Trial Outcomes & Findings for Disseminating Organizational SBI Services at Trauma Centers (NCT NCT00607620)
NCT ID: NCT00607620
Last Updated: 2018-03-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
878 participants
Primary outcome timeframe
The investigators will assess at baseline, 6-month and 12-month.
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
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
|
Usual Care
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Overall Study
STARTED
|
409
|
469
|
|
Overall Study
COMPLETED
|
409
|
469
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Disseminating Organizational SBI Services at Trauma Centers
Baseline characteristics by cohort
| Measure |
Intervention
n=409 Participants
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
|
Usual Care
n=469 Participants
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
Total
n=878 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.4 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 14.0 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
304 Participants
n=5 Participants
|
366 Participants
n=7 Participants
|
670 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Baseline · White
|
253 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
545 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Baseline · Black or African American
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Baseline · American Indian or Alaska Native
|
25 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Baseline · Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Baseline · Hispanic
|
61 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention
n=409 Participants
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
|
Usual Care
n=469 Participants
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Number of Participants With Hazardous Drinking
Baseline
|
292 Participants
|
309 Participants
|
|
Number of Participants With Hazardous Drinking
Month 6
|
201 Participants
|
223 Participants
|
|
Number of Participants With Hazardous Drinking
Month 12
|
166 Participants
|
198 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention
n=409 Participants
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
|
Usual Care
n=469 Participants
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Alcohol Use Problems
Baseline
|
10.5 units on a scale
Standard Deviation 5.1
|
9.7 units on a scale
Standard Deviation 4.9
|
|
Alcohol Use Problems
Month 6
|
8.8 units on a scale
Standard Deviation 6.3
|
8.5 units on a scale
Standard Deviation 6.5
|
|
Alcohol Use Problems
Month 12
|
8.2 units on a scale
Standard Deviation 6.1
|
8.5 units on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention
n=409 Participants
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
|
Usual Care
n=469 Participants
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Number of Abstinent Days
Month 6
|
74.2 days
Standard Error 1.35
|
73.4 days
Standard Error 1.25
|
|
Number of Abstinent Days
Month 12
|
75.5 days
Standard Error 1.37
|
71.3 days
Standard Error 1.27
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
Intervention
n=409 Participants
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
|
Usual Care
n=469 Participants
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Number of Binge Drinking Days
Month 6
|
9.4 days
Standard Error 1.14
|
10.6 days
Standard Error 1.13
|
|
Number of Binge Drinking Days
Month 12
|
9.4 days
Standard Error 1.16
|
11.4 days
Standard Error 1.10
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Intervention
n=409 Participants
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
|
Usual Care
n=469 Participants
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Alcohol Use Problems
Month 6
|
3.3 units on a scale
Standard Error 0.42
|
3.38 units on a scale
Standard Error 0.39
|
|
Alcohol Use Problems
Month 12
|
2.99 units on a scale
Standard Error 0.43
|
3.08 units on a scale
Standard Error 0.41
|
Adverse Events
Intervention
Serious events: 1 serious events
Other events: 62 other events
Deaths: 10 deaths
Usual Care
Serious events: 1 serious events
Other events: 65 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Intervention
n=409 participants at risk
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
|
Usual Care
n=469 participants at risk
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Psychiatric disorders
Suicide Attempt
|
0.24%
1/409 • 1 year
|
0.21%
1/469 • 1 year
|
Other adverse events
| Measure |
Intervention
n=409 participants at risk
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
|
Usual Care
n=469 participants at risk
Usual care for alcohol use problems after American College of Surgeons' Alcohol Screening and Brief Intervention Mandate
|
|---|---|---|
|
Psychiatric disorders
Patient Health Questionnaire (PHQ-9) Score of >0
|
15.2%
62/409 • 1 year
|
13.9%
65/469 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place