Genomic Medicine Pilot For Hypertension And Kidney Disease In Primary Care

初级保健中高血压和肾脏疾病的基因组医学试点

• 批准号: 9091594
• 负责人: Carol R Horowitz
• 金额: $ 104.03万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-16 至 2019-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9091594
• 关键词: Address; Adopted; Adoption; Adult; Affect; African; African American; Albuminuria; Alleles; American; Angiotensins; Area; Attitude; Belief; Blood; Caring; Chromosomes, Human, Pair 22; Chronic Disease; Chronic Kidney Failure; Clinical; Clinical Decision Support Systems; Cluster randomized trial; Communities; Community Health Centers; Computerized Medical Record; Consent; Counseling; Diabetes Mellitus; Diagnostic; Disease Progression; End stage renal failure; Family; Family health status; Genomic medicine; Genomics; Health; Hypertension; Institutes; Institution; Kidney; Kidney Diseases; Kidney Failure; Knowledge; Medical center; New York City; Onset of illness; Outcome; Patient-Focused Outcomes; Patients; Pharmacogenomics; Pilot Projects; Population; Practice Guidelines; Primary Health Care; Probability; Process; Protocols documentation; Provider; Recording of previous events; Renin; Risk; Risk Factors; System; Technology; Testing; Translating; Urine; base; blood pressure regulation; cardiovascular risk factor; clinical care; clinical risk; disorder risk; end stage disease; evidence base; exome; experience; genome sequencing; health disparity; high risk; improved; insight; modifiable risk; non-diabetic; personalized medicine; point of care; primary care setting; programs; prospective; prototype; randomized trial; screening; tumor; underserved minority

DESCRIPTION (provided by applicant): Robust systems to consent, screen, return results, and to evaluate processes and outcomes of incorporating genomic risk information in clinical care for common chronic diseases are missing and urgently needed. We propose that hypertension-associated CKD in African ancestry communities has emerged as a highly relevant and well-suited opportunity for a 'prototype' genomic medicine demonstration project that addresses common chronic illnesses managed in primary care settings. African ancestry populations with hypertension (HTN) have 2- to 3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage renal disease (ESRD) when compared with whites. Recent discoveries demonstrate that testable alleles of the APOL1 locus on chromosome 22 have a major effect on and explain almost all of the excess risk for hypertension-associated CKD and its progression to ESRD in African ancestry populations. In this genomic medicine demonstration pilot project, we plan to implement a cluster randomized trial at primary care facilities of a network of community health centers in Harlem and the Bronx and at Mount Sinai Medical Center. The trial will test whether the desperately low probabilities of correct renal care i.e. appropriate ordering of tests to evaluate CKD and CKD progression, appropriate prescription of renoprotective renin angiotensin blockade, appropriate control of blood pressure in hypertensive patients with albuminuria of African ancestry, will be improved significantly in those facilities that receive EMR-enabled renal care CDS incorporating APOL1 genomic risk information compared with those facilities that receive renal care CDS based on conventional risk information only. The project will have three Specific Aims: 1) Understand knowledge, attitudes, beliefs about testing for APOL1, returning results, and engaging people of African ancestry and their clinicians into a process of testing, counseling and appropriate clinical care. 2) Develop systems and evidence-based advice messages to enable point of care Clinical Decision Support (CDS) for primary care providers advising renal care practice guidelines with our without genomic APOL1 risk information. 3) Conduct a cluster randomized trial assigning eight distinct primary care facilities to receive either renal care CDS with APOL1 genomic risk information (GENOMIC RENAL CARE FACILITY) or with conventional risk information (CONVENTIONAL RENAL CARE FACILITY) to guide primary care for non-diabetic African Americans with hypertension. In the long-term, the proposed genomic medicine demonstration pilot project is expected to generate essential new insights for sustainable adoption and large-scale dissemination of genomic medicine in diverse clinical settings providing care for common adult-onset diseases in general, and for underserved African Ancestry populations with large excess burden of non-diabetic kidney diseases specifically.

描述（由申请人提供）：稳健的系统以同意，筛选，返回结果以及评估将基因组风险信息纳入常见慢性病的临床护理中的过程和结果，并紧急需要。我们建议，非洲血统社区中与高血压相关的CKD已成为一个非常相关且非常合适的机会，用于“原型”基因组医学示范项目，该项目解决了在初级保健环境中管理的常见慢性疾病。高血压（HTN）的非洲血统人群患CKD的风险高2至3倍，与白人相比，进步到终点肾脏疾病（ESRD）的风险增加了5倍。最近的发现表明，22号染色体上APOL1基因座的可检验等位基因对高血压相关CKD的几乎所有过量风险及其在非洲血统人群中的ESRD的进展几乎具有重大影响。在这个基因组医学示范试点项目中，我们计划在哈林和布朗克斯和西奈山医疗中心的社区卫生中心网络的初级保健设施中实施集群随机试验。该试验将测试正确的肾脏护理的急切概率，即适当的测试订购以评估CKD和CKD的进展，适当的处方，适当的处方肾上腺肾素血管紧张素阻止，适当控制非洲祖先的高血压患者血压的适当控制在非洲祖先的高血压患者中，这些设施将在这些设施中得到显着改善，这些设施将在这些设施中得到高度改进，以使Emr-neprabil 1 Appics Inform Appics Informient Informient Informient Informient Informient Informient Informient Informient Appics Informics Informient Informient Informient Informient Appic consemic consign nopicabil 1肾脏护理CD仅基于常规风险信息。 该项目将具有三个具体的目标：1）了解知识，态度，对APOL1测试的信念，返回结果以及使非洲血统及其临床医生的人们参与测试，咨询和适当的临床护理过程。 2）开发系统和基于证据的建议信息，以启用护理点临床决策支持（CD），以使用我们没有基因组APOL1风险信息的肾脏护理实践指南的初级保健提供者。 3）进行一项群集随机试验，分配了八个不同的初级保健设施，以接收具有APOL1基因组风险信息（基因组肾脏护理设施）或传统风险信息（常规肾脏护理设施）的肾脏护理CD，以指导非糖尿病的非糖尿病非裔美国人患有高血压。从长远来看，拟议的基因组医学示范试点项目有望在各种临床环境中为可持续的采用和大规模传播基因组医学的新见解，从而为一般的成人疾病提供护理，并为一般不服务的非洲祖先群体提供，而非糖尿病的非洲祖先群体具有非糖尿病的非糖尿病责任。