Seventy-six percent of the patients had attending-level physicians as their providers, 5% had resident physicians, and 19% had nurse practitioners. Patient exit interviews demonstrated that all except 1 SI participant were counseled about alcohol use and that there were no significant differences between provider type and PEI scores. As described elsewhere,23
the mean score on the PEI for SI participants was 9.8, and 1.7 for UC participants. Of the total study population, 59% had more than 1 additional visit with their provider between the baseline and 6-month assessments. Providers were not cued to administer alcohol counseling between the 6- and 12-month assessment interviews.
Of the original 530 participants, 83 did not complete the 12-month interview, yielding a sample of 447. There was no significant difference between groups in the number of participants who did not complete the 12-month interview, with 44 (17.2%) of UC and 39 (14.2%) of SI not completing the 12-month interview. There were no differences at baseline on age, number of drinks per week, family history of alcohol abuse, gender, proportion of white and nonwhite respondents, and use of sleep medication between participants who completed the 12-month interview and those who did not. However, the group who did not complete the 12-month interview compared to those who did complete it had a lower proportion with a college degree or more (21% vs 44%) and a higher proportion of smokers (54% vs 33%). In addition, for the cohort of 445, there were no significant differences between the UC and SI groups at baseline. Please see for baseline patient characteristics by condition and randomization status.
Baseline Patient Characteristics by Treatment Condition and Randomization Status (N = 445)*
Alcohol Outcome Measures
describes the alcohol intake by treatment condition from baseline to 12 months for the 445 participants who completed both the baseline and 12-month interviews. Compared to the UC, SI participants reported nonstatistically significantly higher levels of both drinks per week and binge drinking at baseline. Means and standard errors for baseline, 6 months, and 12 months for weekly and binge drinking by condition for the 422 participants with respective measurements are presented in .
Baseline and 12-Month Measures of Weekly Alcohol Intake and Monthly Binge Drinking by Treatment Condition and Gender (N = 445)*
Unadjusted Mean Drinks per Week or Mean Binges over Time for Participants with Complete Data (All Three Time Points, N = 422)*
presents the mixed-model results for change in weekly drinking levels and change in the number of monthly binge drinking episodes from baseline to 12 months (n =445) that adjusts for baseline drinking levels. At 12 months, SI participants significantly reduced their alcohol intake by 2.5 drinks per week more than UC (P =.03). Relative to the UC, the SI experienced a reduction of 0.4 binges per month. For every 100 treated there was an increase of 13 safe drinkers in the SI condition versus the UC condition. This means that approximately 8 high-risk drinkers needed to be treated for every 1 extra safe drinker. Although the absolute reduction within the SI group was 2 binges per month, the difference between SI and UC was not statistically significant.
Change in Weekly Drinking Levels and in the Number of Monthly Binge Drinking Episodes from Baseline to 12 Months by Treatment Condition (N = 445)*
Entry into the study was based on either an excessive intake of drinks per week, binge drinking, or both. Patients were categorized into safe or unsafe drinking at both baseline and 12 months for both outcome measures. We then examined the progression from unsafe patterns of intake at baseline to safe levels at 12 months. presents the prevalence of change to safe drinking at 12 months by treatment condition for drinks per week, binge drinking, and both behaviors combined.
The Change in Prevalence of Safe Drinking at 12 Months for Excessive Weekly Drinking, Binge Drinking, and Both Drinking Behaviors Combined by Treatment Condition (N =445)*
When we combined information on weekly drinking and binge drinking into safe/unsafe drinking categories (n =445), we found that 42% of SI subjects were drinking at safe levels compared to 29% of UC. Overall, the odds ratio for SI subjects to progress to safe drinking compared to UC was 1.58 (95% confidence interval [CI], 0.99 to 2.52). When we considered drinks per week (n =343) and binges per month (n =339) separately, the odds ratio was 1.60 comparing SI to UC in likelihood of decreasing alcohol intake to safe levels for drinks per week (95% CI, 1.00 to 2.54) and 1.37 for binges per month (95% CI, 0.86 to 2.12); however, only the improvement for drinks per week attained statistical significance.
Change in Prevalence of Excessive Drinking
As described above, we categorized participants to reflect how their drinking status changed from safe to non–safe drinking over the duration of the study (i.e., from baseline to 6 months and from 6 months to 12 months). Three sets of analyses were done, one for high-risk weekly drinkers, one for high-risk binge drinkers, and one for participants who met either criterion. Conditional on a change to a healthy drinking status at 6 months, we estimated the proportion that relapsed from 6 to 12 months using the mixed-model analysis described above. As seen when both weekly and binge drinking criteria are used, the SI group was significantly less likely to relapse to unsafe drinking from 6 to 12 months, with an odds ratio of relapse of 0.32 favoring the SI group. We also examined the odds that those participants who had not changed to safe drinking at 6 months would change to safe drinking at 12 months. There were no significant differences between the conditions in the proportion of participants changing to safe levels from 6 to 12 months, with approximately 24% of UC and SI participants changing to safe drinking from 6 to 12 months.
Project Health demonstrated that brief (5–10 minute) provider-delivered alcohol counseling conducted in the primary care setting during a regular clinic visit can significantly reduce drinking at 12 months in high-risk drinkers and help them to maintain reductions previously achieved. This was evidenced by a significantly greater reduction in number of drinks per week in SI participants, a significantly larger group of SI participants who progressed to safe drinking at 12-month follow-up when compared to UC, and significantly fewer SI participants who had changed to safe drinking at 6 months relapsing to high-risk drinking when compared to UC.
The reduction in alcohol consumption in the UC is consistent with our 6-month results20
and those of other investigators.12,14,17,27
Regression to the mean was adjusted for by controlling for baseline values in analyses. The measurement techniques were the same for both groups; therefore, we would not expect regression to the mean to affect each group differentially, given that we have adjusted for baseline drinking. Changes in UC alcohol consumption may represent a true improvement in drinking habits over time, the effect of repeated assessment of drinking behaviors over the course of the study, or some combination of both factors. Additionally, although we controlled for the effect of provider, due to the need to add a site to increase enrollment, 1 site was not randomly assigned. Though the UC and SI groups did not differ on variables related to alcohol history, smoking, and demographics (other than gender), there is a possibility that there is some difference between the treatment and control groups that we did not examine that might have differentially affected treatment outcomes.
Because this is a randomized trial with only 2 sites randomized, we also estimated effect size. With 20 physicians per group (13 patients per physician) and an intraclass correlation of 0.025, we would have 85% power for a mean difference of 3.5 drinks per week. At 12 months, the estimated difference between UC and SI was −2.4 drinks per week, with a 95% confidence interval of −4.7 to −0.5.
Strengths of this study include a high rate of follow-up with our participants (91% at 6 months and 84% at 12 months). This high follow-up rate helps to ensure generalizability to primary care settings that have patient demographics similar to our study population. Additionally, our study was a randomized trial using a “regular” primary care visit during which counseling was done. This sets our study apart from others that have used treatment models which include scheduling of “special” visits for alcohol counseling and helps to confirm the generalizability of brief intervention for high-risk drinkers to the primary care setting where providers are often pressed for time to address many health issues. Our results provide evidence that providers in a primary care setting can effectively help their patients reduce high-risk drinking while briefly addressing these issues within a visit that may have been scheduled to focus on another health issue.
In addition, our physician training program, screening, and office system are adaptable to other primary care practices. Our clinician training was implemented in 2.5 hours and has been shown to be effective in helping clinicians to develop counseling skills.23
The screening methods used in the current study were labor intensive because brief screening tools for high-risk drinkers had not been well validated at the time of the onset of the study. Since that time, the 10-item Alcohol Use Disorders Test has shown promise as an easily used screening tool for the identification of high-risk drinkers.28
Office systems that prompt physicians to intervene on other health behaviors (such as smoking) can be modified to include prompting for screening and intervention with high-risk drinkers.
Limitations of this study include the self-report nature of the data. Unfortunately, to date there is not a biological measurement that reliably detects reduction in drinking at moderate levels of alcohol intake, and research indicates that using self-report alcohol consumption is more reliable than other methods of measuring alcohol consumption. We used methods reported in the literature29–31
to help reduce self-report bias in the assessment of alcohol intake by telling the patient that this is a research project, that the results will not be entered into his/her medical chart (interview results were put into separate research charts given to providers prior to appointments and retrieved immediately after appointments), and by masking alcohol questions by embedding them in a questionnaire along with questions about other health habits (eating, physical activity, and smoking). Additionally, we used standardized alcohol report methodology for collecting multiple measurements of alcohol use, and collateral calls were made to facilitate high-quality reporting by participants.
Our sample was primarily white and thus is limited in its generalizability to primary care settings without minority populations.
Taken together, the above results confirm the growing literature that demonstrates that screening and brief intervention is effective in reducing high-risk alcohol consumption to safe levels. It also provides support for the durability of changes in alcohol consumption with brief intervention. Additionally, this study shows that screening and brief intervention for high-risk drinking can be done in a regular primary care visit without involving visits set up specifically to focus on alcohol intervention or additional providers. However, even with screening and brief intervention, a substantial proportion (58%) of alcohol users remained in the unsafe drinking category. Therefore, an important question is whether additional interventions, such as telephone counseling by health counselors, would increase the proportion who become safe drinkers and who remain safe drinkers after initial intervention. Incorporation of provider-delivered brief interventions into the regular patient visit requires reminder and training resources. The provision of such resources is both a public health and clinical challenge.