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

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

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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.

项目摘要摘要当前对启动CKD和的病理生理和社会经济过程的理解他们发展到ESRD的路径知之甚少，导致治疗有限。有一个对前瞻性研究的迫切需求未满足，以便使用组合准确地患有CKD的表型患者肾脏活检，临床，生物学和社会经济因素以发展个性化护理以改善患者结果。在过去的四年中，在地方一级，我们组建了一个高技能的跨学科团队临床研究人员，医师科学家，临床医生，研究护士，倡导者和社区顾问委员会。该团队设计，实施和维持一个非常成功，合理和安全的团队肾脏精密医学项目的招聘现场（RS）：1）我们执行了第一个毕马白财团肾脏活检于2019年9月，是该财团中的第一批肾脏活检，进行30次肾脏活检，成功地招募患有高血压或糖尿病性慢性肾脏疾病的临床诊断患者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）我们将努力集中在非洲 - 美国和拉丁裔人口的率很高，以解决CKD的不成比例负担以及历史上缺乏将这些人群纳入Cljnical研究，由NIH授权，完成在这些群体中，有11个活检中有22人（73％）。在联盟一级，我们的团队成员已经做出了毕马威会计师事务所的主要组织和运营方面的有意义的贡献。该提案的主要目标是人口识别，招募患者和获得临床表型数据，生物样本和肾脏活检。为了实现这一目标，我们将1）确定，招募，注册和活检每年34名来自3个大型HS的患者，可为51,996例CKD和糖尿病患者提供服务和/或高血压并纵向关注患者； 2）实施道德上的，系统的质量保证获取临床和人口统计数据的过程，来自CKD患者的生物样本和肾脏活检纵向临床研究； 3）开发和实施以患者为中心的过程以促进长期 KPMP研究参与者的参与和保留。我们成功的记录作为招聘网站从糖尿病患者中从糖尿病或高血压中采购肾脏组织患者群体使我们成为毕马威会计师事务所继续的理想场所。我们从中招募患者的能力具有新型信息学工具的多个卫生系统，一种在道德上严格的肾脏同意方法活检和严格安全的方法是我们带给毕马威会计师事务所的强大组合。我们的对此FOA的创新方法不仅将提供数据来生成新知识，以改善这两种知识 CKD的诊断和治疗，但也可以作为未来肾脏精密医学计划的模型和随着时间的流逝，他们的扩展。