Disseminating Organizational SBI Services at Trauma Centers

NCT ID: NCT00607620

Last Updated: 2018-03-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

878 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Abuse Alcohol Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Brief Intervention

Intervention Type BEHAVIORAL

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

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Motivational Interviewing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Harborview Injury Prevention and Research Center

OTHER

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Douglas Zatzick

Professor, Psychiatry & Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Douglas F Zatzick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 24450612 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37085877 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01AA016102-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

30660

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multi-Component Breath Alcohol Intervention
NCT06124898 ACTIVE_NOT_RECRUITING NA
Coping Skills for Alcohol Use
NCT05356533 COMPLETED NA
Motivating Campus Change Study
NCT04030325 ACTIVE_NOT_RECRUITING NA
Optimizing and Advancing SBIRT in Schools
NCT06206161 ENROLLING_BY_INVITATION NA