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| ID | Type | Description | Link |
|---|---|---|---|
| 12019006 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs |
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| Name | Class |
|---|---|
| United States Naval Medical Center, San Diego | FED |
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An alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach will be adapted for use in a large military hospital setting, and then pilot tested in a military emergency department (ED) to assess its potential for effectiveness and for further testing in a large-scale trial. SBIRT is an "opportunistic" approach whereby all adult patients in the ED 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.
The feasibility/formative research activities in the first phase (Phase I) of the study are not summative research, and therefore, do not lend themselves to testable hypotheses. Hypotheses with regard to the pilot randomized trial in Phase II are as follows:
Participants in the SBIRT intervention will show relatively greater reductions over a six month period (or less increase) than the brochure/usual care control group in the prevalence of past-month heavy drinking, frequency of heavy drinking, past week number of drinks, and the AUDIT-based drinkers' index.
Alcohol use-related motivation/readiness to change and controlled drinking self-efficacy will show greater change in the SBIRT intervention group relative to the brochure/usual care control group.
In addition, exploratory analyses will examine the following:
Sociodemographic/military variables (e.g., age, race/ethnicity, gender, branch of service, officer/enlisted status, PTS) and social-psychological factors (e.g., baseline readiness to change, self efficacy) will mediate or moderate changes in alcohol misuse.
Deployment frequency and duration and combat exposure are implicated as risk factors for alcohol misuse and PTSD among military personnel. During the past 10 years, Department of Defense healthcare systems have observed steep increases in mental health and substance use services among personnel demobilizing from these conflicts. Although the alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) approach has shown promise as a low-cost, effective strategy for reducing alcohol use in civilians many of whom are risky drinkers but not yet dependent, it has not been adapted or tested in military health care settings for active duty personnel. This 2.5 year civilian-military collaborative study is highly responsive to exploring solutions to this emerging issue. The specific objectives for the overall project are given below.
Objective 1: Feasibility and Acceptability
Objective 2: Adaptation
Objective 3: Pilot Trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | 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 | Active Comparator | Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBIRT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Disorders Identification Test (AUDIT) Total | 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. | Baseline, Follow-up (Up to 7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| AUDIT-C or Drinkers Index | 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. | Baseline, Follow-up (Up to 7 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Reed, PhD | SDSURF - Center for Alcohol & Drug Studies & Services | Principal Investigator |
| Gerard DeMers, DO | United States Naval Medical Center, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | SBIRT | Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:
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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | SBIRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Use Disorders Identification Test (AUDIT) Total | 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. | Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark B. Reed/Professor and Interim Associate Dean | San Diego State University Research Foundation | 619-594-6664 | mreed@sdsu.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| D015438 | Health Behavior |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| D003419 | Crisis Intervention |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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|
| Controlled Drinking Self-Efficacy Scale (CDSES) |
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. |
| Baseline, Follow-up (Up to 7 months) |
| Readiness to Change Scale | 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. | Baseline, Follow-up (Up to 7 months) |
Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:
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.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-Reported PTSD Diagnosis | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Service Branch | Count of Participants | Participants |
|
| Number of Combat Deployments (past 5-years) | Count of Participants | Participants |
|
| Alcohol Use Disorders Identification Test (AUDIT) Score | The AUDIT is the Alcohol Use Disorders identification test (Babor et al., 2001). The AUDIT is a screening assessment designed to help identify risky drinking. The AUDIT ranges from a score of 0 to 40 with higher values indicating riskier drinking. | Mean | Standard Deviation | units on a scale |
|
| Readiness to Change Drinking | 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. | Mean | Standard Deviation | units on a scale |
|
| Controlled Drinking Self-Efficacy Scale (CDSES) | The 20-item Controlled Drinking Self-Efficacy Scale (CDSES; Sitharthan et al., 2003), 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 higher scores indicating more confidence to engage in controlled drinking. Items for the CDSES will be combined and averaged to form a scaled score. | Mean | Standard Deviation | units on a scale |
|
Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:
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. |
|
|
|
| Secondary | AUDIT-C or Drinkers Index | 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. | Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
|
|
|
|
| Secondary | Controlled Drinking Self-Efficacy Scale (CDSES) | 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. | Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
|
|
|
|
| Secondary | Readiness to Change Scale | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II) | 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. | 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) | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
|
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|
|
| Post-Hoc | AUDIT-C or Drinkers Index (Analysis II) | 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. | 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) | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
|
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|
|
| Post-Hoc | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II) | 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. | 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) | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
|
|
|
|
| Post-Hoc | Readiness to Change Scale (Analysis II) | 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. | 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) | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases) | 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. | Complete case analysis | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | AUDIT-C or Drinkers Index (Analysis III Complete Cases) | 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. | Complete case analysis | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases) | 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. | Complete case analysis | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Readiness to Change Scale (Analysis III Complete Cases) | 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. | Complete case analysis | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis IV--Multiple Imputation and Intention to Treat 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. | Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791) | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | AUDIT-C or Drinkers Index (Analysis IV--Intent to Treat Analyses) | 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. | Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791) | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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|
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| Post-Hoc | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis IV--Intent to Treat Analyses) | 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. | Intent to treat analysis using multiple imputation; include all participants allocated to a condition at baseline (n = 791) | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Readiness to Change Scale (Analysis IV--Multiple Imputation and Intention to Treat 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis V--Multiple Imputation and Intention to Treat 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. | Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | AUDIT-C or Drinkers Index (Analysis V--Intent to Treat Analyses) | 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. | Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis V--Intent to Treat Analyses) | 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. | Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| Post-Hoc | Readiness to Change Scale (Analysis V--Multiple Imputation and Intention to Treat 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. | Intent to treat analysis using multiple imputation; includes participants scoring 8 or greater on the AUDIT at baseline. | Posted | Mean | Standard Error | units on a scale | Baseline, Follow-up (Up to 7 months) |
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| 0 |
| 244 |
| 0 |
| 244 |
| EG001 | SBIRT | Those assigned to the SBIRT intervention group will receive 1 of 3 tracks:
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. | 0 | 228 | 0 | 228 |
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| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |