Steno Diabetes Center Aarhus, Aarhus University Hospital, Palle Juul-Jensens Boulevard 11, 8200, Aarhus N, Denmark.
Research Unit for General Practice, Aarhus University, Aarhus, Denmark.
Trials. 2022 Dec 28;23(1):1059. doi: 10.1186/s13063-022-06961-y.
To support the primary care sector in delivering high-quality type 2 diabetes (T2D), literature reviews emphasize the need for implementing models of collaboration that in a simple and effective way facilitate clinical dialogue between general practitioners (GPs) and endocrinologists. The overall aim of the project is to evaluate if virtual specialist conferences between GPs and endocrinologists about patients living with T2D is clinically effective and improves diabetes competences and organization in general practice in comparison to usual practice.
A prospective, pragmatic, and superiority RCT with two parallel arms of general practices in the Municipality of Aarhus, Denmark. All general practices are invited (n = 100). The intervention runs for 12 months and consists of four virtual conferences between endocrinologists and an individual general practice. Before the first conference, an introductory webinar teaches GPs about how to use an IT-platform to identify and manage T2D patients. The main analysis (month 12) concerns the difference between the intervention and control arm. It is expected that the virtual conferences at the patient level will improve adherence to international recommendations on diabetes medication for T2D patients and improve the risk profile with a reduction in glycated haemoglobin, blood pressure, and cholesterol. The study design allows for identifying a significant difference between the intervention (n = 15) and control group (n = 15) regarding the three primary clinical outcomes with a power of 0.8870-0.9941. At the general practice level, it is expected that general practitioners and practice staff in the intervention group will improve self-reported diabetes competence and organization. The control arm will get the intervention when the primary intervention ends (months 12-24), and the intervention arm transitions to a maintenance phase.
The potential of virtual conferences is yet to be fully tapped because of methodological limitations. Studies have also not yet systematically evaluated virtual conferences in the context of chronic care using a high-quality research design. Given the nature of this real-life intervention, general practitioners and endocrinologists cannot be blinded to their allocation to either the intervention or comparison arm.
ClinicalTrials.gov, United States National Institutes of Health trial ID: NCT05268081. Registered on 4 March 2022.
为了支持初级保健部门提供高质量的 2 型糖尿病（T2D）护理，文献综述强调需要实施合作模式，以简单有效的方式促进全科医生（GP）和内分泌学家之间的临床对话。该项目的总体目标是评估 GP 和内分泌学家之间关于 T2D 患者的虚拟专家会议在临床方面是否有效，以及与常规实践相比是否能提高全科实践中的糖尿病能力和组织水平。
这是一项在丹麦奥胡斯市进行的前瞻性、务实的、优势型 RCT，涉及两个平行的全科实践组。邀请所有全科医生（n=100）参加。干预措施持续 12 个月，由内分泌学家与个别全科医生之间的四次虚拟会议组成。在第一次会议之前，一个介绍性的网络研讨会将教授全科医生如何使用一个 IT 平台来识别和管理 T2D 患者。主要分析（第 12 个月）涉及干预组和对照组之间的差异。预计患者层面的虚拟会议将提高 T2D 患者对糖尿病药物治疗的国际建议的依从性，并通过降低糖化血红蛋白、血压和胆固醇来改善风险状况。该研究设计允许识别干预组（n=15）和对照组（n=15）在三个主要临床结局方面的显著差异，效能为 0.8870-0.9941。在全科实践层面，预计干预组的全科医生和实践工作人员将提高自我报告的糖尿病能力和组织水平。对照组将在主要干预结束时（第 12-24 个月）获得干预，而干预组将过渡到维持阶段。
由于方法学上的限制，虚拟会议的潜力尚未得到充分挖掘。研究也尚未系统地在使用高质量研究设计的慢性病背景下评估虚拟会议。鉴于这种真实生活干预的性质，全科医生和内分泌学家无法对他们被分配到干预组或对照组保持盲态。
ClinicalTrials.gov，美国国立卫生研究院试验 ID：NCT05268081。于 2022 年 3 月 4 日注册。
