Disseminating Organizational SBI Services at Trauma Centers (DO-SBIS)
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| ClinicalTrials.gov Identifier: NCT00607620 |
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Recruitment Status :
Completed
First Posted : February 6, 2008
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcohol Abuse Alcohol Dependence | Behavioral: Brief Intervention | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 878 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Disseminating Organizational SBI Services (DO-SBIS) at Trauma Centers |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | September 2013 |
| Arm | Intervention/treatment |
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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
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Behavioral: Brief Intervention
Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
Other Name: Motivational Interviewing |
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No Intervention: Usual Care
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
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- 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.
- 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.
- 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.
- 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
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607620
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98104 | |
| Principal Investigator: | Douglas F Zatzick, MD | University of Washington |
| Responsible Party: | Douglas Zatzick, Professor, Psychiatry & Behavioral Sciences, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00607620 |
| Other Study ID Numbers: |
30660 1R01AA016102-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 6, 2008 Key Record Dates |
| Results First Posted: | March 7, 2018 |
| Last Update Posted: | March 7, 2018 |
| Last Verified: | March 2018 |
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Alcohol Abuse Alcohol Dependence Alcohol Use Disorder |
Screening Brief Intervention Motivational Interviewing |
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Alcoholism Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |