Center to Improve Chronic disease Outcomes through Multi-level and Multi-generational approaches Unifying Novel Interventions and Training for health EquitY (The COMMUNITY Center)

项目摘要/摘要 该项目将通过扩大范围，减少患有多种慢性病的患者的健康差距 我们改善依从性的干预范围公平(IMPACT)试验，以包括转移性患者 乳腺癌(MBC)。Impact试验目前正在招募早期/非转移性乳腺癌患者。 癌症(BC)，以测试专注于数字和制药股权的多组分干预是否改善 坚持心血管药物和内分泌治疗(ET)的辅助BC治疗。其中 患有慢性病的成年人，30%至50%的药物没有按处方服用；药物不遵守是 在少数族裔中尤其普遍，并与较高的死亡和住院风险有关， 医疗保健成本。随着MBC护理中药物依从性的增加，服药依从性已成为一个更突出的问题 新型口服抗癌药物的有效性和有效性，如细胞周期蛋白依赖性激酶4/6抑制剂 (CDK4/6i)。此外，单核细胞存活率的改善也导致了长期存活率的增长。 MBC幸存者面临与衰老相关的心血管疾病(CVD)的风险。心血管疾病危险因素的管理是 这一点至关重要，因为心血管合并症与MBC患者的不良预后相关。然而，几乎没有什么 了解MBC和CVD患者中药物不依从性的发生率和驱动因素。的确有 此外，在这一患者群体中关于依从性干预的研究空白，特别是干预 目标是坚持服用多种慢性药物。 我们提议的研究将利用开发的药物不依从性筛查和干预工具 通过影响试验和社区中心其他组成部分来解决这一研究空白。我们 将进行一项回溯性队列研究，以评估不遵守 具有MBC和CVD危险因素的社会经济差异患者的ET/CDK4/6i和CVD药物治疗 基于电子病历的药房填写/订购数据。我们还将检查与以下因素相关的药物和患者级别的因素 不坚持。我们将对在父母中开发的依从性干预进行试点单臂试验 影响研究(数字培训、智能手机提供、药剂师指导的咨询根据患者的依从性量身定制 障碍)对35例MBC和CVD危险因素进行初步疗效和可接受性评价 在这群人中。最后，我们将更深入地了解健康的社会决定因素的影响 (SDOH)通过与我们的部分参与者进行半结构化访谈来了解药物不依从性 试点试验，利用在2023年社区中心调查员的支持下收集的SDOH数据 发展核心飞行员奖。据我们所知，这将是第一次专注于理解和 改善MBC和其他慢性病患者的全球用药依从性。如果成功，它将 可以为未来的随机试验提供路线图，以公平地改善依从性和临床结果 这群人。

PROJECT SUMMARY/ABSTRACT This project will contribute to reducing health disparities in patients with multiple chronic conditions by expanding the scope of our Intervention to iMProve AdherenCe equiTably (IMPACT) trial to include patients with metastatic breast cancer (MBC). The IMPACT trial is currently enrolling patients with early-stage/non-metastatic breast cancer (BC) to test whether a multicomponent intervention focused on digital and pharmaco-equity improves adherence to both cardiovascular medications and endocrine therapy (ET) for adjuvant BC treatment. Among adults with chronic illness, 30% to 50% of medications are not taken as prescribed; medication nonadherence is particularly prevalent among minorities and is associated with a higher risk of death and hospitalization, and high healthcare costs. Medication adherence has become a more salient issue in MBC care with the increased availability and efficacy of novel oral anticancer therapies such as cyclin-dependent kinase 4/6 inhibitors (CDK4/6i). Furthermore, improvements in MBC survival outcomes have resulted in a growing tail of long-term MBC survivors at risk for aging-associated cardiovascular disease (CVD). Management of CVD risk factors is crucial as cardiovascular comorbidities are associated with poor outcomes in patients with MBC. Yet little is known about the prevalence and drivers of medication nonadherence in patients with MBC and CVD. There is also a research gap concerning adherence interventions in this patient population, especially interventions targeting adherence to multiple chronic medications. Our proposed study will harness the medication nonadherence screening and intervention tools developed through the IMPACT trial and other components of the COMMUNITY Center to address this research gap. We will conduct a retrospective cohort study to evaluate the prevalence and correlates of nonadherence to ET/CDK4/6i and CVD medications in socioeconomically diverse patients with MBC and CVD risk factors, utilizing EHR-based pharmacy fill/order data. We will also examine medication- and patient-level factors associated with nonadherence. We will conduct a pilot, single-arm trial of the adherence intervention developed in the parent IMPACT study (digital training, smartphone provision, pharmacist-led counseling tailored to patient’s adherence barriers) among 35 patients with MBC and CVD risk factors to evaluate its preliminary efficacy and acceptability in this population. Finally, we will gain a deeper understanding of the impact of social determinants of health (SDOH) on medication nonadherence through semi-structured interviews with a subset of participants to our pilot trial, leveraging the SDOH data collected with the support of a 2023 COMMUNITY Center Investigator Development Core pilot award. To our knowledge, this will be the first study focused on understanding and improving global medication adherence among patients with MBC and other chronic conditions. If successful, it could provide a roadmap for future randomized trials to equitably improve adherence and clinical outcomes in this population.