Manhattan Vision Screening and Follow-Up Study in Vulnerable Populations

曼哈顿视力筛查和弱势群体的后续研究

• 批准号: 10415024
• 负责人: Lisa A. Hark
• 金额: $ 70万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2023-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10415024
• 关键词: Manhattan; Vision; Screening; Follow; Up

Glaucoma is a chronic optic neuropathy resulting in visual field defects, progressive vision loss, and blindness. In the United States, glaucoma is the leading cause of blindness in African Americans. African Americans develop glaucoma at a younger age, progress more rapidly, and are almost 7 times more likely to go blind than non-Hispanic Whites. Rates of glaucoma are projected to increase by 50% to 3.36 million people by 2020. The increasing prevalence of glaucoma is expected to cause a significant economic and quality-of-life burden, therefore, we have designed the Manhattan Vision Screening and Follow-up Study in Vulnerable Populations, a cluster randomized controlled trial, to identify and implement innovative strategies to engage populations most at risk, most vulnerable, and least likely to have access to eye care. The study population is comprised of disadvantaged men and women ≥40 years old of diverse race/ethnicity (primarily African American and Hispanic/Latino), with high rates of inadequate eye care, living in affordable housing buildings in New York City. Participants randomized to Enhanced Intervention Using Patient Navigators Arm 1 (7 buildings) who fail the screening and need vision correction will receive free eye glasses. If they are referred to an ophthalmologist, they will receive enhanced support with patient navigators over 2 years to assist with all aspects of follow-up eye care, specifically appointment scheduling and arranging transportation to eye exams and cataract surgery. Participants randomized to the Usual Care Arm 2 (3 buildings) who fail the screening and need vision correction will be given an eye glasses prescription only and a list of optical shops. All participants who pass and/or fail the vision screening in both arms will be invited to the 12-month and 24-month vision screening, which will take place at the same housing buildings. We will follow participants prospectively for 2 years to evaluate the effects of the intervention on presenting visual acuity and health-related quality-of-life (primary outcome), adherence to follow-up eye care and cataract surgery (secondary outcome), falls risk and rates of falls (safety outcomes), and participants’ satisfaction following screenings. The aims of the study are: 1) Develop and implement an innovative, community-based vision screening and follow-up study where people live to increase engagement, detection and management of glaucoma, vision impairment, cataracts, and other eye diseases in vulnerable populations living in New York City affordable housing buildings; 2) Evaluate the effectiveness of an enhanced intervention using patient navigators to improve visual acuity, adherence to follow-up eye care and cataract surgery, and quality-of-life in vulnerable populations living in New York City affordable housing buildings; 3) Conduct an economic analysis of the costs and benefits of the proposed approaches to examine the cost of the screening and intervention, cost per case detected, and the cost- effectiveness of the Intervention vs. Usual Care Arms; and 4) Replicate, scale, and disseminate protocols, materials, and manuscripts.

青光眼是一种慢性视神经病变，导致视野缺损、进行性视力丧失和失明。 在美国，青光眼是非洲裔美国人失明的主要原因。非裔美国人 患青光眼的年龄更小，进展更快，失明的可能性几乎是普通人的7倍。 非西班牙裔白人到2020年，青光眼的发病率预计将增加50%，达到336万人。的 青光眼发病率的增加预计会引起显著的经济和生活质量负担， 因此，我们设计了曼哈顿视力筛查和随访研究， 人群，一项群集随机对照试验，以确定和实施创新策略， 风险最高、最脆弱、最不可能获得眼科护理的人群。研究人群 由不同种族/民族（主要是非洲人）的≥40岁的弱势男性和女性组成 美国人和西班牙裔/拉丁美洲人），眼睛护理不足的比例很高，居住在 纽约市。受试者被随机分配至使用患者导航器的增强干预组1（7栋建筑） 未能通过甄别而需要矫正视力的人士，可获免费配眼镜。如果他们被称为一个 眼科医生，他们将在2年内获得患者导航员的增强支持，以协助所有 后续眼科护理方面，特别是预约安排和安排眼科检查的交通 和白内障手术筛选失败的受试者被随机分配到第2组（3栋建筑物）， 需要矫正视力者，只获配眼镜处方及眼镜店名单。所有参与者 通过和/或未通过两组视力筛查的患者将被邀请参加12个月和24个月的视力检查 检查将在同一栋住房楼进行。我们将前瞻性地跟踪参与者2 年，以评估干预对视力和健康相关生活质量的影响 （主要结局）、随访眼部护理和白内障手术的依从性（次要结局）、福尔斯风险和 福尔斯率（安全性结果）和参与者在筛查后的满意度。这项研究的目的是： 1)制定和实施一项创新的、以社区为基础的视力筛查和随访研究， 提高青光眼、视力障碍、白内障和其他疾病的参与、检测和管理 生活在纽约市经济适用房建筑中的弱势群体的眼病; 2）评估 使用患者导航器改善视力的增强干预的有效性， 随访眼科护理和白内障手术，以及生活在纽约市的弱势群体的生活质量 （3）对拟议的住房建设的成本和效益进行经济分析; 检查筛查和干预费用、每个发现病例的费用以及 干预与家庭护理组的有效性;以及4）复制、扩展和传播方案， 材料和手稿。