Novel Approaches to Identifying and Engaging Disadvantaged Patients with Alzheimer’s Disease (AD) in Clinical Research

项目概要/摘要 尽管阿尔茨海默病（AD）的患病率、发病率、诊断、治疗 和死亡率，来自弱势背景的个人（例如种族/少数民族）不成比例地 在临床AD研究中的代表性不足。目前AD研究的招募方法主要是确定 来自门诊诊所和社区环境的患者，或已有诊断的患者。依赖这些 招聘方法可能会对弱势个人的参与造成障碍，因为这些方法更加复杂， 可能缺乏关于AD服务的信息，未被诊断，并且获得门诊治疗的机会有限。然而， 迫切需要更多的弱势个体进入AD研究，以实现国家目标， AD研究。在急性护理环境中进行有针对性的AD筛查和量身定制的招募具有很强的潜力， 解决这些差距，因为弱势个人往往依赖这些环境来满足他们的健康需求。这 K76提案旨在提供Gilmore-Bykovskyi博士，他是一位接受过老年科培训的护士和AD专家 症状管理与成功所需的培训，作为一个独立的临床医生，科学家专注于 改善AD识别，促进更多参与研究和获得有效护理， 特别是针对高危弱势群体的治疗。的首要目标 建议的研究是设计筛选和招募方法，以识别和吸引 在急性护理环境中进行的研究中，处于不利地位的AD患者/护理人员及其亲生子女。的 一项提案包括使用电子健康记录（EHR）验证AD的表型模型 初步研究中确定的临床数据（目标1），以及该型号的性能规范 （目标1a）。为了解决从急性护理环境中招募的问题， 方法策略将告知适合急性护理的定制招募方法的设计 (Aim 2）将在30名AD患者/护理人员中进行试点，以确定其可行性、可接受性 以及对试验登记研究入组意愿的初步影响（目标2a）。作为一名初级教员， 该机构为早期研究人员提供广泛支持，并在AD差异方面拥有重要的基础设施 Gilmore-Bykovskyi博士在一个理想的环境中完成了拟议的研究 并追求与其职业目标相关的高级培训。Gilmore-Bykovskyi博士的职业发展计划 整合教学和实践培训，个人辅导和指导的研究活动，在1） 临床试验设计，2）先进的统计和机器学习技术，3）急性护理研究，4）AD健康 差距，5）招募和留住弱势群体和6）领导。这一提议的裁决 解决根本的差距和障碍，以改善弱势个人纳入AD研究 同时提供培训和指导研究，这对吉尔摩-贝科夫斯基博士领导一个独立的 临床AD研究的研究计划。

PROJECT SUMMARY/ABSTRACT Despite well-documented disparities in Alzheimer’s disease (AD) prevalence, incidence, diagnosis, treatment, and mortality, individuals from disadvantaged backgrounds (e.g. racial/ethnic minorities) are disproportionately under-represented in clinical AD research. Current recruitment methods for AD research predominantly identify patients from outpatient clinics and community settings, or with pre-existing diagnoses. Reliance on these recruitment approaches may create barriers to participation for disadvantaged individuals as they are more likely to lack information about AD services, be undiagnosed and have limited access to outpatient care. Yet, greater enrollment of disadvantaged individuals into AD studies is critically needed to achieve national goals for AD research. Targeted AD screening and tailored recruitment within acute care settings has strong potential to address these gaps, as disadvantaged individuals often rely on these settings to meet their health needs. This K76 proposal is designed to provide Dr. Gilmore-Bykovskyi, PhD, a geriatric trained nurse and expert in AD symptom management with the training required for success as an independent clinician-scientist focused on improving AD identification to promote greater participation in research and access to effective care and therapies, specifically targeting high-risk disadvantaged populations. The overarching objective of the proposed research is to design screening and recruitment approaches for identifying and engaging disadvantaged AD patients/caregivers and their biological children in research from acute care settings. The proposal consists of validation of an electronic health record (EHR) Phenotype Model for AD using EHR clinical data identified in preliminary studies (Aim 1), and specification of this Model for performance among disadvantaged individuals (Aim 1a). To address recruitment from acute care environments, mixed methods strategies will inform the design of tailored recruitment approaches appropriate to acute care (Aim 2) which will be piloted with 30 AD patients/caregivers to determine their feasibility, acceptability and preliminary impact on willingness to enroll in a Trial Registry (Aim 2a). As a junior faculty member at an institution with extensive support for early stage investigators and significant infrastructure in AD disparities and EHR Phenotyping, Dr. Gilmore-Bykovskyi is in an ideal environment to complete the proposed research and pursue advanced training relevant to her career goals. Dr. Gilmore-Bykovskyi’s career development plan integrates didactic and practical training, individual mentoring and mentored research activities in the areas of 1) clinical trial design, 2) advanced statistical and machine learning techniques, 3) acute care research, 4) AD health disparities, 5) recruitment and retention of vulnerable populations and 6) leadership. This proposed award addresses fundamental gaps and barriers to improve inclusion of disadvantaged individuals in AD research while affording training and mentored research critical for Dr. Gilmore-Bykovskyi to lead an independent research program in clinical AD research.