention and Research Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00607620
Brief Title
Disseminating Organizational SBI Services at Trauma Centers
Acronym
DO-SBIS
Official Title
Disseminating Organizational SBI Services (DO-SBIS) at Trauma Centers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Harborview Injury Prevention and Research Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence
Keywords
Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder, Screening, Brief Intervention, Motivational Interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
878 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Other Intervention Name(s)
Motivational Interviewing
Intervention Description
Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
Primary Outcome Measure Information:
Title
Number of Participants With Hazardous Drinking
Description
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.
Time Frame
The investigators will assess at baseline, 6-month and 12-month.
Title
Alcohol Use Problems
Description
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.
Time Frame
The investigators will assess at baseline, 6-month and 12-month.
Secondary Outcome Measure Information:
Title
Number of Abstinent Days
Description
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.
Time Frame
The investigators will assess at 6- and 12-month.
Title
Number of Binge Drinking Days
Description
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
Time Frame
The investigators will assess at 6-month and 12-month.
Title
Alcohol Use Problems
Description
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.
Time Frame
The investigators will assess at 6-month and 12-month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas F Zatzick, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24450612
Citation
Zatzick D, Donovan DM, Jurkovich G, Gentilello L, Dunn C, Russo J, Wang J, Zatzick CD, Love J, McFadden C, Rivara FP. Disseminating alcohol screening and brief intervention at trauma centers: a policy-relevant cluster randomized effectiveness trial. Addiction. 2014 May;109(5):754-65. doi: 10.1111/add.12492. Epub 2014 Feb 28.
Results Reference
result

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Disseminating Organizational SBI Services at Trauma Centers

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