Enhanced Primary Care Via Telehealth for Children With Medical Complexity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 909
- 试验地点
- 1
- 主要终点
- Number of Days Outside the Home (DOH)
研究概览
简要总结
Children with medical complexity (CMC) have very high needs for health and support services. CMC have very rare diseases that involve multiple organ systems. As a result, all CMC have multiple chronic conditions and need care from many specialists and services. While there are important benefits to the child and family in living at home, the continuing need for complex medical care places a profound burden on caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.
详细描述
The specific aims of this study are to: compare the effectiveness of Enhanced Primary Care via Telehealth (E-PRIME) verses usual care in improving child-level appointment and outcome measures; compare the effectiveness of (E-PRIME) verses usual care in reducing caregiver stress and improving caregiver satisfaction in primary care and care coordination services; evaluate how acceptable, appropriate, and feasible E-PRIME is from the perspective of practice providers and staff, and caregivers. Telehealth has long been considered a potential solution to barriers in access to care for children. The purpose of this research is to test whether telehealth can help pediatric primary care providers (PCPs) as they treat, monitor, and manage children with medical complexity (CMC). Additionally, it is to reduce caregiver and child burden as well as improve care coordination between multiple providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 18 years of age on the date of enrollment (date consented)
- •Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months
- •Complexity of the condition, defined as needing ongoing care with 4 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)
排除标准
- •CMC whose permanent address is outside of the state of North Carolina
- •CMC at a long-term care facility
- •CMC who are wards of the state, except when the caregiver is a legal guardian and can consent
- •CMC whose caregivers do not speak English or Spanish
结局指标
主要结局
Number of Days Outside the Home (DOH)
时间窗: Year 1
Number of hospital days + ER visit days + number of in-person appointments / child year
Number of Days Outside the Home (DOH)
时间窗: Baseline
Number of hospital days + ER visit days + number of in-person appointments / child year
次要结局
- Change in Caregiver Burden scores(Month 19)
- Change in Caregiver Satisfaction with coordination of care scores(Month 19)
- Number of Emergency Room (ER) visits(Year 1)
- Number of Hospital Days(Year 1)
- Number of Hospitalizations(Year 1)
- Appointment Completion Rate(Year 1)