Caregivers' Reactions and Experience: Imaging Dementia Evidence for Amyloid Scanning CARE IDEAS

摘要 据估计，2015年有530万美国人患有阿尔茨海默病(AD)。 除非有科学创新，否则 有多少美国人患有 预计到2025年，广告将增加到700万以上，并 到2050年将达到1380万人。 在……里面 2013年，医疗保险和医疗补助服务中心(CMS)确定，淀粉样蛋白PET扫描将是 在CMS证据保险政策和成像痴呆症-淀粉样蛋白证据下覆盖 建立扫描(IDEAS)研究。IDEAS研究淀粉样蛋白PET扫描如何引导医生 诊断阿尔茨海默病和其他痴呆，在疾病进展的早期，原因不明，导致 临床管理的变化。计划于年初开始招募18,500名联邦医疗保险受益人 2016年，正在提出对丰富的临床数据进行补充研究。因此，在全力支持下， IDEAS执行委员会和阿尔茨海默氏症协会，我们建议5年照顾者反应 和经验-想法补充研究(关怀想法)。它将填补我们在理解上的重要空白 作为照料者/倡导者的配偶和患者对淀粉样蛋白PET扫描结果的反应。我们 建议在基线(电话)、6-9个月(电话和网络)和18个月(电话)a进行招聘和面试 3500名符合联邦医疗保险资格的患者及其符合联邦医疗保险资格的配偶的样本 IDEAS通过阳性和阴性淀粉样蛋白PET扫描进行研究。使用《国民健康与老龄化趋势》 研究作为调查的核心，我们将询问患者的社会环境、行为后果 记忆缺陷以及他们如何以及为什么试图通过淀粉样蛋白PET确认AD的诊断。我们还将 描述配偶的健康素养、他们支持系统的广度和复原力以及他们的参与 进行正电子发射计算机断层扫描。使用这些调查数据与IDEAS临床和联邦医疗保险索赔数据合并，我们将： (目标1)评估淀粉样蛋白PET扫描阳性与患者接受医疗保险的关系 已报销AD相关诊断测试和医疗保健费用，控制选定患者和 配偶特征。第二，我们将(目标2)评估初级保健一体化的影响和 在收到医疗保险报销的AD时与患者的早期诊断测试经验接触 未来几年的相关诊断测试和医疗支出；第三，(目标3)我们将评估影响 关于患者在随访时参与护理和生活规划的淀粉样PET扫描结果(即完成 高级指令、更改医疗计划和进行遗产规划)，控制患者 和配偶特征。第四，(目标四)我们将评估患者的检测结果对配偶的影响 抑郁症状和精神卫生服务使用情况。最后，(目标5)我们将使用基于网络的调查和 在登记后6至9个月跟踪电话，以确定医疗保健的中间变化 使用，生活规划和其他调整患者和配偶归因于听力和理解他们的 淀粉样蛋白PET扫描测试结果。

ABSTRACT An estimated 5.3 million Americans have Alzheimer's Disease (AD) in 2015. Barring scientific innovations, the number of Americans with AD is expected to increase to over 7 million by 2025 and to 13.8 million by 2050. In 2013 the Centers for Medicare and Medicaid Services (CMS) established that amyloid PET scans would be covered under the CMS Coverage with Evidence policy and the Imaging Dementia – Evidence for Amyloid Scanning (IDEAS) study was established. IDEAS examines how amyloid PET scans can guide doctors in diagnosing AD and other dementias, early in disease progression, where the cause is ambiguous, leading to changes in clinical management. With recruitment of 18,500 Medicare beneficiaries scheduled to begin in early 2016, supplemental studies expanding on the rich clinical data are being proposed. Thus, with full support of the IDEAS Executive Committee and the Alzheimer's Association, we propose the 5 year Caregiver Reactions and Experiences – IDEAS supplemental study (CARE IDEAS). It will fill important gaps in our understanding of how spouses serving as caregivers/advocates and patients react to the results of amyloid PET scans. We propose to recruit and interview, at baseline (phone), 6-9 months (phone and web), and 18 months (phone) a sample of 3500 Medicare eligible patients and their Medicare eligible spouses from among patients in the IDEAS study with positive and negative Amyloid PET scans. Using the National Health and Aging Trends Study as the survey core, we will ask patients' about their social circumstances, behavioral consequences of memory deficits and how and why they sought to confirm a diagnosis of AD via amyloid PET. We will also characterize spouses' health literacy, the breadth and resiliency of their support system and their involvement in seeking a PET scan. Using these survey data merged with IDEAS clinical and Medicare claims data, we will: (Aim 1) estimate the relationship between a positive Amyloid PET scan and patients' receipt of Medicare reimbursed AD related diagnostic tests and health care expenditures, controlling for selected patient and spouse characteristics. Second, we will (Aim 2) estimate the effect of primary care integration and engagement with patients' earlier diagnostic testing experience on the receipt of Medicare reimbursed AD related diagnostic tests and health care expenditures in future years; Third, (Aim 3) we will estimate the effect of amyloid PET scan results on patients' participation in care and life planning at follow-up (i.e. completing advanced directives, altered medical treatment plans and undertaking estate planning), controlling for patient and spouse characteristics. Fourth, (Aim 4) we will estimate the effect of the patients' test results on spouses' symptoms of depression and mental health service use. Finally, (Aim 5) we will use a web-based survey and follow up phone calls at 6 to 9 months post-enrollment to characterize intermediate changes in medical care use, life planning and other adjustments patients and spouses attribute to hearing and understanding their amyloid PET scan test results.