Background: Some Medicare Part D enrollees whose drug expenditures exceed a threshold enter a coverage gap with full cost-sharing, increasing their risk for reduced adherence and adverse outcomes. Objective: To examine comorbidities and demographic characteristics associated with gap entry and exit. Design: We linked 2005-2006 pharmacy, outpatient, and inpatient claims to enrollment and Census data. We used logistic regression to estimate associations of 2006 gap entry and exit with 2005 medical comorbidities, demographics, and Census block characteristics. We expressed all results as predicted percentages. PATIENTS: 287,713 patients without gap coverage, continuously enrolled in a Medicare Advantage Part D (MAPD) plan serving eight states. Patients who received a low-income subsidy, could not be geocoded, or had no 2006 drug fills were excluded. Results: Of enrollees, 15.9% entered the gap, 2.6% within the first 180 days; among gap enterers, only 6.7% exited again. Gap entry was significantly associated with female gender and all comorbidities, particularly dementia (39.5% gap entry rate) and diabetes (28.0%). Among dementia patients entering the gap, anti-dementia drugs (donepezil, memantine, rivastigmine, and galantamine) and atypical antipsychoticmedications (risperidone, quetiapine, and olanzapine) together accounted for 40% of pre-gap expenditures. Among diabetic patients, rosiglitazone accounted for 7.2% of pre-gap expenditures. Having dementia was associated with twice the risk of gap exit. Conclusions: Certain chronically ill MAPD enrollees are at high risk of gap entry and exposure to unsubsidized medication costs. Clinically vulnerable populations should be counseled on how to best manage costs through drug substitution or discontinuation of specific, non-essential medications. © 2010 Society of General Internal Medicine.

Background: Health promotion interventions often include multiple components and several patient contacts. The objective of this study was to examine how participation within a multicomponent intervention (Project SHARE) is associated with changes in at-risk drinking among older adults. Methods: We analyzed observational data from a cluster-randomized trial of 31 primary care physicians and their patients aged ≥60 years, at a community-based practice with 7 clinics. Recruitment occurred between 2005 and 2007. At-risk drinkers in a particular physician's practice were randomly assigned as a group to usual care (n = 640 patients) versus intervention (n = 546 patients). The intervention included personalized reports, educational materials, drinking diaries, in-person physician advice, and telephone counseling by health educators (HEs). The primary outcome was at-risk drinking at follow-up, defined by scores on the Comorbidity Alcohol Risk Evaluation Tool (CARET). Predictors included whether a physician-patient alcohol risk discussion occurred, HE call occurred, drinking agreement with the HE was made, and patients self-reported keeping a drinking diary as suggested by the HE. Results: At 6 months, there was no association of at-risk drinking with having had a physician-patient discussion. Compared to having had no HE call, the odds of at-risk drinking at 6 months were lower if an agreement was made or patients reported keeping a diary (odds ratio [OR] 0.58, 95% confidence interval [CI] 0.37 to 0.90), or if an agreement was made and patients reported keeping a diary (OR 0.52, CI 0.28 to 0.97). At 12 months, a physician-patient discussion (OR 0.61, CI 0.38 to 0.98) or an agreement and reported use of a diary (OR 0.45, CI 0.25) were associated with lower odds of at-risk drinking. Conclusions: Within the Project SHARE intervention, discussing alcohol risk with a physician, making a drinking agreement, and/or self-reporting the use of a drinking diary were associated with lower odds of at-risk drinking at follow-up. Future studies targeting at-risk drinking among older adults should consider incorporating both intervention components.

Background: At-risk drinking, defined as alcohol use that is excessive or potentially harmful in combination with select comorbidities or medications, affects about 10% of older adults in the United States and is associated with higher mortality. The Project SHARE intervention, which uses patient and provider educational materials, physician counseling, and health educator support, was designed to reduce at-risk drinking among this vulnerable population. Although an earlier study showed that this intervention was successful in reducing rates of at-risk drinking, it is unknown whether these reductions translate into improved health and health-related quality of life (HRQL). Objective: The aim of this study was to examine changes in health and HRQL of older adult at-risk drinkers resulting from a patient-provider educational intervention. Research design: A randomized controlled trial to compare the health and HRQL outcomes of patients assigned to the Project SHARE intervention vs. care as usual at baseline, 6- and 12-months post assignment. Control patients received usual care, which may or may not have included alcohol counseling. Intervention group patients received a personalized patient report, educational materials on alcohol and aging, a brief provider intervention, and a telephone health educator intervention. Subjects: Current drinkers 60. years and older accessing primary care clinics around Santa Barbara, California (N= 1049). Measurements: Data were collected from patients using baseline, 6- and 12-month mail surveys. Health and HRQL measures included mental and physical component scores (MCS and PCS) based on the Short Form-12v2 (SF-12v2), the SF-6D, which is also based on the SF-12, and the Geriatric Depression Scale (GDS). Adjusted associations of treatment assignment with these outcomes were estimated using generalized least squares regressions with random provider effects. Regressions controlled for age group, sex, race/ethnicity, marital status, education, household income, home ownership and the baseline value of the dependent variable. Results: After regression adjustment, the intervention was associated with a 0.58 point (95% CI: -0.06, 1.21) increase in 6-month MCS and a 0.14 point (95% CI: 0.01, 0.26) improvement in 12-month GDS score, compared to the control group. The intervention also increased adjusted SF-6D scores by 0.01 points at both 6 and 12. months (6-month 95% CI: 0.01, 0.02; 12-month 95% CI: 0.01, 0.01). Conclusions: Despite the previously shown effectiveness of the Project SHARE intervention to reduce at-risk drinking among older adults, this effect translated into effects on health and HRQL that were statistically but not necessarily clinically significant. Effects were most prominent for patients who received physician discussions, suggesting that provider counseling may be a critical component of primary care-based interventions targeting at-risk alcohol use.