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

通过多层次、多代人方法统一新型干预措施和培训以促进健康公平改善慢性病结果的中心（社区中心）

• 批准号: 10892467
• 负责人: Elizabeth Gross Cohn
• 金额: $ 22.1万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10892467
• 关键词: Address; Adherence; Adult; Aging; Award; Black race; Breast Cancer Patient; Breast Cancer Risk Factor; Breast Cancer Treatment; Breast Cancer survivor; CDK4 gene; Cardiovascular Diseases; Cardiovascular system; Cellular Phone; Chronic; Chronic Disease; Clinical; Counseling; Data; Development; Disease Outcome; Environment; Equity; Future; Health; Health Care Costs; Hospitalization; Housing; Hypertension; Intervention; Interview; Metastatic breast cancer; Minority; Nonmetastatic; Oncology; Oral; Outcome; Parents; Participant; Patient Noncompliance; Patient Outcomes Assessments; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Polypharmacy; Population; Population Heterogeneity; Prevalence; Publishing; Qualitative Methods; Reduce health disparities; Regimen; Research; Research Personnel; Retrospective cohort study; Risk; Risk Factors; Role; Screening procedure; Structure; Survival Rate; Tail; Testing; Training; Transportation; adjuvant endocrine therapy; adverse outcome; arm; black patient; breast cancer survival; cancer care; cancer therapy; cardiovascular disorder risk; cardiovascular risk factor; community center; comorbidity; compliance behavior; digital; food insecurity; hazard; health care disparity; health data; health disparity; health equity; health training; high risk; hormone therapy; improved; inhibitor; low socioeconomic status; malignant breast neoplasm; medication compliance; medication nonadherence; mortality; mortality risk; multi-component intervention; multiple chronic conditions; novel; participant enrollment; patient population; patient-level barriers; pilot trial; primary endpoint; randomized trial; screening; secondary endpoint; social; social health determinants; socioeconomics; statistics; survival outcome; tool

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.

项目总结/摘要 该项目将通过扩大医疗保健服务， 我们的IMPACT（Intervention to iM Prove AdherenCe Equilibly）试验的范围包括转移性乳腺癌患者， 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药物公平性的多组分干预是否改善 坚持心血管药物和内分泌治疗（ET）作为辅助BC治疗。之间 患有慢性病的成年人，30%至50%的药物没有按规定服用;药物不依从性是 在少数民族中尤其普遍，与死亡和住院的风险较高有关， 医疗费用。药物依从性已成为MBC护理中一个更加突出的问题， 新型口服抗癌疗法如细胞周期蛋白依赖性激酶4/6抑制剂的可用性和功效 (CDK4/6i）。此外，MBC生存结局的改善导致了长期生存率的增加。 MBC幸存者存在年龄相关心血管疾病（CVD）风险。CVD危险因素的管理 这一点至关重要，因为心血管合并症与MBC患者的不良结局相关。但很少有人 了解MBC和CVD患者中药物不依从性的患病率和驱动因素。有 也存在关于该患者人群依从性干预的研究空白，特别是干预 针对多种慢性药物的依从性。 我们提出的研究将利用开发的药物不依从性筛查和干预工具 通过IMPACT试验和社区中心的其他组成部分来解决这一研究空白。我们 将进行一项回顾性队列研究，以评估不依从的患病率和相关因素， ET/CDK 4/6 i和CVD药物在具有MBC和CVD风险因素的社会经济学不同患者中的应用， 基于EHR的药房填写/订单数据。我们还将研究与下列因素相关的药物和患者水平因素： 不依从。我们将进行一项试点，单臂试验的依从性干预开发的父母， IMPACT研究（数字培训、智能手机供应、针对患者依从性量身定制的药剂师主导的咨询 在35例有MBC和CVD危险因素的患者中评估其初步疗效和可接受性 在这个人群中。最后，我们将更深入地了解健康的社会决定因素的影响 （SDOH）通过对一部分参与者进行半结构化访谈， 试点试验，利用在2023社区中心调查员支持下收集的SDOH数据 发展核心试点奖。据我们所知，这将是第一次研究集中在理解和 改善MBC和其他慢性病患者的全球药物依从性。如果成功，它 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局， 这个人口。