PRimary Care Education and Practice Adoption Resource Evaluation for Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Change in practice-reported prescriptions of Continuous Glucose Monitors
研究概览
简要总结
The overarching goal of this study is to decrease disparities and increase access to continuous glucose monitoring (CGM) for patients with diabetes, regardless of where people receive their diabetes care. This study aims to evaluate the effectiveness of three implementation strategies for CGM in primary care practices in an efficient, sustainable, and scalable fashion. The investigators will also perform economic analysis of the implementation strategies.
This 3-year study will compare practices that implement CGM with (a) an evidence-based educational module only, (b) an educational module plus practice facilitation support, or (c) a virtual CGM initiation clinic for patients. There will be up to 30 practices in each group for a possible total of 90 primary care practices. The investigators expect to enroll up to 500 patient participants across these 90 practices and to compare outcomes among patients from each study arm.
This comparison will help investigators to understand the different implementation strategies and their ability to help primary care practice adopt, implement, and maintain CGM for their patients. The information the investigators collect will also help to understand how patients in these primary care practices experience initiation and use of CGM. The results will help to develop strategies and tools to train more primary care practices to offer CGM more widely to patients for whom it is recommended, especially for those where access to specialty care is limited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages of 18 and 89 years
- •Has diagnosis of type 1 diabetes or type 2 diabetes
- •Recommended by primary care clinician to use continuous glucose monitoring to manage diabetes
- •Ability to read or speak English or Spanish
排除标准
- •Pregnant women
- •Younger than 18 years of age
- •Older than 89 years of age
结局指标
主要结局
Change in practice-reported prescriptions of Continuous Glucose Monitors
时间窗: Baseline, 6, and 12 months from baseline
Change in number of patients over time by study arm with diabetes prescribed a Continuous Glucose Monitoring Device. This is a practice-level indicator of patient reach in primary care settings.
次要结局
- Glycemic control (a)(Baseline to 12 months after enrollment)
- Glycemic control (c)(Baseline, 3, 6, and 12 months from baseline)
- Glycemic control (b)(Baseline, 3, 6, and 12 months from baseline)
- Diabetes-related distress(Baseline, 3, and 6 months from baseline)
- Cost Analysis and Economic Sustainability(6 months from baseline)
- Glycemic control (e)(Baseline, 3, 6, and 12 months from baseline)
- Implementation and Maintenance(6 and 12 months from baseline)
- Glycemic control (d)(Baseline, 3, 6, and 12 months from baseline)
- Glucose Monitoring Satisfaction Survey(Baseline, 3, and 6 months from baseline)