ARISE (Achieving Routine Intervention and Screening for Emotional health)

摘要 糖尿病（DM）影响美国3000万人，非洲裔美国人和西班牙裔美国人分别为1.4和1.2 患糖尿病的可能性是非西班牙裔白人的两倍。糖尿病困扰-压力，恐惧和内疚 与管理糖尿病有关-与血糖控制不良有关， 2型糖尿病（T2 DM）的美国人和西班牙裔成人。美国糖尿病协会 (ADA)发布了促进筛查和解决糖尿病困扰（DD）的指南， 临床护理的一部分。然而，只有24%的成年糖尿病患者报告他们的医疗保健团队询问他们如何 糖尿病影响了他们的生活。努力系统地查明和解决发展与退化问题可能是一项重要战略， 改善弱势群体的糖尿病预后，解决糖尿病差异。社区 卫生中心（CHC）可以成为这一努力的重要合作伙伴; CHC为250万成年人提供初级保健 患有糖尿病超过70%的CHC患者的收入低于联邦贫困线的100%， 是有色人种没有研究系统地实施DD筛查和治疗干预 或者使用基于指南的方法。为了填补这一空白，我们开发了 ARISE（实现常规干预和情绪健康筛查）干预。基于已发表 指导方针，ARISE结合了经过验证的筛查工具，从干预措施中提取，以改善 DD和个性化的DD患者的域。ARISE包括一个标准化的筛选程序 成人T2 DM DD患者，培训健康中心工作人员如何解决患者的痛苦 遭遇，以及基于被识别为来源的域的动作步骤和转介的算法。 痛苦本研究旨在比较ARISE与增强型常规护理（针对医疗保健团队的教学培训， DD）在CHCs中使用I型混合有效性-实现设计，通过群集随机化语用 审判首先，我们将使用表格将ARISE应用于两个社区卫生中心（一个城市和一个农村）的临床工作流程 复杂健康干预框架的功能域。利用从 适应，我们将在12个社区卫生服务中心（6个ARISE和6个增强）进行一项集群随机化务实试验， 常规护理），以在A1 c> 8%的T2 DM成人患者中测试ARISE与增强常规护理。初级 结果将是两组之间A1 C从基线到12个月的变化。次要结局将包括 ARISE组内DD从基线至6个月的变化和患者收缩压的变化， 低密度脂蛋白（LDL）和体重指数（BMI）。我们会评估收养情况， 实施和维护ARISE干预措施。我们将利用获得的知识， 全国各地的社区卫生服务中心的做法，负责照顾美国医疗保健的最大份额， 2型糖尿病患者。

ABSTRACT Diabetes mellitus (DM) affects 30 million people in the U.S. African-Americans and Hispanics are 1.4 and 1.2 times more likely to have DM compared to non-Hispanic whites. Diabetes distress—stress, fear, and guilt related to managing diabetes—is linked to poor glycemic control and disproportionately affects African Americans and Hispanic adults with type 2 diabetes mellitus (T2DM). The American Diabetes Association (ADA) has published guidelines promoting screening for and addressing diabetes distress (DD) as a critical part of clinical care. However, only 24% of adults with diabetes report their health care team asked them how diabetes affected their lives. Efforts to systematically identify and address DD could be an important strategy to improve diabetes outcomes among disadvantaged populations and address diabetes disparities. Community health centers (CHCs) can be important partners in this effort; CHCs provide primary care for 2.5 million adults with diabetes. More than 70% of CHC patients have income below 100% of the federal poverty level and 57% are people of color. No studies have systematically implemented DD screening and treatment interventions into a real-world primary care setting or used a guideline based approach. To fill this gap, we developed the ARISE (Achieving Routine Intervention and Screening for Emotional health) intervention. Based on published guidelines, ARISE incorporates validated screening instruments, draws from interventions shown to improve DD and is individualized to patients’ domains of DD. ARISE includes a standardized process for screening adult patients with T2DM for DD, training for health center staff on how to address distress in the patient encounter, and an algorithm for action steps and referrals based on the domains identified as sources of distress. This study aims to compare ARISE to enhanced usual care (didactic training for health care teams on DD) in CHCs using a type I hybrid effectiveness-implementation design via a cluster randomized pragmatic trial. First, we will adapt ARISE into clinical workflows in two CHCs (one urban and one rural) using the Form and Function domains of the Complex Health Intervention Framework. Using the lessons learned from the adaptation, we will conduct a cluster randomized pragmatic trial across 12 CHCs (six ARISE and six enhanced usual care) to test ARISE vs. enhanced usual care among adult patients with T2DM and A1c>8%. Primary outcome will be change in A1C from baseline to 12-months between arms. Secondary outcomes will include change in DD from baseline to 6-months within the ARISE arm and change in patients’ systolic blood pressure, low density lipoprotein (LDL), and body mass index (BMI) across the two arms. We will assess the adoption, implementation, and maintenance of the ARISE intervention. We will use knowledge gained to develop best practices for CHCs across the country that are charged with caring for the largest share of America’s medically vulnerable patients with T2DM.