Introduction Community clinics often face pragmatic barriers, hindering program initiation and replication of controlled research trial results. Mentoring is a potential strategy to overcome these barriers. We piloted an in-person and telehealth mentoring strategy to implement the T elehealth-supported, I ntegrated Community Health Workers (CHWs), M edication-access, group visit E ducation (TIME) program in a community clinic. Research design and methods Participants (n=55) were low-income Latino(a)s with type 2 diabetes. The study occurred in two, 6-month phases. Phase I provided proof-of-concept and an observational experience for the clinic team; participants (n=37) were randomized to the intervention (TIME) or control (usual care), and the research team conducted TIME while the clinic team observed. Phase II provided mentorship to implement TIME, and the research team mentored the clinic team as they conducted TIME for a new single-arm cohort of participants (n=18) with no previous exposure to the program. Analyses included baseline to 6-month comparisons of diabetes outcomes (primary outcome: hemoglobin A1c (HbA1c)): phase I intervention versus control, phase II (within group), and research-run (phase I intervention) versus clinic-run (phase II) arms. We also evaluated baseline to 6-month CHW knowledge changes. Results Phase I: compared with the control, intervention participants had superior baseline to 6-month improvements for HbA1c (mean change: intervention: −0.73% vs control: 0.08%, p=0.016), weight (p=0.044), target HbA1c (p=0.035), hypoglycemia (p=0.021), medication non-adherence (p=0.0003), and five of six American Diabetes Association (ADA) measures (p<0.001–0.002). Phase II: participants had significant reductions in HbA1c (mean change: −0.78%, p=0.006), diastolic blood pressure (p=0.004), body mass index (0.012), weight (p=0.010), medication non-adherence (p<0.001), and six ADA measures (p=0.007–0.005). Phase I intervention versus phase II outcomes were comparable. CHWs improved knowledge from pre-test to post-tests (p<0.001). Conclusions A novel, mentored approach to implement TIME into a community clinic resulted in improved diabetes outcomes. Larger studies of longer duration are needed to fully evaluate the potential of mentoring community clinics. Data are available upon reasonable request.

中文翻译：

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在服务不足的社区启动糖尿病计划的指导实施：一项试点研究


简介 社区诊所经常面临务实障碍，阻碍项目的启动和对照研究试验结果的复制。指导是克服这些障碍的潜在策略。我们试行了面对面和远程医疗指导策略，以在社区诊所实施远程医疗支持的综合社区卫生工作者 (CHW)、药物获取、团体访视教育 (TIME) 计划。研究设计和方法 参与者 (n=55) 是患有 2 型糖尿病的低收入拉丁裔。该研究分两个为期 6 个月的阶段进行。第一阶段为临床团队提供了概念验证和观察经验；参与者（n = 37）被随机分配到干预组（TIME）或对照组（常规护理），研究团队进行TIME，而临床团队进行观察。第二阶段提供实施 TIME 的指导，研究团队指导临床团队为一组新的单臂参与者 (n=18) 实施 TIME，之前没有接触过该项目。分析包括糖尿病结局的基线与 6 个月比较（主要结局：糖化血红蛋白 (HbA1c)）：I 期干预与对照、II 期（组内）以及研究运行（I 期干预）与临床运行（阶段II) 武器。我们还评估了 6 个月 CHW 知识变化的基线。结果 第一阶段：与对照组相比，干预参与者的 HbA1c 基线优于 6 个月改善（平均变化：干预：-0.73% vs 对照组：0.08%，p=0.016）、体重（p=0.044）、目标 HbA1c (p=0.035)、低血糖 (p=0.021)、药物不依从性 (p=0.0003) 以及美国糖尿病协会 (ADA) 六项措施中的五项 (p<0.001–0.002)。第二阶段：参与者的 HbA1c 显着降低（平均变化：-0.78%，p=0。006）、舒张压（p=0.004）、体重指数（0.012）、体重（p=0.010）、药物不依从性（p<0.001）和六项 ADA 指标（p=0.007-0.005）。 I 期干预与 II 期干预结果具有可比性。社区卫生工作者从测试前到测试后提高了知识水平 (p<0.001)。结论 在社区诊所中实施 TIME 的新颖、受指导的方法可以改善糖尿病的治疗结果。需要进行更大规模、持续时间更长的研究来充分评估指导社区诊所的潜力。数据可根据合理要求提供。