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Disseminating Organizational SBI Services at Trauma Centers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00607620
Acronym
DO-SBIS
Enrollment
878
Registered
2008-02-06
Start date
2008-09-30
Completion date
2013-09-30
Last updated
2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Alcohol Dependence

Keywords

Alcohol Abuse, Alcohol Dependence, Alcohol Use Disorder, Screening, Brief Intervention, Motivational Interviewing

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.

Interventions

BEHAVIORALBrief Intervention

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

Sponsors

Harborview Injury Prevention and Research Center
CollaboratorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Hazardous DrinkingThe 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 ProblemsThe 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.

Secondary

MeasureTime frameDescription
Number of Abstinent DaysThe 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 DaysThe 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 ProblemsThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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 Brief Intervention: Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
409
Usual Care
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
469
Total878

Baseline characteristics

CharacteristicUsual CareTotalIntervention
Age, Continuous36.4 years
STANDARD_DEVIATION 14
36.9 years
STANDARD_DEVIATION 14.3
37.4 years
STANDARD_DEVIATION 14.7
Race/Ethnicity, Customized
Baseline
American Indian or Alaska Native
13 Participants38 Participants25 Participants
Race/Ethnicity, Customized
Baseline
Asian
6 Participants14 Participants8 Participants
Race/Ethnicity, Customized
Baseline
Black or African American
63 Participants125 Participants62 Participants
Race/Ethnicity, Customized
Baseline
Hispanic
95 Participants156 Participants61 Participants
Race/Ethnicity, Customized
Baseline
White
292 Participants545 Participants253 Participants
Sex: Female, Male
Female
103 Participants208 Participants105 Participants
Sex: Female, Male
Male
366 Participants670 Participants304 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
10 / 4093 / 469
other
Total, other adverse events
62 / 40965 / 469
serious
Total, serious adverse events
1 / 4091 / 469

Outcome results

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.

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

Population: Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up

ArmMeasureGroupValue (MEAN)Dispersion
InterventionAlcohol Use ProblemsBaseline10.5 units on a scaleStandard Deviation 5.1
InterventionAlcohol Use ProblemsMonth 68.8 units on a scaleStandard Deviation 6.3
InterventionAlcohol Use ProblemsMonth 128.2 units on a scaleStandard Deviation 6.1
Usual CareAlcohol Use ProblemsBaseline9.7 units on a scaleStandard Deviation 4.9
Usual CareAlcohol Use ProblemsMonth 68.5 units on a scaleStandard Deviation 6.5
Usual CareAlcohol Use ProblemsMonth 128.5 units on a scaleStandard Deviation 6.3
95% CI: [-2.1, -0.3]
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.

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

Population: Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
InterventionNumber of Participants With Hazardous DrinkingBaseline292 Participants
InterventionNumber of Participants With Hazardous DrinkingMonth 6201 Participants
InterventionNumber of Participants With Hazardous DrinkingMonth 12166 Participants
Usual CareNumber of Participants With Hazardous DrinkingBaseline309 Participants
Usual CareNumber of Participants With Hazardous DrinkingMonth 6223 Participants
Usual CareNumber of Participants With Hazardous DrinkingMonth 12198 Participants
95% CI: [0.79, 0.98]
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.

Time frame: The investigators will assess at 6-month and 12-month.

Population: Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up

ArmMeasureGroupValue (MEAN)Dispersion
InterventionAlcohol Use ProblemsMonth 63.3 units on a scaleStandard Error 0.42
InterventionAlcohol Use ProblemsMonth 122.99 units on a scaleStandard Error 0.43
Usual CareAlcohol Use ProblemsMonth 63.38 units on a scaleStandard Error 0.39
Usual CareAlcohol Use ProblemsMonth 123.08 units on a scaleStandard Error 0.41
95% CI: [-1.02, 0.99]
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.

Time frame: The investigators will assess at 6- and 12-month.

Population: Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up

ArmMeasureGroupValue (MEAN)Dispersion
InterventionNumber of Abstinent DaysMonth 674.2 daysStandard Error 1.35
InterventionNumber of Abstinent DaysMonth 1275.5 daysStandard Error 1.37
Usual CareNumber of Abstinent DaysMonth 673.4 daysStandard Error 1.25
Usual CareNumber of Abstinent DaysMonth 1271.3 daysStandard Error 1.27
95% CI: [0.4, 6.4]
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

Time frame: The investigators will assess at 6-month and 12-month.

Population: Overall number of participants analyzed differs from the number of participants analyzed in Month 6 and Month 12 due to lost to follow-up

ArmMeasureGroupValue (MEAN)Dispersion
InterventionNumber of Binge Drinking DaysMonth 69.4 daysStandard Error 1.14
InterventionNumber of Binge Drinking DaysMonth 129.4 daysStandard Error 1.16
Usual CareNumber of Binge Drinking DaysMonth 610.6 daysStandard Error 1.13
Usual CareNumber of Binge Drinking DaysMonth 1211.4 daysStandard Error 1.1
95% CI: [-3.3, 1.9]

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026