E-PRIME For Children With Medical Complexity

NCT06216548 | Recruiting

• 2 other identifiers: IRB00102234TE-2022C3-30607
• Study Type: interventional
• Target: 909
• Locations: 1 country
• Sites: 1

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

Keywords

Collaboration; Providers; Telehealth

Outcome Measures

Primary Outcomes (2)

• Number of Days Outside the Home (DOH)

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

  Baseline

• Number of Days Outside the Home (DOH)

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

  Year 1

Secondary Outcomes (6)

• Number of Hospitalizations

  Year 1

• Number of Emergency Room (ER) visits

  Year 1

• Number of Hospital Days

  Year 1

• Appointment Completion Rate

  Year 1

• Change in Caregiver Burden scores

  Month 19

Study Arms (2)

Delayed Enhanced Primary Care (E-PRIME) Group

ACTIVE COMPARATOR

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

Other: Usual Care and Enhanced Primary Care

Early Enhanced Primary Care (E-PRIME) Group

EXPERIMENTAL

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

Other: Enhanced Primary Care

Interventions

Usual Care and Enhanced Primary Care OTHER

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.

Also known as: Delayed E-PRIME

Delayed Enhanced Primary Care (E-PRIME) Group

Enhanced Primary Care OTHER

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.

Also known as: E-PRIME

Early Enhanced Primary Care (E-PRIME) Group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Study Officials

• Savithri Nageswaran, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Sabina Gesell, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savithri Nageswaran, MD

CONTACT

336-716-6508; snageswa@wakehealth.edu

Madeleine Nieto, MPH

CONTACT

336.978.1913; mnieto@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention participants will complete the Enhanced Primary Care via Telehealth (E-PRIME) intervention for 12 months while Comparison participants will receive usual care for 6 months then complete the E-PRIME intervention for 12 months.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)