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

共同领导者：改善系统性红斑狼疮患者的医患沟通和药物依从性的干预措施

• 批准号: 10772887
• 负责人: Kai Sun
• 金额: $ 66.41万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-23 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10772887
• 关键词: Address; Adherence; Adoption; Area; Autoimmune Diseases; Award; Behavior; Black Populations; Black race; Clinic; Clinic Visits; Cluster randomized trial; Communication; Conduct Clinical Trials; Data; Decision Making; Disparity; Education; Equity; Eye; Frequencies; Funding Opportunities; Goals; Health; Health system; Incidence; Intervention; Kidney Failure; Life Expectancy; Lupus; Maintenance; Mediating; Mediation; Medical; Medicine; Methods; Mission; Modeling; National Institute on Minority Health and Health Disparities; Organ; Outcome; Patient Care; Patient Noncompliance; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Persons; Pharmacy facility; Population; Positioning Attribute; Public Health; Quality of life; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Reporting; Research; Rheumatology; Severities; Standardization; Surveys; System; Systemic Lupus Erythematosus; Techniques; Testing; Therapeutic; Training; Trust; Visit; Work; black patient; compliance behavior; experience; flexibility; health care disparity; health disparity; hybrid type 1 design; implementation evaluation; implementation outcomes; implementation science; improved; innovation; intervention delivery; intervention effect; medication compliance; medication nonadherence; multidisciplinary; outcome disparities; patient oriented; patient-clinician communication; pilot test; poor health outcome; racial disparity; racial diversity; randomized trial; skills; success; tool; treatment as usual; trial comparing

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.

抽象的 全身性红斑狼疮（SLE）是一种多器官自身免疫性疾病，在2-4x中更为常见 黑人白人。黑人SLE患者患肾衰竭和死亡的可能性更高13 年轻。加剧这些分布，黑色SLE患者的药物也较差 依从性，这是关于药物和医疗系统的错误解释。可以建立信任 通过有效的患者 - 斜线沟通，但不幸的是，有效的依从性沟通发生 偶尔的，黑人患者与临床医生的沟通质量较差，参与较少 诊所访问中的决策。迄今为止，SLE的依从性干预措施在 患者提醒和教育，尚未注意到患者 - 阵容沟通的质量 专注于改善SLE药物依从性的种族分布。长期目标是减少种族 差异并改善SLE患者的健康状况。该提议的总体目的是 优化适当的文化交付并测试共同领导者的效果（狼疮的通信 与剂量 - 非辅助识别和补充数据的依从性公平性，这是一种简单而灵活的干预措施 结合围绕黑人患者需求的沟通技巧的临床培训，以有效 使用患者报告的依从性障碍利用药房补充数据。共同领导者的飞行员数据表明 1）它是可行的，2）可以以高保真度执行，3）它可以与一致的依从性讨论 出色的患者 - 阵容沟通，以及4）它可以改善药物依从性，同时减少种族 差异。 I型I型设计将用于在2处进行共同领导者的群集随机试验 种族多样的风湿病诊所。由以患者为中心的沟通的生态模型告知 中心假设是共同领导者使临床医生能够始终如一地发现和协作 解决患者的依从性障碍。然后，更有效的依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，特别是对于黑人 患者。该研究的目的将比较随机分配的临床医生之间的重要结果 领导者和通常的护理，以测试干预对1）通过诊所的患者临床沟通的影响 访问录音和患者调查，以及2）通过药房补充数据依从性的SLE药物依从性。 研究还将简单地评估相关的实施结果，以确定改进的领域 干预的交付。这项创新的提案是第一个用眼睛测试SLE依从性干预措施的提案 用于患者 - 智慧的沟通和药物依从性方面的公平性。该提议很重要，因为 成功完成该奖项将为具有很高的文化量身定制干预措施提供强大的数据 在许多卫生系统中实施的潜力，以填补S​​LE患者护理的关键空白。