Paradigm for Treatment Intensification of Type 2 Diabetes in ... - JMCP

RESEARCH

“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 Nella Bieszk, PharmD; Shannon L. Reynolds, MSPH; Wenhui Wei, PhD, MS, MBA; Cralen Davis, MS; Pravin Kamble, RPh, MS, PhD; and Claudia Uribe, MD, MHA, PhD

ABSTRACT 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 diabetesrelated 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).

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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. J Manag Care Spec Pharm. 2016;22(9):1028-38 Copyright © 2016, Academy of Managed Care Pharmacy. All rights reserved.

What is already known about this subject • A low proportion of patients with type 2 diabetes (T2D) experience care that aligns with the American Diabetes Association (ADA) position statement regarding glycated hemoglobin (A1c) testing frequency; the average patient has an A1c level > 7.0% for approximately 10 years and > 8.0% for approximately 5 years before insulin initiation. • Positive effects on diabetes-related outcomes have been reported from studies that evaluated interventions aimed at improving diabetes management delivered in the form of educational mail-outs that targeted patients and physicians. • The majority of intervention studies used a preversus postintervention comparison without the inclusion of control groups.

What this study adds • This randomized controlled study showed that, compared with standard care, an educational intervention program such as “Act on Threes” did not result in a significant difference in treatment intensification with insulin and glycemic control in high-risk patients with T2D, despite an increase in A1c testing frequency in both cohorts during the study period. • An intervention that would increase awareness among physicians and patients of the long-term outcomes of an A1c level > 8.0% and delayed insulin initiation may be better able to help overcome clinical inertia and promote insulin initiation in alignment with the current ADA recommendations.

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“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

What this study adds (continued) • The lack of effect of the Act on Threes educational intervention challenges the validity of other studies of educational interventions that have shown significant changes in diabetes-related outcomes based on a pre- to postintervention design without the use of appropriate control groups.

O

ptimal glycemic control is critical in order to reduce the risk of diabetes-related morbidity and complications, as well as to reduce medical costs and health care utilization. However, optimal management of patients with type 2 diabetes (T2D) is a significant clinical challenge for any general practitioner or specialist physician.1,2 Despite extensive research demonstrating the clinical benefits of glycemic control—and, notably, the benefits of early insulin initiation3,4 —at least 60% of U.S. patients with T2D enrolled in commercial or Medicaid health maintenance organization plans who are appropriate candidates for stringent glycated hemoglobin (A1c) goals fail to attain the American Diabetes Association (ADA) recommended A1c goal of 7.0% or less.1,5,6 Even considering the recent emphasis of the ADA on patient-centered care and the appropriateness of less stringent A1c targets such as in older patients with comorbidities, an estimated 54.5% of Medicaid patients, 41.1% of patients on a commercial insurance plan, and 34.5% of Medicare patients fail to achieve an A1c goal of 8.0% or less.5,6 For patients with good glycemic control and who meet treatment goals, A1c testing is recommended twice a year, with quarterly testing for those not at goal and whose therapy has changed.7 Yet, in a large U.S. cohort of adult patients with T2D, just 7% were adherent for 1 year to ADA guidelines for A1c testing frequency, and therapy was modified in accordance with guidelines in just 39%.8 Another study indicated that from T2D diagnosis, the average patient spent approximately 10 years with an A1c level > 7.0% and approximately 5 years with an A1c level > 8.0% before initiating insulin.9 Patient and physician concerns, particularly in relation to insulin initiation, contribute to delays in treatment intensification in patients with T2D10; this clinical inertia may put patients at risk of diabetes-related complications.1,2 Managed care organizations and the pharmaceutical industry invest heavily in physician- and patient-targeted educational outreach programs to overcome clinical inertia and patients’ reluctance to initiate insulin, but little is currently known about the impact of such programs. Positive results from studies that have evaluated preversus postintervention outcomes of educational initiatives that targeted patients and physicians via mail-outs have encouraged similar interventions in managed care. However, these studies did not employ a randomized controlled study design to evaluate

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the impact on outcomes in those exposed versus those not exposed to the interventions.11,12 The objective of the “Act on Threes” educational intervention was to align patients with T2D and their physicians with the 2012 ADA position statement on T2D management5 and to assess 3 vital aspects of A1c control: the timely measurement of A1c levels every 3 months; timely treatment intensification to meet A1c goals, with treatment intensified every 3 months if A1c is not at goal; and insulin initiation when appropriate, including in patients already receiving ≥ 3 oral antidiabetes drugs (OADs) with A1c not at goal. Unlike previous studies, the Act on Threes intervention used a rigorous, randomized design with the objective of evaluating the impact of the educational intervention on A1c testing frequency and insulin initiation in patients with T2D who had not received A1c testing or had suboptimal control of their A1c (≥ 8.0%) according to the 2012 ADA position statement.5 The secondary objective was to identify factors that predict insulin initiation in patients with T2D enrolled in the study. ■■  Methods Study Design This was a 12-month, prospective, randomized, and interventional study of adult patients with T2D that evaluated the effects of the Act on Threes educational intervention on A1c testing frequency and insulin initiation through the analysis of administrative claims data from the Humana database. Humana is a for-profit health insurance company with more than 13 million U.S.-based customers. Following retrospective identification of patients with high-risk status using medical, pharmacy, laboratory, and enrollment indices of A1c screening frequency; number of noninsulin antihyperglycemic medications; and/or A1c test results as per ADA criteria for A1c testing frequency and antidiabetic treatment modifications8 (identification period May 1, 2011-April 30, 2013), patients were randomized 3:1 to receive either the Act on Threes educational intervention in conjunction with standard care (intervention group) or standard care alone (control group; Figure 1). Controls were eligible only if the treating physician was a different physician from that of any intervention patient. The full study period included a 12-month pre-intervention (baseline) period and a 12-month postintervention (follow-up) period, with the index date being the date of the most recent diagnosis of T2D during the identification period. Patients and Physicians High-risk Medicare Advantage with prescription drug coverage (MAPD) members were eligible if they were aged 18-85 years with ≥ 1 inpatient or 2 physician visits dated ≥ 30 days apart with a primary or secondary diagnosis of T2D using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes 250.x0 or 250.x2. Patients were

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FIGURE 1

Patient Selection and Cohort Attrition in Humana MAPD Dataset MAPD members aged 18-85 years with diabetes diagnosis N = 194,663

Continuously enrolled with medical and pharmacy benefits for 12 months before most recent diabetes diagnosis N = 153,725

Selection Indicator 1 T2D patients with no A1c evaluations in the 12 months before most recent T2D diagnosis N = 5,730

Selection Indicator 2 T2D patients concurrently on ≥ 3 noninsulin antihyperglycemic agents without insulin in 12 months before most recent T2D diagnosis but no evidence of A1c test N = 203

Selection Indicator 3 T2D patients with ≥ 1 A1c value recorded that occurred ≥ 6 months before most recent T2D diagnosis at value of ≥ 8% and are not having A1c evaluations every 3 months as recommended N = 802

Selection Indicator 4 T2D patients on ≥ 3 noninsulin antihyperglycemic agents and have ≥ 1 A1c value ≥ 8% in 12 months before most recent T2D diagnosis and are potential candidates for insulin N = 2,168

Selection Indicator 5 T2D patients with A1c ≥ 8% in 12 months before most recent T2D diagnosis with no subsequent changes in therapy over course of 3 A1c measures regardless of current therapy N = 256

Patients selected using indicators 1-5 N = 9,159 Patients excluded because of Humana market review N = 939 Number of patients randomized to intervention and control groups N = 8,220 Excluded postinterventiona N = 747 Excluded: patients not continuously enrolled with medical and pharmacy benefits 12 months pre- and postintervention N = 951 Excluded: patients with insulin use between index and intervention N = 279 Final cohort N = 6,243

Intervention group N = 4,555

Control group N = 1,688

a Ineligible

or unreachable based on provider feedback and returned mailings. A1c = glycated hemoglobin; MAPD = Medicare Advantage Plan D; T2D = type 2 diabetes.

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TABLE 1

Patient Demographic and Baseline Clinical Characteristics

Intervention Patients Control Patients Standardized Characteristic N = 4,555 N = 1,688 P Value Difference Age, years, mean [SD] 70.3 [8.3] 70.7 [8.2] 0.062 0.053 Female, n (%) 2,002 (44.0) 716 (42.4) 0.277 0.031 Race, n (%) 0.826 White 3,580 (78.6) 1,325 (78.5) 0.002 Black 717 (15.7) 275 (16.3) 0.015 Hispanic 107 (2.4) 34 (2.0) 0.023 Other 151 (3.3) 54 (3.2) 0.007 Low-income subsidy, n (%) 893 (19.6) 334 (19.8) 0.872 0.005 MAPD plan type, n (%) 0.790 Standard (HMO) 2,084 (45.8) 764 (45.3) 0.010 Enhanced (PPO) 1,948 (42.8) 737 (43.7) 0.018 Complete (FFS) 523 (11.5) 187 (11.1) 0.013 A1c, mean [SD], % 8.66 [1.5] 8.53 [1.4] 0.043 0.098 A1c category, n (%) 0.537