I-TRUST: Implementation of Teleophthalmology in Rural Health Systems Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Proportion of Patients Who Complete Annual Diabetic Eye Screening
研究概览
简要总结
This pragmatic clinical trial is being conducted to test the effectiveness of I-SITE (Implementation for Sustained Impact in Teleophthalmology), an implementation program to sustain increased diabetic eye screening rates using teleophthalmology in rural, multi-payer health systems. Up to 10 rural health systems providing teleophthalmology to 10,000 patients with diabetes and 100 clinical care personnel participating in the I-SITE intervention will be enrolled for up to 48 months.
详细描述
The investigators' long-term goal is to reduce vision loss nationwide through widespread teleophthalmology use. The next step in the project is to determine whether I-SITE is an effective, generalizable strategy across multiple rural health systems.
The investigators will test the primary hypothesis that I-SITE will sustain significant diabetic eye screening rate increases of ≥ 20% (e.g., from 40% to ≥ 60%) compared to baseline. The primary outcome measure will be the change in diabetic eye screening rates between baseline and 24 months after initiation of I-SITE implementation. Secondary outcome measures include characterizing pre/post changes in screening rates at 12, 36, and up to 48 months after I-SITE implementation at all sites, follow-up rates for in-person eye care among screen positives, identifying key factors and core implementation components distinguishing high and low teleophthalmology-use health systems following I-SITE implementation, and measuring implementation costs.
I-Site implementation will include:
- Teleophthalmology in primary care clinic
- I-SITE online toolkit
- Technical assistance from study team via email
- Introductory live webinar with question & answer session (30 min) between I-SITE Coach and primary care clinic
- Series of 2 in-person meetings over 6 weeks (45-60 min.) between I-SITE Coach and local implementation team
- Series of 10 monthly teleconferences (15-30 min.) between I-SITE Coach and local implementation team
- Series of 4 quarterly group teleconferences (45-60 min.) between I-SITE Coach and local implementation teams
Aim 1: To test the effectiveness of I-SITE vs. usual care teleophthalmology for increasing diabetic eye screening rates among 10 rural health systems across 6 states. The investigators will use a cluster-randomized study design with a stepped wedge initiation of the intervention to optimize longitudinal assessment of sustained increases in diabetic eye screening rates up to 48 months. The investigators will also measure follow-up rates for in-person eye care among screen positives every 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Health system serves rural patients as defined as those patients living in counties considered rural by the federal Office of Management and Budget (OMB)
- •Health system has an active clinical teleophthalmology program providing diabetic eye screening in primary care prior to study randomization
- •Health system agrees to share de-identified patient data at the requested time intervals
排除标准
- •Health system does not serve a rural patient population
- •Health system has a diabetic eye screening rate of greater than 50% (e.g., above the national average) as it may limit the ability to measure improvement from I-SITE
研究组 & 干预措施
Intervention
Up to 10 rural health systems will be participating in I-SITE implementation with cluster-randomization of the order of initiation for the intervention. All sites will receive usual care teleophthalmology prior to I-SITE implementation.
干预措施: I-SITE (Other)
结局指标
主要结局
Proportion of Patients Who Complete Annual Diabetic Eye Screening
时间窗: 24 months
Comparison of proportion of patients with diabetes adherent with yearly diabetic eye screening guidelines (i.e., "screening rates") between baseline and 24 months following initiation of I-SITE implementation at each site.
次要结局
- Change in Proportion of Patients Who Complete Annual Diabetic Eye Screening(baseline, 12 months, 36 months, 48 months)
- Change in follow-up rates for in-person eye care among screen positive patients(baseline, 12 months, 36 months, 48 months)
- Mean Implementation Cost(up to 48 months)
- Identification of workflow strategies, organizational factors, and implementation components that distinguish between health systems with high and low teleophthalmology use(up to 13 months)