Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of “Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management” (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants—patients of an interprofessional primary care team—were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n = 20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes. Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. ClinicalTrials.gov, NCT02715791 . Registered 22 March 2016—retrospectively registered.

中文翻译：

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由志愿者、技术和跨专业初级卫生保健团队支持的糖尿病自我管理复杂干预的试点随机对照试验

大多数糖尿病患者的医疗保健发生在家庭实践中，但平衡帮助这些患者的时间和资源可能很困难。赋予患者权力、利用社区资源和协助自我管理的干预措施可以使患者和提供者受益。因此，探索了“健康团队提升患者体验，通过糖尿病管理的健康连接器加强质量”（Health TAPESTRY-HC-DM）作为支持糖尿病自我管理的方法的可行性和有效性潜力，以告知未来大型规模试验。为期四个月的试点随机对照试验 (RCT)，顺序解释性定性部分。参与者——跨专业初级保健团队的患者——年龄超过 18 岁，被诊断患有糖尿病和高血压，并且具有互联网访问权限和以下条件之一：不受控制的 HbA1c、近期糖尿病诊断、终末期/继发性器官损伤或提供者转诊。Health TAPESTRY-HC-DM 干预侧重于患者健康目标/需求，整合社区志愿者、电子健康技术、跨专业初级保健团队和系统导航。试点结果包括流程措施（招聘、保留、计划参与）、感知的计划可行性、收益和需要改进的领域，以及风险或安全问题。主要试验结果是管理糖尿病的自我效能。有许多次要试验结果。在邀请的 425 名符合条件的患者中，50 名签署同意书（11.8%），35 名完成了计划（15 名干预，20 名对照）。志愿者 (n = 20) 在 234 次客户接触中会见了 28 位客户（家访、电话、电子信息）；向跨专业团队发送了 27 份报告。在 4 个月时，控制基线，与对照组相比，干预组的大多数结果都更好；体力活动明显好转。最常见的目标领域是身体活动、饮食/营养和社会联系。客户认为最大的影响是实现目标的动力。他们在一些技术上苦苦挣扎。一些参与者认为该计划并不适合，大多数参与者认为他们已经很好地管理了他们的糖尿病。Health TAPESTRY-HC-DM是可行的；大规模随机对照试验似乎是可能的。然而，需要进一步关注改善招聘和留任。干预措施很受欢迎，尽管比其他人更适合某些参与者。ClinicalTrials.gov，NCT02715791。2016 年 3 月 22 日注册——追溯注册。