Status:
RECRUITING
E-PRIME For Children With Medical Complexity
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Children With Medical Complexity
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
909 Patients enrolled
Trial Details
Trial ID
NCT06216548
Start Date
June 19 2024
End Date
April 1 2028
Last Update
January 8 2026
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157