Tools to Optimize Patient Presentation Speed after Onset of Exudative Macular Deg

渗出性黄斑脱位发生后优化患者就诊速度的工具

• 批准号: 7912553
• 负责人: Mark C Roser
• 金额: $ 51.37万
• 依托单位: RESULTS GROUP
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7912553
• 关键词: Address; Adherence; Adult; Advertising; Age; Age related macular degeneration; Appointment; Awareness; Blindness; Books; Businesses; Caring; Charge; Clinical Research; Communication; Data; Defect; Diagnosis; Disease; Disease Progression; Drops; Education; Effectiveness; Electronics; Elements; Ensure; Evaluation; Eye; Feedback; Focus Groups; Fostering; Glass; Gold; Group Interviews; Health Professional; Hearing; Home environment; Homes for the Aged; Individual; Injectable; Internet; Knowledge; Learning; Legal patent; Location; Macular degeneration; Measures; Medicare; Methods; Monitor; Newly Diagnosed; Ophthalmic examination and evaluation; Outcome; Pamphlets; Paper; Patient Education; Patient Preferences; Patient Schedules; Patients; Performance; Phase; Population; Principal Investigator; Printing; Provider; Quality of life; Regimen; Reporting; Research Design; Retinal; Risk; Sales; Schedule; Self Care; Sensitivity and Specificity; Series; Solutions; Speed; Spottings; Staging; Symptoms; Target Populations; Technology; Testing; Variant; Vision; Visit; Visual; Visual Acuity; Visual impairment; advanced disease; base; bevacizumab; clinical Diagnosis; compliance behavior; cost; experience; improved; macula; novel; outreach; patient population; phase 1 study; programs; prototype; public health relevance; research clinical testing; response; socioeconomics; standard of care; tool; usability; web site

DESCRIPTION (provided by applicant): Specific Aims: 1 - to refine a novel set of low cost patent pending interactive home AMD education and monitoring tools that combine tests evaluated favorably in Phase I together with additional novel tools currently in prototype. 2 - To clinically evaluate the effectiveness of these tools in reducing the delay between onset of symptoms and presentation, thus potentially minimizing vision loss. Significance: Macular degeneration is the leading cause of blindness in those over 60. New anti-VEGF treatments introduced in 2005 are effective if given early but patients typically wait for up to 5 months after the onset of symptoms to see a healthcare professional, leading to unnecessary vision loss. This results in incremental costs of care (which most often accrue to Medicare), a higher societal burden and lower patient quality of life. In earlier studies, we have identified critical reasons for patient delay and significant gaps in the current standard of care. Our solutions address the most significant reasons for patient delay in a cost-effective format capable of distribution to millions of patients, that, if successful, will accelerate presentation and minimize vision loss for a significant population of patients. Background: There are almost 10 million people with early AMD in the US, with the number expected to rise to 17.8 million by 2050. 2,3 of this population, 10 to 15% of dry patients will eventually convert to wet AMD.4 The conversion from dry to wet AMD can occur suddenly and has been historically difficult to recognize and respond to by patients. Delays in presentation of up to 5 months are common.8 In a recent study of patients with newly diagnosed wet AMD, the most common patient-cited reasons for delay were lack of confidence in symptoms, and a lack of appreciation of the urgency of the problem. The current gold standard of home monitoring, the Amsler Grid, developed in the 1940's, does not address the top reasons for delay, nor does it address the variety of symptoms that patients experience with advancing disease. New electronic technologies for improving home monitoring AMD have demonstrated sensitivity and specificity, but their cost and learning curve can limit broad-scale distribution. A solution is required that 1) addresses the multiple reasons for delay, 2) is low-cost and amenable to distribution across large populations, 3) includes multiple interactive elements that address patient compliance and individual needs, and 4) fosters appropriate and timely action. Research design and methods: 1) conduct focus group evaluation of current prototype tools. 2) Refine the prototypes based upon patient feedback. 3) Conduct a clinical evaluation of the performance of the novel tools, measuring drop in visual acuity prior to presentation after onset of wet AMD. If successful, tools will enable broad-scale outreach, reduce educational disparities, foster routine eye exams, help accelerate patient presentation, help reduce vision loss, and help lower the socioeconomic burden of AMD. PUBLIC HEALTH RELEVANCE: Age-related macular degeneration (AMD) is the leading cause of blindness in adults over the age of 60.1 New injectable treatments introduced in 2005 are effective if given early but patients typically wait for up to 5 months after the onset of symptoms to see a healthcare professional, leading to unnecessary vision loss. This results in incremental costs of care (which most often accrue to Medicare), a higher societal burden and lower patient quality of life. The current study refines a patent pending novel group of low cost tools and assesses their ability to reduce presentation delay.

具体目标：1 -改进一组新颖的低成本专利未决交互式家庭AMD教育和监控工具，其将在第I阶段中有利地评估的联合收割机测试与当前处于原型中的附加新颖工具组合在一起。2 -临床评估这些工具在减少症状发作和表现之间的延迟方面的有效性，从而可能最大限度地减少视力丧失。黄斑变性是60岁以上人群失明的主要原因。2005年引入的新的抗VEGF治疗如果早期给予是有效的，但患者通常在症状发作后等待长达5个月才能看到医疗保健专业人员，导致不必要的视力丧失。这导致医疗成本增加（通常由医疗保险承担），社会负担增加，患者生活质量降低。在早期的研究中，我们已经确定了患者延迟的关键原因以及当前护理标准的重大差距。我们的解决方案以具有成本效益的方式解决了患者延迟的最重要原因，能够分发给数百万患者，如果成功，将加速演示并最大限度地减少大量患者的视力丧失。背景：美国有近1000万人患有早期AMD，预计到2050年这一数字将增加到1780万。2，3在这一人群中，10%至15%的干性AMD患者最终会转化为湿性AMD。4干性AMD向湿性AMD的转化可能突然发生，并且患者历来难以识别和应对。在最近一项对新诊断的湿性AMD患者的研究中，患者最常见的延迟原因是对症状缺乏信心，以及缺乏对问题紧迫性的认识。目前家庭监测的黄金标准，即20世纪40年代开发的Amsler Grid，并没有解决延迟的主要原因，也没有解决患者在疾病进展中经历的各种症状。用于改善家庭监测AMD的新电子技术已经证明了灵敏度和特异性，但其成本和学习曲线可能限制大规模分布。需要一种解决方案，1）解决延迟的多种原因，2）成本低，适合在大量人群中分发，3）包括解决患者依从性和个人需求的多种互动元素，以及4）促进适当和及时的行动。研究设计和方法：1）对现有原型工具进行焦点小组评估。2)根据患者反馈完善原型。3)对新工具的性能进行临床评价，测量湿性AMD发作后出现之前的视力下降。如果成功，这些工具将能够实现广泛的推广，减少教育差距，促进常规眼科检查，帮助加速患者就诊，帮助减少视力丧失，并帮助降低AMD的社会经济负担。 公共卫生关系：视网膜相关性黄斑变性（AMD）是导致60岁以上成年人失明的主要原因。1 2005年推出的新的注射治疗方法如果早期使用是有效的，但患者通常在症状发作后等待长达5个月才去看医疗保健专业人员，导致不必要的视力丧失。这导致医疗成本增加（通常由医疗保险承担），社会负担增加，患者生活质量降低。目前的研究改进了一组正在申请专利的低成本工具，并评估了它们减少演示延迟的能力。