Telehealth support for children with complex medical needs
Enhanced Primary Care Via Telehealth for Children With Medical Complexity
This study tests if using telehealth support can help children with complex medical needs get better care and make it easier for their families to manage their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 909 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06216548 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of Enhanced Primary Care via Telehealth (E-PRIME) compared to usual care for children with medical complexity (CMC). The study focuses on improving appointment outcomes, reducing caregiver stress, and enhancing care coordination among multiple healthcare providers. By utilizing telehealth, the study seeks to address barriers in access to care and alleviate the burden on families managing complex health conditions. The perspectives of practice providers, staff, and caregivers will also be assessed to determine the feasibility and acceptability of the E-PRIME approach.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old with chronic conditions requiring ongoing care from multiple specialists.
Not a fit: Patients who may not benefit include those living outside North Carolina or those in long-term care facilities.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of care for children with medical complexity and reduce the burden on their caregivers.
How similar studies have performed: Other studies have shown promise in using telehealth for managing complex pediatric conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Savithri Nageswaran, MD — Wake Forest University Health Sciences
- Study coordinator: Savithri Nageswaran, MD
- Email: snageswa@wakehealth.edu
- Phone: 336-716-6508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.