Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

自付费用沟通和财务导航 (CostCOM) 对癌症患者的有效性

• 批准号: 10498114
• 负责人: Gelareh Sadigh
• 金额: $ 65.27万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-04 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10498114
• 关键词: Address; Advocate; Cancer Patient; Caring; Client satisfaction; Communication; Community Clinical Oncology Program; Complement; Complex; Conduct Clinical Trials; Counseling; Diagnosis; Disclosure; Dose; Drug Prescriptions; Education; Effectiveness; Enrollment; Ethnic Origin; Financial Hardship; Financial Support; Foundations; Geography; Goals; Health; Health system; Hospitals; Hour; Income; Insurance Benefits; Insurance Coverage; Intervention; Interview; Learning; Link; Malignant Neoplasms; Measures; Medical; Newly Diagnosed; Nonmetastatic; Office Visits; Outcome; Pamphlets; Patient Care; Patient Outcomes Assessments; Patient Self-Report; Patients; Perception; Population; Preparation; Price; Professional counselor; Program Sustainability; Provider; Qualitative Methods; Quality of life; Race; Randomized, Controlled Trials; Recommendation; Reporting; Research; Resources; Risk; Services; Site; Solid Neoplasm; Surveys; System; Testing; Time; Treatment Cost; United States; United States Centers for Medicare and Medicaid Services; arm; cancer care; cancer diagnosis; cancer therapy; care costs; care delivery; comparative cost effectiveness; cost; cost effectiveness; effectiveness evaluation; effectiveness testing; enhanced care; experience; follow up assessment; health care service utilization; improved; innovation; interest; multidisciplinary; multiple sclerosis patient; participant enrollment; patient engagement; patient population; personalized intervention; personalized medicine; primary endpoint; primary outcome; process evaluation; programs; recruit; satisfaction; shared decision making; socioeconomics; telecoaching; telephone session; therapy design; tool; treatment as usual; usual care arm; video session

PROJECT SUMMARY High out-of-pocket costs (OOPC) of cancer treatment and lost income result in financial hardship. There is compelling evidence that OOPC communication complemented by financial navigation and counseling will decrease financial hardship by enabling cancer patients to anticipate and accommodate treatment costs and proactively seek financial assistance. Importantly, this intervention aligns with the Centers for Medicare and Medicaid Services (CMS) price transparency mandate. We will evaluate the effectiveness of an innovative personalized intervention designed to improve cost-related cancer care non-adherence by conducting a randomized controlled trial of OOP cost communication and financial navigation (CostCOM) vs. enhanced usual care (EUC) at NCI Community Oncology Research Program (NCORP) practices. Our multidisciplinary team has experience with all facets of the proposed intervention including conducting clinical trials at NCORP practices. CostCOM comprises four 1-hour counseling sessions to impart: (1) OOPC communication, individualized, patient-specific education of the anticipated OOPC using a price estimator tool; (2) Financial navigation, real-time professional guidance to identify financial assistance programs that will alleviate costs of care and discuss information to improve insurance coverage; and (3) Financial counseling to address the range of patients’ financial concerns and enroll patients in financial assistance programs. We will recruit 720 patients with newly diagnosed solid tumors (1:1 non-metastatic vs. metastatic) who plan to receive anticancer therapy at one of the participating NCORP practices. CostCOM arm patients will participate in four phone or video sessions with a remote financial counselor at baseline, 3, 6, and 12 months, with all three components of CostCOM delivered at each session. At enrollment, EUC arm patients will receive usual care enhanced by providing an educational brochure describing services and contact information of the Patient Advocate Foundation (PAF), a national non-profit financial navigation organization. Patients will complete surveys at baseline, 3, 6, and 12 months after enrollment. Our goals are to (1) compare the effectiveness of CostCOM vs. EUC at 12 months on patient-reported cost-related cancer care nonadherence, defined as any self-reported incident of delay, forgo, stop or change in cancer care due to cost concerns, as well as (2) patient-reported material financial hardship, financial worry, and quality of life; and (3) conduct a process evaluation to examine practice providers and CostCOM arm patients’ satisfaction with the intervention and their perceptions of barriers and facilitators to CostCOM delivery (for providers) or receipt (for patients). A successful CostCOM is a scalable and financially sustainable program that can be disseminated across systems, conditions, and populations and improve cancer care delivery, patients’ experience, and health outcomes.

项目概要 癌症治疗的高额自付费用 (OOPC) 和收入损失导致经济困难。 令人信服的证据表明，以财务导航和咨询为补充的 OOPC 沟通将 通过使癌症患者能够预测和适应治疗费用来减少经济困难 重要的是，这种干预措施与医疗保险中心和医疗保险中心保持一致。 我们将评估创新医疗补助服务 (CMS) 价格透明度规定的有效性。 旨在通过进行个性化干预来改善与费用相关的癌症护理不依从性 OOP 成本沟通和财务导航 (CostCOM) 与 OOP 的随机对照试验 NCI 社区肿瘤​​学研究计划 (NCORP) 实践中的强化常规护理 (EUC)。 多学科团队对拟议干预措施的各个方面都有经验，包括进行临床 NCORP 实践中的试验包括四次 1 小时的咨询课程，旨在传授：(1) OOPC。 使用价格估算工具对预期 OOPC 进行沟通、个性化、针对特定患者的教育； （2）金融导航，实时专业指导，确定经济援助方案 护理费用并讨论提高保险覆盖范围的信息；以及 (3) 财务缓解咨询 我们将解决患者的一系列财务问题并将患者纳入财务援助计划。 招募 720 名新诊断实体瘤患者（非转移性与转移性 1:1）并计划接受治疗 参与的 NCORP 诊所之一的抗癌治疗患者将参加四项治疗。 在基线、3、6 和 12 个月时与远程财务顾问进行电话或视频会议，所有三个 入组时，EUC 组患者将接受常规护理。 通过提供描述患者服务和联系信息的教育手册来增强 倡导基金会 (PAF)，一个全国性非营利金融导航组织，患者将完成。 我们的目标是 (1) 比较基线、入组后 3、6 和 12 个月的调查。 CostCOM 与 EUC 在 12 个月时关于患者报告的与费用相关的癌症护理不依从性（定义为任何 自我报告因费用问题而延迟、放弃、停止或改变癌症护理的事件，以及 (2) 患者报告的物质经济困难、财务担忧和生活质量；以及 (3) 进行流程； 评估以检查实践提供者和 CostCOM 患者对干预的满意度 他们对 CostCOM 交付（对于提供者）或收据（对于患者）的障碍和促进因素的看法 A。 成功的 CostCOM 是一个可扩展且财务上可持续的计划，可以在各个领域传播 系统、条件和人群，并改善癌症护理服务、患者体验和健康 结果。