Evaluating telementoring to initiate a multidimensional diabetes program for Latino(a)s in community clinics: A Randomized Clinical Trial

项目摘要/摘要 糖尿病是拉丁裔的主要公共卫生问题(甲)S。拉丁裔人数不断攀升(甲)S 与其他种族相比，被诊断为糖尿病的比例不成比例。众多干预措施 已经开始改善少数群体的医疗保健，包括糖尿病小组访问，这在 改善教育和血糖控制。在我们的团体访问调查中，我们发起了社区健康 工人(CHW)-当地社区成员，他们是医疗保健部门的文化敏感患者联络人 系统--作为多学科团队的一部分。我们证明了CHW是至关重要的团队成员 在确定药物获取障碍方面尤其有用。然而，社区卫生工作者是第一线的工作人员，经常 无人支持，监管不力。我们利用这些数据开创了四种糖尿病的组合 我们时间试验中的干预措施(远程医疗支持、综合CHW、用药途径、团体访问 教育)。时间试验表明，随机分配时间的个体显著改善了血糖控制， 与常规护理相比，患者的血压和对美国糖尿病协会标准的遵守程度更高。这项研究 还表明远程医疗(移动医疗(MHealth)和变焦视频会议)在 支持卫生福利院的工作，加强与病人的沟通。 新冠肺炎的流行突显了远程医疗的广泛使用及其改进的能力 医疗保健。它还强调迫切需要改善对低收入少数群体的照顾。尽管 糖尿病项目在改善教育和临床效果方面很有价值，但往往很难启动 在低收入环境中。务实实施，使用远程医疗指导当地诊所团队的提供商和 CHWS承诺解决这些障碍。我们有试验数据显示远程传送本地 临床开始的时间已经导致HbA1c水平的改善，但我们现在需要在更大的样本中进行测试。 在拟议的研究中，我们将在一项随机临床试验(N=250；干预=125)中评估该方法 低收入成年拉丁裔(A)S 2型糖尿病患者随机到时间(干预)与常规护理相比得到加强 教育(EUC)。我们的研究小组将为当地诊所团队提供远程支持，以启动时间进入 他们的诊所。为了评估疗效，我们将比较时间和EUC临床变化，包括HbA1c(主要 结果)，血压，胆固醇和体重指数从基线到12个月(目标1)。进行比较 研究臂的纵向数据，我们将跟踪这些临床措施直到36个月(目标2)。我们还将 为参与者和临床团队提供从基线到12年的时间计划可接受性和评估数据- 月(AIM 3)。我们假设时间参与者将有更好的和更可持续的临床 结果与EUC患者相比，干预措施将具有高水平的可接受性和 评估数据。我们预计，拟议的研究将提供启动时间的远程监测的理由 并有有力证据改善低收入拉丁裔(A)S糖尿病患者的纵向护理。

PROJECT SUMMARY/ABSTRACT Diabetes is a major public health problem in Latino(a)s. There are escalating numbers of Latino(a)s diagnosed with diabetes and at disproportionate rates compared to other ethnicities. Numerous interventions have been initiated to improve minority healthcare including diabetes group visits, which have been valuable in improving education and glycemic control. In our group visit investigations, we initiated Community Health Workers (CHWs)—local community members who serve as culturally-sensitive patient liaisons to the healthcare system—as part of the multidisciplinary team. We demonstrated that CHWs are vital team members and particularly helpful in identifying medication-access barriers. However, CHWs are frontline workers and often left unsupported and poorly supervised. We used these data to pioneer the combination of four diabetes interventions in our TIME trial (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education). The TIME trial showed that individuals randomized to TIME significantly improved glycemic control, blood pressure and adherence to American Diabetes Association standards compared to usual care. The study also showed that telehealth (mobile health (mHealth) and ZOOM video conferencing) was instrumental in supporting CHWs in their work and enhancing their communication with patients. The COVID-19 pandemic has highlighted the expansive use of telehealth and its ability to improve healthcare. It has also underscored the pressing need to improve care for low-income minorities. Though diabetes programs are valuable in improving education and clinical outcomes, they are often difficult to initiate in low-income settings. Pragmatic implementation using telehealth to mentor local clinic teams of providers and CHWs is promising to address these barriers. We have pilot data showing the feasibility of telementoring a local clinic to initiate TIME that has resulted in improved HbA1c levels but we now need to test it within a larger sample. In the proposed study we will evaluate this approach in a randomized clinical trial (N=250; intervention=125) of low-income, adult Latino(a)s with type 2 diabetes randomized to TIME (intervention) versus usual care enhanced with education (EUC). Our research group will provide telementoring to local clinic teams to initiate TIME into their clinics. To evaluate efficacy, we will compare TIME versus EUC clinical changes including HbA1c (primary outcome), blood pressure, cholesterol, and body mass index from baseline to 12-months (AIM 1). To compare longitudinal data of study arms, we will follow these clinical measures until 36 months (AIM 2). We will also provide TIME program acceptability and evaluation data for participants and clinic teams from baseline to 12- months (AIM 3). We hypothesize that TIME participants will have superior and more sustainable clinical outcomes compared to EUC individuals and that the intervention will have high levels of acceptability and evaluation data. We anticipate that the proposed study will provide justification of telementoring to initiate TIME and strong evidence to improve the longitudinal care of low-income Latino(a)s with diabetes.