EVALUATING ALTERNATE RETINOPATHY SCREENING INTERVENTIONS

糖尿病视网膜病变是严重的，昂贵的和普遍的，特别是在少数民族人群中。每年的眼科检查和适当的后续护理将大大节省可预防的视力丧失，医疗保健费用和生产力损失。然而，大多数人没有得到这些服务。在我们之前的研究中，我们使用多组分干预使低收入非洲裔美国人的眼科检查率增加了一倍。我们现在建议在更广泛的糖尿病人群中，包括讲西班牙语的患者，评估该干预措施的增量效应和成本。拟议研究的具体目标是：1）测试定制电话干预将导致比标准打印干预更高的眼科检查率的假设; 2）提高对人们接受眼科检查的原因的理解，并评估亚组中的差异（性别和西班牙语偏好）; 3）提高对诊断患有糖尿病眼病的人接受或不接受推荐的后续治疗的原因的理解;以及4）进行成本效益分析。研究设计是一项随机、对照、设盲的干预试验;个体是采样、分配和分析的单位。将从两个大型城市卫生系统的数据库中抽取800名1型或2型糖尿病患者，他们在过去一年中没有进行过散瞳检查。在确定合格性并获得书面知情同意书后，患者将在研究中心内按性别和首选语言（西班牙语或英语）随机分配至定制电话组或标准打印组。样本量的确定是基于具有足够的功效以在p<0.05的显著性水平下检测组间差异。主要研究结局将是在随机化后6个月接受散瞳眼科检查（通过病历摘要确定），并在随机化后18个月进行第二次结局评估。还将评估确诊眼病的后续护理接受情况。干预前和干预后的电话访谈将提供关于眼科检查的知识、信念、风险认知和行为变化的数据。将使用标准化方法收集费用数据。研究结果将为实施和传播实用的低成本干预措施提供信息，以增加眼科检查和随访护理，从而有助于降低糖尿病人群的视力丧失和医疗保健费用。

Diabetic retinopathy is serious, costly and prevalent, especially among minority populations. Annual ophthalmic examinations and appropriate follow-up care would result in substantial savings in preventable vision loss, health care costs, and lost productivity. However, most people do not receive these services. In our previous study, we doubled the rate of ophthalmic examinations in a low-income African-American population using a multi-component intervention. We now propose to evaluate the incremental effects and costs of components of that intervention in a broader diabetes population, including Spanish-speaking patients The specific aims of the proposed study are to: 1) test the hypothesis that a tailored telephone intervention will result in a higher rate of ophthalmic examinations than a standard print intervention; 2) improve understanding about reasons why people obtain an ophthalmic examination and assess differences in subgroups (gender and Spanish language preference); 3) improve understanding about reasons why people who are diagnosed with diabetic eye disease do or do not receive recommended follow-up treatment; and 4) conduct cost-effectiveness analyses. The study design is a randomized, controlled intervention trial with masking; the individual is the unit of sampling, assignment, and analyses. A total of 800 patients with type 1 or type 2 diabetes mellitus who have not had a dilated eye examination in the last year will be sampled from the databases of two large urban health systems. After eligibility is ascertained and written informed consent is obtained, patients will be randomized within site by gender and preferred language (Spanish or English) to either the tailored telephone group or the standard print group. Sample size determinations are based on having sufficient power to detect differences between groups at the p<0.05 level of significance. The main study outcome will be receipt of a dilated eye exam at 6 months post-randomization as ascertained by medical record abstraction, with a second outcome assessment conducted at 18 months post randomization. Receipt of follow-up care for diagnosed eye disease will also be assessed. Pre- and post-intervention telephone interviews will provide data on changes in knowledge, beliefs, risk perceptions and behavior regarding ophthalmic exams. Cost data will be collected using standardized methods. Study results will inform implementation and dissemination of practical, low-cost interventions to increase ophthalmic examinations and follow-up care, and thereby contribute to a decrease in vision loss and health care costs in diabetes populations.