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: 10368003
• 负责人: Amit Khera
• 金额: $ 41.21万
• 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 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10368003
• 关键词: Address; Affect; Age; Blood; Blood Donations; Blood donor; Caring; Charge; Cholesterol; Clinic; Clinical Trials; Communities; Community Physician; Complement; Consolidated Framework for Implementation Research; Coronary Arteriosclerosis; Country; Data; Databases; Development; Diagnosis; Disease; Familial Hypercholesterolemia; Family member; Feedback; General Population; Guidelines; Home; Human Resources; Individual; Interview; LDL Cholesterol Lipoproteins; Life; Lipids; Medical; Methods; Mission; Notification; Patients; Persons; Pharmaceutical Preparations; Phase; Phenotype; Pilot Projects; Population; Prevalence; Process; Public Health; Randomized; Reporting; Research; Risk; Services; Structure; System; Testing; Texas; Time; United States; Work; arm; base; blood treatment; diagnostic criteria; disorder risk; effectiveness evaluation; effectiveness implementation trial; effectiveness outcome; evidence base; heart disease prevention; implementation evaluation; implementation outcomes; implementation science; implementation strategy; improved; innovation; medical specialties; meetings; multi-component intervention; novel; novel strategies; patient registry; primary outcome; programs; randomized trial; screening; theories

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.

项目摘要 在美国，家族性高胆固醇血症（FH）的诊断不足和治疗程度不足。最近的 PI的工作表明能够在类似的患病率下以FH识别献血者 预期在普通人群中。这项混合方法研究的总体目标是应用 实施策略以改善FH对献血者的治疗。中心假设是 献血系统可以是增加FH患者接受治疗的有效门户。这 中央假设将通过追求四个具体目标来检验：1）确定障碍和促进者以接收 （低密度脂蛋白胆固醇）用FH的献血者中的LDL-C治疗，以告知实施 战略制定，2）制定和生产实施策略捆绑包以增加LDL-C治疗 在具有FH的献血者中，3）进行2型实施效应试验，以降低LDL-C 基于社区的血液捐赠中心，4）使用混合方法评估实施捆绑包。 这项研究将由实施科学研究的合并框架（CFIR）指导， 并将使用实施映射（理论和证据的过程）来开发，实施和 评估这些治疗增强策略。在第一个目标中，半结构化访谈将用于引起 主要利益相关者的他汀类药物治疗的障碍和促进者，包括：a）FH的献血者b）家庭 捐助者的成员c）献血人员d）社区医生。利益相关者的反馈将是 迭代整合以在第二个目标中制定，制作和完善实施策略捆绑 这将在AIM 3中进行测试。第三个目标是由FH的血液捐献者进行两臂随机试验 比较a）通常通知高胆固醇或b）AIM 2的实施策略捆绑 LDL-C水平从基线到6个月的变化差异的主要结果。第四个目标 评估实施策略捆绑的可接受性，适当性和可行性，并将告知 开发在其他献血者中心实施FH计划的传播方案。这 在我们看来，在本应用程序中提出的研究具有创新性，因为它结合了献血者 程序，一种全新的识别和治疗FH的方法。这个新颖的增强FH处理的门户 涉及年轻人，他们不太可能寻求定期医疗保健并补充传统 专注于医疗家庭患者的策略。最终，如果成功的话，该计划已告知 实施科学方法可以迅速扩展到全国涉及6.4的献血中心 每年有百万捐助者，对FH护理中的差距有直接影响。