Louisiana Experiment to Address Diabetes: Zero-Dollar Copayment (LEAD-ZDC) for Improving Disease Management

摘要 在美国，2型糖尿病(T2 DM)仍然是一个主要的公共卫生问题，特别是在 路易斯安那州由于贫困，糖尿病、并发症和心血管疾病(CVD)的死亡率很高 糖尿病管理。药物治疗不依从性在糖尿病管理中普遍存在，且成本高昂 与费用相关的不遵守药物治疗(CRN)必须作为社会 健康的决定因素。我们建议路易斯安那州自然实验中心(LNEC)包括 学术/研究机构、付款人、社区非营利组织和社区/患者合作伙伴， 和卫生系统，以改善对糖尿病的护理，减少风险因素和并发症。LNEC将是 由卫生研究行动网络(REACHnet)的基础设施加强。LNEC的路易斯安那州 应对糖尿病的实验：零美元共同支付(Lead-ZDC)项目将审查这项政策 ZDC降低部分药物(抗糖尿病药物、抗高血压药物和 他汀类药物)在患有T2 DM的路易斯安那州蓝十字和蓝盾(BCBSLA)全保险成员中。这个 假设ZDC计划将改善服药依从性，并最终改善健康 结果。总体目标是研究ZDC如何降低CRN、总体用药不依从性、健康 护理利用和糖尿病并发症。这三个具体目标将根据REACH进行评估， 有效性、采用、实施和维护(RE-AIM)框架。第一个目标是评估 ZDC计划的健康影响如何改善主要有效性衡量标准：用药依从性 有ZDC的抗糖尿病药物名单和多项次级疗效措施，如全面用药 坚持服用危险因素药物(抗高血压药物和他汀类药物)，糖尿病控制， 并发症、卫生保健利用和患者报告的结果。第二个目标是评估 与路易斯安那州ZDC计划相关的障碍(如种族/民族和城乡差距)和促进者。 第三个目标是从卫生系统和社会两方面评估ZDC方案的成本效益 使用建模技术的透视图。患者和利益相关者的参与将作为 Lead-ZDC项目的基石，该项目将探索患者、提供者、卫生系统和 社区层面，告知患者、让患者参与和增强患者能力，并与T2 DM患者合作并支持他们 实现更好的健康结果。拟议的研究将产生关于有效、实用、 以及消除健康差距和减少糖尿病相关疾病负担的可持续计划。这个 研究结果将有助于(1)患者更好地获得所需药物，以及(2)提供者和付款人 提高了对如何解决遵守障碍的理解，以便他们可以更好地与 使患者能够负担得起药物治疗并改善糖尿病预后。进一步传播和扩大 这些努力将为美国更多样化的医疗体系和支付者创造巨额回报。

Abstract Type 2 diabetes mellitus (T2DM) remains a major public health concern in the United States, especially in Louisiana where mortality from diabetes complications and cardiovascular disease (CVD) is high due to poor diabetes management. Medication treatment non-adherence is prevalent and costly in diabetes management where Cost-Related Non-adherence (CRN) with medication therapies has to be addressed as part of the social determinants of health. We propose a Louisiana Natural Experiment Center (LNEC) that includes academic/research institutions, payers, community non-profit organizations and community/patient partners, and health systems to improve care for diabetes and reduce risk factors and complications. The LNEC will be enhanced by the infrastructure of Research Action for Health Network (REACHnet). The LNEC's Louisiana Experiment to Address Diabetes: Zero-Dollar Copayment (LEAD-ZDC) project will examine the policy intervention of lowering out-of-pocket cost by ZDC for select medications (antidiabetics, antihypertensives, and statins) among fully insured Blue Cross and Blue Shield of Louisiana (BCBSLA) members with T2DM. The hypothesis is that the ZDC program will improve medication adherence and ultimately improve health outcomes. The overall goal is to study how ZDC may reduce CRN, overall medication non-adherence, health care utilization, and diabetes complications. The three specific aims will be evaluated according to the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework. The first aim is to evaluate how health impacts of the ZDC program improve the primary effectiveness measure: medication adherence with ZDC list of antidiabetics and multiple secondary effectiveness measures such as overall medication adherence, adherence with medications for risk factors (antihypertensives and statins), diabetes control, complications, health care utilization, and patient-reported outcomes. The second aim is to evaluate the barriers (e.g. racial/ethnic and rural/urban disparities) and facilitators related to the ZDC program in Louisiana. The third aim is to estimate the cost-effectiveness of the ZDC program from health system and social perspectives using modelling techniques. Patient and stakeholder engagement will be implemented as a cornerstone of the LEAD-ZDC project, which will explore the barriers at patient, provider, health system, and community levels, to inform, engage and empower patients, and to partner with and support T2DM patients to achieve better health outcomes. The proposed study will generate urgently needed data on effective, practical, and sustainable programs for eliminating health disparities and reducing diabetes-related disease burden. The study findings will assist (1) patients with better access to needed medications, and (2) providers and payers with improved understanding of how to address barriers to adherence so that they may better work with patients to make medications affordable and improve diabetes outcomes. Further dissemination and scale-up efforts will create large returns for more diverse health systems and payers in the United States.