The Effectiveness of Shared Decision-making for Diabetes Prevention: 24- and 36-Month Results From the Prediabetes Informed Decision and Education (PRIDE) Trial.

OBJECTIVE: We conducted a cluster-randomized, shared decision-making (SDM) trial offering lifestyle change, metformin, or both options, to adults at risk for diabetes in a primary care network (n = 20 practices). RESEARCH DESIGN AND METHODS: We used propensity score matching to identify control patients and used electronic health record data to compare weight loss at 24 and 36 months of follow-up and diabetes incidence at 36 months of follow-up. RESULTS: In adjusted post hoc analyses, SDM participants (n = 489) maintained modestly greater 24-month weight loss of -3.1 lb and 36-month weight loss of -2.7 lb versus controls (n = 1,430, both comparisons P < 0.001). SDM participants who chose both lifestyle change and metformin sustained weight loss at 36 months of -4.1 lb (P < 0.001 vs. controls). We found no differences in incident diabetes (15% of SDM participants, 14% of control participants; P = 0.64). CONCLUSIONS: This is one of the first studies to demonstrate weight loss maintenance up to 36 months after diabetes prevention SDM.

A randomized controlled trial of a shared decision making intervention for diabetes prevention for women with a history of gestational diabetes mellitus: The Gestational diabetes Risk Attenuation for New Diabetes (GRAND study).

BACKGROUND: Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Metformin and lifestyle change through a Diabetes Prevention Program (DPP) are equally effective in preventing diabetes in patients with a GDM history, so women can choose a strategy based on their preferences. This study aims to test whether shared decision making (SDM) can help women with a history of GDM increase adoption of evidence-based strategies and lose weight to lower their risk of incident diabetes in real-world settings. METHODS: This pragmatic randomized controlled trial (RCT) will test the effectiveness of SDM for diabetes prevention among 310 overweight/obese women with a history of GDM and prediabetes from two large health care systems (n = 155 from UCLA Health and n = 155 from Intermountain Healthcare). The primary outcome is the proportion of participants who lose ≥5% body weight at 12 months. Secondary outcomes include uptake of DPP and/or metformin and other patient-reported outcomes such as patient activation and health-related quality of life. Rates of GDM in a subsequent pregnancy will be an exploratory outcome. A descriptive analysis of costs related to SDM implementation will also be conducted. CONCLUSION: This is the first RCT to examine the effectiveness of SDM on weight loss, lifestyle change and/or metformin use, and other patient-reported outcomes in participants with a GDM history at risk of developing diabetes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03766256. Registered on 6 December 2018.

The Diabetes Health Plan and Healthcare Utilization Among Beneficiaries with Low Incomes.

BACKGROUND: The socioeconomic status (SES) gradient in hospital and emergency room utilization among adults with type 2 diabetes (T2DM) is partially driven by cost-related non-adherence. OBJECTIVE: To test the impact of the Diabetes Health Plan (DHP), a diabetes-specific health plan incorporating value-based insurance design principles on healthcare utilization among low-income adults with T2DM. DESIGN: To examine the impact of the DHP on healthcare utilization, we employed a difference-in-differences (DID) study design with a propensity-matched comparison group. We modeled count and dichotomous outcomes using Poisson and logit models, respectively. PARTICIPANTS: Cohort of adults (18-64) with T2DM, with an annual household income <$ 30,000, and who were continuously enrolled in an employer-sponsored UnitedHealthcare plan for at least 2 years between 2009 and 2014. INTERVENTIONS: The DHP reduces or eliminates out-of-pocket costs for disease management visits, diabetes-related medicines, and diabetes self-monitoring supplies. The DHP also provides access to diabetes-specific telephone case management as well as other online resources. MAIN MEASURES: Number of disease management visits (N = 1732), any emergency room utilization (N = 1758), and any hospitalization (N = 1733), within the year. KEY RESULTS: DID models predicting disease management visits suggested that DHP-exposed beneficiaries had 1.7 fewer in-person disease management visits per year (- 1.70 [95% CI: - 2.19, - 1.20], p < 0.001), on average, than comparison beneficiaries. Models for emergency room (0.00 [95% CI: - 0.06, 0.06], p = 0.966) and hospital utilization (- 0.03 [95% CI: - 0.08, - 0.01], p = 0.164) did not demonstrate statistically significant changes associated with DHP exposure. CONCLUSIONS: While no relationship between DHP exposure and high-cost utilization was observed in the short term, fewer in-person disease management visits were observed. Future studies are needed to determine the clinical implications of these findings.

Association of Type 2 Diabetes Risk Perception With Interest in Diabetes Prevention Strategies Among Women With a History of Gestational Diabetes.

Objectives: The aims of this study were to identify predictors of perception of type 2 diabetes risk in women with a history of gestational diabetes mellitus (GDM) and to determine factors associated with interest in evidence-based strategies for type 2 diabetes prevention. Research Design and Methods: We surveyed women with a history of GDM who had not progressed to type 2 diabetes from a large academic medical center. We used multivariate logistic regression to assess predictors of high levels of perception of type 2 diabetes risk. We also tested associations between risk perception and interest in a lifestyle change program and/or metformin therapy. Results: In our diverse sample of 264 women, 28% were unaware that GDM is a risk factor for incident type 2 diabetes after pregnancy, and 48% believed their personal risk of type 2 diabetes was low. In multivariate analyses, family history of diabetes (odds ratio [OR] 2.2, 95% CI 1.2-4.4) and knowledge of GDM as a risk factor for incident type 2 diabetes (OR 4.5, 95% CI 2.1-9.8) were significant predictors of greater perception of type 2 diabetes risk. Women with higher risk perception were more likely to express interest in a lifestyle change program compared with women with lower risk perception (OR 2.4, 95% CI 1.3-4.5). Conclusion: Although some women are aware that GDM is a risk factor for incident type 2 diabetes, many still perceive their own risk of developing type 2 diabetes as low. Higher risk perception predicted interest in an evidence-based diabetes prevention program, highlighting the importance of personalized risk assessment and communication about risk for women who have had GDM.

Does the diabetes health plan have a differential impact on medication adherence among beneficiaries with fewer financial resources?

BACKGROUND: The Diabetes Health Plan (DHP), a value-based insurance plan that reduces cost sharing, was previously shown to modestly increase employer-level medication adherence. It is unclear how the DHP might impact individuals with different incomes. OBJECTIVE: To examine the impact of the DHP on individual-level medication adherence, by income level. METHODS: This is a retrospective, quasiexperimental study. An employer-level propensity score match was done to identify suitable control employers, followed by individual-level propensity score weighing. These weights were applied to difference-in-difference models examining the effect of the DHP and the effect of income on changes in adherence to metformin, statins, and angiotensin-converting enzymes/angiotensin receptor blockers. The weights were then applied to a differences-in-differences-in-differences model to estimate the differential impact of DHP status on changes in adherence by income group. RESULTS: The study population included 2,065 beneficiaries with DHP and 17,704 matched controls. There were no significant differences in changes to adherence for any medications between beneficiaries enrolled in the DHP vs standard plans. However, adherence to all medications was higher among those with incomes greater than $75,000 (year 1: metformin: +7.3 percentage points; statin +4.3 percentage points; angiotensin-converting enzymes/angiotensin receptor blockers: +6.2 percentage points; P < 0.01) compared with those with incomes less than $50,000. The differences-in-differences-in-differences term examining the impact of income on the DHP effect was not significant for any comparisons. CONCLUSIONS: We did not find significant associations between the DHP and changes in individual-level medication adherence, even for low-income beneficiaries. New strategies to improve consumer engagement may be needed to translate value-based insurance designs into changes in patient behavior. DISCLOSURES: Drs Ettner and Moin received grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases (Principal Investigator: Carol Mangione). Mr Luchs received support for attending meetings and/or travel (minimal-mileage and hotel on 2 occasions). Mr Chan has an employee benefit to purchase stock for UnitedHealth Group.

The diabetes health plan and medication adherence among individuals with low incomes.

OBJECTIVE: To test the impact of the Diabetes Health Plan (DHP), a diabetes-specific insurance plan that lowers out-of-pocket costs for diabetes-related medications and clinical visits, on adherence to oral hypoglycemic medications among low-income adults with Type 2 Diabetes (T2DM). DATA SOURCES AND STUDY SETTING: Cohort of adults (18-64) with T2DM, an annual household income

Differences in Weight Loss by Race and Ethnicity in the PRIDE Trial: a Qualitative Analysis of Participant Perspectives.

BACKGROUND: Many Diabetes Prevention Program (DPP) translation efforts have been less effective for underresourced populations. In the cluster-randomized Prediabetes Informed Decision and Education (PRIDE) trial, which evaluated a shared decision-making (SDM) intervention for diabetes prevention, Hispanic and non-Hispanic Black participants lost less weight than non-Hispanic White participants at 12-month follow-up. OBJECTIVE: To explore perspectives about weight loss from PRIDE participants of different racial and ethnic groups. PARTICIPANTS: Sample of participants with prediabetes who were randomized to the PRIDE intervention arm (n=24). APPROACH: We conducted semi-structured interviews within three groups stratified by DPP participation and % weight loss at 12 months: (DPP+/WL+, enrolled in DPP and lost >5% weight; DPP+/WL-, enrolled in DPP and lost <3% weight; DPP-/WL-, did not enroll in DPP and lost <3% weight). Each group was further subdivided on race and ethnicity (non-Hispanic Black (NHB), non-Hispanic White (NHW), Hispanic). Interviews were conducted on Zoom and transcripts were coded and analyzed with Dedoose. KEY RESULTS: Compared to NHW participants, Hispanic and NHB participants more often endorsed weight loss barriers of limited time to make lifestyle changes due to long work and commute hours, inconvenient DPP class locations and offerings, and limited disposable income for extra weight loss activities. Conversely, facilitators of weight loss regardless of race and ethnicity included retirement or having flexible work schedules; being able to identify convenient DPP classes; having a strong, positive support system; and purchasing supplementary resources to support lifestyle change (e.g., gym memberships, one-on-one activity classes). CONCLUSIONS: We found that NHB and Hispanic SDM participants report certain barriers to weight loss more commonly than NHW participants, particularly barriers related to limited disposable income and/or time constraints. Our findings suggest that increased lifestyle change support and flexible program delivery options may be needed to ensure equity in DPP reach, participant engagement, and outcomes.

Educational Attainment, Decision-Making Preferences, and Interest in Evidence-Based Diabetes Prevention among Women with a History of Gestational Diabetes Mellitus.

Background: The Diabetes Prevention Program (DPP) showed that lifestyle change or metformin is equally efficacious in preventing diabetes in women who have had gestational diabetes mellitus (GDM). Few studies have investigated the relationship between education and willingness to engage in either intervention and between education and preferred decision-making style. Methods: Within a large health system, we surveyed insured women 18-64 years old with a history of GDM, identified through the electronic health record. We estimated preference for decision-making style and interest in DPP lifestyle change and/or metformin by educational level, using multivariate logistic regression models controlling for age, race, and ethnicity. Results: Our sample (n = 264) was 36% Latino, 29% Asian, 28% non-Latino white, and 5% African American, with a mean age of 37 years. In terms of education, 31% had a postgraduate degree, 41% were college graduates, and 29% did not graduate from college. In multivariate analyses, willingness to engage in either intervention did not vary by education. Women who did not graduate from college were more likely to leave medical decisions to their provider (p = 0.004) compared to women with a college or postgraduate degree. However, regardless of education, over 80% of women preferred to make medical decisions themselves or jointly with their provider. Conclusions: Most women prefer to play an active role in their own medical decisions and have an interest in both evidence-based diabetes prevention strategies. This suggests that shared decision-making is appropriate for many women with a history of GDM and different levels of educational attainment.

Choice of Intensive Lifestyle Change and/or Metformin after Shared Decision Making for Diabetes Prevention: Results from the Prediabetes Informed Decisions and Education (PRIDE) Study.

INTRODUCTION: While the Diabetes Prevention Program Study demonstrated that intensive lifestyle change and metformin both reduce type 2 diabetes incidence, there are little data on patient preferences in real-world, clinical settings. METHODS: The Prediabetes Informed Decisions and Education (PRIDE) study was a cluster-randomized trial of shared decision making (SDM) for diabetes prevention. In PRIDE, pharmacists engaged patients with prediabetes in SDM using a decision aid with information about both evidence-based options. We recorded which diabetes prevention option(s) participants chose after the SDM visit. We also evaluated logistic regression models examining predictors of choosing intensive lifestyle change ± metformin, compared to metformin or usual care, and predictors of choosing metformin ± intensive lifestyle change, compared to intensive lifestyle change or usual care. RESULTS: Among PRIDE participants (n = 515), 55% chose intensive lifestyle change, 8.5% chose metformin, 15% chose both options, and 21.6% declined both options. Women (odds ratio [OR] = 1.60, P = 0.023) had higher odds than men of choosing intensive lifestyle change. Patients >60 years old (OR = 0.50, P = 0.028) had lower odds than patients <50 years old of choosing metformin. Participants with higher body mass index (BMI) had higher odds of choosing intensive lifestyle change (OR = 1.07 per BMI unit increase, P = 0.005) v. other options and choosing metformin (OR = 1.06 per BMI unit increase, P = 0.008) v. other options. CONCLUSIONS: Patients with prediabetes are making choices for diabetes prevention that generally align with recommendations and expected benefits from the published literature. Our results are important for policy makers and clinicians, as well as program planners developing systemwide approaches for diabetes prevention.

Association of the Diabetes Health Plan with emergency room and inpatient hospital utilization: a Natural Experiment for Translation in Diabetes (NEXT-D) Study.

INTRODUCTION: To examine the association of a novel disease-specific health plan, known as the Diabetes Health Plan (DHP), with emergency room (ER) and hospital utilization among patients with diabetes and pre-diabetes. RESEARCH DESIGN AND METHODS: Quasi-experimental design, with employer group as the unit of analysis, comparing changes in any ER and inpatient hospital utilization over a 3-year period. Inverse probability weighting was used to control for differences between employers purchasing DHP versus standard plans. Estimated differences in utilization are calculated as average treatment effects on the treated. We used employees and dependents from employer groups contracting with a large, national private insurer between 2009 and 2012. Eligibility and claims data from continuously covered employees and dependents with diabetes and pre-diabetes (n=74 058) were aggregated to the employer level. The analysis included 9 DHP employers (n=7004) and 183 control employers (n=67 054). RESULTS: DHP purchase was associated with 2.4 and 1.8 percentage points absolute reduction in mean rates of any ER utilization, representing 13% and 10% relative reductions at 1 and 2 years post-DHP (p=0.012 and p=0.046, respectively). There was no significant association between DHP purchase and hospital utilization. CONCLUSION: Employers purchasing diabetes-specific health benefit designs may experience lower rates of resource-intensive services such as ER utilization.

Results from NEXT-D: the association of a pre-diabetes-specific health plan and rates of incident diabetes among a national sample of working-age adults.

BACKGROUND: Pre-diabetes affects one-third of adults in the USA and a subset will progress to type 2 diabetes. Our objective was to determine whether a disease-specific health plan, known as the Diabetes Health Plan (DHP), designed to improve care for persons with pre-diabetes and diabetes also led to lower rates of incident diabetes among adults with pre-diabetes. METHODS: We examined eligibility and claims data from a large payer who offered the DHP to a national sample of employers. We included adult employees and dependents who were continuously covered by the DHP over a 4-year study window. The primary outcome was incident diabetes. We conducted propensity score matching at the employer level to find comparable control employer groups offering standard plans. Using an adjusted logistic regression model at the individual level, we tested the association between DHP employer group status and incident diabetes diagnosis during the 3 years of postbaseline follow-up. FINDINGS: Our analysis included data from 11 965 continuously enrolled adults with pre-diabetes (n=1538 from nine employers offering DHP; n=10 427 from 105 control employers offering standard plans). DHP employees and covered dependents with pre-diabetes had an 8% lower absolute predicted probability of incident diabetes compared with individuals from employer groups offering standard benefit plans (29% predicted probability of incident diabetes for DHP vs 37% for controls, p<0.001). CONCLUSIONS: A pre-diabetes-specific health benefit design was associated with lower rates of incident diabetes and represents an area of needed future study.

Effectiveness of Shared Decision-making for Diabetes Prevention: 12-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial.

IMPORTANCE: Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences. OBJECTIVE: To test the effectiveness of a prediabetes SDM intervention. DESIGN: Cluster randomized controlled trial. SETTING: Twenty primary care clinics within a large regional health system. PARTICIPANTS: Overweight/obese adults with prediabetes (BMI ≥ 24 kg/m2 and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics. INTERVENTION: Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care. MAIN OUTCOMES AND MEASURES: Primary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months. RESULTS: Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p < .001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (- 5.3 vs. - 0.2, p < .001). LIMITATIONS: Absence of DPP supplier participation data for matched patients in usual care clinics. CONCLUSIONS AND RELEVANCE: A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk. TRIAL REGISTRATION: This study was registered at clinicaltrails.gov (NCT02384109)).

Diabetes Prevention Program attendance is associated with improved patient activation: Results from the Prediabetes Informed Decisions and Education (PRIDE) study.

The Diabetes Prevention Program (DPP) is a 12-month behavior change program designed to increase physical activity and improve dietary patterns among patients at risk for Type 2 diabetes, in order to facilitate modest weight loss and improve cardio-metabolic profiles. It is unknown whether baseline patient activation is related to increased DPP uptake, and whether DPP attendance leads to subsequent improvement in patient activation. We analyzed data from 352 adult participants in the Prediabetes Informed Decisions and Education (PRIDE) trial of shared decision-making (SDM) in diabetes prevention, collected from November 2015 through September 2017. PRIDE participants completed baseline and 4-month follow-up surveys, including the Altarum Consumer Engagement (ACE) Measure™ of patient activation. We tracked DPP attendance over 8 months using data from partnering DPP providers. In multivariate models, we measured whether self-reported baseline activation was associated with DPP "uptake" (1+ session attended) or DPP "attendance" (9+ sessions). We also examined whether DPP attendance was associated with change in activation at 4-months follow-up. We did not find an association between baseline activation and DPP uptake or attendance. However, we did find that DPP attendance was associated with an increase in the overall ACE score (6.68 points, 95% CI 1.97-11.39, p = 0.005) and increased activation in 2 of the 3 ACE subscales (Commitment and Informed Choice). Our finding of increased patient activation with DPP attendance suggests a mechanism for the improved health outcomes seen in DPP real-world translational studies. This work has important implications for diabetes prevention and other behavior change programs.

Adherence to Metformin, Statins, and ACE/ARBs Within the Diabetes Health Plan (DHP).

BACKGROUND: Reducing patient cost-sharing and engaging patients in disease management activities have been shown to increase uptake of evidence-based care. OBJECTIVE: To evaluate the effect of employer purchase of a disease-specific plan with reduced cost-sharing and disease management (the Diabetes Health Plan/DHP) on medication adherence among eligible employees and dependents. DESIGN: Employer-level "intent to treat" cohort study, including data from eligible employees and their dependents with diabetes, regardless of whether they were enrolled in the DHP. SETTING: Employers that contracted with a large national health plan administrator in 2009, 2010, and/or 2011. PARTICIPANTS: Ten employers that purchased the DHP and 191 employers that did not (controls). Inverse probability weighting (IPW) estimation was used to adjust for inter-group differences. INTERVENTION: The DHP includes free or low-cost medications and physician visits. Enrollment strategies and specific benefit designs are determined by the employer and vary in practice. DHP participants are notified up front that they must engage in their own health care (e.g., receiving diabetes-related screening) in order to remain enrolled. MAIN OUTCOME MEASURE: Mean employee adherence to metformin, statins, and ACE/ARBs at the employer level at one year post-DHP implementation, as measured by the proportion of days covered (PDC). RESULTS: Baseline adherence to the three medications was similar across DHP and control employers, ranging from 64 to 69 %. In the first year after DHP implementation, predicted employer-level adherence for metformin (+4.9 percentage points, p = 0.017), statins (+4.8, p = 0.019), and ACE/ARBs (+4.4, p = 0.02) was higher with DHP purchase. LIMITATIONS: Non-randomized, observational study. CONCLUSIONS: The Diabetes Health Plan, an innovative health plan that combines reduced cost-sharing and disease management with an up-front requirement of enrollee participation in his or her own health care, is associated with a modest improvement in medication adherence at 12 months.

Metformin prescription for insured adults with prediabetes from 2010 to 2012: a retrospective cohort study.

BACKGROUND: Prediabetes affects 1 in 3 Americans. Both intensive lifestyle intervention and metformin can prevent or delay progression to diabetes. Over the past decade, lifestyle interventions have been translated across various settings, but little is known about the translation of evidence surrounding metformin use. OBJECTIVE: To examine metformin prescription for diabetes prevention and patient characteristics that may affect metformin prescription. DESIGN: Retrospective cohort analysis over a 3-year period. SETTING: Employer groups that purchased health plans from the nation's largest private insurer. PARTICIPANTS: A national sample of 17 352 working-age adults with prediabetes insured for 3 continuous years between 2010 and 2012. MEASUREMENTS: Percentage of health plan enrollees with prediabetes who were prescribed metformin. RESULTS: Only 3.7% of patients with prediabetes were prescribed metformin over the 3-year study window. After adjustment for age, income, and education, the predicted probability of metformin prescription was almost 2 times higher among women and obese patients and more than 1.5 times higher among patients with 2 or more comorbid conditions. LIMITATION: Missing data on lifestyle interventions, possible misclassification of prediabetes and metformin use, and inability to define eligible patients exactly as defined in the American Diabetes Association guidelines. CONCLUSION: Evidence shows that metformin is rarely prescribed for diabetes prevention in working-age adults. Future studies are needed to understand potential barriers to wider adoption of this safe, tolerable, evidence-based, and cost-effective prediabetes therapy. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention (Division of Diabetes Translation) and the National Institute of Diabetes and Digestive and Kidney Diseases.

Patterns of prescription drug expenditures and medication adherence among medicare part D beneficiaries with and without the low-income supplement.

BACKGROUND: The association between the Medicare Part D low-income subsidy (LIS), gap coverage, and outcomes such as medical expenditures, prescription fills, and medication adherence is not well understood. The purpose of this study was to examine the relationship between the LIS and these measures for patients within a large, national Part D plan in the United States. METHODS: In this cross-sectional, retrospective analysis, we compared total and plan expenditures, out-of-pocket costs, and medication fills and adherence for three categories of Medicare beneficiaries: non-LIS beneficiaries without gap coverage (non-LIS/non-GC), non-LIS beneficiaries with gap coverage (non-LIS/GC), and LIS beneficiaries (LIS). RESULTS: LIS beneficiaries, relative to non-LIS/non-GC and non-LIS/GC beneficiaries, had higher total expenditures ($1,887 vs. $1,360 vs. $1,341); lower out-of-pocket costs ($148 vs. $546 vs. $570); more expenditures exceeding the gap threshold (27.6% vs. 18.4% vs. 16.9%); and slightly higher adherence to blood pressure (65.6% vs. 64.2% vs. 62.4%); diabetes (62.5% vs. 57.7 vs. 57.4%); and lipid-lowering (59.6% vs. 57.0 vs. 55.6%) medications. CONCLUSION: LIS beneficiaries had higher total expenditures, lower out-of-pocket costs, and modestly better adherence to diabetes medications than non-LIS/non-GC and non-LIS/GC beneficiaries.

Association of Medicare Part D low-income cost subsidy program enrollment with increased fill adherence to clopidogrel after coronary stent placement.

STUDY OBJECTIVE: To determine the association between enrollment in the Medicare Part D low-income subsidy (LIS) program, which reduces out-of-pocket medication costs, and fill adherence to the antiplatelet drug clopidogrel after coronary stent placement. DESIGN: Retrospective cohort study. DATA SOURCE: Pharmacy claims database of a large national Medicare Part D insurer. PATIENTS: We selected a total of 2967 beneficiaries of a national Medicare Part D plan who had a coronary stent placed between April and December 2006 and were prescribed clopidogrel but were not preexisting users of clopidogrel. Of these patients, 504 were enrolled in the LIS program and 2463 were not. MEASUREMENTS AND MAIN RESULTS: We defined LIS status as enrollment in the LIS program at any point during the 12 months after the procedure. We examined the association between LIS status and good medication fill adherence to clopidogrel, defined as proportion of days covered of 80% or more, or discontinuation of clopidogrel over the 12-month window starting from the date of their stent placement. We also identified patients with claims-based diagnoses of major bleeding events while taking clopidogrel. For those patients, we calculated fill adherence only for the period between medication initiation and the onset of major bleeding and/or did not classify them as having inappropriately discontinued the medication. We created a propensity score predicting the propensity of being eligible for the LIS benefit and used inverse propensity score weighting with regression adjustment to generate estimates of the effect parameters. LIS enrollment was associated with a higher predicted likelihood of good clopidogrel fill adherence after stent placement (54.8% for LIS enrollees vs 47.6% for non enrollees; p=0.008). No significant difference was noted between the two groups in predicted risk of discontinuing clopidogrel after stent placement (18.3% for LIS enrollees vs 21.0% for non enrollees; p=0.21). CONCLUSION: The LIS benefit was associated with better clopidogrel fill adherence after stent placement. Although clopidogrel is now available in generic form, our work underscores the need for efforts to identify and enroll patients in the LIS benefit who require costly antiplatelet medications for coronary heart disease.

Optimizing enrollment in employer health programs: a comparison of enrollment strategies in the Diabetes Health Plan.

BACKGROUND: Many health programs struggle with low enrollment rates. OBJECTIVES: To compare the characteristics of populations enrolled in a new health plan when employer groups implement voluntary versus automatic enrollment approaches. STUDY DESIGN: We analyzed enrollment rates resulting from 2 different strategies: voluntary and automatic enrollment. We used regression modeling to estimate the associations of patient characteristics with the probability of enrolling within each strategy. The subjects were 5014 eligible employees from 11 self-insured employers who had purchased the Diabetes Health Plan (DHP), which offers free or discounted copayments for diabetes related medications, testing supplies, and physician visits. Six employers used voluntary enrollment while 5 used automatic enrollment. The main outcome of interest was enrollment into the DHP. Predictors were gender, age, race/ethnicity, dependent status, household income, education level, number of comorbidities, and employer group. RESULTS: Overall, the proportion of eligible members who were enrolled within the automatic enrollment strategy was 91%, compared with 35% for voluntary enrollment. Income was a significant predictor for voluntary enrollment but not for automatic enrollment. Within automatic enrollment, covered dependents, Hispanics, and persons with 1 nondiabetes comorbidity were more likely to enroll than other subgroups. Employer group was also a significant correlate of enrollment. Notably, all demographic groups had higher DHP enrollment rates under automatic enrollment than under voluntary enrollment. CONCLUSIONS: For employer-based programs that struggle with low enrollment rates, especially among certain employee subgroups, an automatic enrollment strategy may not only increase the total number of enrollees but may also decrease some enrollment disparities.

Potential savings associated with drug substitution in Medicare Part D: the Translating Research into Action for Diabetes (TRIAD) study.

BACKGROUND: Drug substitution is a promising approach to reducing medication costs. OBJECTIVE: To calculate the potential savings in a Medicare Part D plan from generic or therapeutic substitution for commonly prescribed drugs. DESIGN: Cross-sectional, simulation analysis. PARTICIPANTS: Low-income subsidy (LIS) beneficiaries (n = 145,056) and non low-income subsidy (non-LIS) beneficiaries (n = 1,040,030) enrolled in a large, national Part D health insurer in 2007 and eligible for a possible substitution. MEASUREMENTS: Using administrative data from 2007, we identified claims filled for brand-name drugs for which a direct generic substitute was available. We also identified the 50 highest cost drugs separately for LIS and non-LIS beneficiaries, and reached consensus on which drugs had possible therapeutic substitutes (27 for LIS, 30 for non-LIS). For each possible substitution, we used average daily costs of the original and substitute drugs to calculate the potential out-of-pocket savings, health plan savings, and when applicable, savings for the government/LIS subsidy. RESULTS: Overall, 39 % of LIS beneficiaries and 51 % of non-LIS beneficiaries were eligible for a generic and/or therapeutic substitution. Generic substitutions resulted in an average annual savings of $160 in the case of LIS beneficiaries and $127 in the case of non-LIS beneficiaries. Therapeutic substitutions resulted in an average annual savings of $452 in the case of LIS beneficiaries and $389 in the case of non-LIS beneficiaries. CONCLUSIONS: Our findings indicate that drug substitution, particularly therapeutic substitution, could result in significant cost savings. There is a need for additional studies evaluating the acceptability of therapeutic substitution interventions within Medicare Part D.

Evaluation of the diabetes health plan to improve diabetes care and prevention.

Investigators from the University of California, Los Angeles (UCLA), and members of the leadership and data analysis teams at UnitedHealthcare (UHC) are partnering to evaluate the Diabetes Health Plan (DHP), an innovative disease-specific insurance product designed by UHC specifically for patients with prediabetes or diabetes. The DHP provides improved access to care management, telephone coaching, and enhanced Internet-based communication with enrollees. The evaluation will use a quasi-experimental design, comparing patients from employer groups that offer the DHP with patients from groups that do not, to determine the effect of the DHP on incidence of diabetes, adherence to metformin, and costs of care among patients with prediabetes. Other factors studied will be cardiovascular risk factor control, adherence to preventive services, health care use, and costs of care among patients with existing diabetes.