Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 817
- 试验地点
- 2
- 主要终点
- HbA1c<7%
研究概览
简要总结
Therapeutic inertia may result from providers, patients, and/or systems, but can be detrimental to a patients' health by putting them at risk for diabetes complications, though addressing it early can mitigate some of its effects. In Type 2 diabetes (T2D) care, this may look like failure to initiate metformin therapy early in the disease course. This project aims to evaluate the effects of proactive outreach by a non-physician clinician (Accountable Population Manager [APM]) to patients with newly diagnosed Type 2 diabetes. The team hypothesizes individuals receiving proactive outreach by an APM will be more likely to achieve glycemic targets at 6 months following start of the intervention.
详细描述
This is a 3-arm randomized clinical trial comparing patients in the following arms: 1) usual Type 2 diabetes care, 2) primary care physicians have been exposed to physician education on therapeutic inertia, and 3) primary care physicians have been exposed to physician education on therapeutic inertia and patients are referred to APM proactive outreach. The APM is a non-physician clinician, including clinical pharmacists and nurses. Eligible members will be identified via electronic health record (EHR) data in two stages: 1) identification of individuals with newly diagnosed T2D, 2) identification of the subset of newly diagnosed individuals with metformin-related therapeutic inertia. The content of the APM visit will be the same as what currently occurs in standard diabetes care, including discussing the risks and benefits of pharmacologic treatment and initiating treatment (with patient agreement), supporting medication adherence, and providing education and support for overall T2D management. The main outcome will be HbA1c at 6, 12, and 18 months post-intervention.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kaiser Permanente Northern California (KPNC) member age 18-74
- •Incident Type 2 Diabetes
- •Patient of primary care physician (PCP) working in the randomized service areas
- •Identified metformin-related therapeutic inertia
- •At least one A1c 6.5-7.9 from 4 months post-diagnosis up to the time of randomization
排除标准
- •Evidence of preceding T2D diagnosis
- •Pregnant at the time of T2D diagnosis
- •Likely to have Type 1 diabetes
结局指标
主要结局
HbA1c<7%
时间窗: 18 months
Proportion of patients with HbA1c less than 7% at 18 months following the start of the .intervention.
HbA1c<8%
时间窗: 18 months
Proportion of patients with HbA1c less than 8% at 18 months following the start of the intervention.
HbA1c<9%
时间窗: 18 months
Proportion of patients with HbA1c less than 9% at 18 months following the start of the intervention.
次要结局
- Adherence to HbA1c monitoring(18 months)
- Emergency room visits and hospitalizations post-intervention start(18 months)
- Time to metformin initiation(18 months)
- Time to achievement of glycemic targets (HbA1c<7%, <8%, and <9%)(18 months)
- Hypoglycemia events post-intervention start(18 months)
- Metformin adherence(18 months)
- Time to initiation of non-metformin anti-diabetes medication(18 months)
- Absolute mean reduction in HbA1c from baseline(18 months)