Varenicline for smoking cessation: nausea severity and variation in nicotinic receptor genes.

This study evaluated association between common and rare sequence variants in 10 nicotinic acetylcholine receptor subunit genes and the severity of nausea 21 days after initiating the standard, Food and Drug Administration-approved varenicline regimen for smoking cessation. A total of 397 participants from a randomized clinical effectiveness trial with complete clinical and DNA resequencing data were included in the analysis (mean age=49.2 years; 68.0% female). Evidence for significant association between common sequence variants in CHRNB2 and nausea severity was obtained after adjusting for age, gender and correlated tests (all P(ACT)<0.05). Individuals with the minor allele of CHRNB2 variants experienced less nausea than did those without the minor allele, consistent with previously reported findings for CHRNB2 and the occurrence of nausea and dizziness as a consequence of first smoking attempt in adolescents, and with the known neurophysiology of nausea. As nausea is the most common reason for discontinuance of varenicline, further pharmacogenetic investigations are warranted.

Dopamine receptor DRD2 genotype and smoking cessation outcome following treatment with bupropion SR.

The A1 allele of the dopamine D2 receptor gene (DRD2) is associated with a reduced number of dopamine binding sites in the brain and with the increased likelihood of substance abuse and addictive behavior. In a study of smokers enrolled in an open-label, randomized effectiveness trial, we investigated whether variants in the DRD2 receptor gene are associated with smoking cessation outcomes following treatment with a combination of bupropion SR and behavioral counseling. Adherence to treatment and point-prevalent smoking status were assessed at 3 and 12 months, respectively, following a target quit date. Compared to women who carry both A2 alleles, women with at least one A1 allele were more likely to report having stopped taking bupropion due to medication side effects (odds ratio (OR)=1.91, 95% confidence interval (CI)=1.01-3.60; P<0.04) and at 12 months were somewhat more likely to report smoking (OR=0.76, 95% CI=0.56-1.03; P<0.076). Significant associations or trends were not observed in men. In women, individual variability in responsiveness to bupropion-based treatment may be partially due to differences in genetic variants influencing dopamine receptor function.

The uninsured and Medicaid Oregon tobacco user experience in a real world, phone based cessation programme.

OBJECTIVE: To describe the experience of uninsured and Medicaid Oregon tobacco users who registered in Free & Clear (F&C), a telephone based cessation programme including five scheduled outbound calls. DESIGN AND SETTING: Using a retrospective cohort design, 1334 (423 uninsured, 806 Medicaid, and 105 commercially insured) Oregon tobacco users who registered in F&C between 18 November 1998 and 28 February 2000 were identified and followed for 12 months post-registration; 648 (48.6%) were successfully contacted at 12 months. Information was collected from the F&C database. Unconditional logistic regression, adjusted for race and education, was used. RESULTS: The seven day quit rate at 12 months, assuming non-respondents were smokers, was 14.8% (95% confidence interval (CI) 13.0 to 16.9). This rate was significantly higher among commercially insured participants (v Medicaid but not uninsured) and among participants who completed > or = 5 calls (v < 5 calls). The quit rate for those contacted at 12 months was 30.6% (95% CI 27.0% to 34.3%) and varied, however not significantly, by insurance and number of calls. After adjustment, respondents who completed > or = 5 calls were 60% more likely to quit tobacco (odds ratio (OR) 1.6, 95% CI 0.9 to 3.1), and uninsured respondents who completed > or = 5 calls were 70% more likely to quit tobacco (OR 1.7, 95% CI 0.9 to 3.5), relative to those who completed < 5 calls, but the difference was not significant. CONCLUSIONS: The quit rates are similar to those reported in efficacy trials. The observed variation in quitting tobacco for respondents by number of calls completed and by insurance merits further investigation concentrating on increasing compliance with the call schedule, particularly for the uninsured.

HIV prevention in primary care: impact of a clinical intervention.

Discomfort, lack of confidence in skills, and environmental constraints may cause primary care providers to miss opportunities to discuss human immunodeficiency virus (HIV) risk with patients. We used a systems approach to address both intrapersonal and environmental barriers to HIV risk assessment and prevention counseling in a managed care clinical setting. The design was one-group pretest/posttest. The study took place in two primary care clinics of a large Pacific Northwest managed care organization. Participants (n = 49) included physicians, physician assistants, nurse practitioners, registered nurses, and social workers. The intervention included training, clarification of provider/staff roles, assess to tools and materials, and reminders/reinforcers. Outcome measures were provider attitudes, beliefs, outcome expectations, knowledge, confidence in skills, and perceived supports and barriers, measured by written pretest/posttest surveys administered 12 months apart. Seven months after the most intensive part of the intervention, providers' attitudes and beliefs were more favorable to HIV risk assessment and prevention counseling. They were less likely to express frustration with high-risk patients (decrease from 100% to 79% agreement, p = 0.001) and more confident that their advice would be effective with gay men and single adult heterosexuals (p = 0.002 and 0.005, respectively). They reported more confidence in their training in sexual history taking (p = 0.0003) and their skills assessing readiness for change (p = 0.007), and more support in practice environments. This study demonstrated that it is possible to affect important personal and environmental factors that influence primary care providers' HIV prevention behavior using an interactive, real-world systems approach. Further research is needed on providers' impact on patient behavior.

Enhancing primary care HIV prevention: a comprehensive clinical intervention.

CONTEXT: Human immunodeficiency virus (HIV) and sexually transmitted disease (STD) risk assessment and counseling are recommended for a large proportion of the population, yet measured rates of such counseling remain low. OBJECTIVE: Use a comprehensive intervention to improve and sustain rates of HIV/STD risk assessment and counseling by providers. DESIGN: Patient telephone survey using a one-group pre- and post-intervention design with measurements over a 62-week period. SETTING AND PARTICIPANTS: Patients (N=1042) from two outpatient clinics at a health maintenance organization (HMO) presenting for either of two types of index visit: symptomatic (n=210), or routine physical examination or birth control (n=832) visits. MAIN OUTCOME MEASURES: Telephone survey performed within 3 weeks of the index visit. Patients' recall of a general discussion of HIV/STDs and specific discussion of sexual behaviors/risk factors. RESULTS: The intervention was associated with increased patient recall of providers: discussing HIV/STD in general (OR 1.6; 95% CI, 1.12-2.22), asking about sexual behaviors/risk factors (OR 1.7; 95% CI, 1.2-2.6), discussing HIV prevention generally (OR 2.4; 95% CI, 1.4-4.0), and discussing personal risk reduction (OR 2.6; 95% CI, 1.6-4.3). Provision of written materials concerning HIV/STD also increased significantly (OR 2.8; 95% CI, 1.3-4.3). A clear-cut pattern of improved provider effort was seen, with the most pronounced improvements in high-risk patients. Results were stable over a 38-week follow-up period. CONCLUSION: A sustained improvement in HIV/STD risk assessment and counseling can be achieved in an outpatient HMO setting using a relatively non-intensive systematized intervention.

Use and cost effectiveness of smoking-cessation services under four insurance plans in a health maintenance organization.

BACKGROUND: Lack of information about the effect of insurance coverage on the demand for and use of smoking-cessation services has prevented widescale adoption of coverage for such services. METHODS: In a longitudinal, natural experiment, we compared the use and cost effectiveness of three forms of coverage with those of a standard form of coverage for smoking-cessation services that included a behavioral program and nicotine-replacement therapy. The study involved seven employers and a total of 90,005 adult enrollees. The standard plan offered 50 percent coverage of the behavioral program and full coverage of nicotine-replacement therapy. The other plans offered 50 percent coverage of both the behavioral program and nicotine-replacement therapy (reduced coverage), full coverage of the behavioral program and 50 percent coverage of nicotine-replacement therapy (flipped coverage), or full coverage of both the behavioral program and nicotine-replacement therapy. RESULTS: Estimated annual rates of use of smoking-cessation services ranged from 2.4 percent (among smokers with reduced coverage) to 10 percent (among those with full coverage). Smoking-cessation rates ranged from 28 percent (among users with full coverage) to 38 percent (among those with standard coverage). The estimated percentage of all smokers who would quit smoking per year as a result of using the services ranged from 0.7 percent (with reduced coverage) to 2.8 percent (with full coverage). The average cost to the health plan per user who quit smoking ranged from $797 (with standard coverage) to $1,171 (with full coverage). The annual cost per smoker ranged from $6 (with reduced coverage) to $33 (with full coverage). The annual cost per enrollee ranged from $0.89 (with reduced coverage) to $4.92 (with full coverage). CONCLUSIONS: Use of smoking-cessation services varies according to the extent of coverage, with the highest rates of use among smokers with full coverage. Although the rate of smoking cessation among the benefit users with full coverage was lower than the rates among users with plans requiring copayments, the effect on the overall prevalence of smoking was greater with full coverage than with the cost-sharing plans.

The role of tobacco intervention in population-based health care: a case study.

Managed care organizations are in an excellent position to implement population-based, as well as patient-centered, approaches to reduce behavioral risk factors associated with major chronic diseases. Group Health Cooperative of Puget Sound employed a population-based model for smoking that contributed to a decrease from 25% to 15.5% in smoking prevalence in 10 years among its more than 550,000 adult enrollees in western Washington. This model may have application to other arenas where health systems can support beneficial behavior change.

Improving community-based prevention by transforming managed care organizations into health improvement organizations.

Large nongovernmental health systems are taking over much of the direct delivery of healthcare to populations previously served by health departments. This article explores ways in which governmental and academic public health systems can help maximize positive effects of this trend on community health. The experience of Group Health Cooperative of Puget Sound is reviewed, with particular attention to its prevention structure and work to address tobacco use. An ideal preventive health improvement system model is presented, and future directions and key lessons are explored.

Waking the health plan giant: Group Health Cooperative stops counting sheep and starts counting key tobacco indicators.

Implementing a comprehensive approach to decreasing tobacco use in a large health plan requires hard work and commitment on the part of many individuals. We found that major organisational change can be accomplished and sustained. Keys to our success included our decision to remove access barriers to our cessation programmes (including cost); obtaining top leadership buy-in; identifying accountable individuals who owned responsibility for change; measuring key processes and outcomes; and finally keeping at it tenaciously through multiple cycles of improvement.

Addressing a neglected coronary heart disease risk factor in an HMO: exercise counseling and fitness testing at group health cooperative.

Group Health Cooperative, following the lead of the American Heart Association (AHA), the Centers for Disease Control (CDC), and the US Preventive Services Task Force (USPSTF), has identified inactivity as one of the most significant risk factors for the prevention of coronary heart disease (CHD). This paper reports on the programs being developed at Group Health Cooperative to address inactivity. A clinical tool designed to make fitness testing and comprehensive exercise counseling practical in routine primary care was designed and piloted. The fitness test was based on the One-Mile Walk Test, with computerization of the results analysis and reporting. The test helped the physician assess the patient's current exercise habits and physical fitness in terms of Vo2max (maximal oxygen consumption). The computer program showed the patient and the physician how the individual's Vo2max compared to norms for the patient's age and gender. The program provided comprehensive written exercise counseling and individualized advice about activity and fitness based on the patient's current exercise habits. The test cost little to administer, and helped reduce the time and effort of the primary physician in providing exercise counseling, while making optimal use of the physician's power to motivate. Exercise counseling is a very cost-effective preventive intervention. We believe that an organized and systematic exercise counseling program, together with a program for measuring fitness, would be the most effective intervention. Evidence indicates that effective exercise counseling should result in substantial reduction in disease in our population.

Awakening the sleeping giant: mainstreaming efforts to decrease tobacco use in an HMO.

Group Health Cooperative (GHC) of Puget Sound is developing, within a framework of quality improvement, a comprehensive population-based approach to decreasing the prevalence of tobacco use. Broad organizational support has been obtained, centralized support is being integrated with clinic-level activity, local ownership of outcomes is encouraged with empowerment of health care teams, and support for community and policy-based activities is being provided. GHC's smoking prevalence has decreased from 25% to 15.5% over the past decade, while the state of Washington's prevalence declined from 23.7% to 21.8%.

Primary and secondary prevention services in clinical practice. Twenty years' experience in development, implementation, and evaluation.

This article reviews lessons from 20 years of experience in development and provision of clinical preventive services at Group Health Cooperative of Puget Sound, a large health maintenance organization. Critical factors for enhancing service include the use of a population-based epidemiologic viewpoint coupled with specific evidence-based criteria to examine issues; involvement of practitioners in the process; a systems approach to implementation focused on predisposing factors of the practitioners and enabling factors in the practice, organizational, and community environments; feedback of program outcomes; and the use of automated clinical information systems. Outcome results from our clinical prevention efforts include a 32% decrease in late-stage breast cancer (1989 to 1990); 89% of 2-year-old children with complete immunizations (1994); decrease in adult smokers from 25% to 17% (1985 to 1994); and an increase in bicycle safety helmet use among children from 4% to 48% along with a 67% decrease in bicycle-related head injuries (1987 to 1992). Systematic population-based approaches to the development and provision of clinical preventive services targeting the one-to-one level of primary care and multiple infrastructure levels of care are forging a synthesis of clinical medicine and public health approaches. This approach will become pervasive as clinical information systems improve, risk information is captured routinely, and practitioners gain skills in the art of patient risk behavior change and population-based care.