Bronx A1c: Bring it Down for Health

描述（由申请人提供）：糖尿病代谢控制，通过血红蛋白A1c （HbA1c）测量，降低微血管并发症的风险。卫生保健提供者通常不符合管理HbA1c的标准，糖尿病患者通常不知道他们的HbA1c值。为了解决这些问题并降低因HbA1c升高而导致的人群归因风险，纽约市卫生和心理卫生部门（DOHMH）开发了一种创新的HbA1c登记处，要求所有主要实验室以电子方式报告HbA1c结果。我们建议利用该注册中心开展一项随机对照试验，以实现以下具体目标：1)评估分层、量身定制、以患者为中心的电话干预（英语和西班牙语）对平均HbA1c水平的增量效果，超过DOHMH注册干预中心向患者和提供者邮寄打印材料所达到的水平；2)确定哪些患者人口统计学和社会心理因素介导干预措施的效果；3)提供分层定制电话干预的实施成本估算，以便与纸质干预进行比较。个人是抽样、分配和分析的单位。在评估合格性并通过电话获得知情同意后，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解决问题，以解决药物依从性障碍，改善生活方式行为，并与他们的提供者有效沟通。DOHMH的打印材料将向患者及其提供者传达糖化血红蛋白结果，并提供改进策略。研究结果将是从基线到随机化后一年注册记录的HbA1c值的变化。总共需要941名糖尿病患者提供83%的功率来检测绝对HbA1c至少0.3%的组间统计学显著差异（p<0.05）。将通过电话收集有关抑郁症、健康行为和风险认知的社会心理数据。将评估干预成本数据的结果转化和可扩展性。在研究结束时，我们将知道这种干预将在多大程度上改善纽约南布朗克斯DOHMH HbA1c登记的低收入多种族样本的代谢控制。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信息。

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.