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

加强对糖尿病未受控制的黑人和西班牙裔患者的糖尿病管理干预的多阶段优化策略

• 批准号: 10716904
• 负责人: Olayinka Shiyanbola
• 金额: $ 65.51万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-05 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10716904
• 关键词: Address; Adherence; Adult; Behavioral Mechanisms; Belief; Black Populations; Black race; Cessation of life; Communities; Community Health Aides; Complement; Complications of Diabetes Mellitus; Cost Effectiveness Analysis; Diabetes Mellitus; Disparity; Education; Effectiveness; Ethnic Population; Glycosylated hemoglobin A; Goals; Health; Hispanic; Hispanic Populations; Intervention; Interview; Long-Term Effects; Maintenance; Mediation; Mediator; Medication Management; Medicine; Methods; Modeling; Morbidity - disease rate; Not Hispanic or Latino; Outcome; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Public Health; Qualitative Methods; Randomized; Risk; Self Management; Social support; Stress; Testing; Translations; Work; adherence rate; chronic care model; contextual factors; cost effective; cost effective intervention; cost effective treatment; cost effectiveness; design; diabetes management; diabetes risk; diabetes self-management; disparity reduction; effective intervention; empowerment; experience; experimental study; food insecurity; glycemic control; health disparity; improved; innovation; intervention participants; medication compliance; medication nonadherence; mortality; multiphase optimization strategy; negative affect; optimal treatments; peer; peer support; primary outcome; psychosocial; racial population; secondary outcome; social culture; social health determinants; theories; treatment as usual; treatment optimization

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.

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 白人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差。不仅黑 西班牙裔成年人比非西班牙裔白人遭受更多与不受控制的糖尿病相关的并发症， 但他们的药物依从率也较低。此外，这些糖尿病差异是由以下因素强烈驱动的： 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 包括吃药。因此，迫切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 糖尿病管理干预专家，药物依从性，健康差异，多阶段 优化战略试验、混合方法和成本效益分析将与一个既定的 连锁药店和社区合作伙伴进行随机析因混合方法试验，以优化 糖尿病不受控制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 确定一种有效和具有成本效益的糖尿病管理干预措施， 通过测试理论驱动， 干预成分/组合。这6个月的干预将确定干预措施 组件/组件的组合，即，(1)药物治疗管理优化用药 治疗，（2）社区卫生工作者解决SDOH障碍，糖尿病自我管理和解决 糖尿病和药物误解，加上常规护理，有效地改善糖尿病的结果 （效率优化）和成本效益（成本效益优化）。扩大的慢性病护理 模型和Leventhal的扩展常识模型将被用来解释上下文因素， 黑人和西班牙裔成年人患糖尿病的风险更大差异，以及心理社会和行为机制 接受测试一项随机析因混合方法试验将评估每种干预措施的主要效果 组件和干预组件之间的相互作用，以确定最佳组合 成分，将对（1）HbA 1c，（2）药物依从性（使用自我评估） 报告和药房补充），和（3）这些结果的心理社会/社会文化调解人。最后利用 定性访谈，我们将探讨每个干预成分/组合的可接受性，以及 通过了解参与者的经验，确定有效/具有成本效益的组成部分。该项目涉及 一个未满足的关键需求，以优化有效和具有成本效益的糖尿病自我管理干预措施，为黑人 西班牙裔成年人在历史上一直受到糖尿病相关危害的困扰。更广泛地执行最有效的 具有成本效益的糖尿病管理干预措施具有降低发病率和死亡率的巨大潜力。