IMPLEMENTING MULTICOMPONENT INTERVENTIONS TO TREAT BLOOD DONORS WITH FAMILIAL HYPERCHOLESTEROLEMIA

实施多成分干预措施治疗患有家族性高胆固醇血症的献血者

• 批准号: 10584870
• 负责人: Amit Khera
• 金额: $ 54.41万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 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 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10584870
• 关键词: IMPLEMENTING; MULTICOMPONENT; INTERVENTIONS; TREAT; BLOOD

PROJECT SUMMARY Familial Hypercholesterolemia (FH) remains woefully underdiagnosed and undertreated in the US. Recent work from the PI demonstrated the ability to identify blood donors with FH at a similar prevalence as would be expected in the general population. The overall objective in this mixed methods study is to apply implementation strategies to improve treatment of blood donors with FH. The central hypothesis is that the blood donation system can be an effective portal to increase receipt of treatment for individuals with FH. The central hypothesis will be tested by pursuing four specific aims: 1) identify barriers and facilitators to receipt of (low-density lipoprotein cholesterol) LDL-C treatment in blood donors with FH to inform implementation strategy development, 2) develop and produce an implementation strategy bundle to increase LDL-C treatment in blood donors with FH, 3) conduct a Type 2 implementation-effectiveness trial for LDL-C lowering in a community-based blood donation center, and 4) evaluate the implementation bundle using mixed methods. This research will be guided by the Consolidated Framework for Implementation Science Research (CFIR), and will use Implementation Mapping, a theory- and evidence-based process, to develop, implement, and evaluate these treatment enhancing strategies. In the first aim, semi-structured interviews will be used to elicit barriers and facilitators of statin treatment from key stakeholders including: a) blood donors with FH b) family members of donors c) blood donation personnel d) community physicians. Stakeholder feedback will be iteratively integrated to develop, produce, and refine an implementation strategies bundle in the second aim, that will be tested in Aim 3. The third aim consists of a two-arm randomized trial among blood donors with FH comparing a) usual notification of high cholesterol or b) the implementation strategies bundle from Aim 2 with the primary outcome of difference in change in LDL-C levels from baseline to 6 months. The fourth aim will assess the acceptability, appropriateness, and feasibility of the implementation strategy bundle and will inform development of a dissemination package to implement an FH program in other blood donor centers. The research proposed in this application is innovative, in our opinion, because it incorporates the blood donor program, an entirely new approach to identifying and treating FH. This novel portal of enhancing FH treatment involves younger individuals who are less likely to seek regular medical care and complements traditional strategies focusing on patients with medical homes. Ultimately, if successful, this program, informed by implementation science methods, can be rapidly scaled to blood donation centers nationally involving 6.4 million donors annually, having an immediate impact on gaps in FH care.

项目总结 可悲的是，在美国，家族性高胆固醇血症(FH)仍未得到充分诊断和治疗。近期 PI的工作表明，有能力识别患有FH的献血者，其患病率与 在普通人群中是可以预期的。这项混合方法研究的总体目标是应用 实施战略，以改善FH献血者的治疗。中心假设是 献血系统可以成为增加FH患者接受治疗的有效途径。这个 将通过追求四个具体目标来检验中心假设：1)确定接受 (低密度脂蛋白胆固醇)低密度脂蛋白-C治疗FH献血员的实施情况 战略制定，2)制定和制作实施战略捆绑包，以增加低密度脂蛋白-C治疗 在患有FH的献血者中，3)进行一项降低低密度脂蛋白-C的第二类实施有效性试验 以社区为基础的献血中心，以及4)采用混合方法对实施包进行评估。 这项研究将由实施科学研究综合框架(CFIR)指导， 并将使用实施映射，这是一个基于理论和证据的过程，以开发、实施和 评估这些强化治疗的策略。在第一个目标中，将使用半结构化访谈来引出 来自主要利益攸关方的他汀类药物治疗的障碍和促进者包括：a)有FH的献血者b)家庭 献血者成员c)献血人员d)社区医生。利益相关者的反馈将是 迭代集成以开发、产生和改进第二个目标中的实施策略捆绑， 这将在第三个目标中进行测试。第三个目标是在患有FH的献血者中进行一项双臂随机试验 将a)通常的高胆固醇通知或b)目标2的实施战略捆绑与 从基线到6个月低密度脂蛋白胆固醇水平变化的主要结果。第四个目标将是 评估实施战略捆绑包的可接受性、适当性和可行性，并将 开发传播一揽子计划，以便在其他献血中心实施FH计划。这个 在我们看来，这项申请中提出的研究是创新的，因为它纳入了献血者 计划，一种识别和治疗FH的全新方法。加强FH治疗的新途径 涉及较年轻的人，他们不太可能寻求定期医疗护理，并补充传统的 以拥有医疗院的患者为重点的策略。最终，如果成功，该计划将由 实施科学方法，可迅速推广到全国献血中心，涉及6.4 每年有数以百万计的捐赠者，对妇幼保健方面的差距产生直接影响。