Recruiting

E-PRIME

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06216548

Conditions

Children With Medical Complexity

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Usual Care and Enhanced Primary Care

Enhanced Primary Care

Study Details

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 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.

Conditions

Children With Medical Complexity

Study ID

NCT06216548

Start date

Jun 19, 2024

Status verified date

Jan, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

909 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Delayed Enhanced Primary Care (E-PRIME) Group

Children will receive usual care before receiving E-PRIME intervention.

experimental: Early Enhanced Primary Care (E-PRIME) Group

Subjects of this arm will receive E-PRIME intervention at the start of enrollment.

Interventions

Usual Care and Enhanced Primary Care

Usual Care: Interdisciplinary complex care teams help coordinate appointments, facilitate communication between the many specialist providers involved in the child's care, support families, assist with practical needs, and are available as a resource (as consultants) for Primary Care Physicians (PCPs) to care for Children with Medical Complexity (CMC). The complex care teams in tertiary care children's hospital is the focus for providing comprehensive care for CMC.

Enhanced Primary Care: The E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. A team of telehealth experts will help PCPs in using telehealth in their practice.

Enhanced Primary Care

The intervention has the following components: (A) The staff of the E-PRIME team will support the CMC and their caregivers with navigating the patient access portal and how to use the video visit platform for the telehealth visits. (B) The physician or nurse of the E-PRIME team will create clinical summaries about CMC's visit to specialists and hospital and share this health information about CMC with his/her PCP to help the PCP provide care for CMC at home. (C) A team of telehealth experts will help PCPs in using telehealth in their practice.

Primary outcome measure

  • Number of Days Outside the Home (DOH) [ Time Frame: Baseline ]
  • Number of Days Outside the Home (DOH) [ Time Frame: Year 1 ]

Central Contacts and Locations

Central contacts

Savithri Nageswaran, MD

336-716-6508snageswa@wakehealth.edu

Madeleine Nieto, MPH

336.978.1913mnieto@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Savithri Nageswaran, MD

336-716-6508snageswa@wakehealth.edu

Sabina Gesell, PhD

336-713-8738sgesell@wakehealth.edu

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Collaboration
  • Providers
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-01-08.