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。这种差异的主要原因之一是他们对糖尿病药物的依从性不佳。不仅黑色 与非西班牙裔白人相比，西班牙裔成年人患与不受控制的糖尿病有关的并发症， 但是他们的药物依从性率也较低。另外，这些糖尿病差异是由 卫生的社会决定者（SDOH）障碍，例如粮食不安全和健康误解 - 负面 相信糖尿病/药物会对黑人和西班牙裔糖尿病的能力产生负面影响 包括服药。仅需要有效的糖尿病，只是管理干预措施 改善黑人和西班牙裔成年人的健康状况，并减少差异。我们的跨学科团队 糖尿病管理干预措施，药物依从性，健康差异，多相的专家 优化策略试验，混合方法和成本效益分析将与已建立的 药房链和社区合作伙伴进行随机阶乘混合方法试验以优化 黑人和西班牙裔成年人患有不受控制的糖尿病的糖尿病管理。这种伙伴关系将导致 识别有效且具有成本效益的糖尿病管理干预措施，以减少药物 通过测试理论驱动 干预组件/组合。这六个月的干预将确定干预措施 组件/组件组合，即（1）药物治疗管理优化药物 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 糖尿病和医学误解，加入了通常的护理中，可有效改善糖尿病结局 （有效性优化）并且具有成本效益（成本效益优化）。扩大的慢性护理 模型和Leventhal的扩展常识模型将用于解释上下文因素 黑人和西班牙裔成年人面临更大的糖尿病差异风险，以及社会心理和行为机制 要测试。随机阶乘混合方法试验将评估每种干预的主要效果 组件和干预组件之间的相互作用，以确定最佳组合 组件，将对（1）HBA1C，（2）药物依从性产生长期影响（使用自我评估 报告和药房补充）和（3）这些结果的社会心理/社会文化介体。最后，使用 定性访谈，我们将探讨每个干预组件/组合的可接受性 通过了解参与者体验的有效/具有成本效益的组件。该项目解决 未满足的迫切需求，优化有效且具有成本效益的糖尿病，仅对黑色进行管理干预措施 西班牙裔成年人历来受到与糖尿病有关的危害的困扰。最有效的更广泛的实施 并且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高潜力。