Disseminating Organizational SBI Services at Trauma Centers

Alcohol Dependence Clinical Trial

— DO-SBIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607620
• Other study ID #: 30660
• Secondary ID: 1R01AA016102-01
• Status: Completed
• Phase: N/A
• First received: January 29, 2008
• Last updated: March 2, 2018
• Start date: September 2008
• Est. completion date: September 2013

Study information

• Verified date: March 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 878
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcoholism

Intervention

Behavioral:
• Brief Intervention
Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Harborview Injury Prevention and Research Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Addic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	The investigators will assess at 6- and 12-month.
Secondary	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	The investigators will assess at 6-month and 12-month.
Secondary	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.	The investigators will assess at 6-month and 12-month.