NIA AD/ADRD Health Care Systems Research Collaboratory

项目摘要 超过500万美国人患有阿尔茨海默病（AD）或AD相关痴呆症（AD/ADRD）。这些高- 需要，高成本的患者容易接受质量差，不协调的护理，最终导致 不良的健康结果、生活质量差和资源滥用。正如联邦政府最近得出的结论- 资助的痴呆症护理研究峰会，改善残疾人及其CG的护理是一项紧迫的公共卫生 必须通过高质量的证据来应对和了解这些挑战。虽然先前的研究已经阐明了 改善残疾人及其CG护理的机会，采取有希望的干预措施， 由于缺乏研究评估其在“现实世界”条件下实施的有效性而受阻。 嵌入医疗系统（HCS）的实用临床试验（ePCT）有可能加速 将循证干预措施转化为临床实践。自2012年成立以来，NIH Common 基金HCS研究合作实验室为推进ePCT的开展做出了关键贡献。 然而，正如在2017年NIA主办的会议上得出的结论，对PWD及其CG进行的ePCT 值得特别关注的独特考虑因素。因此，本提案的总体目标是在 美国国立卫生研究院合作实验室建立国家老龄化研究所（NIA）AD/ADRD研究的模式 合作实验室，由多个主要研究者（MPI）共同领导，Vince莫尔博士（布朗大学）和Susan 米切尔（希伯来老年生活（HSL））和共同管理的各自机构。目标是：1.到 建立AD/ADRD协作实验室的基础设施，2.制定和传播 与HCS合作，在残疾人及其CG中开展ePCT的各个方面，3。加强研究 发展和研究者能力，在HCS内对PWD及其CG进行ePCT，以及4.到 传播知识和最佳做法，让利益攸关方参与这项研究。已完成的研究者 来自全国各地的领导将领导以下工作组核心：1。技术和数据（B），J. Bynum，MD， MPH; 2.监管与伦理（C），J. Karlawish，MD; 3.设计与统计（D），H. 4.第四章试点研究 (E)、白花野牡丹A. Brody，PhD，RN; 5.患者和CG报告的结局（F），L。Hanson，MD，MPH; 6.传播和 实施（G）、L. Gitlin，PhD/J. Gaugler，PhD; 7. HCS（H）：E. Larson，MD，MPH，and Training（I）：C. 卡拉汉医学博士Torke MD.行政核心（A）将整合协作实验室的所有关键职能。 影响：迫切需要改善HCS为残疾人及其CG提供的护理。开展的ePCT 非常适合测试旨在改善其健康结果的干预措施的有效性，但需要 具体的专业知识、方法、数据来源和行业合作伙伴关系。知识，调查 AD/ADRD合作实验室产生的经验、合作和证据有可能改变 为来自各种背景的AD/ADRD及其CG的美国人提供护理的交付，质量和结果。

PROJECT SUMMARY Over five million Americans have Alzheimer's disease (AD) or an AD-related dementia (AD/ADRD). These high- need, high-cost patients are vulnerable to receiving poor quality, uncoordinated care, ultimately leading to adverse health outcomes, poor quality of life, and misuse of resources. As recently concluded by the federally- funded Research Summit on Dementia Care, improving the care of PWD and their CGs is an urgent public health challenge that must be met and informed by high quality evidence. While prior research has elucidated opportunities to improve the care of PWD and their CGs, the adoption of promising interventions has been stymied by the lack of research evaluating their effectiveness when implemented under “real-world” conditions. Pragmatic clinical trials embedded (ePCTs) in healthcare systems (HCS) have the potential to accelerate the translation of evidence-based interventions into clinical practice. Since its inception in 2012, the NIH Common Fund HCS Research Collaboratory has made pivotal contributions towards advancing the conduct of ePCTs. However, as concluded in a 2017 NIA-sponsored conference, ePCTs conducted with PWD and their CGs have unique considerations that merit specific focus. Thus, the overarching objective of this proposal is to build on the model of the NIH Collaboratory to establish the National Institute on Aging (NIA) AD/ADRD Research Collaboratory, co-led by the multiple principal investigators (MPIs), Drs. Vince Mor (Brown University) and Susan Mitchell (Hebrew SeniorLife (HSL)) and co-administered by their respective institutions. The Aims are: 1. To establish the infrastructure of the AD/ADRD Collaboratory, 2. To develop and disseminate guidelines for the conduct of all aspects of ePCTs among PWD and their CGs in partnership with HCS, 3. Enhance research development and investigator capacity to conduct ePCTs in PWD and their CGs within HCS, and 4. To disseminate knowledge and best practices to engage stakeholders in this research. Accomplished investigators from across the nation will lead the following Working Group Cores: 1. Technical and Data (B), J. Bynum, MD, MPH; 2. Regulation and Ethics (C), J. Karlawish, MD; 3. Design and Statistics (D), H. Allore, PhD; 4. Pilot Studies (E), A. Brody, PhD, RN; 5. Patient and CG Reported Outcomes (F), L. Hanson, MD, MPH; 6. Dissemination and Implementation (G), L. Gitlin, PhD/J. Gaugler, PhD; 7. HCS (H): E. Larson, MD, MPH, and Training (I): C. Callahan MD/A. Torke MD. An Administration Core (A) will integrate all critical functions across the Collaboratory. IMPACT: There is an urgent need to improve care provided by HCS for PWD and their CGs. ePCTs conducted are ideally-suited to test the effectiveness of interventions aimed at improving their health outcomes but require specific expertise, methodology, data sources, and industry partnerships. The knowledge, investigative experience, collaborations, and evidence generated by an AD/ADRD Collaboratory has the potential to transform the delivery, quality, and outcomes of care for Americans from all backgrounds with AD/ADRD and their CGs.