E-PRIME For Children With Medical Complexity

Conditions

• Children With Medical Complexity

Eligibility Criteria

Sex

ALL

Age

N/A - 17 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jun 19, 2024

Status verified

Jan 2026

Primary completion

Apr 30, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

909 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

• Savithri Nageswaran, MD
  336-716-6508
  [email protected]
• Madeleine Nieto, MPH
  336.978.1913
  [email protected]

Locations (1)

Find similar trials in Winston-Salem, NC

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