Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

使用患者导航仪增强羟基脲在镰状细胞病中的应用

基本信息

批准号：
8698808
负责人：
Wally R Smith
金额：
$ 59.56万
依托单位：
VIRGINIA COMMONWEALTH UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-15 至 2017-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8698808
关键词：
Academic Medical Centers Address Adherence Adopted Adult Age Alcohol consumption Caring Clinical Communities Dose Effectiveness Eligibility Determination FDA approved Face Failure Fright Genotype Guidelines Health Health Status Hemoglobin Hospitals Life Maximum Tolerated Dose Measures Mental Health Modeling Pain Patients Pharmaceutical Preparations Phase Physicians Provider Quality of life Randomized Relative (related person)Reticulocyte count Sickle Cell Anemia Silicon Dioxide Social support Specialist Training United States National Institutes of Health Virginia Visit White Blood Cell Count procedure arm base coping demographics efficacy testing hydroxyurea improved innovation mean corpuscular volume observed medical specialties older patient primary outcome programs public health relevance secondary outcome treatment as usual

项目摘要

DESCRIPTION (provided by applicant): Large percentage of patients may not be in SCD specialty care, and may face barriers to care. For adults, not having specialty care may be fatal, because specialists may prescribe Hydroxyurea (HU), the first and only FDA approved remittive drug for SCD. Additional barriers to HU include physician fears or misconceptions about its use, inconsistent determination of HU eligibility and inconsistent dose escalation, and patient failure to take HU, due to ignorance or mistrust of relative benefit sand harms, inconvenience associated with therapy, or poor medication access. To overcome these barriers, the state of Virginia, including the Virginia Department of Health and two academic medical centers, plans a two phase demonstration, first of improvement in the percentage of adults with SCD who are in SCD specialty care (PhaseI), then of improvement in adherence to HU of eligible SCD adults (PhaseII). Both phases will use existing academic SCD providers, and an innovative, multimodal strategy, featuring specially trained SCD patient navigators (PNs), that addresses barriers to care and to HU use. In Phase I we will demonstrate the feasibility of utilizing PNs to overcome patient access barriers to SCD care. In Phase II we will test the efficacy of PNs for overcoming barriers to acceptance of and adherence with Hu therapy. Patients will be randomized to a PN or usual care arm. Providers will implement NIH guidelines for HU eligibility and prescribing in both arms. The primary outcome variable for Phase I will be the percentage of enrollees who in the subsequent three months achieve a visit with a specialty SCD provider. The primary outcome for Phase II will be improvement in the HbF level at 1 year post randomization. Secondary outcomes will include: four measures of adherence to HU; percent of patients achieving either maximum tolerated dose, a clinical endpoint, or maximum dose; ED and hospital visits; mean corpuscular volume; total hemoglobin; white blood cell count; reticulocyte count; and quality of life. Co variates in PhaseII will include: patient demographics; genotype; social support; SCD associated pain conditions; mental health status and alcohol use; and coping measures. This project will be critically important and impactful by demonstrating the feasibility of a statewide community based strategy to assist vulnerable SCD adults in obtaining SCD specialty care and likely prolonging life, a model that other states could adopt.

描述（由申请人提供）：很大一部分患者可能没有接受 SCD 专业护理，并且可能面临护理障碍。对于成年人来说，没有专业护理可能是致命的，因为专家可能会开出羟基脲 (HU)，这是 FDA 批准的第一个也是唯一一个缓解 SCD 的药物。 HU 的其他障碍包括医生对其使用的恐惧或误解、对 HU 资格的确定不一致和剂量递增不一致以及患者由于对相对益处和危害的无知或不信任而未能服用 HU、与治疗相关的不便或药物获取不畅。为了克服这些障碍，弗吉尼亚州，包括弗吉尼亚卫生部和两个学术医疗中心，计划进行两个阶段的示范，首先是提高接受 SCD 专业护理（第一阶段）的 SCD 成年人的百分比，然后是改善符合条件的 SCD 成人对 HU 的依从性（第二阶段）。这两个阶段都将使用现有的学术 SCD 提供者和创新的多模式策略，以经过专门培训的 SCD 患者导航员 (PN) 为特色，以解决护理和 HU 使用的障碍。在第一阶段，我们将展示利用 PN 克服患者获得 SCD 护理的障碍的可行性。在第二阶段，我们将测试 PN 克服接受和坚持 Hu 疗法障碍的功效。患者将被随机分配到 PN 组或常规护理组。提供者将执行 NIH 关于 HU 资格和双臂处方的指南。第一阶段的主要结果变量将是在接下来的三个月内拜访专业 SCD 提供商的参与者的百分比。 II 期的主要结果是随机分组后 1 年后 HbF 水平的改善。次要成果将包括：遵守 HU 的四项措施；达到最大耐受剂量、临床终点或最大剂量的患者百分比；急诊科和医院就诊；平均红细胞体积；总血红蛋白；白细胞计数；网织红细胞计数；和生活质量。第二阶段的协变量将包括：患者人口统计数据；基因型;社会支持； SCD 相关的疼痛状况；心理健康状况和饮酒情况；以及应对措施。该项目将证明基于全州社区的战略的可行性，以帮助弱势 SCD 成年人获得 SCD 专业护理并可能延长寿命，这一项目将至关重要且具有影响力，其他州也可以采用这一模式。