Sinai Urban Health Institute, Sinai Health System, 1500 South Fairfield Avenue, Chicago, IL, 60608, USA.
Parkinson School of Health Sciences and Public Health, Loyola University Chicago, 2160 S 1St Ave, Maywood, IL, USA.
Trials. 2024 Jul 24;25(1):504. doi: 10.1186/s13063-024-08346-9.
Diabetes is the eighth leading cause of death in the USA. Inequities driven by structural racism and systemic oppression have led to racial/ethnic disparities in diabetes prevalence, diagnosis, and treatment. Diabetes-self management training (DSMT), remote glucose monitoring (RGM), and tailored support from a community health worker (CHW) have the potential to improve outcomes. This study will examine the implementation of these interventions in a safety-net healthcare setting.
Using implementation science and racial equity principles, this study aims to (1) evaluate the appropriateness; (2) measure fidelity; and (3) compare the effectiveness of varying the combination and sequence of three interventions. An exploratory aim will measure sustainability of intervention adherence and uptake. This mixed-methods trial employs a sequential, multiple assignment randomized trial (SMART) design, patient focus group discussions, and staff interviews. Eligible Black/Latine patients will be recruited using patient lists extracted from the electronic medical record system. After a detailed screening process, eligible patients will be invited to attend an in-person enrollment appointment. Informed consent will be obtained and patients will be randomized to either DSMT or RGM. At 6 months, patients will complete two assessments (diabetes empowerment and diabetes-related distress), and HbA1c values will be reviewed. "Responders" will be considered those who have an HbA1c that has improved by at least one percentage point. "Responders" remain in their first assigned study arm. "Nonresponders" will be randomized to either switch study arms or be paired with a CHW. At 6 months participants will complete two assessments again, and their HbA1c will be reviewed. Twelve patient focus groups, two for each intervention paths, will be conducted along with staff interviews.
This study is the first, to our knowledge, that seeks to fill critical gaps in our knowledge of optimal sequence and combinations of interventions to support diabetes management among Black and Latine patients receiving care at a safety-net hospital. By achieving the study aims, we will build the evidence for optimizing equitable diabetes management and ultimately reducing racial and ethnic healthcare disparities for patients living in disinvested urban settings.
ClinicalTrials.gov: NCT06040463. Registered on September 7, 2023.
糖尿病是美国第八大死因。结构种族主义和系统性压迫所导致的不平等现象，导致了糖尿病在患病率、诊断和治疗方面存在种族/民族差异。糖尿病自我管理培训 (DSMT)、远程血糖监测 (RGM) 和社区卫生工作者 (CHW) 的个性化支持，有可能改善结果。本研究将在一个医疗保障体系中检验这些干预措施的实施情况。
本研究运用实施科学和种族公平原则，旨在：(1)评估干预措施的适宜性；(2)衡量实施的保真度；(3)比较不同组合和顺序的三种干预措施的效果。一个探索性目标将衡量干预措施坚持和采用的可持续性。这项混合方法试验采用顺序、多重分配随机试验 (SMART) 设计、患者焦点小组讨论和员工访谈。将使用从电子病历系统中提取的患者名单招募符合条件的黑人和拉丁裔患者。经过详细的筛选过程后，符合条件的患者将被邀请参加现场入组预约。获得知情同意后，患者将被随机分配到 DSMT 或 RGM 组。在 6 个月时，患者将完成两项评估（糖尿病能力和糖尿病相关困扰），并审查 HbA1c 值。“应答者”将被定义为 HbA1c 至少提高一个百分点的患者。“应答者”继续留在他们最初分配的研究组中。“非应答者”将被随机分配到更换研究组或与 CHW 配对。在 6 个月时，参与者将再次完成两项评估，并审查他们的 HbA1c 值。将进行 12 次患者焦点小组讨论，每次讨论针对两种干预路径，同时还将进行员工访谈。
据我们所知，这是第一项旨在填补我们在了解为在医疗保障医院接受治疗的黑人和拉丁裔患者提供支持的最佳干预顺序和组合方面的知识空白的研究。通过实现研究目标，我们将为优化公平的糖尿病管理提供证据，并最终为生活在投资不足的城市环境中的患者减少种族和民族医疗保健差距。
ClinicalTrials.gov：NCT06040463。于 2023 年 9 月 7 日注册。
