PROTECT2: Diabetes Care - Eye Exam
试验速览
- 阶段
- 不适用
- 入组人数
- 4,500
- 试验地点
- 2
- 主要终点
- Qualified eye examination rate
研究概览
简要总结
The PROTECT2 pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study.
The PROTECT2 main study is a prospective randomized controlled multi-center three group clinical trial. The primary endpoint is the percentage of participants in each study group obtaining a qualified eye examination within 12 months of their enrollment in the study.
详细描述
The primary objective of this study is to compare the qualified eye examination rate in two groups of patients with diabetes receiving a new intervention, with the rate in a control group of patients with diabetes receiving usual care only.
Secondary objectives are to:
- Improve our understanding of the barriers to obtaining eye examinations;
- Evaluate the communication between eye care providers (ECP) and referring primary care providers (PCP), as determined by rates of follow-up reports sent and received;
- Characterize eye examinations provided to patients with diabetes;
- Explore the relationships between systemic variables known to affect the severity of diabetic retinopathy and the patient's risk of vision-threatening diabetic retinopathy.
Design and Primary Endpoint
- The pilot study is a single cohort prospective study to gather pilot data and finalize operational details of the main study.
- The main study is a prospective randomized controlled multi-center three group clinical trial. The primary endpoint is the percentage of participants in each study group obtaining a qualified eye examination within 12 months of their enrollment in the study.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed diabetes using the criteria documented in the 2016 Physician Quality Reporting System (PQRS) Measure Specifications Manual for Claims and Registry Reporting of Individual Measures.
- •18 through 75 years of age
- •Have a PCP appointment scheduled within 90 days of the date of medical record review.
排除标准
- •Patients not diagnosed with diabetes
- •History of photosensitive epilepsy
- •Inability or unwillingness of the participant to give verbal or written informed consent.
结局指标
主要结局
Qualified eye examination rate
时间窗: 12 months
Percent of participants in each study group obtaining a qualified eye examination.
次要结局
- Eye examination components(12 months)
- PCP medical record rate(12 months)
- Eye examination barriers(12 months)
- Eye care costs(12 months)
- PCP report rate(12 months)
- Risk correlations(12 months)
- Eye examination findings(12 months)
- Participant perceptions(12 months)
- Increased risk group eye examination rate(12 months)