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

为不同人群进行基于血液的阿尔茨海默病生物标志物测试做好准备：开发初级保健决策支持工具

• 批准号: 10722716
• 负责人: Fred Ketchum
• 金额: $ 13.76万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10722716
• 关键词: Address; Alzheimer disease detection; Alzheimer' s Disease; Alzheimer' s disease diagnosis; Alzheimer' s disease patient; Alzheimer' s disease related dementia; Alzheimer’s disease biomarker; American; Attitude; Award; Behavior Therapy; Biological Markers; Blood; Blood Tests; Caring; Characteristics; Clinical; Cognitive; Communication; Complex; Conduct Clinical Trials; Data; Decision Making; Development; Diagnosis; Diagnostic; Disease; Disparity; Doctor of Philosophy; Early Diagnosis; Elderly; Engineering; Environment; Ethics; Evaluation; Face; Focus Groups; Future; Goals; Grant; Healthcare; Healthcare Systems; Impaired cognition; Infrastructure; Institution; Intervention; Interview; Medical; Memory; Memory Loss; Mentors; Methods; Modification; Neurobehavioral Manifestations; Neurologist; Outcome; Participant; Pathologic; Patient Care; Patient-Focused Outcomes; Patients; Pattern; Performance; Phase; Pilot Projects; Population; Population Heterogeneity; Primary Care; Process; Qualitative Research; Research; Research Personnel; Risk; Sampling; Science; Scientist; Specialist; Structure; Surveys; Testing; Training; Work; age related; behavioral clinical trial; blood-based biomarker; care systems; career; career development; clinical encounter; design; effective intervention; ethnic diversity; ethnic minority; ethnic minority population; experience; follow-up; improved; minority patient; pilot test; pre-clinical; preference; primary care practice; primary care provider; primary care setting; primary outcome; prodromal Alzheimer' s disease; psychosocial; racial diversity; racial minority; racial minority population; recruit; research clinical testing; screening; shared decision making; simulation; skills; social; support tools; tool; usability; user centered design

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.

项目摘要/摘要 这份职业发展建议旨在为弗雷德·凯彻姆医学博士提供必要的 培训成为一名独立的临床医生-科学家，开发干预措施以改善决策 关于临床前生物标记物检测的制定和沟通，以满足不同群体的需求 阿尔茨海默病和相关痴呆患者(ADRD)。凯彻姆博士将在他的基础上 在定性研究和医学沟通方面的现有技能，以获得1)用户的额外技能- 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。作为一名职业生涯早期的研究员，在一家拥有广泛 基础设施，以支持早期调查人员和坚定的专家导师，凯彻姆博士处于 理想的环境是完成拟议研究和培训的理想环境。 这项提案旨在开发和试点一种干预措施，以支持有关血液的决策 初级保健环境中的生物标记物检测。血液生物标志物筛选的快速进展 临床前阿尔茨海默病是朝着解决阿尔茨海默病破坏性后果迈出的重要一步 通过减少诊断延迟，扩大不同人群的访问范围，最终 使疾病改良疗法能够更快地开始。血液生物标志物检测预计将是 由初级保健提供者(PCP)大量使用，他们做出关于筛查、诊断、 以及对有认知障碍的患者的转介。然而，关于测试的决定是复杂的，而且 迫切需要支持初级保健医生和他们的患者之间的决定，以解决 未来生物标记物的可获得性和纳入初级保健医生的常规诊断决策，从而 推进NIA的战略优先事项，即开发有效的干预措施，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，并确定患者和初级保健医生的决策支持需求。 AIM 2将调整用于血液生物标记物检测的决策支持工具，用于诊断评估 不同人群中的PCP通过以用户为中心的设计流程进行认知投诉。目标3 将测试干预的可用性和可接受性，以及对共享决策的影响。这些 数据将支持在本奖项结束时提交R01提案，以确定 临床前血液生物标志物检测共享决策支持工具 阿尔茨海默氏症在一个大的国家样本中。