Patient-centered home-based hematopoietic stem cell transplantation

以患者为中心的家庭造血干细胞移植

• 批准号: 9266772
• 负责人: Nelson J. Chao
• 金额: $ 64.57万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-01 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9266772
• 关键词: Adverse event; Affect; Antibiotics; Anxiety; Back; Bacteria; Blood; Blood Transfusion; Caregiver support; Caregivers; Caring; Clinical; Common Terminology Criteria for Adverse Events; Data; Disease; Disease-Free Survival; Drug Interactions; Electrolytes; Electronic Health Record; Environment; Exercise; Exposure to; Facilities and Administrative Costs; Family; Feedback; Funding; Goals; Health; Health Resources; Hematopoietic Stem Cell Transplantation; Home environment; Homeostasis; Hospital Nursing; Hospitalization; Hospitals; IV Fluid; Immune; Infection; Inflammation; Inpatients; Intervention; Knowledge; Laboratory Study; Lead; Length of Stay; Life; Longevity; Love; Malignant - descriptor; Malignant Neoplasms; Mediator of activation protein; Medical; Modeling; Morbidity - disease rate; National Cancer Institute; Non-Malignant; Nosocomial Infections; Nurses; Nutritionist; Outcome; Outpatients; Patient Outcomes Assessments; Patient risk; Patient-Focused Outcomes; Patients; Performance Status; Phase II Clinical Trials; Physicians; Provider; Quality of Care; Quality of life; Randomized; Recovery; Reporting; Research; Research Infrastructure; Resources; Safety; Self Efficacy; Social Workers; Social support; Stress; Symptoms; Technology; Testing; Time; Transplantation; Videoconferences; Visit; Work; arm; base; blood product; clinical efficacy; comparative efficacy; cost; design; diaries; economic evaluation; experience; graft vs host disease; gut microbiota; health care quality; health information technology; hospital laboratories; improved; innovation; intestinal homeostasis; laptop; meetings; mortality; novel; nutrition; pathogen; patient oriented; patient safety; personalized care; phase 2 study; prevent; programs; public health relevance; standard care; standard of care; wasting

 DESCRIPTION (provided by applicant): Hematopoietic stem cell transplantation (HCT) has the potential to cure people with cancer and other life- threatening diseases. However, patients risk prolonged vulnerability to infections and other complications as well as substantial treatment-related mortality. Consequently, HCT typically occurs in the hospital, with stays lasting three months or more. Yet hospitalization is not without problems, including nosocomial infections, disrupted homeostasis, and increased resource utilization and costs. Patient-centered home transplant (PCHT) is a novel alternative that may improve patient safety, clinical efficacy, and value for HCT patients. PCHT begins with a comprehensive assessment of each patient's needs. This includes meetings with patients, caregivers, social workers, nutritionists, nurses, and physicians. Following an individualized care plan, clinicians visit patients in their homes every morning to perform assessments and draw labs. Labs are analyzed at the hospital, and nurses return to patient homes to deliver needed medical interventions (e.g. antibiotics, blood transfusions). Leveraging the power of our electronic health record, clinician laptops allow remote access to all of a patient's health information, potential drug interactions, and other important details. In addition, patients are provided with iPads to videoconference daily with physicians to report complications or concerns. We have successfully piloted this approach with HCT patients, demonstrating feasibility. By allowing patients to stay at home, PCHT may reduce exposure to hospital pathogens, decreasing nosocomial infections. PCHT may also reduce graft-versus-host disease (GVHD), which affects 40-60% of HCT patients and is a leading cause of morbidity and mortality. GVHD is driven by inflammation, which may be triggered by changes in the bacteria living in the gut. This "gut microbiota" is affected by changes in the environment (e.g. hospitalization); however, if patients stay in their normal environment (home), they may preserve their normal gut microbiota, decreasing inflammation and GVHD. Staying at home also may promote independence and improve quality of life (QOL) by allowing greater access to nutrition, exercise, and social support. While more intensive staffing may be needed, these advantages may combine to lower overall costs. This proposal describes a randomized phase 2 study to compare PCHT vs. standard care. The first aim is to compare clinical outcomes, include GVHD (primary endpoint), infections, survival, quality of life, and symptoms. Potential mediators of these outcomes (e.g. nutrition, exercise, social support, self -efficacy) will also be evaluated. The second aim is to evaluate the safety of this approach, assessing treatment-related mortality and adverse events. The third aim is to conduct an economic evaluation of the direct medical costs, health resources utilization, and indirect costs (e.g., patient time) with PCHT vs. standard care. The long-term objectives are to improve patient safety and longevity by preventing complications such as GVHD and infections, promote QOL, and lower costs while improving quality of care.

 描述（由适用提供）：造血干细胞移植（HCT）有可能治愈癌症患者和其他威胁生命的疾病。但是，患者可能会长时间脆弱感染和其他并发症以及与治疗相关的大量死亡率。因此，HCT通常发生在医院，持续三个月或更长时间。然而，住院并非没有问题，包括医院感染，稳态中断以及资源利用率和成本的增加。以患者为中心的家庭移植（PCHT）是一种新颖的替代方法，可以提高患者的安全性，临床效率和HCT患者的价值。 PCHT首先是对每个患者需求的全面评估。这包括与患者，看护人，社会工作者，营养学家，护士和医生的会议。遵循个性化的护理计划，临床医生每天早晨在家里拜访患者进行评估并绘制实验室。在医院分析实验室，护士返回患者家庭以提供所需的医疗干预措施（例如抗生素，血液传播）。利用我们的电子健康记录的力量，临床笔记本电脑可以远程访问患者的所有健康信息，潜在的药物相互作用以及其他重要细节。此外，还向患者提供iPad，每天与医生每天进行视频会议，以报告并发症或疑虑。我们已经成功地使用了HCT患者进行了这种方法，证明了可行性。通过允许患者待在家里，PCHT可以减少病原体的接触，从而减少医院感染。 PCHT还可能减少移植物抗宿主病（GVHD），这会影响40-60％的HCT患者，并且是发病率和死亡率的主要原因。 GVHD是由感染驱动的，这种感染可能是由生活在肠道中的细菌的变化引起的。这种“肠道微生物群”受环境变化的影响（例如住院）；但是，如果患者留在正常环境（家中），他们可能会保留正常的肠道菌群，减少感染和GVHD。待在家里也可以通过更多地获得营养，运动和社会支持来促进独立并改善生活质量（QOL）。尽管可能需要更密集的人员配备，但这些优势可能会结合降低整体成本。该提案描述了一项随机2阶段研究，以比较PCHT与标准护理。第一个目的是比较临床结果，包括GVHD（主要终点），感染，生存，生活质量和症状。还将评估这些结果的潜在介体（例如营养，运动，社会支持，自我效能感）。第二个目的是评估这种方法的安全性，评估与治疗相关的死亡率和不良事件。第三个目的是通过PCHT与标准护理对直接医疗费用，健康资源利用率和间接成本（例如患者时间）进行经济评估。长期目标是通过预防GVHD和感染，促进QOL和降低成本的同时，在改善护理质量的同时，提高患者的安全和寿命。