Actively Recruiting
Enhanced Primary Care Via Telehealth for Children With Medical Complexity
Led by Wake Forest University Health Sciences · Updated on 2026-01-08
909
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how telehealth can support pediatric primary care providers (PCPs) in treating, monitoring, and managing children with medical complexity (CMC). These children have rare diseases affecting multiple organs and require care from many specialists. The study aims to see if telehealth improves care coordination, reduces the burden on caregivers and children, and enhances appointment and health outcomes compared to usual care. The study compares Enhanced Primary Care via Telehealth (E-PRIME) with usual care. Usual care involves interdisciplinary complex care teams coordinating appointments and communication among specialists. The E-PRIME intervention includes helping families use patient portals and video visits, sharing clinical summaries with PCPs, and providing telehealth support to PCPs. Participants receive usual care initially or start with E-PRIME at enrollment. Participants will be monitored for outcomes such as the number of days children spend outside the home, hospitalizations, emergency room visits, hospital days, appointment completion, caregiver burden, and satisfaction with care coordination. Assessments occur over about 19 months. The study involves collecting data on child health, caregiver experiences, and care coordination to evaluate the impact of telehealth support.
CONDITIONS
Brief Title
E-PRIME For Children With Medical Complexity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Less than 18 years of age on the date of enrollment
- Presence of a chronic condition expected to last 12 months or more
- Complexity defined as needing ongoing care with 4 or more specialists or dependent on at least one technology such as gastrostomy, tracheostomy, oxygen, or ventilator
You will not qualify if you...
- Permanent address outside of the state of North Carolina
- Living in a long-term care facility
- Wards of the state unless caregiver is a legal guardian and can consent
- Caregivers who do not speak English or Spanish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 19 months
Participants receive either usual care initially or the Enhanced Primary Care via Telehealth (E-PRIME) intervention to support care coordination and reduce caregiver burden.
Ongoing telehealth and primary care visits as part of the intervention
Duration - Up to 19 months
Participants are monitored for outcomes such as hospitalizations, emergency room visits, appointment completion, and caregiver burden and satisfaction after receiving the intervention.
Periodic assessments during and after treatment
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Savithri Nageswaran, MD
M
Madeleine Nieto, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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