An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity Receiving Comprehensive Care: a Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Number of Days Care Provided in a Medical Setting
研究概览
简要总结
The purpose of this study is to assess if the benefits for children with medical complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be further improved by enhanced telemedicine program (ETM) provided during clinic hours using mobile devices to measure temperature and oxygen saturation, auscultate the heart & lungs, and view the skin, throat, and tympanic membranes in the home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than or equal to 2 hospitalizations or greater than or equal to 1 ICU admission in the year before joining the comprehensive care program
- •Greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director
排除标准
- •Major heart disease
- •Mitochondrial disorders
- •Active cancer
- •Do-Not-Resuscitate (DNR) order
- •Patients receiving compassionate care
研究组 & 干预措施
Comprehensive care (CC) program
干预措施: Comprehensive care (CC) program (Other)
Comprehensive care (CC) program augmented with enhanced telemedicine (ETM)
干预措施: Comprehensive care (CC) program (Other)
Comprehensive care (CC) program augmented with enhanced telemedicine (ETM)
干预措施: Enhanced telemedicine (ETM) (Device)
结局指标
主要结局
Number of Days Care Provided in a Medical Setting
时间窗: end of study(about 24 months)
Total Number of Episodes of Serious Illnesses (Causing Death, Pediatric ICU Admission, and Hospital Stay > 7d).
时间窗: end of study(about 24 months)
次要结局
- Cost Effectiveness of ETM(end of study(about 24 months))
- Number of Hospital Admissions Due to All-Cause Infections(end of study(about 24 months))
- Average Numbers of Clinic Visits(end of study(about 24 months))
- Average Total Number of Emergency Department Visits(end of study(about 24 months))
- Average Number of Hospital Days(end of study(about 24 months))
- Average Number of Pediatric Intensive Care Unit (PICU) Days(end of study(about 24 months))
- Total Number of Deaths(end of study(about 24 months))
- Parent Ratings of Care Assessed Using the Consumer Assessment of Healthcare Providers and Systems Survey(end of study(about 24 months))
研究者
Ricardo A. Mosquera
Associate Professor
The University of Texas Health Science Center, Houston