Purpose

We describe the recruitment strategies and personnel and materials costs associated with two community-based research studies in a Mexican-origin population. We also highlight the role that academic-community partnerships played in the outreach and recruitment process for our studies. We reviewed study documents using case study methodology to categorize recruitment methods, examine community partnerships, and calculate study costs.

Results

We employed several recruitment methods to identify and solicit 154 female caregivers for participation in qualitative interviews and quantitative surveys. Recruitment approaches included using flyers and word of mouth, attending health fairs, and partnering with nonprofit community-based organizations (CBOs) to sponsor targeted recruitment events. Face-to-face contact with community residents and partnerships with CBOs were most effective in enrolling caregivers into the studies. Almost 70% of participants attended a recruitment event sponsored or supported by CBOs. The least effective recruitment strategy was the use of flyers, which resulted in only 7 completed interviews or questionnaires. Time and costs related to carrying out the research varied by study, where personal interviews cost more on a per-participant basis ($1,081) than the questionnaires ($298). However, almost the same amount of time was spent in the community for both studies.

Implications

Partnerships with CBOs were critical for reaching the target enrollment for our studies. The relationship between the University of California-Los Angeles (UCLA) Resource Center for Minority Aging Research/Center for Health Improvement for Minority Elderly and the Department of Aging provided the infrastructure for maintaining connections with academic-community partnerships. Nevertheless, building partnerships required time, effort, and resources for both researchers and local organizations.

Background

Although Medicare Part D improved drug benefits for many beneficiaries, its impact on the coverage of Medicare Advantage Part D (MAPD) enrollees depended on their pre-existing benefits and whether they had gap coverage under Part D.

Objective

To examine changes in prescription drug utilization and expenditures associated with drug benefit changes resulting from the implementation of Part D.

Patients

We studied 248,773 continuously enrolled MAPD patients in eight states. Patients whose insurance product or Census block could not be identified or who had atypical benefits, low-income subsidies or Medicaid coverage were excluded.

Main measures

The main outcomes were changes in prescription drug days supply and expenditures from 2005 to 2006 and 2005 to 2007.

Design

We linked Census data with 2005-7 MAPD claims, encounter, enrollment, and benefits data and estimated associations of the outcomes with changes in drug benefits, controlling for 2005 comorbidities, demographics, and Census population characteristics.

Key results

MAPD enrollees whose drug benefits became potentially less generous after Part D had the smallest increases in drug utilization and expenditures (e.g., drug expenditures increased by $130 between 2005 and 2006), while those who potentially gained the most from Part D experienced the largest increases ($302). The differences in benefit design changes had a stronger association with drug utilization and outcomes among patients at high risk of gap entry than among the entire sample.

Conclusions

Although Medicare Part D unambiguously improved drug coverage for many elderly, it led to heterogeneous changes in drug benefits among MAPD enrollees, who already had generic and sometimes branded drug benefits. After 2006, benefits were worse for individuals who had branded drug coverage in 2005 but now had a coverage gap, but benefits may have improved for individuals who acquired branded drug coverage. Commensurate with these differential changes in benefits following Part D, changes in drug utilization and expenditures varied substantially as well.

Abstract Background The National Institutes of Health has called for expansion of practice-based research to improve the clinical research enterprise. Methods This paper presents a model for the reorganization of clinical research to foster long-term participation by community clinicians. Based on the literature and interviews with clinicians and other stakeholders, we posited a model, conducted further interviews to test the viability of the model, and further adapted it. Results We propose a three-dimensional system of checks and balances to support community clinicians using research support organizations, community outreach, a web-based registry of clinicians and studies, web-based training services, quality audits, and a feedback mechanism for clinicians engaged in research. Conclusions The proposed model is designed to offer a systemic mechanism to address current barriers that prevent clinicians from participation in research. Transparent mechanisms to guarantee the safety of patients and the integrity of the research enterprise paired with efficiencies and economies of scale are maintained by centralizing some of the functions. Assigning other responsibilities to more local levels assures flexibility with respect to the size of the clinician networks and the changing needs of researchers.

Objective

To compare drug costs and adherence among Medicare beneficiaries with the standard Part D coverage gap versus supplemental gap coverage in 2006.

Data sources

Pharmacy data from Medicare Advantage Prescription Drug (MAPD) plans.

Study design

Parallel analyses comparing beneficiaries aged 65+ with diabetes in an integrated MAPD with a gap versus no gap (n=28,780); and in a network-model MAPD with a gap versus generic-only coverage during the gap (n=14,984).

Principal findings

Drug spending was 3 percent (95 percent confidence interval [CI]: 1-4 percent) and 4 percent (CI: 1-6 percent) lower among beneficiaries with a gap versus full or generic-only gap coverage, respectively. Out-of-pocket expenditures were 189 percent higher (CI: 185-193 percent) and adherence to three chronic drug classes was lower among those with a gap versus no gap (e.g., odds ratio=0.83, CI: 0.79-0.88, for oral diabetes drugs). Annual out-of-pocket spending was 14 percent higher (CI: 10-17 percent) for beneficiaries with a gap versus generic-only gap coverage, but levels of adherence were similar.

Conclusions

Among Medicare beneficiaries with diabetes, having the Part D coverage gap resulted in lower total drug costs, but higher out-of-pocket spending and worse adherence compared with having no gap. Having generic-only coverage during the gap appeared to confer limited benefits compared with having no gap coverage.

Abstract Background New National Institutes of Health policies call for expansion of practice-based research to improve the clinical research enterprise and facilitate dissemination of evidence-based medicine. Objective This paper describes organizational strategies that influence clinicians' decisions to participate in clinical research. Design We reviewed the literature and interviewed over 200 clinicians and stakeholders. Results The most common barriers to community clinician participation in clinical research relate to beliefs that clinical research is too burdensome and has little benefit for the participating clinician or patient. We identified a number of approaches healthcare organizations can use to encourage clinicians to participate in research, including an outreach campaign to promote the benefits of clinical research; selection of study topics of interest to clinicians; establishment and enforcement of a set of research principles valuing the clinician and patient; development of a transparent schedule of reimbursement for research tasks; provision of technological and technical assistance to practices as needed; and promotion of a sense of community among clinicians involved in practice-based research. Conclusions Many types of existing healthcare organizations could provide the technical and intellectual assistance community clinicians need to participate in clinical research. Multiple approaches are possible.

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. To examine comorbidities and demographic characteristics associated with gap entry and exit. 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. 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. 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 antipsychotic medications (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. 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.

Abstract Background Translating the extraordinary scientific and technological advances occurring in medical research laboratories into care for patients in communities throughout the country has been a major challenge. One contributing factor has been the relative absence of community practitioners from the US biomedical research enterprise. Identifying and addressing the barriers that prevent their participation in research should help bridge the gap between basic research and practice to improve quality of care for all Americans. Methods We interviewed over 200 clinicians and other healthcare stakeholders from 2004 through 2005 to develop a conceptual framework and set of strategies for engaging a stable cadre of community clinicians in a clinical research program. Results Lack of engagement of community practitioners, lack of necessary infrastructure, and the current misalignment of financial incentives and research participation emerged as the three primary barriers to community clinician research participation. Although every effort was made to learn key motivators for engagement in clinical research from interviewees, we did not observe their behavior and self-report by clinicians does not always track with their behavior. Conclusions A paradigm shift involving acknowledgement of the value of clinicians in the context of community research, establishment of a stable infrastructure to support a cohort of clinicians across time and research studies, and realignment of incentives to encourage participation in clinical research is required.

BACKGROUND:The specialist's role in caring for managed care patients is likely to grow. Thus, assessing the correlates of patient satisfaction with specialty care is essential. OBJECTIVE:To examine the association between characteristics of eye care practices and satisfaction with eye care among working age patients with open-angle glaucoma (OAG) or diabetic retinopathy (DR). SUBJECTS/STUDY SETTING: A total of 913 working age patients with OAG or DR enrolled in six commercial managed care health plans. The patients were treated in 144 different eye care practices. STUDY DESIGN:We used a patient survey to obtain information on patient characteristics and satisfaction with eye care, measured by scores on satisfaction subscales of the 18-item Patient Satisfaction Questionnaire. We used a survey of eye care practices to obtain information on practice characteristics, including provider specialties, practice organization, financial features, and utilization and quality management systems. We estimated logistic regression models to assess the association of patient and practice characteristics with high levels of patient satisfaction. PRINCIPAL FINDINGS:Treatment in a practice with a glaucoma specialist (for OAG patients) or a retina specialist (for DR patients) was associated with higher satisfaction, whereas treatment in a practice that obtained a high proportion of its revenues from capitation payments or in a group practice where providers obtained a high proportion of their incomes from bonuses was associated with lower satisfaction. CONCLUSIONS:Many eye care patients prefer to be treated by specialists with expertise in their conditions. Financial arrangement features of eye care practices also are associated with patient satisfaction with care. The most likely mechanisms underlying these associations are effects on provider behavior and satisfaction, which in turn influence patient satisfaction. Managed care plans and provider groups should aim to minimize the negative impact of managed care features on patient satisfaction.

Objective

To examine drug costs and entry and exit rates into the Part D coverage gap for beneficiaries with diabetes in Medicare Advantage managed care plans.

Study design

Cross-sectional observational study.

Methods

Study patients were Medicare Advantage Part D beneficiaries with diabetes from 2 large California health plans who were continuously enrolled in 2006 and had a drug coverage gap starting at $2250. Entry and exit into the gap, total drug costs, and out-of-pocket drug costs were determined using pharmacy databases.

Results

In 2006, 26% of the 42,801 beneficiaries with diabetes reached the coverage gap; 2% of beneficiaries exited the gap and qualified for catastrophic coverage. Beneficiaries incurred a mean of $2182 in total drug costs during 2006. Drug expenditures remained stable over the year for beneficiaries who did not enter the gap. For beneficiaries who entered the gap, total drug costs were higher overall and decreased at year's end as out-of-pocket expenses increased.

Conclusions

Fewer diabetes patients in this study entered the coverage gap than had been previously estimated, but the entry rate was much higher than that of the general Medicare Advantage Part D population. Patients entering the gap had lower subsequent monthly drug expenditures; this may be due to lower-than-expected drug prices and greater use of generics in managed care, or it may potentially signal poorer drug adherence. Future work should examine these hypotheses and explore risk factors for entering the Part D coverage gap.

Background

Little is known about drug cost communications of Medicare Part D beneficiaries with chronic conditions such as diabetes. The purpose of this study is to assess Medicare Part D beneficiaries with diabetes' levels of communication with physicians regarding prescription drug costs; the perceived importance of these communications; levels of prescription drug switching due to cost; and self-reported cost-related medication non-adherence.

Methods

Data were obtained from a cross-sectional survey (58% response rate) of 1,458 Medicare beneficiaries with diabetes who entered the coverage gap in 2006; adjusted percentages of patients with communication issues were obtained from multivariate regression analyses adjusting for patient demographics and clinical characteristics.

Results

Fewer than half of patients reported discussing the cost of medications with their physicians, while over 75% reported that such communications were important. Forty-eight percent reported their physician had switched to a less expensive medication due to costs. Minorities, females, and older adults had significantly lower levels of communication with their physicians regarding drug costs than white, male, and younger patients respectively. Patients with < $25 K annual household income were more likely than higher income patients to have talked about prescription drug costs with doctors, and to report cost-related non-adherence (27% vs. 17%, p < .001).

Conclusions

Medicare Part D beneficiaries with diabetes who entered the coverage gap have low levels of communication with physicians about drug costs, despite the high perceived importance of such communication. Understanding patient and plan-level characteristics differences in communication and use of cost-cutting strategies can inform interventions to help patients manage prescription drug costs.