Translating telephonic diabetes self-management support to primary care practice

描述（由申请人提供）：本申请解决了行为干预对成年糖尿病患者的已证实疗效与“现实世界”临床实践中可实现的效果之间的差距。我们建议将两种有效的方法整合到常规糖尿病护理中：1）自我管理干预，以治疗依从性为目标，2）认知行为技能方法，旨在减少情绪困扰，这是糖尿病患者生活中常见且未被认识到的方面。如果广泛传播，这些干预措施有可能对公共卫生产生重大影响。我们的目标是评估一种有成本意识的综合方法改善糖尿病结局的有效性。通过与纽约市卫生和心理卫生部合作，我们将通过现有的可持续计划向符合条件的患者提供干预措施，该计划专注于改善糖尿病和其他慢性病患者的健康状况。该计划支持电子病历（EMR）系统的开发和质量改进，在整个纽约市的参与实践。该计划雇用预防外展专家，通过EMR数据识别在护理方面存在差距的高风险患者，并与护理提供者协商，通过电话联系这些患者，使他们重新参与护理。我们将利用这个现有的计划来检查以下具体目标：1）进行一项有效性试验，评估全面的电话自我管理支持的影响（远程短信）对HbA 1c的影响（主要结局）、痛苦、治疗依从性、血脂和血压（次要结果）; 2）应用RE-AIM评估传播和实施，并促进翻译到其他网站;以及3）获得关于实施Tele-SMS的成本相对于治疗益处的信息。在初级保健实践中接受护理的个人将被随机分配到两个组中的一个，即电话短信或加强常规护理。Tele-SMS将专注于解决药物依从性障碍的问题，改善生活方式行为，并与提供者进行有效沟通。此外，它将涉及使用特定的沟通策略，以加强情绪困扰和矛盾心理的表达和正常化，并为患者经历重大痛苦，将提供指导和实践与认知行为技能。此外，将实施与护理提供者进行信息交换的正式流程，以解决临床惰性问题，并鼓励在有指征时对糖尿病和抑郁症进行指南一致的护理。加强日常护理参与者将获得常规护理加上打印自我管理支持材料。共计875人 将提供83%的把握度来检测绝对HbA 1c至少为0.5%的组间显著差异（p<0.05）。将进行全面的RE-AIM评估，并将评估干预成本数据，以转换结果和可扩展性。结果将告知公众 该研究将为纽约市以及全国其他城市地区的卫生政策和实践提供参考，并可能朝着缩小全面糖尿病护理方面的翻译差距迈出重要一步。

DESCRIPTION (provided by applicant): This application addresses the gap between the demonstrated efficacy of behavioral interventions for adults with diabetes and what is achievable in "real-world" clinical practice. We propose to integrate two efficacious adjuncts to routine diabetes care: 1) self-management interventions, targeting treatment adherence, and 2) cognitive behavioral skills approaches, aimed at reducing emotional distress, a common and under-recognized aspect of living with diabetes. If widely disseminated, these interventions have the potential for significant public health impact. Our objective is to evaluate the effectiveness f a cost-conscious, comprehensive approach to improving diabetes outcomes. In partnership with the New York City Department of Health and Mental Hygiene, we will deliver the intervention to eligible patients through an existing and sustainable program focused on the improvement of health outcomes for individuals with diabetes and other chronic illnesses. This program supports electronic medical record (EMR) systems development and quality improvements in participating practices throughout NYC. The program employs prevention outreach specialists to identify high- risk patients with gaps in care via EMR data and, in consultation with care providers, contact these patients via telephone to re-engage them with care. We will use this existing program to examine the following specific aims: 1) to conduct an effectiveness trial evaluating the impact of comprehensive telephonic self-management support (Tele-SMS) on HbA1c (primary outcome), distress, treatment adherence, lipids, and blood pressure (secondary outcomes); 2) to apply RE-AIM to evaluate dissemination and implementation and facilitate translation to other sites; and 3) to obtain information on the cost of implementing Tele-SMS relative to treatment benefits. Individuals receiving care at primary care practices will be randomly assigned to one of two arms, Tele-SMS or enhanced usual care. Tele-SMS will focus on problem solving for barriers to medication adherence, improving lifestyle behaviors, and communicating effectively with providers. Additionally, it will involve the use of specific communication strategies to enhance the expression and normalization of emotional distress and ambivalence and, for patients experiencing significant distress, will provide instruction and practice with cognitive behavioral skills. Further, a formalized process for information exchange with care providers will be implemented to address clinical inertia and encourage guideline-concordant care of diabetes and depression, when indicated. Enhanced usual care participants will receive routine care plus print self- management support materials. A total of 875 individuals with diabetes will provide 83% power to detect a significant difference (p<0.05) between groups of at least 0.5% in absolute HbA1c. A full RE-AIM evaluation will be conducted and intervention cost data will be evaluated for translation of findings and scalability. Results will inform public health policies and practices in New York City, as well as other urban areas throughout the nation and could make a significant step towards closing the translation gap in comprehensive diabetes care.