Enhanced Primary Care Telemedicine at Home: a Pilot Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Retention
研究概览
简要总结
The goal of this single arm pilot clinical trial is to test the feasibility and acceptability of providing families of infants with kits of tele-peripheral devices to use during telemedicine visits with their usual primary care practice.
The main question it aims to answer are:
- the feasibility of providing families of infants with a kit to tele-peripheral devices to use during at-home, same-day live-interactive primary care telemedicine visits.
Participants will receive a kit with tele-peripheral devices which they will have the option to use during telemedicine visits with their primary care practice. Participants will be asked to consent to electronic record review and to complete surveys about their experiences receiving care.
详细描述
The investigators will prospectively enroll 100 children (6 month 0 days to 8 months 30 days) in this one-arm pilot feasibility study. Enrolled participants will receive kits including pulse oximeters, thermometers, and tele-otoscopes as well as respiratory viral swab tests and will complete a test call with study team members to confirm ability to connect and use the devices.
After enrollment, families will continue to seek care based on their own preferences and primary care clinic guidance, but will have the ability to provide additional information to their primary care clinicians when primary care telemedicine visits occur.
The investigators will ask families to complete online surveys at 0, 30, and 180 days, and the investigators will perform chart reviews to capture visits (telemedicine and in-person to primary care, urgent care, and emergency department) and antibiotic receipt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 20 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants receiving care at study sites presenting for primary care child visit
- •Infants between 6m0d and 20m30d
排除标准
- •Caregiver not able to consent in English or Spanish
- •Child has chronic condition (prematurity <33 weeks, congenital anomaly)
- •Child is ward of the state
- •Family lacks device and/or wifi plan to be able to participate in telemedicine visits
研究组 & 干预措施
Tele-Device Kit Arm
Families of 6 month old infants will receive tele-device kits that include thermometers, pulse oximeters, and tele-otoscopes and respiratory swab tests, which families will then have the option to use when they schedule telemedicine visits with their usual primary care practice.
干预措施: Remote Enhanced Assessment for Care at Home (REACH) Kit (Other)
结局指标
主要结局
Retention
时间窗: From enrollment to survey completed 6 months after enrollment, up to 18 months
Percent who complete 6 months survey
次要结局
- Recruitment(Day approached for recruitment, up to one year)
- Kit utilization(From enrollment to survey completed 6 months after enrollment)
- Caregiver Satisfaction(From enrollment to survey completed 6 months after enrollment, up to 18 months)
研究者
Kristin Ray
Associate Professor
University of Pittsburgh