Long-term Impact of Reduced Patient Out-of-pocket Costs on Diabetes Complications

减少患者自付费用对糖尿病并发症的长期影响

• 批准号: 10096588
• 负责人: James Franklin Wharam
• 金额: $ 44.96万
• 依托单位: HARVARD PILGRIM HEALTH CARE, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2025-09-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10096588
• 关键词: Long; term; Impact; Reduced; Patient

PROJECT SUMMARY/ABSTRACT This project seeks to determine whether 3 natural experiments that reduce out-of-pocket costs for diabetes patients improve acute and chronic diabetes complications over the longer term. These natural experiments include: (1) employer adoption of preventive drug lists (PDLs) that make diabetes-related medications $0, (2) state legislation capping patient out-of-pocket costs for insulin, and (3) employer transitions from high- deductible health plans (HDHPs) with substantial financial barriers for most services to generous low- deductible plans. Results could provide evidence about actionable interventions at multiple levels that improve the health of diabetes patients. Studies will leverage a large, national health insurance claims database from 2007-2023 that the research team has refined under previous projects. The Specific Aims of the project are to: 1. Assess 15-year national trends in (a) diabetes complications and (b) uptake of federal, state, and employer natural experiments of interest. Analyses will assess 2009-2023 trends in acute preventable and chronic microvascular and macrovascular complications, including stratification by key subgroups of interest. Measures related to natural experiment uptake will comprise annual PDL adoption, state-level insulin cost trends, and HDHP to low-deductible plan switches. These analyses will use a longitudinal, calendar time series design with joinpoints, adjusted for changing demographics, socio-economic status, and co-morbidity. 2. Determine if reducing drug out-of-pocket costs improves diabetes complications. Over 4 follow-up years, Aim 2a will examine whether employer switches from health savings account (HSA)-HDHPs with high drug out-of-pocket costs to PDL HSA-HDHPs with $0 preventive drugs reduce acute and chronic diabetes complications. Aim 2b will assess these outcomes before and after approximately 10 US states limit insulin cost sharing. Analyses will use a highly rigorous interrupted time series with control series study design and Aim 2a will also apply a segmented survival with control group design. 3. Determine if reducing outpatient and emergency department out-of-pocket costs improves diabetes complications. Analyses will assess if switching from HDHPs with high cost sharing for outpatient and emergency department care to generous low-deductible plans reduces the risk of acute and chronic diabetes complications over 4 follow-up years. This aim will also use rigorous controlled interrupted time series and segmented survival designs. 4. Examine the long-term impact of reduced out-of-pocket costs on key diabetes subgroups including low-income and high-morbidity members. Aim 4 will involve stratifying Aims 2 and 3 analyses by characteristics such as income, morbidity, race/ethnicity, and diabetes severity. This aim will use the same study designs as for Aims 2 and 3 but stratified by the factors of interest.

项目概要/摘要 该项目旨在确定 3 个自然实验是否可以降低糖尿病的自付费用 从长远来看，患者可以改善急性和慢性糖尿病并发症。这些自然实验 包括：(1) 雇主采用预防药物清单 (PDL)，使糖尿病相关药物的费用为 0 美元，(2) 州立法限制患者自付费用的胰岛素，以及 (3) 雇主从高成本转型 可扣除的健康计划（HDHP）对大多数服务都存在巨大的财务障碍，以提供慷慨的低额服务 免赔额计划。结果可以提供有关多个层面上可采取行动的干预措施的证据，以改善 糖尿病患者的健康。研究将利用一个大型的全国健康保险索赔数据库 2007-2023年，研究团队根据之前的项目进行了完善。该项目的具体目标是： 1. 评估 15 年全国趋势：(a) 糖尿病并发症和 (b) 联邦、州和 雇主自然感兴趣的实验。分析将评估 2009-2023 年急性可预防和 慢性微血管和大血管并发症，包括按感兴趣的关键亚组进行分层。 与自然实验采用相关的措施将包括年度 PDL 采用、州级胰岛素成本 趋势，以及 HDHP 向低免赔额计划转换。这些分析将使用纵向日历时间序列 具有连接点的设计，根据不断变化的人口统计、社会经济地位和合并症进行调整。 2. 确定减少药物自付费用是否可以改善糖尿病并发症。超过4次跟进 年，目标 2a 将检查雇主是否从健康储蓄账户 (HSA)-HDHP 中转为高收入账户 PDL HSA-HDHP 的药物自付费用为 0 美元，预防药物可减少急性和慢性糖尿病 并发症。目标 2b 将评估美国大约 10 个州限制胰岛素之前和之后的这些结果 成本分摊。分析将使用高度严格的中断时间序列以及控制序列研究设计和 目标 2a 还将应用分段生存和对照组设计。 3. 确定减少门诊和急诊科自付费用是否可以改善糖尿病 并发症。分析将评估是否从 HDHP 转换为门诊患者和患者分担高成本 急诊科护理和慷慨的低免赔额计划可降低急性和慢性糖尿病的风险 随访 4 年出现并发症。该目标还将使用严格控制的中断时间序列和 分段生存设计。 4. 检查自付费用减少对关键糖尿病亚组的长期影响，包括 低收入和高发病率的成员。目标 4 将涉及对目标 2 和 3 进行分层分析 收入、发病率、种族/民族和糖尿病严重程度等特征。这个目标将使用相同的 研究设计与目标 2 和 3 相同，但按感兴趣的因素进行分层。