A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients with Uncontrolled Diabetes

University Of Michigan At Ann Arbor, Ann Arbor MI

Investigators

Abstract

dults with uncontrolled diabetes experience higher rates of diabetes-related morbidity and mortality than non-those with controlled diabetes. One primary reason for this health difference is their poor adherence to diabetes medicines. Not only do adults with uncontrolled diabetes suffer more from diabetes complications, but their medication adherence rates are lower as well. Also, these diabetes outcomes are strongly driven by social contributors to health such as food insecurity, and health misperceptions - negative beliefs about diabetes/medicines, that negatively impact the ability to manage diabetes including taking medicines. There is an immense need for effective diabetes self-management interventions that improve health outcomes for adults with uncontrolled diabetes and reduce differences in health outcomes. Our interdisciplinary team of experts in diabetes management interventions, medication adherence, multiphase optimization strategy trials, mixed methods, and cost-effectiveness analysis will partner with an established pharmacy chain, and community partners to conduct a randomized factorial mixed methods trial to optimize diabetes management in adults with uncontrolled diabetes. This partnership will lead to the identification of an effective and cost-effective diabetes management intervention that reduces medication nonadherence and improves glycemic control (HbA1c) for adults with uncontrolled diabetes by testing theory-driven intervention components/combination. This 6-month intervention will identify the intervention components/combination of components, i.e., (1) medication therapy management optimizing medication therapy, (2) community health workers addressing social contributors to diabetes self-management and addressing diabetes and medicine misperceptions, added to usual care, that are effective in improving diabetes outcomes (effectiveness optimization) and are cost-effective (cost-effectiveness optimization). The expanded Chronic Care Model and Leventhal’s Extended Common Sense Model will be used to explain the contextual factors that put adults with uncontrolled diabetes with greater risk factors for diabetes outcome differences, and psychosocial and behavioral mechanisms to be tested. A randomized factorial mixed methods trial will evaluate the main effect of each intervention component and the interactions between intervention components to determine the optimal combination of components, that will have a long-term effect on (1) HbA1c, (2) medication adherence (assessed using self-report and pharmacy refills), and (3) psychosocial mediators of these outcomes. Finally, using qualitative interviews, we will explore the acceptability of each intervention component/combination as well as the effective/cost-effective components through understanding participant experiences. This project addresses an unmet critical need to optimize effective and cost-effective diabetes self-management interventions for adults with uncontrolled diabetes beset by diabetes-related harms. Broader implementation of the most effective and cost-effective diabetes management intervention has a high potential to lower morbidity and mortality.