Translating telephonic diabetes self-management support to primary care practice

描述(由申请人提供)：这项申请解决了成人糖尿病患者行为干预所证明的有效性与在“真实世界”临床实践中所能达到的效果之间的差距。我们建议将两种有效的辅助手段整合到常规的糖尿病护理中：1)自我管理干预，针对治疗依从性，以及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一个方面。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具有成本意识的综合方法改善糖尿病预后的有效性。我们将与纽约市卫生和心理卫生局合作，通过一项现有的、可持续的计划，向符合条件的患者提供干预措施，重点是改善糖尿病和其他慢性病患者的健康结果。该计划支持整个纽约市参与实践的电子病历(EMR)系统开发和质量改进。该计划聘请预防外展专家通过EMR数据识别有护理缺口的高危患者，并与护理提供者协商，通过电话联系这些患者，重新让他们参与护理。我们将利用这一现有计划来检查以下具体目标：1)进行有效性试验，评估全面电话自我管理支持(Tele-SMS)对HbA1c(主要结果)、苦恼、治疗依从性、血脂和血压(次要结果)的影响；2)应用RE-AIM来评估传播和实施情况，并促进翻译到其他网站；以及3)获得与治疗福利相关的实施Tele-SMS成本的信息。在初级保健诊所接受护理的个人将被随机分配到两个部门中的一个，远程短信或增强型常规护理。电话短信将专注于解决药物依从性障碍的问题，改善生活方式行为，并与供应商进行有效沟通。此外，它还将涉及使用特定的沟通策略来增强情绪痛苦和矛盾心理的表达和正常化，并将为经历重大痛苦的患者提供认知行为技能的指导和练习。此外，将实施与护理提供者交换信息的正式程序，以解决临床惰性问题，并鼓励在需要时遵循指南对糖尿病和抑郁症进行护理。增强的日常护理参与者将获得常规护理外加印刷的自我管理支持材料。总共有875只 糖尿病将提供83%的力量来检测HbA1c绝对值至少0.5%的组之间的显著差异(p&lt；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。结果将公之于众 在纽约市以及全国其他城市地区推广卫生政策和做法，并可能在缩小全面糖尿病护理方面的翻译差距方面迈出重要一步。

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.