Patient-Centered Online Disease Management Using a Personal Health Record System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 6
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years of age
- •Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)
- •Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months
- •Diagnosis of diabetes
- •Baseline A1C >= 7.5%
排除标准
- •Initial diagnosis of diabetes within the last 12 months
- •Diagnosis of Type 1 diabetes
- •Inability to speak and read in English
- •Lack of regular access to a computer with Internet and email capabilities
- •Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%
- •Pregnant, planning to become pregnant, or lactating
- •Currently enrolled in a care management program at Palo Alto Medical Foundation or elsewhere
- •PCP determination that the study is inappropriate or unsafe for the patient
- •Investigator discretion for clinical safety or protocol adherence reasons
研究组 & 干预措施
Online disease management
The PAMFOnline-mediated Personalized Health Care Program, which couples a multidisciplinary diabetes care management team with an EHR-integrated Online Disease Management (ODM) system.
干预措施: Online disease management (Behavioral)
Usual care
Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management.
结局指标
主要结局
Hemoglobin A1C
时间窗: Baseline, 6 months and 12 months
次要结局
- Cardiovascular risk (e.g., blood pressure and lipids)(Baseline, 6 months and 12 months)
- Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)(Baseline, 6 months and 12 months)
- Patient experience and satisfaction (e.g., relevant CAHPS measures)(Baseline and 12 months)
- Patient psychosocial well-being (e.g., diabetes-related emotional distress)(Baseline, 6 months and 12 months)
- Processes of care (e.g., frequency of lab testing)(Baseline, 6 months and 12 months)
研究者
Paul Tang
Vice President
Palo Alto Medical Foundation