Population Health Management for Kaiser Permanente Northern California (KPNC) Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Average hemoglobin A1c (HbA1c)
研究概览
简要总结
This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.
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
- •Age 18-74 years
- •Newly diagnosed with type 2 diabetes
- •Kaiser Permanente Northern California member receiving care in a participating service area
- •If age ≤45 years, then HbA1c>8%
- •If age<45 years, then HbA1c>10%
排除标准
- •Individuals who are pregnant
- •Individuals with likely type 1 diabetes (T1D)
研究组 & 干预措施
Usual Initial Type 2 Diabetes (T2D) Care
Patients in the usual care arm will receive the standard T2D care provided to Kaiser Permanente Northern California members with recently diagnosed T2D. This care includes any counseling or treatment recommendations made by the primary care provider and the assigned care manager.
Augmented Initial Type 2 Diabetes (T2D) Care
The intervention - Augmented Initial T2D Care - comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team and self-management support by care managers, health educators, and dieticians.
干预措施: Augmented Initial Type 2 Diabetes Care (Behavioral)
结局指标
主要结局
Average hemoglobin A1c (HbA1c)
时间窗: 12-months
Between-arm differences in HbA1c
Average hemoglobin A1c (HbA1c)
时间窗: 6-months
Between-arm differences in HbA1c
次要结局
- Adherence to HbA1c monitoring(12-months)
- Time to achievement of glycemic targets(12-months)
- Type 2 diabetes medication and statin initiation(12-months)
- Type 2 diabetes medication adherence(12-months)
- Completion of preventative screening(12-months)
- Time to achievement of glycemic targets(6-months)
- Adherence to HbA1c monitoring(6-months)
- Type 2 diabetes medication adherence(6-months)
- Type 2 diabetes medication and statin initiation(6-months)
- Completion of preventative screening(6-months)