NCT00607620

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
878

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 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

First Submitted

Initial submission to the registry

January 29, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 7, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

4 years

First QC Date

January 29, 2008

Results QC Date

October 26, 2017

Last Update Submit

March 2, 2018

Conditions

Keywords

Alcohol AbuseAlcohol DependenceAlcohol Use DisorderScreeningBrief InterventionMotivational Interviewing

Outcome Measures

Primary Outcomes (2)

  • 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.

    The investigators will assess at baseline, 6-month and 12-month.

  • 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.

    The investigators will assess at baseline, 6-month and 12-month.

Secondary Outcomes (3)

  • Number of Abstinent Days

    The investigators will assess at 6- and 12-month.

  • Number of Binge Drinking Days

    The investigators will assess at 6-month and 12-month.

  • Alcohol Use Problems

    The investigators will assess at 6-month and 12-month.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing

Also known as: Motivational Interviewing
Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • 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.

  • Zatzick D, Palinkas L, Chambers DA, Whiteside L, Moloney K, Engstrom A, Prater L, Russo J, Wang J, Abu K, Iles-Shih M, Bulger E. Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis. Trials. 2023 Apr 21;24(1):288. doi: 10.1186/s13063-023-07313-0.

MeSH Terms

Conditions

Alcoholism

Interventions

Crisis InterventionMotivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Douglas Zatzick, MD
Organization
University of Washington

Study Officials

  • Douglas F Zatzick, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Psychiatry & Behavioral Sciences

Study Record Dates

First Submitted

January 29, 2008

First Posted

February 6, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

March 7, 2018

Results First Posted

March 7, 2018

Record last verified: 2018-03

Locations