Trial Outcomes & Findings for Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility (NCT NCT02228967)

NCT ID: NCT02228967

Last Updated: 2020-09-09

Results Overview

The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 791 participants
• Primary outcome timeframe: Baseline, Follow-up (Up to 7 months)
• Results posted on: 2020-09-09

Participant Flow

Participant milestones

Measure	Usual Care Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Overall Study STARTED	403	388
Overall Study COMPLETED	244	228
Overall Study NOT COMPLETED	159	160

Reasons for withdrawal

Measure	Usual Care Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Overall Study Lost to Follow-up	146	142
Overall Study Withdrawal by Subject	13	18

Baseline Characteristics

Alcohol Screening, Brief Intervention, and Referral to Treatment in a Military Treatment Facility

Baseline characteristics by cohort

Measure	Usual Care n=403 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=388 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.	Total n=791 Participants Total of all reporting groups
Age, Continuous	26.4 Years STANDARD_DEVIATION 6 • n=5 Participants	26.3 Years STANDARD_DEVIATION 5.7 • n=7 Participants	26.3 Years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants	108 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	300 Participants n=5 Participants	280 Participants n=7 Participants	580 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	85 Participants n=5 Participants	64 Participants n=7 Participants	149 Participants n=5 Participants
Race/Ethnicity, Customized African-American	74 Participants n=5 Participants	71 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized White	215 Participants n=5 Participants	214 Participants n=7 Participants	429 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Hawaiian/Pacific Islander	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	403 participants n=5 Participants	388 participants n=7 Participants	791 participants n=5 Participants
Self-Reported PTSD Diagnosis Yes	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Self-Reported PTSD Diagnosis No	387 Participants n=5 Participants	367 Participants n=7 Participants	754 Participants n=5 Participants
Marital Status Single	203 Participants n=5 Participants	185 Participants n=7 Participants	388 Participants n=5 Participants
Marital Status Married/Co-habitating	161 Participants n=5 Participants	173 Participants n=7 Participants	334 Participants n=5 Participants
Marital Status Divorced/Separated/Widowed	39 Participants n=5 Participants	30 Participants n=7 Participants	69 Participants n=5 Participants
Education Level High School Graduate/GED	169 Participants n=5 Participants	149 Participants n=7 Participants	318 Participants n=5 Participants
Education Level Some College	123 Participants n=5 Participants	128 Participants n=7 Participants	251 Participants n=5 Participants
Education Level 2-Year College Degree (AA)	52 Participants n=5 Participants	43 Participants n=7 Participants	95 Participants n=5 Participants
Education Level 4-Year Degree (BA/BS)	46 Participants n=5 Participants	50 Participants n=7 Participants	96 Participants n=5 Participants
Education Level Graduate Degree	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Service Branch Navy	336 Participants n=5 Participants	320 Participants n=7 Participants	656 Participants n=5 Participants
Service Branch Marine Corps	57 Participants n=5 Participants	54 Participants n=7 Participants	111 Participants n=5 Participants
Service Branch Army/Air Force/Coast Guard	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Service Branch Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Number of Combat Deployments (past 5-years) None	211 Participants n=5 Participants	214 Participants n=7 Participants	425 Participants n=5 Participants
Number of Combat Deployments (past 5-years) 1-2	173 Participants n=5 Participants	148 Participants n=7 Participants	321 Participants n=5 Participants
Number of Combat Deployments (past 5-years) 3 or more	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Number of Combat Deployments (past 5-years) Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Alcohol Use Disorders Identification Test (AUDIT) Score	7.7 units on a scale STANDARD_DEVIATION 4.2 • n=5 Participants	8.0 units on a scale STANDARD_DEVIATION 5.1 • n=7 Participants	7.7 units on a scale STANDARD_DEVIATION 4.6 • n=5 Participants
Readiness to Change Drinking	1.95 units on a scale STANDARD_DEVIATION 1.17 • n=5 Participants	1.96 units on a scale STANDARD_DEVIATION 1.15 • n=7 Participants	1.96 units on a scale STANDARD_DEVIATION 1.16 • n=5 Participants
Controlled Drinking Self-Efficacy Scale (CDSES)	76.9 units on a scale STANDARD_DEVIATION 15.3 • n=5 Participants	78 units on a scale STANDARD_DEVIATION 15 • n=7 Participants	77.9 units on a scale STANDARD_DEVIATION 15.2 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Excludes low-risk participants defined as AUDIT \<=7 at baseline. A total of 17 participants were excluded from the analysis.

The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

Outcome measures

Measure	Usual Care n=240 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=215 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Alcohol Use Disorders Identification Test (AUDIT) Total	5.91 units on a scale Standard Error 0.26	5.5 units on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Excludes low-risk participants defined as AUDIT \<=7 at baseline. A total of 17 participants were excluded from the analysis.

The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.

Outcome measures

Measure	Usual Care n=240 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=215 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
AUDIT-C or Drinkers Index	4.41 units on a scale Standard Error 0.14	4.05 units on a scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Excludes low-risk participants defined as AUDIT \<=7 at baseline. A total of 17 participants were excluded from the analysis.

The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.

Outcome measures

Measure	Usual Care n=240 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=215 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Controlled Drinking Self-Efficacy Scale (CDSES)	78.42 units on a scale Standard Error 1.01	81.67 units on a scale Standard Error 1.07

SECONDARY outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Excludes low-risk participants defined as AUDIT \<=7 at baseline. A total of 17 participants were excluded from the analysis as they were low-risk at baseline. Additionally, missing data on the Readiness to Change measure resulted in a total of 444 participants for this analysis. Six were missing from usual care and five were missing from SBIRT.

A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.

Outcome measures

Measure	Usual Care n=234 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=210 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Readiness to Change Scale	2.23 units on a scale Standard Error 0.08	2.19 units on a scale Standard Error 0.09

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: For this study, at-risk drinking was defined as: AUDIT total \>=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 \> 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)

The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

Outcome measures

Measure	Usual Care n=100 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=90 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II)	8.2 units on a scale Standard Error 0.47	7.31 units on a scale Standard Error 0.34

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: For this study, at-risk drinking was defined as: AUDIT total \>=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 \> 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)

The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.

Outcome measures

Measure	Usual Care n=100 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=90 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
AUDIT-C or Drinkers Index (Analysis II)	5.42 units on a scale Standard Error 0.24	4.63 units on a scale Standard Error 0.25

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: For this study, at-risk drinking was defined as: AUDIT total \>=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 \> 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)

The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.

Outcome measures

Measure	Usual Care n=100 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=89 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II)	70.45 units on a scale Standard Error 1.55	79.34 units on a scale Standard Error 1.65

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: For this study, at-risk drinking was defined as: AUDIT total \>=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 \> 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)

A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.

Outcome measures

Measure	Usual Care n=98 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=89 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Readiness to Change Scale (Analysis II)	2.29 units on a scale Standard Error 0.13	2.46 units on a scale Standard Error 0.14

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Complete case analysis

The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

Outcome measures

Measure	Usual Care n=244 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=227 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases)	5.87 units on a scale Standard Error 0.25	5.48 units on a scale Standard Error 0.26

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Complete case analysis

The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.

Outcome measures

Measure	Usual Care n=244 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=227 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
AUDIT-C or Drinkers Index (Analysis III Complete Cases)	4.4 units on a scale Standard Error .14	4.05 units on a scale Standard Error .15

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Complete case analysis

The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.

Outcome measures

Measure	Usual Care n=244 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=227 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases)	78.66 units on a scale Standard Error 1.0	81.82 units on a scale Standard Error 1.04

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Complete case analysis

A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.

Outcome measures

Measure	Usual Care n=238 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=221 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Readiness to Change Scale (Analysis III Complete Cases)	2.21 units on a scale Standard Error 0.08	2.20 units on a scale Standard Error 0.09

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)

The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

Outcome measures

Measure	Usual Care n=403 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=388 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat Analysis)	4.47 units on a scale Standard Error 0.16	4.15 units on a scale Standard Error 0.13

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)

The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.

Outcome measures

Measure	Usual Care n=403 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=388 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses)	5.95 units on a scale Standard Error 0.21	5.62 units on a scale Standard Error 0.23

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791)

The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.

Outcome measures

Measure	Usual Care n=403 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=388 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses)	78.42 units on a scale Standard Error 0.85	81.30 units on a scale Standard Error 1.05

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.

Outcome measures

Measure	Usual Care n=403 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=388 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat Analysis)	2.22 units on a scale Standard Error 0.07	2.16 units on a scale Standard Error 0.07

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.

The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.

Outcome measures

Measure	Usual Care n=166 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=161 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat Analysis)	5.38 units on a scale Standard Error 0.25	4.85 units on a scale Standard Error 0.20

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.

The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.

Outcome measures

Measure	Usual Care n=166 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=161 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses)	8.09 units on a scale Standard Error 0.39	7.64 units on a scale Standard Error 0.38

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.

The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.

Outcome measures

Measure	Usual Care n=166 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=161 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses)	72.18 units on a scale Standard Error 1.38	77.84 units on a scale Standard Error 1.55

POST_HOC outcome

Timeframe: Baseline, Follow-up (Up to 7 months)

Population: Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline.

A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.

Outcome measures

Measure	Usual Care n=166 Participants Those participants assigned to the usual care control group will be given a brochure on safe drinking limits, will be reminded of the 6-month follow-up, and thanked for their time.	SBIRT n=161 Participants Those assigned to the SBIRT intervention group will receive 1 of 3 tracks: 1. Brief Intervention (BI) for At Risk Individuals (scores lower than 15) - Brief motivational intervention with feedback related to their use and change strategies. 2. Brief Treatment (BT) for High Risk Individuals (scores of 16-19) - Brief Intervention on site and be offered 6 individual confidential sessions with a civilian Brief Treatment Counselor over the phone. 3. Referral to Treatment (RT) for Severe Risk Individuals (scores of 20-40) - Brief Intervention on site and will be given a list of services where they may self-refer for further assessment and support. SBIRT: SBIRT is an "opportunistic" approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a "teachable moment," are delivered a brief, motivational intervention matched to their level of risk.
Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat Analysis)	2.33 units on a scale Standard Error 0.10	2.35 units on a scale Standard Error 0.12

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SBIRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark B. Reed/Professor and Interim Associate Dean

San Diego State University Research Foundation

Phone: 619-594-6664

Email: mreed@sdsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place