Kidney Precision Medicine Project - Patient Engagement

肾脏精准医学项目 - 患者参与

基本信息

批准号：
10701778
负责人：
ROBERT Daniel TOTO
金额：
$ 45万
依托单位：
UT SOUTHWESTERN MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-15 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10701778
关键词：
Address Adverse event Advocate Affect African American American Biological Biopsy Blood COVID-19 pandemic Caring Case Study Cessation of life Chronic Kidney Failure Clinical Clinical Data Clinical Research Clinical and Translational Science Awards Collaborations Collection Communities Consent Coupled Data Diabetes Mellitus Diagnosis Doctor of Philosophy Electronic Health Record End stage renal failure Enrollment Ensure Ethics Evaluation Faculty Feces Feedback Focus Groups Fostering Future Goals Health system Healthcare Systems Hispanic Hypertension Individual Information Technology Intervention Interview Kidney Kidney Diseases Kidney Failure Knowledge Latinx population Leadership Link Longitudinal cohort study Medical Economics Metadata Methodology Methods Modeling Molecular Nurses Nursing Research Outcome Participant Pathologic Patient Recruitments Patient-Focused Outcomes Patients Phenotype Physicians Policies Population Positioning Attribute Precision Medicine Initiative Privatization Procedures Process Prospective Studies Protocols documentation Public Health Publications Questionnaires Reporting Research Research Personnel Safety Sampling Scientist Shipping Site Socioeconomic Factors Structure Time Tissue Banks Tissues Underrepresented Populations Underserved Population United States National Institutes of Health Update Urine Vulnerable Populations Work adjudication clinical diagnosis clinical phenotype cohort community engagement design diabetic electronic health record system follow-up high risk hypertensive improved informatics tool innovation kidney biopsy member novel novel strategies operation participant enrollment patient engagement patient oriented patient population personalized care phenotypic data precision medicine primary outcome radiologist recruit safety net skills socioeconomics sound success

项目摘要

Project Summary Abstract The current understanding of the pathophysiologic and socio-economic processes that initiate CKD and the paths by which they progress to ESRD are poorly understood, resulting in limited treatments. There is a compelling unmet need for prospective studies to accurately phenotype patients with CKD using a combination of kidney biopsy, clinical, biologic, and socioeconomic factors to develop individualized care to improve patient outcomes. Over the past four years, at the local level we assembled a highly skilled, interdisciplinary team of clinical researchers, physician-scientists, clinicians, research nurses, patient advocates and a Community Advisory Board. This team designed, implemented and sustained a highly successful, ethically sound and safe recruitment site (RS) for the Kidney Precision Medicine Project: 1) We performed the very first KPMP consortium kidney biopsy in September 2019 and were the first RS in the consortium to perform 30 kidney biopsies, successfully enrolling patients with a clinical diagnosis of hypertensive or diabetic chronic kidney disease and yielding sufficient tissue for research protocols as well as for pathological diagnosis; 2) We collected and linked clinical, biological and socioeconomic data of the biopsy participants; 3) We focused our efforts on African- American and Latinx populations at a very high rate in order to address the disproportionate burden of CKD as well as the historical lack of inclusion of these populations in cljnical research, mandated by the NIH, completing 22 out of 11 (73%) of biopsies among these groups. At the consortium level our team members have made meaningful contributions to the major organizational and operational aspects of KPMP. The main goal in this proposal will be population identification, patient recruitment and obtaining clinical phenotype data, biosamples and kidney biopsies. To accomplish this goal we will 1) Identify, recruit, enroll, and biopsy 34 patients annually from 3 large HS serving more than 51,996 patients with CKD and diabetes and/ or hypertension and follow patients longitudinally; 2) Implement ethically-sound, systematic quality-assured processes to obtain clinical and demographic data, bio-samples and kidney biopsies from patients with CKD in a longitudinal clinical study; and 3) Develop and implement patient-centered processes to promote long-term engagement and retention of study participants in KPMP. Our successful track record as a recruitment site for procurement of kidney tissue from patients with CKD attributed to diabetes or hypertension from a large, diverse patient population makes us an ideal site for the continuation of the KPMP. Our ability to recruit patients from multiple health systems with novel informatics tools, an ethically rigorous approach to consenting for kidney biopsy and coupled with a rigorous and safe methodology is a powerful combination we bring to the KPMP. Our innovative approach to this FOA will not only provide the data to generate new knowledge to improve both the diagnosis and treatment of CKD, but also serve as a model for future kidney precision medicine initiatives and their expansion over time.

项目概要摘要目前对引发 CKD 的病理生理学和社会经济过程的理解人们对他们进展为 ESRD 的途径知之甚少，导致治疗方法有限。有一个使用组合药物准确对 CKD 患者进行表型分型的前瞻性研究的迫切需求尚未得到满足肾活检、临床、生物学和社会经济因素，以制定个性化护理以改善患者的状况结果。过去四年，我们在地方层面组建了一支高技能、跨学科的团队临床研究人员、医师科学家、临床医生、研究护士、患者权益倡导者和社区顾问委员会。该团队设计、实施并维持了一个非常成功、道德合理且安全的项目肾脏精准医学项目招募网站（RS）：1）我们进行了第一个 KPMP 联盟于 2019 年 9 月进行了肾活检，是联盟中第一个进行 30 次肾活检的 RS，成功招募临床诊断为高血压或糖尿病慢性肾病的患者，并且产生足够的组织用于研究方案以及病理诊断； 2）我们收集并链接活检参与者的临床、生物学和社会经济数据； 3）我们把重点放在非洲—— 美国人和拉丁裔人口的比例非常高，以解决 CKD 的不成比例的负担以及历史上缺乏将这些人群纳入 NIH 规定的临床研究的情况，完成这些组中 11 例中有 22 例 (73%) 进行了活检。在联盟层面，我们的团队成员已经做出了对 KPMP 的主要组织和运营方面做出了有意义的贡献。该提案的主要目标是人群识别、患者招募和获得临床数据表型数据、生物样本和肾活检。为了实现这一目标，我们将 1) 识别、招募、注册和每年对来自 3 个大型 HS 的 34 名患者进行活检，为超过 51,996 名 CKD 和糖尿病患者提供服务，和/或高血压并纵向跟踪患者； 2) 实施道德合理、系统化的质量保证从 CKD 患者获取临床和人口数据、生物样本和肾活检的流程纵向临床研究； 3) 制定并实施以患者为中心的流程，以促进长期 KPMP 中研究参与者的参与度和保留率。我们作为招聘网站的成功记录从糖尿病或高血压导致的 CKD 患者身上获取肾组织，来源广泛、多样化患者群体使我们成为继续开展 KPMP 的理想场所。我们有能力招募患者多个卫生系统拥有新颖的信息学工具、一种符合伦理的严格的肾脏同意方法活检与严格、安全的方法相结合是我们为 KPMP 带来的强大组合。我们的该 FOA 的创新方法不仅会提供数据来生成新知识，以改善 CKD 的诊断和治疗，同时也可以作为未来肾脏精准医学计划的典范随着时间的推移它们的扩张。