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E-PRIME for Children With Medical Complexity

This study, called E-PRIME, is looking at how telehealth can help children with medical complexity (CMC) and their families. CMC are children under 18 with long-lasting health conditions that require care from many specialists or technology support (like a feeding tube). The study compares two approaches: usual care, where a team helps coordinate appointments and support families, and Enhanced Primary Care (E-PRIME). E-PRIME adds support for families to use patient portals and video visits for telehealth. Researchers want to see if E-PRIME can improve how often children are home (Days Outside the Home), reduce stress for caregivers, and improve their satisfaction with care. The study aims to enroll 909 children and is currently unclear regarding its recruitment status.

Study design
This interventional study compares two different care approaches for children with medical complexity. It plans to enroll 909 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at baseline and again at Year 1.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06216548

E-PRIME For Children With Medical Complexity

Recruiting
NAUp to 17InterventionalSupportive care
Wake Forest University Health Sciences
~909 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Usual Care and Enhanced Primary CareEnhanced Primary Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Days Outside the Home (DOH)
Measured over Baseline
+1 more outcome measured

Conditions

Children With Medical Complexity

Explore related trials

Children With Medical Complexity

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Savithri Nageswaran, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
  • Sabina Gesell, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Savithri Nageswaran, MD
[email protected]
336-716-6508
Email the study team

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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

What this trial measures

  • Number of Days Outside the Home (DOH)Baseline

    Number of hospital days + ER visit days + number of in-person appointments / child year

  • Number of Days Outside the Home (DOH)Year 1

    Number of hospital days + ER visit days + number of in-person appointments / child year