Personalized Care and the Role of Insulin as a Vehicle to Optimizing Treatments in Diabetes Care.

BACKGROUND: In patients with type 2 diabetes (T2D) with poor glycemic control, there is an unmet need for treatment optimization involving the initiation and/or intensification of insulin therapy, which is often delayed because of clinical inertia. Educational initiatives that target patients and physicians might be one way to address this need. OBJECTIVE: To evaluate the effectiveness of educational materials mailed to physicians and their patients in affecting initiation of insulin therapy and other health care outcomes. METHODS: This study, named PIVOTs (Personalized care and the role of Insulin as a Vehicle to Optimizing Treatments), used integrated medical and pharmacy claims data from the U.S.-based HealthCore Integrated Research Database between January 1, 2006, and April 4, 2014, to identify patients who were potential candidates for insulin therapy. Eligible patients were aged 18-75 years, currently enrolled in a commercial or Medicare Advantage health plan, with T2D diagnosis codes. Patients selected for insulin treatment education had glycated hemoglobin A1c (A1c) > 10%, irrespective of the number of noninsulin antihyperglycemic drugs used, or A1c > 8.0% and ≤ 10% while receiving ≥ 2 noninsulin antihyperglycemic drugs. For each identified patient, a corresponding treating physician was identified on a hierarchical basis. Physician-level randomization was conducted to assign physicians and their linked patients to the following 4 cohorts: (1) a cross-sectional cohort in which educational materials were sent to patients and physicians on a single outreach date; (2) a longitudinal cohort in which educational materials were sent to patients and physicians on 2 occasions, 3 months apart; (3) an enhanced cohort in which patients and physicians received the same mailings as the longitudinal cohort, plus physicians were invited to attend a 1:1 video conference academic detailing session; and (4) a control cohort in which patients and physicians did not receive any educational materials. Insulin initiation rates, A1c levels, and medical and pharmacy costs were assessed from claims over 6 and 12 months follow-up within each cohort. RESULTS: Mean insulin initiation rates at 12 months ranged from 9.2%-10.3% (all patients) to 12.3%-14.9% (subset with baseline A1c ≥ 9.0%), with similar rates across the intervention and control cohorts. Reductions in A1c from baseline were also similar across cohorts for all patients (0.1%-0.6%), as well as for those with a baseline A1c ≥ 9.0% (0.9%-1.6%). Approximately 14%-20% of patients achieved A1c < 7.0%, with no differences across cohorts. Changes in mean total all-cause and diabetes-related health care costs were also similar across cohorts. CONCLUSIONS: The findings of this real-world, randomized intervention call into question the value of educational mailings as a means to overcoming clinical inertia and improving health outcomes in patients with T2D, at least in the context of insulin initiation. DISCLOSURES: This study was funded by Sanofi US. Bieszk and Wei are employees of Sanofi US. Grabner, Barron, and Quimbo are employees of HealthCore, which was under contract with Sanofi US for the conduct of this study. Yan is an employee of PHAR, LLC and was employed by HealthCore at the time this study was conducted and completed. Biel is an employee of Anthem. Chu is a consultant for Sanofi US; a member of the lecture bureaus for AstraZeneca, Eli Lilly, and Sanofi US; and has received research funding from Novo Nordisk. Study concept and design were contributed by Bieszk, Grabner, Wei, Quimbo, and Barron. Yan, Barron, Quimbo, and Grabner collected the data, which were interpreted by Biel, Chu, Bieszk, and Wei, with assistance from the other authors. The manuscript was written by Bieszk, with assistance from the other authors, and revised by Bieszk, Grabner, Biel, and Chu, along with the other authors. Part of this work was presented in poster format at the 76th Scientific Sessions of the American Diabetes Association; June 10-14, 2016; New Orleans, Louisiana.

The SWEET SPOTS study: a real-world interpretation of the 2012 American Diabetes Association Position Statement regarding individualized A1C targets.

OBJECTIVE: To evaluate awareness of the 2012 American Diabetes Association (ADA) Position Statement among physicians and assess its effects on patient-centered glycated hemoglobin (A1C) goals in the management of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: The Summarizing Real-World Individualized TrEatmEnT GoalS and Potential SuppOrT Systems in Type 2 Diabetes (SWEET SPOTS) study used the HealthCore claims database to identify T2D patients, stratified by risk, and their treating physicians to assess primary care physician and endocrinologist awareness of the 2012 ADA Position Statement. Physicians completed online surveys on A1C targets before and after receiving an educational intervention to review the position statement. RESULTS: Of 125 responding physicians (mean age 50.3 years, 12.8% endocrinologists) who were linked to 125 patient profiles (mean age 56.9 years, 42% female, mean A1C 7.2%), 92% were at least somewhat aware of the position statement prior to the intervention and 59% believed that the statement would impact how they set A1C targets. The educational intervention resulted in mostly less stringent goal setting for both lower and higher risk patients, but changes were not significant. The proportion of physician-assigned A1C targets within ADA-recommended ranges increased from 56% to 66% post-intervention (P<0.0001). CONCLUSION: Physicians treating T2D are aware of the 2012 ADA Position Statement and believe that it may influence treatment goals. While patient-specific A1C targets were not significantly impacted, physicians indicated that they would make targets more or less stringent for lower and higher risk patients, respectively, across their practice. Further research into optimizing physician education regarding individualized A1C targets is warranted.

Are patients on basal insulin attaining glycemic targets? Characteristics and goal achievement of patients with type 2 diabetes mellitus treated with basal insulin and physician-perceived barriers to achieving glycemic targets.

AIMS: To investigate treatment patterns and achievement of glycemic targets in patients with type 2 diabetes mellitus treated with basal insulin in a real-world setting, and to determine physicians' beliefs and practices regarding these patients. METHODS: This study had two components; a retrospective analysis using a US claims database of patient and treatment data, and a survey of physicians' beliefs and practices. RESULTS: A total of 39,074 patients treated with basal insulin were included in this analysis. The proportion of patients achieving HbA1c<7.0% (53mmol/mol) was similar in ongoing basal insulin users at baseline (26%) and at 3months follow-up (27%). The number of new initiators achieving HbA1c<7.0% (53mmol/mol) increased from baseline (11%) to 3months (27%). In the physician survey component, the majority of physicians indicated they would continue to increase basal insulin dose as long as was needed to reach HbA1c/fasting blood glucose goals (85% of physicians treating 'not on-goal' patients, 78% of physicians treating 'on-goal' patients). Physician-perceived barriers to insulin intensification included patient's lifestyle, non-adherence, and concerns about out-of-pocket costs. CONCLUSIONS: A large proportion of patients on insulin-based therapy fail to reach glycemic goals. More education of clinicians may improve insulin intensification rates and increase the proportion of patients reaching glycemic targets.

"Act on Threes" Paradigm for Treatment Intensification of Type 2 Diabetes in Managed Care: Results of a Randomized Controlled Study with an Educational Intervention Targeting Improved Glycemic Control.

BACKGROUND: Clinical inertia, which has been defined as the recognition of a problem with a patient's management but failing to act, is a concern in type 2 diabetes (T2D) because it places the patient at risk of diabetes-related complications. Despite managed care organizations making significant investment in this area, little is known about the impact of educational programs aimed at aligning patients and their physicians with diabetes guidelines and thus overcoming clinical inertia. OBJECTIVE: To assess the impact of an educational intervention specifically designed to align patients and their physicians with 2012 American Diabetes Association (ADA) guidelines on glycated hemoglobin (A1c) testing frequency and insulin initiation. METHODS: The "Act on Threes" educational intervention was a 12-month, randomized controlled prospective study that included Medicare Advantage patients aged 18-85 years with T2D, who received ≥ 3 oral antidiabetes drugs (OADs) and/or had A1c not at goal and/or had no recent A1c evaluation over 12 months, as identified through the analysis of administrative claims data (May 1, 2011-April 30, 2013) from the Humana database. Identified patients were randomized 3:1 to receive the Act on Threes educational intervention in conjunction with standard care (intervention group) or standard care alone (control group). For the educational intervention, patients and physicians were simultaneously mailed general and targeted information aimed at aligning them to 3 vital aspects of A1c control: timely measurement of A1c every 3 months; timely treatment intensification to meet A1c goals with treatment intensification every 3 months if A1c is not at goal; and insulin initiation when appropriate, including patients receiving ≥ 3 OADs with A1c not at goal. Control patients were only enrolled if the treating physician was not involved in the care of any patients in the intervention group. The primary outcome measures were A1c testing frequency based on the ADA standard for compliance of ≥ 2 tests per year and insulin initiation in the 12-month postintervention period. A1c levels were evaluated for the subgroup of patients with available A1c measurements in the pre- and postintervention periods. Descriptive statistics were used to analyze differences between the intervention and control groups. Multiple logistic regression analysis was used to identify determinants of insulin initiation in the full study cohort. RESULTS: 6,243 patients (mean age 70 years; 43.5% female) were identified: 4,555 were randomized to the intervention group and 1,688 to the control group. The percentage of patients with ≥ 2 A1c tests per year was not significantly different postintervention for patients in the intervention and control groups (47.7% vs. 46.8%, respectively; P = 0.995). Intriguingly, the frequency of A1c testing increased significantly from pre- to postintervention in the intervention and control groups. Change in A1c level from pre- to postintervention was also similar for the 2 groups (P = 0.240). A similar percentage of patients in the intervention and control groups initiated insulin during the postintervention period (6.3% vs. 7.6%, respectively; P = 0.059). CONCLUSIONS: This randomized controlled study demonstrated that, compared with standard care, the Act on Threes educational intervention combined with standard care did not result in any significant differences in the frequency of A1c testing or in the initiation of insulin in patients with T2D. These findings are in contrast to uncontrolled comparative studies showing significant improvements in outcomes postintervention and reinforce the importance of study design in evaluating the effectiveness of educational programs. DISCLOSURES: This study was funded by Sanofi U.S. Reynolds, Davis, Kamble, and Uribe are employees of Comprehensive Health Insights, which was contracted by Sanofi U.S. to conduct, publish, and present this study. Bieszk and Wei are employees of Sanofi U.S. Reynolds and Uribe provided expertise and key clinical insights for the study design and methodology, provided interpretations of the data, contributed to the discussion, and reviewed the manuscript. Bieszk and Wei codeveloped the study design, researched data, contributed to discussion, and reviewed the manuscript. Davis and Kamble collected the data, provided study design, clinical insights, statistical and analytic reflections of the data, drafted the study reports, and reviewed the manuscript. All authors had full access to all the data in the study. Reynolds is the guarantor of this work and, as such, takes responsibility for the integrity of the data and the accuracy of the data analysis. ACKNOWLEDGMENTS: Writing/editorial support in the preparation of this manuscript, which was funded by Sanofi U.S., was provided by Rosalie Gadiot, PhD, of Excerpta Medica, who wrote the initial draft of the manuscript.

Detection of medication nonadherence through review of pharmacy claims data.

The utility of pharmacy claims data in detecting improper medication use, medication changes, and formulary adherence was assessed. Pharmacists provided six months of pharmacy claims data to primary care physicians for patients on the day of their scheduled clinic appointments. Similar data, not supplied to physicians, were generated for a matched population of patients on the day of their scheduled clinic appointments. A blinded pharmacist abstracter reviewed dictated office notes for both control and treatment groups. Medication adherence and medication changes were assessed by the abstracter as well as the difference in total medication costs for each of the groups before and after the pharmacy claims data were supplied. Surveys were distributed to physicians to determine whether pharmaceutical care was improved by the pharmacy claims data. In the treatment group, physicians detected medication nonadherence in 30.5% of their patients, while the abstracter noted nonadherence in 58.1% of patients. Physicians failed to detect any nonadherence in the control group, but the abstractor detected nonadherence in 57.1% of these patients. Changes in medication regimens occurred more often in the treatment group (p < 0.001). The mean percentage of patients switched to formulary agents significantly differed between the treatment and control groups (27.7% versus 0.0%, respectively) (p < 0.001). There were no differences in median drug costs for either group before or after the pharmacy claims data were provided. Provision of pharmacy claims data to physicians helped them detect medication nonadherence, evaluate therapeutic duplication or omissions, increase formulary use, and reduce the time required to obtain an accurate medication history.

Clotrimazole/betamethasone diproprionate: a review of costs and complications in the treatment of common cutaneous fungal infections.

The use of antifungal/corticosteroid combinations as topical therapy for dermatophytoses has been criticized as being less effective, more expensive, and the cause of more adverse cutaneous reactions than antifungal monotherapy. The combination of clotrimazole and betamethasone diproprionate (Lotrisone) is a mix of an azole antifungal and a high-potency corticosteroid, and is one of the most widely prescribed of these combinations. Our objective was to describe the beneficial and deleterious effects of Lotrisone in the treatment of common cutaneous fungal infections and its relative cost-effectiveness. We did a literature review documenting clinical trial data and adverse reactions to Lotrisone and collected a cost analysis of topical antifungal prescribing data over a 2-month period from a large midwestern staff-model health maintenance organization (HMO). Lotrisone is approved by the U.S. Food and Drug Administration (FDA) for the treatment of tinea pedis, tinea cruris, and tinea corporis in adults and children more than 12 years of age. Treatment is limited to 2 weeks in the groin area and 4 weeks on the feet. The most concerning adverse effects of Lotrisone were reported in children and included treatment failure, striae distensae, hirsuitism, and growth retardation. This combination was also reported to have decreased efficacy in clearing candidal and Trichophyton infections as compared to single-agent antifungals. Lotrisone was considerably more expensive than clotrimazole alone and was found to account for more than 50% of topical antifungal expenditures as prescribed by primary care physicians, but only 7% of topical antifungals prescribed by dermatologists. We found that Lotrisone was shown to have the potential to induce many steroid-related side effects and to be less cost effective than antifungal monotherapy. This combination should be used judiciously in the treatment of cutaneous fungal infections and may not be appropriate for use in children.