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

黑人和西班牙裔成年人的糖尿病相关发病率和死亡率高于非西班牙裔成年人 白色的。造成这种差异的一个主要原因是他们对糖尿病药物的依从性很差。不仅布莱克 与非西班牙裔白人相比，西班牙裔成年人更容易患上与无法控制的糖尿病相关的并发症， 但他们的服药依从率也较低。此外，这些糖尿病差异的强烈驱动因素是 健康的社会决定因素(SDOH)障碍，如粮食不安全和健康误解-负面 对糖尿病/药物的信念，对黑人和西班牙裔管理糖尿病的能力产生负面影响 包括服药。非常需要有效的糖尿病自我管理干预措施， 改善黑人和西班牙裔成年人的健康状况，缩小差距。我们的跨学科团队 糖尿病管理干预、用药依从性、健康差异、多阶段的专家 优化策略试验、混合方法和成本效益分析将与已建立的 药房连锁，与社区合作伙伴进行随机析因混合方法试验，以优化 未控制糖尿病的黑人和西班牙裔成年人的糖尿病管理。这一伙伴关系将导致 确定可减少用药的有效且经济实惠的糖尿病管理干预措施 通过测试理论驱动的测试，黑人和西班牙裔成年人的不依从性和改善血糖控制(HbA1c) 干预组件/组合。这项为期6个月的干预将确定干预措施 组件/组件组合，即(1)优化用药治疗管理 治疗，(2)社区卫生工作者解决糖尿病自我管理和解决的SDOH障碍 糖尿病和药物误解，加上常规护理，对改善糖尿病预后有效 (效益优化)，并具有成本效益(成本效益优化)。扩大的慢性护理 模型和莱文塔尔的扩展常识模型将被用来解释语境因素 黑人和西班牙裔成年人患糖尿病的风险更大，以及心理社会和行为机制 接受测试。随机析因混合方法试验将评估每个干预措施的主要效果 组件和干预组件之间的相互作用来确定最佳组合 对(1)糖化血红蛋白(HbA1c)、(2)服药依从性(使用自我评估)产生长期影响的成分 报告和药房补充)，以及(3)这些结果的心理社会/社会文化中介。最后，使用 定性访谈，我们将探索每个干预组件/组合的可接受性以及 通过了解参与者的体验来实现有效/经济高效的组成部分。本项目致力于 未得到满足的迫切需要，以优化有效和成本效益高的糖尿病自我管理干预措施 而西班牙裔成年人历来受到糖尿病相关伤害的困扰。更广泛地实施最有效的 成本效益高的糖尿病管理干预措施在降低发病率和死亡率方面具有很大潜力。

Black and Hispanic adults experience higher rates of diabetes-related morbidity and mortality than non-Hispanic whites. One primary reason for this disparity is their poor adherence to diabetes medicines. Not only do Black and Hispanic adults suffer more from complications related to uncontrolled diabetes than non-Hispanic whites, but their medication adherence rates are lower as well. Also, these diabetes disparities are strongly driven by social determinants of health (SDOH) barriers such as food insecurity, and health misperceptions - negative beliefs about diabetes/medicines, that negatively impact Blacks and Hispanics ability to manage diabetes including taking medicines. There is an immense need for effective diabetes self-management interventions that improve health outcomes for Black and Hispanic adults and reduce disparities. Our interdisciplinary team of experts in diabetes management interventions, medication adherence, health disparities, 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 Black and Hispanic 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 Black and Hispanic adults 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 SDOH barriers 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 Black and Hispanic adults at a greater risk for diabetes disparities, 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/sociocultural 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 Black and Hispanic adults historically 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.