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E-PRIME For Children With Medical Complexity

RecruitingNAAges any - 17 YearsAllWake Forest University Health Sciences
NCT06216548 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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.) Exclusion Criteria: * 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
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What it tests

  • Usual Care and Enhanced Primary Care
  • Enhanced Primary Care
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Where

1 site
Wake Forest University Health Sciences
Winston-Salem, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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