Alcohol Abuse, Alcohol Dependence
Conditions
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
Training in brief interventions for alcohol use disorders, with a focus on motivational interviewing
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hazardous Drinking | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Abstinent Days | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 878 |
Baseline characteristics
| Characteristic | Usual Care | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 36.4 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 Participants | 38 Participants | 25 Participants |
| Race/Ethnicity, Customized Baseline Asian | 6 Participants | 14 Participants | 8 Participants |
| Race/Ethnicity, Customized Baseline Black or African American | 63 Participants | 125 Participants | 62 Participants |
| Race/Ethnicity, Customized Baseline Hispanic | 95 Participants | 156 Participants | 61 Participants |
| Race/Ethnicity, Customized Baseline White | 292 Participants | 545 Participants | 253 Participants |
| Sex: Female, Male Female | 103 Participants | 208 Participants | 105 Participants |
| Sex: Female, Male Male | 366 Participants | 670 Participants | 304 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 409 | 3 / 469 |
| other Total, other adverse events | 62 / 409 | 65 / 469 |
| serious Total, serious adverse events | 1 / 409 | 1 / 469 |
Outcome results
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Alcohol Use Problems | Baseline | 10.5 units on a scale | Standard Deviation 5.1 |
| Intervention | Alcohol Use Problems | Month 6 | 8.8 units on a scale | Standard Deviation 6.3 |
| Intervention | Alcohol Use Problems | Month 12 | 8.2 units on a scale | Standard Deviation 6.1 |
| Usual Care | Alcohol Use Problems | Baseline | 9.7 units on a scale | Standard Deviation 4.9 |
| Usual Care | Alcohol Use Problems | Month 6 | 8.5 units on a scale | Standard Deviation 6.5 |
| Usual Care | Alcohol Use Problems | Month 12 | 8.5 units on a scale | Standard Deviation 6.3 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With Hazardous Drinking | Baseline | 292 Participants |
| Intervention | Number of Participants With Hazardous Drinking | Month 6 | 201 Participants |
| Intervention | Number of Participants With Hazardous Drinking | Month 12 | 166 Participants |
| Usual Care | Number of Participants With Hazardous Drinking | Baseline | 309 Participants |
| Usual Care | Number of Participants With Hazardous Drinking | Month 6 | 223 Participants |
| Usual Care | Number of Participants With Hazardous Drinking | Month 12 | 198 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Alcohol Use Problems | Month 6 | 3.3 units on a scale | Standard Error 0.42 |
| Intervention | Alcohol Use Problems | Month 12 | 2.99 units on a scale | Standard Error 0.43 |
| Usual Care | Alcohol Use Problems | Month 6 | 3.38 units on a scale | Standard Error 0.39 |
| Usual Care | Alcohol Use Problems | Month 12 | 3.08 units on a scale | Standard Error 0.41 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Abstinent Days | Month 6 | 74.2 days | Standard Error 1.35 |
| Intervention | Number of Abstinent Days | Month 12 | 75.5 days | Standard Error 1.37 |
| Usual Care | Number of Abstinent Days | Month 6 | 73.4 days | Standard Error 1.25 |
| Usual Care | Number of Abstinent Days | Month 12 | 71.3 days | Standard Error 1.27 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Number of Binge Drinking Days | Month 6 | 9.4 days | Standard Error 1.14 |
| Intervention | Number of Binge Drinking Days | Month 12 | 9.4 days | Standard Error 1.16 |
| Usual Care | Number of Binge Drinking Days | Month 6 | 10.6 days | Standard Error 1.13 |
| Usual Care | Number of Binge Drinking Days | Month 12 | 11.4 days | Standard Error 1.1 |