Preparing for Blood-Based Alzheimer’s Disease Biomarker Testing in Diverse Populations: Development of a Decision-Support Tool for Primary Care

项目总结/摘要 这份职业发展计划旨在为Fred凯彻姆，医学博士，博士提供必要的 培训成为一个独立的临床医生，科学家制定干预措施，以改善决策， 制定和沟通临床前生物标志物检测，以满足不同人群的需求 阿尔茨海默病和相关痴呆症（ADRD）患者。凯彻姆医生将在他的 现有的定性研究和医学沟通技能，以获得额外的技能，1）用户- 基于医疗保健系统工程方法的集中设计和实施; 2）设计 对不同种族和民族的人群进行行为干预的临床试验; 3)决策科学培训。作为一个早期的职业研究员， 基础设施，以支持早期阶段的调查人员和承诺的专家导师，凯彻姆博士是在一个 理想的环境，以完成拟议的研究和培训。 该提案旨在开发和试点测试干预措施，以支持有关血液的决策 在初级保健环境中进行生物标志物检测。血液生物标志物的快速发展，以筛选 临床前阿尔茨海默病是解决阿尔茨海默病的破坏性后果的重要一步。 通过减少诊断延误，扩大不同人群的可及性， 使疾病改善疗法能够更早地开始。血液生物标志物检测预计将在 主要由初级保健提供者（PCP）使用，他们对筛查，诊断， 以及对有认知障碍的病人进行转诊。然而，关于测试的决定是复杂的， 迫切需要支持PCP及其患者之间的决策，以解决PCP与患者之间的差距， 生物标志物的未来可用性以及PCP对常规诊断决策的整合， 推进NIA的战略优先事项，制定有效的干预措施，以解决年龄负担， 相关疾病如ADRD。目标1旨在描述与临床相关的决策过程 评估认知投诉，并确定患者和PCP的决策支持需求。 目标2将采用血液生物标志物检测的决策支持工具，用于以下诊断评估： 通过以用户为中心的设计过程，在不同人群中的PCP的认知投诉。目标3 将测试干预措施的可用性和可接受性，以及对共同决策的影响。这些 数据将支持在本裁决结束时提交R 01提案，以确定 关于临床前血液生物标志物检测的共享决策的决策支持工具 老年痴呆症在一个大的国家样本。

PROJECT SUMMARY/ABSTRACT This career development proposal is designed to provide Fred Ketchum, MD, PhD, with the necessary training to become an independent clinician-scientist developing interventions to improve decision- making and communication about preclinical biomarker testing that are inclusive to the needs of diverse patients with Alzheimer’s Disease and Related Dementias (ADRD). Dr. Ketchum will build upon his existing skills in qualitative research and medical communication to acquire additional skills in 1) user- centered design and implementation based on healthcare systems engineering approaches; 2) design and conduct of clinical trials of behavioral interventions with racially and ethnically diverse populations; 3) training in decision sciences. As an early-career researcher at an institution with an extensive infrastructure to support early-stage investigators and committed expert mentors, Dr. Ketchum is in an ideal environment to complete the proposed research and training. This proposal seeks to develop and pilot test an intervention to support decision-making about blood biomarker testing in primary care settings. Rapid advances towards blood biomarkers to screen for preclinical Alzheimer’s Disease are a major step towards addressing the devastating consequences of this condition by reducing diagnostic delays, broadening access for diverse populations, and ultimately allowing disease modifying therapies to be started sooner. Blood biomarker testing is expected to be used heavily by Primary Care Providers (PCPs), who make initial decisions about screening, diagnosis, and referral for patients with cognitive complaints. However, decisions about testing are complex, and there is a crucial need to support decisions among PCPs and their patients to address the gap between the future availability of biomarkers and integration into routine diagnostic decisions by PCPs, thereby advancing NIA’s strategic priority of developing effective interventions to address the burden of age- related diseases like ADRD. Aim 1 seeks to characterize decision-making processes related to clinical evaluations for cognitive complaints and identify decision-support needs among patients and PCPs. Aim 2 will adapt a decision-support tool for blood biomarker testing for use in diagnostic evaluations of cognitive complaints by PCPs in diverse populations through a user-centered design process. Aim 3 will test usability and acceptability of the intervention, and effects on shared decision-making. These data will support submission of an R01 proposal at the end of this award to determine the effects of the decision support tool on shared decision-making about blood biomarker testing in preclinical Alzheimer’s Disease in a large national sample.