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

项目总结/摘要 糖尿病是拉丁美洲人的一个主要公共卫生问题。拉丁美洲人的数量不断增加 被诊断为糖尿病，与其他种族相比比例不成比例。许多干预措施 已经开始改善少数民族的医疗保健，包括糖尿病小组访问，这在以下方面很有价值： 改善教育和血糖控制。在我们的小组访问调查中，我们启动了社区卫生 工作人员（CHW）-当地社区成员，作为具有文化敏感性的患者与医疗保健机构的联络人 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， 特别有助于识别药物获取障碍。然而，社区卫生工作者是一线工作人员， 无人支持无人监管我们利用这些数据开创了四种糖尿病的组合 TIME试验中的干预措施（远程医疗支持、综合CHW、药物获取、小组访视 教育）。TIME试验显示，随机分配到TIME的个体显著改善了血糖控制， 与常规护理相比，血压和遵守美国糖尿病协会标准。研究 还表明，远程医疗（移动的医疗（mHealth）和ZOOM视频会议）有助于 支持社区卫生工作者的工作，并加强他们与病人的沟通。 2019冠状病毒病疫情凸显了远程医疗的广泛使用及其改善 健康护理它还强调迫切需要改善对低收入少数群体的照顾。虽然 糖尿病项目在改善教育和临床结果方面很有价值，但它们通常很难启动 在低收入环境中。使用远程保健指导当地诊所提供者团队的务实实施， CHW承诺解决这些障碍。我们有试验数据显示远程监控当地 临床启动TIME，导致HbA1c水平改善，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）中评估这种方法， 低收入、成年2型糖尿病拉丁美洲人（a），随机分配至TIME（干预）组与常规护理增强组 教育（EUC）。我们的研究小组将为当地诊所团队提供远程指导， 他们的诊所。为了评价疗效，我们将比较TIME与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（AIM 1）。比较 根据研究组的纵向数据，我们将随访这些临床指标直至36个月（AIM 2）。我们还将 为参与者和诊所团队提供从基线到12- 月（AIM 3）。我们假设TIME参与者将获得上级和更可持续的临床研究。 与EUC个体相比，干预措施具有较高的可接受性， 评价数据我们预计，拟议的研究将提供远程监护启动时间的理由 和强有力的证据，以改善低收入拉丁美洲（a）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.