OBJECTIVE This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance–based health system (Scripps Health). RESEARCH DESIGN AND METHODS A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). RESULTS All clinical outcomes improved significantly over 1 year in the overall sample (statistical significance [P] <0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = −0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = −1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. CONCLUSIONS This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.

中文翻译：

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初级保健中 2 型糖尿病医疗助理健康指导：实用整群随机对照试验的结果


目的 该集群（诊所水平）随机对照试验 (RCT) 在两种不同的现实世界初级保健环境中，对 2 型糖尿病高危成人患者进行医疗助理 (MA) 健康指导 (MAC) 与常规护理 (UC) 的比较：联邦合格的医疗中心（FQHC；邻里医疗保健）和大型非营利性私人保险医疗系统（斯克里普斯健康）。研究设计和方法 共有 600 名 2 型糖尿病成人患者入组，他们在过去 90 天内满足以下一项或多项标准： HbA1c ≥ 8% 和/或 LDL 胆固醇 ≥ 100 mg/dL 和/或收缩压(收缩压) ≥140 毫米汞柱。 MAC 诊所的参与者接受了经过专门培训的 MA 健康教练为期 12 个月的面对面和电话自我管理支持。电子病历用于检查整个样本的临床结果。在子样本（n = 300）中评估行为和心理社会结果。结果 总体样本的所有临床结果在一年内均显着改善（统计显着性 [P]<0.001）。 MAC 组与 UC 组相比，HbA1c 的降低显着更大（非标准化 B 相互作用 = -0.06；P = 0.002）。逐组位点交互的显着时间还表明，相对于 Scripps Health，在 Neighborhood Healthcare 中，MAC 比 UC 更能改善 LDL 胆固醇（Binteraction = -1.78 vs. 1.49；P < 0.05）。没有观察到其他统计上显着的影响。结论 这是第一个大规模实用随机对照试验，支持 MAC 在美国初级保健机构中治疗 2 型糖尿病的实际有效性。研究结果表明，这种基于团队的方法可能对改善 FQHC 环境中的糖尿病结局特别有效。