Bronx A1c: Bring it Down for Health

描述(由申请人提供)：糖尿病的代谢控制，以血红蛋白A1c(HbA1c)衡量，可降低微血管并发症的风险。卫生保健提供者经常不符合管理HbA1c的标准，糖尿病患者往往不知道他们的HbA1c值。为了解决这些问题并减少由于HbA1c升高而导致的人群归因性风险，纽约市卫生和精神卫生局(DOHMH)开发了一个创新的HbA1c登记系统，要求所有主要实验室以电子方式报告HbA1c结果。我们建议利用这一登记处进行一项随机对照试验，旨在解决以下具体目标：1)评估分级和量身定制的、以患者为中心的英语和西班牙语电话干预对平均HbA1c水平的递增影响，超过DOHMH登记处干预措施邮寄给患者和提供者的印刷材料所达到的水平；2)确定哪些患者人口统计和心理社会因素调节干预措施的效果；以及3)提供分级的、量身定制的电话干预实施成本的估计，以便与印刷干预进行比较。个体是抽样、分配和分析的单位。在对资格进行评估并通过电话获得知情同意后，该个人将被随机分配到两组中的一组。患者电话干预将侧重于协作性问题解决，以解决坚持服药的障碍，改善生活方式行为，并与提供者进行有效沟通。DOHMH的印刷材料将向患者和他们的提供者传达HbA1c结果，并提出改进策略。这项研究的结果将是将登记记录中的HbA1c值从基线改为随机化后一年。总共需要941名糖尿病患者提供83%的能量来检测HbA1c绝对值至少0.3%的组间统计学上的显著差异(p&lt；0.05)。有关抑郁、健康行为和风险认知的心理社会数据将通过电话收集。将对干预成本数据进行评估，以转换调查结果和可扩展性。在研究结束时，我们将知道这种干预措施将在多大程度上改善低收入、多种族样本的代谢控制，这些样本是纽约南布朗克斯DOHMH HbA1c登记的一部分。这些发现将为纽约市以及全国其他城市地区的公共卫生政策和实践提供参考。

DESCRIPTION (provided by applicant): Metabolic control of diabetes, measured by hemoglobin A1c (HbA1c), reduces the risk of microvascular complications. Health care providers frequently do not meet standards for managing HbA1c and individuals with diabetes are often not aware of their HbA1c values. To address these issues and reduce population- attributable risk due to elevated HbA1c, the New York City Department of Health and Mental Hygiene (DOHMH) developed an innovative HbA1c registry, which requires all major laboratories to report HbA1c results electronically. We propose to utilize this registry to conduct a randomized controlled trial addressing the following specific aims: 1) to evaluate the incremental effect of a tiered and tailored, patient-centered telephone intervention, in English and Spanish, on the mean HbA1c levels beyond that achieved with print materials mailed to patients and providers by the DOHMH registry intervention; 2) determine what patient demographic and psychosocial factors mediate the effect of the interventions; and 3) provide estimates of implementation costs of the tiered, tailored telephone intervention for comparison with the print intervention. The individual is the unit of sampling, assignment and analysis. After eligibility is assessed and informed consent is obtained by telephone, the individual will be randomly assigned to one of the two groups. The patient telephone intervention will focus on collaborative problem solving for resolving barriers to medication adherence, improving lifestyle behaviors, and communicatiing effectively with their providers. The print materials from the DOHMH will communicate HbA1c results to patients and their providers, with strategies to improve them. The study outcome will be change in HbA1c values from the registry records from baseline to one-year post-randomization. A total of 941 individuals with diabetes will be needed to provide 83% power to detect a statistically significant difference (p<0.05) between groups of at least 0.3% in absolute HbA1c. Psychosocial data on depression, health behaviors, and risk perceptions will be collected by telephone. Intervention cost data will be evaluated for translation of findings and scalability. At study end, we will know the extent to which this intervention will improve metabolic control in a low-income, multi-ethnic sample who are part of the DOHMH HbA1c registry in the South Bronx, New York. These findings will inform public health policies and practices in New York City, as well as other urban areas throughout the nation.