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 家族性高胆固醇血症（FH）在美国仍然严重诊断不足和治疗不足。最近 PI的工作证明，能够以类似的患病率识别FH献血者， 预计在一般人群中。这项混合方法研究的总体目标是应用 实施策略，以改善FH献血者的治疗。核心假设是， 献血系统可以成为增加FH患者接受治疗的有效途径。的 中心假设将通过追求四个具体目标进行测试：1）确定接受的障碍和促进因素 （低密度脂蛋白胆固醇）LDL-C治疗在献血者与FH通知实施 策略制定，2）制定和制作一个实施策略包，以增加LDL-C治疗 在患有FH的献血者中，3）在一个受试者中进行2型LDL-C降低的实施有效性试验， 以社区为基础的献血中心，和4）评估的实施捆绑使用混合方法。 这项研究将由实施科学研究综合框架（CFIR）指导， 并将使用实施图，一个基于理论和证据的过程，以开发，实施， 评估这些加强治疗的策略。在第一个目标中，半结构化访谈将被用来引出 来自关键利益相关者的他汀类药物治疗的障碍和促进因素，包括：a）FH献血者B）家族 献血员c）献血人员d）社区医生。利益相关者的反馈将是 反复整合，以开发、产生和完善第二个目标中的实施战略包， 将在目标3中进行测试。第三个目标是在FH献血者中进行一项双臂随机试验 比较a）高胆固醇的通常通知或B）目标2的实施策略与 主要结局为LDL-C水平从基线至6个月的变化差异。第四个目标是 评估实施战略包的可接受性、适当性和可行性，并将告知 开发一个传播包，以便在其他献血中心实施FH计划。的 在我们看来，这项申请中提出的研究是创新的，因为它将献血者 计划，一个全新的方法来识别和治疗FH。这种增强FH治疗的新门户 涉及不太可能寻求定期医疗护理的年轻人，并补充传统的 战略重点放在病人的医疗之家。最终，如果成功的话，这个计划，由 实施科学的方法，可迅速扩大到全国献血中心，涉及6.4 每年有100万名捐赠者，对FH护理的差距产生直接影响。