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，一个非营利性的研究和宣传组织，以完善和测试两个有前途的方法， 在FH患者中实施级联筛查。尽管有FH诊断的循证指南， 治疗，超过100万患有这种遗传性疾病的美国人仍然没有被诊断出来， 种族/族裔少数群体（黑人和非裔美国人、亚洲人）和性别 （妇女）。级联筛查是一种循证实践， FH先证者的亲属，提高及时FH诊断和降低发病率成本效益。级联 在卫生系统在通报方面发挥关键作用的其他国家，筛查项目也取得了成功 亲属，但主要的实施挑战限制了美国的吸收。 包括限制卫生系统外展的监管限制以及难以与外界家庭成员联系 一个特定的卫生系统。在美国，级联筛选必须涉及先证者给定的监管约束。 应用行为经济学的进展有很大的潜力，以改善级联筛选的实施 通过先证者介导的策略。由具有实施科学专业知识的MPI（Beidas）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 策略，以增加在宾夕法尼亚大学医学300先证者的级联筛选的覆盖范围。我们的随机 一项对照试验将测试（a）使用自动短信的卫生系统介导策略，（B）FH 使用导航仪的基础介导策略，以及（c）级联筛查的“常规护理”方法。两 积极的战略将由行为经济学提供信息。在R61阶段，我们将共同设计卫生系统- 与FH合作，使用行为经济学，以FH基金会为中介的实施战略 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 先证者以确定可行性、可接受性和适当性（目标2）。在R33阶段，我们将进行 一项3臂混合型3型有效性-实施RCT，并比较卫生系统介导， FH基金会介导的和常见的护理方法（至少有一种 完成筛选的家庭成员）、筛选的家庭成员数量、家庭成员数量 诊断为FH和先证者LDL-C水平（目的1）。我们将使用混合方法来确定实施情况 通过对存在差异的人口进行过度抽样，建立注重卫生公平的战略机制（目标2）。 通过测试可持续和可扩展的实施方法，我们的研究结果将有望指导未来 大规模实施级联筛查FH和其他遗传性疾病的内外大 同时也回答与公平执行有关的重要问题。成功 可以根据NHLBI战略目标6，在全国范围内采取战略来拯救生命。