Addressing Alcohol Problems in Primary Care: A Cluster Randomized, Controlled Trial of a Systems Intervention: The Screening and Intervention in Primary Care (SIP) Study

Context Brief interventions can reduce problem drinking, but physicians infrequently use them. Contribution This randomized trial, from an academic primary care setting, tested whether prompting physicians with positive alcohol screening results that are linked to specific management recommendations works. Prompted faculty, but not residents, tended to discuss alcohol problems and counsel patients more often than did their counterparts who were not prompted. At 6 months, however, only patients of prompted residents had reduced their drinking. Implications Prompting physicians with positive alcohol screening results and recommendations for action may or may not be effective, depending on patient, physician, and setting characteristics. The Editors Alcohol use disorders are a leading cause of disability and are as common and costly as coronary artery disease and depression (1-6). Primary care settings are ideal for alcohol screening and intervention (7). Valid, brief, practical screening tools exist, and brief interventions can reduce drinking and improve health when delivered to primary care patients with alcohol problems (8-11). However, alcohol problems are often unrecognized and untreated in primary care settings (12-16). Barriers to screening and intervention include issues related specifically to addictions (such as patient readiness and physician discomfort, frustration, lack of confidence or skills, or pessimism about efficacy of intervention) and issues related to the delivery of preventive services in general (such as cost, acceptability, priorities, and time) (17, 18). Physician prompting can improve the likelihood of cancer screening, administration of immunizations, and smoking cessation interventions (19-21). Screening and intervention for alcohol problems, however, involve more complex assessment and intervention. The effectiveness of providing physicians with screening results and a prompt without training is unknown. Such a systems intervention would be easier and less costly to implement than training all physicians about addressing alcohol problems. We tested the hypotheses that providing physicians with patients' alcohol screening results and simple individualized recommendations would increase physician alcohol counseling and decrease patient drinking. Methods Study Description The study was a cluster randomized trial at the physician level because randomization at the patient level would have risked contamination. The institutional review board of the Boston University Medical Center in Boston, Massachusetts, approved the study. Patients gave informed consent and were told that the physician may be given the results of alcohol screening questions. We obtained a Certificate of Confidentiality from the federal government. Participants Physicians were recruited, enrolled, and randomly assigned before patients were enrolled. All faculty and resident primary care physicians in an urban academic practice (excluding the authors) were eligible. Physicians who had seen fewer than 80 patients in the previous 3 years or who anticipated leaving the practice within 6 months were excluded. We informed physicians that we would conduct a health screening study. We used a self-administered questionnaire to screen and enroll patients who spoke English or Spanish (staff were available to assist) (22). This was done before a visit with one of the enrolled physicians. Eligible patients were current hazardous drinkers [23], which was defined as having consumed alcohol in the past month and either 1) answered yes to one or more of the CAGE (24-26) alcohol screening questions (modified to refer to the past year rather than lifetime) [27] or 2) drank hazardous amounts in the past month (28, 29). Hazardous amounts for men and women, respectively, were defined as more than 4 standard drinks per occasion or 14 drinks per week and as more than 3 standard drinks per occasion or 7 drinks per week in the past 30 days (26, 30). Assessments Before patients were enrolled, physicians completed a confidential written survey (July 1997). They were asked about their attitudes toward patients with addictions; their professional satisfaction when caring for patients with alcohol problems; whether they or someone they knew had an alcohol or drug problem; and other issues related to alcohol and physicians, including the physician's usual practices (18). A trained staff researcher interviewed enrolled patients before and after their visits with a physician (between February 1998 and August 1999). All questions not available in Spanish (31) were translated, back-translated, and checked for accuracy. The assessment visit that occurred before the physician visit addressed demographic characteristics, previous counseling for alcohol problems, and readiness to change (32, 33). Patients were also asked about medication use, medical comorbidity (34, 35), psychiatric comorbidity (36, 37), and tobacco and other drug use. Immediately after the physician visit, patients were interviewed to determine whether counseling had occurred, drinking amounts (38, 39), the quality of communication with the physician (40), alcohol dependence symptoms (41), and alcohol problems (Short Inventory of Problems [SIP-2R]) (42). Six months later, patients were interviewed by telephone to determine alcohol consumption in the past 30 days; the validated Timeline Followback method was used (43). Patients and staff researchers were not blinded to group assignment (in addition, patients were not necessarily given this information); at follow-up, interviews were done without knowledge of group assignment. Randomization and Intervention Physicians were stratified by level of training (resident or faculty) and were randomly assigned to the intervention or control group at the start of the study. The computer-generated randomization was done by off-site data management personnel who had no patient or physician contact. The staff researcher attached the intervention, a sheet of paper, to the encounter record the physician routinely received immediately before each patient visit. One side of the paper provided the patient's alcohol screening results, a preliminary assessment, and specific recommendations. The screening results included answers to each of the CAGE questions, reports of usual weekly and per occasion maximum drinking amounts, and the patient's report of readiness to change on a 10-point scale (44) (see Appendix Figure). For patients reporting hazardous drinking amounts but no affirmative CAGE questionnaire responses, the assessment was drinking hazardous amounts and the recommendation was consider advising safe drinking limits and consider providing patients with a pamphlet provided by the study titled How to Cut Down on Your Drinking (27). For patients reporting any affirmative CAGE responses but no hazardous drinking amounts, the assessment was possible alcohol problems and recommendations were consider advising abstinence, provide the pamphlet, and referral to addiction treatment. For patients reporting affirmative CAGE questionnaire responses and hazardous drinking amounts, the assessment was both possible alcohol problems and drinking hazardous amounts and recommendations were consider advising abstinence and referral to addiction treatment. The other side of the paper provided the predictive value of CAGE based on the prevalence of alcohol abuse or dependence in the practice (26, 31), definitions of hazardous drinking, an approach for patients who are not ready to change, a list of abuse or dependence symptoms, and referral information. To increase counseling rates (not for data collection), we attached a Post-it note to the encounter form asking physicians to indicate whether alcohol was discussed and, if not, why (45). Physicians in the control group did not receive any information from the study. Statistical Analysis All analyses were performed by using SAS software, version 8.1 [SAS Institute, Inc., Cary, North Carolina]. The primary prespecified outcomes of the study were the occurrence of physician discussions regarding alcohol problems during the physicianpatient encounter and a decrease in patient drinking. Patients were asked whether they had 1) received alcohol counseling, defined as advice on safe drinking limits, advice to cut down or abstain, or referral to an alcohol specialist or treatment program; 2) received any advice [including counseling]; or 3) participated in any discussion about alcohol (including advice). An example question was: Did the doctor give you any advice about your drinking habits? Drinks per drinking day was the primary drinking outcome. We examined additional measures in secondary analyses: days drinking (any day on which a drink was taken), days binge drinking (any day on which per occasion amounts noted previously were exceeded), proportion drinking hazardous amounts, proportion binge drinking, and proportion abstinent. We compared sociodemographic characteristics, level of training, and mean number of patients enrolled for physicians in the intervention and control groups by using the two independent samples t-test and the Fisher exact test, as applicable. We then compared patients who were seen by physicians in the intervention and control groups with respect to measured characteristics. We compared patients who were available and unavailable at the 6-month follow-up by randomized group, physician level of training, and sociodemographic characteristics. Outcomes were compared between physicians in the intervention and control groups by using an intention-to-treat analysis (physicians were analyzed in the groups to which they were randomly assigned). Generalized estimating equations (GEE) were used to adjust for clustering of patients by physician (PROC GENMOD, SAS software, version 8.1) (46). For continuous outcomes, we specified the identity link function; for dichotomous outcomes, we specified the logit link func