E-PRIME For Children With Medical Complexity
ConditionChildren With Medical Complexity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
Qualifiers
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.)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Usual Care and Enhanced Primary Care
- Enhanced Primary Care
Treatment groups
909 Participants
are divided into 2 treatment groupsSponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov