Leveraging behavioral economics to equitably implement cascade screening in individuals with familial hypercholesterolemia in partnership with the FH Foundation

与 FH 基金会合作，利用行为经济学对家族性高胆固醇血症患者公平地实施级联筛查

• 批准号: 10367999
• 负责人: Rinad Sary Beidas
• 金额: $ 39.22万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10367999
• 关键词: Address; African American; African American population; American; Asian population; Atherosclerosis; Authorization documentation; Biological; Black American; Black race; Cardiac; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical Trials; Consolidated Framework for Implementation Research; Country; Diabetes Mellitus; Diagnosis; Early identification; Effectiveness; Ethnic Origin; Event; Evidence based practice; Familial Hypercholesterolemia; Family member; Foundations; Future; Gender; Genetic Diseases; Genomics; Health system; Hybrids; Hypertension; Incidence; Income; Individual; Inherited; International; Interview; LDL Cholesterol Lipoproteins; Lipids; Low income; Measures; Mediating; Medical; Medicine; Methods; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Notification; Other Genetics; Patients; Persons; Phase; Pilot Projects; Plant Roots; Play; Population; Populations at Risk; Public Health; Race; Randomized Controlled Trials; Research; Risk; Testing; Text Messaging; Time; Trust; Woman; Work; advocacy organizations; arm; behavioral economics; cardiovascular risk factor; cost; cost effective; design; effectiveness-implementation RCT; ethnic minority; evidence based guidelines; experience; follow-up; health equity; implementation barriers; implementation efforts; implementation science; implementation strategy; improved; indexing; information gathering; men; outreach; pilot test; premature; proband; racial and ethnic; screening; screening program; secondary endpoint; treatment as usual; uptake; willingness

The proposed project leverages our longstanding partnership with the Familial Hypercholesterolemia (FH) Foundation, a nonprofit research and advocacy organization, to refine and test two promising approaches to implement cascade screening in individuals with FH. Despite evidence-based guidelines for FH diagnosis and treatment, over 1 million Americans with this inherited condition remain undiagnosed, and substantial disparities exist with regard to racial/ethnic minorities (Black and African American people, Asian people) and gender (women). Cascade screening is an evidence-based practice of contacting and screening first-degree biological relatives of FH probands and improves timely FH diagnosis and reduces morbidity cost-effectively. Cascade screening programs have been successful in other countries where health systems play a key role in notification of relatives, but major implementation challenges limit uptake in the U.S. Pilot projects have identified barriers including regulatory constraints limiting health system outreach and difficulty contacting family members outside a given health system. In the U.S., cascade screening must involve the proband given regulatory constraints. Applying advances in behavioral economics has great potential to improve implementation of cascade screening via proband-mediated strategies. Led by MPIs with expertise in implementation science (Beidas), behavioral economics (Volpp), and FH (Rader), we will co-design, pilot, and test two patient-facing implementation strategies to increase reach of cascade screening with 300 probands within Penn Medicine. Our randomized controlled trial will test (a) a health system-mediated strategy using automated text messages, (b) a FH Foundation-mediated strategy using a navigator, and (c) the “usual care” approach to cascade screening. Both active strategies will be informed by behavioral economics. In the R61 phase, we will co-design health system- and FH Foundation-mediated implementation strategies using behavioral economics in partnership with the FH Foundation and key stakeholders from diverse backgrounds (Aim 1) and then pilot our strategies with 20 FH probands to ascertain feasibility, acceptability, and appropriateness (Aim 2). In the R33 phase, we will conduct a 3-arm hybrid Type 3 effectiveness-implementation RCT, and compare the effect of health system-mediated, FH Foundation-mediated, and usual care approaches on reach (proportion of probands who have at least one family member who completes screening), number of family members screened, number of family members diagnosed with FH, and proband LDL-C levels (Aim 1). We will use mixed methods to identify implementation strategy mechanisms focusing on health equity by oversampling populations that experience disparities (Aim 2). By testing sustainable and scalable implementation approaches, our study results will be poised to guide future wide-scale implementation of cascade screening for FH and other genetic conditions within and outside large health systems while also answering important questions related to equitable implementation. Successful strategies can be taken to scale nationally to save lives, in keeping with NHLBI Strategic Objective 6.

拟议的项目利用了我们与家族性高胆固醇血症 (FH) 的长期合作关系 基金会是一个非营利性研究和倡导组织，旨在完善和测试两种有前途的方法 尽管有基于证据的 FH 诊断和指南，但仍对 FH 患者实施级联筛查。 治疗方面，超过 100 万患有这种遗传性疾病的美国人仍未得到诊断，并且存在巨大差异 存在关于种族/族裔少数群体（黑人和非裔美国人、亚洲人）和性别的问题 （女性）级联筛查是一种接触和筛查一级生物学的循证实践。 FH 先证者的亲属，提高及时 FH 诊断并经济有效地降低发病率。 筛查计划在卫生系统在通知中发挥关键作用的其他国家取得了成功 亲属，但实施方面面临的重大挑战限制了美国的采用 试点项目已发现障碍 包括限制卫生系统外展的监管限制以及与外界联系家庭成员的困难 在美国，鉴于监管限制，级联筛查必须涉及先证者。 应用行为经济学的进步具有改善级联筛选实施的巨大潜力 通过先证者介导的策略，由具有实施科学（Beidas）、行为方面专业知识的 MPI 领导。 经济学 (Volpp) 和 FH (Rader)，我们将共同设计、试点和测试两个面向患者的实施 扩大 Penn Medicine 内 300 名先证者的级联筛查范围的策略。 对照试验将测试 (a) 使用自动短信的卫生系统介导的策略，(b) FH 使用导航器的基金会介导策略，以及（c）级联筛查的“常规护理”方法。 在 R61 阶段，我们将共同设计卫生系统，以制定积极的策略。 与 FH 基金会合作，利用行为经济学制定实施策略 基金会和来自不同背景的主要利益相关者（目标 1），然后与 20 个 FH 一起试点我们的战略 先证者确定可行性、可接受性和适当性（目标 2）。 一项 3 组混合型 3 型有效性实施随机对照试验，并比较卫生系统介导的效果， FH 基金会介导的常规护理方法（先证者中至少拥有一项护理的比例） 完成筛查的家庭成员）、筛查的家庭成员人数、家庭成员人数 诊断为 FH 和先证者 LDL-C 水平（目标 1）我们将使用混合方法来确定实施情况。 通过对经历差异的人群进行过采样来关注健康公平的战略机制（目标 2）。 通过测试可持续和可扩展的实施方法，我们的研究结果将指导未来 广泛实施针对 FH 和大范围内外其他遗传状况的级联筛查 卫生系统，同时还回答与公平实施相关的重要问题。 根据 NHLBI 战略目标 6，可以在全国范围内采取战略来拯救生命。