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

项目摘要/摘要 在6000万接受他汀类药物治疗的美国成年人中，只有一半的人接受了他汀类药物，并坚持 持久力不强。停用他汀类药物最常见的原因是他汀类药物相关的肌肉症状。 (SAMS)，患者认为无法忍受的一系列肌肉症状，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是不安全的，并进一步传播 通过误解、阴谋论和媒体的负面报道。超过90%的患者 经验SAMS可以耐受持续的他汀类药物治疗后，简单的方案修改，如剂量 减少，改用不同的他汀类药物，或隔日给药。改善的最有效的干预措施 SAMS患者的他汀类药物的使用、剂量强度和结果包括仔细的随访和处理 基于团队的护理模式。然而，报销模式、患者和提供者的接受度以及其他因素 是广泛实施以团队为基础的护理的重大障碍。即使基于团队的护理是 可获得性、时间限制和与SAMS管理相关的独特心理导致 在经历过SAMS的患者中，只有50%的人曾再次挑战他汀类药物治疗。基于系统的实践-- 使用辅助人员、中层提供者、面向提供者的健康信息技术和患者自我 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)： 一种自我引导的基于Web的工具，包括(1)收集自我报告的患者信念、用药情况 行为和症状；(2)他汀类药物使用导致自我报告的可能性的评估 症状；(3)提供个性化的心血管风险、他汀类药物受益和SAMS治疗选项，包括 (4)适当时，患者自我管理的能力。 SAMS根据既定方案修改他们的他汀类药物方案。首先，我们将使用用户迭代设计和 开发VSM软件的可用性测试(目标1)。然后，我们提出了一种混合类型II有效性- 实施随机试验，确定VSM是否可以提高治疗的效率和效果 以团队为基础的护理在管理SAMS方面(目标2)，并确定影响接受的促进者和障碍， VSM战略在基于团队的护理环境中的采用和影响(目标3)。我们的分析结果 这一创新方法将回答有关如何改进战略的重要和及时的问题 患者观察他汀类药物并鼓励他汀类药物通过循证的他汀类药物方案修改再次挑战 在SAMS发生后。这将解决紧迫的公共卫生需求，并为研究开辟新的途径 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.