CO-LEADER: Intervention to Improve Patient-Provider Communication and Medication Adherence among Patients with Systemic Lupus Erythematosus

摘要 系统性红斑狼疮(SLE)是一种多器官自身免疫性疾病，在 黑的那个白的人。患有系统性红斑狼疮的黑人患者患肾衰竭和死亡的可能性是普通人的6-7倍 比他年轻几岁。加剧这些差异的是，患有SLE的黑人患者也有更差的药物治疗 坚持，部分原因是对药物和医疗系统的不信任。信任是可以建立的 通过有效的患者-临床医生沟通，但不幸的是，有效的坚持沟通发生了 偶尔，黑人患者与临床医生的沟通质量较差，参与较少 就诊中的决策。到目前为止，系统性红斑狼疮的依从性干预只取得了有限的成功 患者提醒和教育，没有关注患者与临床医生沟通的质量，也没有 重点是改善SLE用药依从性方面的种族差异。长期目标是减少种族歧视 改善系统性红斑狼疮患者的健康状况。这项提议的总体目标是 优化文化上合适的交付，并测试联合领导者(狼疮传播)的效果 公平遵守剂量-非坚持-SLE和重新填充数据)，一种简单而灵活的干预措施， 结合临床医生以黑人患者需求为中心的沟通技能培训，有效地 利用具有患者报告的依从性障碍的药房重新灌装数据。联合领先者的试点数据表明 1)它是可行的，2)它可以高保真地执行，3)它支持一致的遵守讨论 良好的患者-临床医生沟通，4)在减少种族差异的同时提高了服药依从性 差距。将使用混合类型I设计来进行CO-Leader在2 不同种族的风湿病诊所。在以患者为中心的沟通生态模式的启发下， 中心假设是，联合领导者使临床医生能够一致地发现并协作 解决患者的依从性障碍。更有效的遵从性讨论将增强共享 理解、治疗联盟和信任，从而改善药物依从性，特别是对Black 病人。这项研究的目的是比较随机分为两组的临床医生之间的重要结果。 领导和常规护理，以测试干预对1)临床患者与临床医生沟通的效果 访问录音和患者调查，以及2)通过药房续药数据来遵守SLE的用药情况。这个 研究还将同时评估相关的执行结果，以确定需要改进的领域 干预措施的实施。这一创新的方案是第一个用眼睛测试SLE坚持干预的方案 在患者-临床医生沟通和用药依从性方面的公平性。这项提议意义重大，因为 该奖项的成功完成将提供关于文化定制干预的强有力的数据，该干预具有很高的 在许多卫生系统中实施的潜力，以填补系统性红斑狼疮患者护理方面的关键空白。

ABSTRACT Systemic lupus erythematosus (SLE) is a multi-organ autoimmune disease that is 2-4x more common among Black that White persons. Black patients with SLE are 6-7x more likely to suffer from kidney failure and die 13 years younger. Exacerbating these disparities, Black patients with SLE also have worse medication adherence, which is partially explained by mistrust about medicines and the medical system. Trust can be built through effective patient-clinician communication, but unfortunately, effective adherence communication occurs sporadically, and Black patients experience poorer communication quality with clinicians and participate less in decision making in clinic visits. Adherence interventions in SLE to date have only had limited success with patient reminders and education and have not attended to the quality of patient-clinician communication nor focused on ameliorating racial disparities in SLE medication adherence. The long-term goal is to reduce racial disparities and improve health outcomes among patients with SLE. The overall objective of this proposal is to optimize the culturally appropriate delivery and test the effect of CO-LEADER (COmmunication for Lupus Equity in Adherence with DOSE-Nonadherence-SLE and Refill data), a simple and flexible intervention that combines clinician training in communication skills centered around the needs of Black patients to effectively utilized pharmacy refill data with patient-reported adherence barriers. Pilot data for CO-LEADER suggest that 1) it is feasible, 2) it can be performed with high fidelity, 3) it enables consistent adherence discussions with excellent patient-clinician communication, and 4) it improves medication adherence while reducing racial disparities. A Hybrid Type I design will be used to conduct a cluster randomized trial of CO-LEADER at 2 racially diverse rheumatology clinics. Informed by the Ecological Model of Patient-Centered Communication, the central hypothesis is that CO-LEADER enables clinicians to consistently discover and collaboratively address patients’ adherence barriers. More effective adherence discussions will then enhance shared understanding, therapeutic alliance, and trust, thereby improving medication adherence, particularly for Black patients. The aims of the study will compare important outcomes between clinicians randomized to CO- LEADER and usual care to test the effect of the intervention on 1) patient-clinician communication via clinic visit audio recordings and patient surveys, and 2) SLE medication adherence via pharmacy refill data. The study will also simultaneously evaluate relevant implementation outcomes to identify areas for improvement in the intervention’s delivery. This innovative proposal is the first to test a SLE adherence intervention with an eye for equity in patient-clinician communication and medication adherence. The proposal is significant because successful completion of the award will provide robust data on a culturally tailored intervention that has high potential for implementation across many health systems to fill a critical gap in the care of patients with SLE.