背景:糖尿病是美国第八大死亡原因。结构性种族主义和系统性压迫导致的不平等导致了糖尿病患病率的种族/族裔差异,诊断,和治疗。糖尿病自我管理培训(DSMT)远程血糖监测(RGM),和来自社区卫生工作者(CHW)的量身定制的支持有可能改善结果。本研究将检查这些干预措施在安全网医疗保健环境中的实施情况。
方法:使用实施科学和种族公平原则,本研究旨在(1)评估适当性;(2)测量保真度;(3)比较改变三种干预措施的组合和顺序的有效性.探索性目标将衡量干预措施依从性和吸收的可持续性。这个混合方法试验采用了一个顺序,多重分配随机试验(SMART)设计,患者焦点小组讨论,和员工面试。符合条件的黑人/拉丁患者将使用从电子病历系统中提取的患者名单进行招募。经过详细的筛选过程,符合条件的患者将被邀请参加面对面的登记预约。将获得知情同意,患者将被随机分配到DSMT或RGM。6个月时,患者将完成两项评估(糖尿病授权和糖尿病相关的痛苦),和HbA1c值将被审查。“响应者”将被认为是HbA1c至少提高了一个百分点的人。“响应者”保留在他们指定的第一个研究小组中。“无应答者”将被随机分配以切换研究臂或与CHW配对。6个月后,参与者将再次完成两次评估,和他们的HbA1c将被审查。十二个患者焦点小组,每条干预路径有两条,将与员工面试一起进行。
结论:这项研究是第一个,根据我们的知识,旨在填补我们对在安全网医院接受护理的黑人和拉丁患者中支持糖尿病管理的最佳干预措施顺序和组合的知识中的关键空白。通过实现研究目标,我们将为优化公平的糖尿病管理并最终减少生活在投资不足的城市环境中的患者的种族和族裔医疗保健差异建立证据。
背景:ClinicalTrials.gov:NCT06040463。2023年9月7日注册。
BACKGROUND: 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.
METHODS: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov: NCT06040463. Registered on September 7, 2023.