Development, testing, and implementation of virtual statin associated muscle symptom (SAMS) management

项目总结/摘要 在超过6000万的美国成年人中，只有一半的人接受他汀类药物治疗， 持久性低。他汀类药物停药最常见的原因是他汀类药物相关的肌肉症状 （SAMS），一系列肌肉症状，患者认为无法忍受，足以影响日常活动 和生活质量。SAMS的主要驱动因素包括患者认为他汀类药物不安全，进一步传播 误解阴谋论和负面的媒体报道超过90%的患者 经验：SAMS在简单的方案调整（如剂量调整）后可以耐受持续的他汀类药物治疗， 减量、转换为不同的他汀类药物或隔日给药。最有效的干预措施，以改善 SAMS患者的他汀类药物使用、剂量强度和结局包括仔细随访和管理， 以团队为基础的护理模式。然而，报销模式、患者和提供者的接受程度以及其他因素 是广泛实施团队护理的重大障碍。即使团队护理 时间限制和与SAMS管理相关的独特心理导致了 只有50%经历SAMS的患者曾经重新挑战他汀类药物治疗。基于系统的实践， 使用辅助人员，中级提供者，面向提供者的健康信息技术，以及患者自我 管理-结合临床心理学和新技术的见解可以帮助解决这些问题 有效管理SAMS的挑战。我们建议开发和测试虚拟SAMS管理（VSM）： 一个自我指导的、基于网络的工具，包括（1）收集自我报告的患者信念、药物使用 行为和症状;（2）评估他汀类药物使用导致自我报告的 症状;（3）提供个体化的心血管风险，他汀类药物获益和SAMS治疗选择， 通过认知去偏文献告知交付;（4）适当时，患者自我管理其 SAMS通过修改他们的他汀类药物方案，根据设定的协议。首先，我们将使用用户迭代设计， 开发VSM软件的可用性测试（目标1）。然后，我们提出了一个混合型II有效性- 实施随机试验，以确定VSM是否可以提高效率和有效性， 以团队为基础的护理管理SAMS（目标2），并确定促进者和影响吸收的障碍， 采用和VSM战略在团队护理环境中的影响（目标3）。我们分析的结果显示， 这种创新的方法将回答重要和及时的问题，有关战略，以改善如何 患者查看他汀类药物，并鼓励他汀类药物重新激发，并进行基于证据的他汀类药物治疗方案调整 在SAMS发生后。这将解决紧迫的公共卫生需求，并开辟新的研究途径， 优化SAMS管理，提高他汀类药物的依从性和持久性，从而降低 ASCVD风险。

PROJECT SUMMARY/ABSTRACT Only half of the >60 million US adults for whom statin therapy is indicated receive statins, and adherence and persistence is low. The most common reason of statin discontinuation is statin-associated muscle symptoms (SAMS), a spectrum of muscle symptoms the patient perceives as intolerable enough to impair daily activities and quality of life. A major driver of SAMS includes patient beliefs that statins are unsafe, further propagated by misconceptions, conspiracy theories, and negative lay media coverage. Over 90% of patients who experience SAMS can tolerate continued statin therapy after simple regimen modifications such as dose reductions, switching to a different statin, or alternate-day dosing. The most effective interventions to improve statin use, dose intensity, and outcomes in patients with SAMS include careful follow-up and management with team-based care models. However, reimbursement models, patient and provider acceptance, and other factors are significant barriers to the widespread implementation of team-based care. Even when team-based care is available, time constraints and the unique psychology associated with SAMS management have resulted in only 50% of those who experience SAMS ever re-challenging statin therapy. Systems-based practice—which uses ancillary personnel, mid-level providers, provider-facing health information technology, and patient self- management—combined with insights from clinical psychology and novel technology can help address these challenges to effectively managing SAMS. We propose to develop and test virtual SAMS management (VSM): a self-guided, web-based tool that incorporates (1) collection of self-reported patient beliefs, medication use behavior, and symptoms; (2) assessment of the likelihood that statin use is causing the self-reported symptoms; (3) provision of individualized cardiovascular risk, statin benefit, and SAMS treatment options, with delivery informed by cognitive debiasing literature; and (4) as appropriate, patients’ ability to self-manage their SAMS by modifying their statin regimen according to set protocols. First, we will use user iterative design and usability testing to develop the VSM software (Aim 1). Then, we propose a hybrid type II effectiveness- implementation randomized trial to determine whether VSM can improve the efficiency and effectiveness of team-based care at managing SAMS (Aim 2), and to identify facilitators and barriers that affect the uptake, adoption, and impact of the VSM strategy in team-based care settings (Aim 3). Results from our analysis of this innovative approach will answer important and timely questions concerning strategies for improving how patients view statins and encouraging statin re-challenge with evidence-based statin regimen modifications after SAMS occur. This will address an urgent public health need and open new avenues for research by optimizing SAMS management leading to increased statin adherence and persistence and, thereby, decreased ASCVD risk.