E-PRIME For Children With Medical Complexity

Wake Forest University (WFU)

Status: Enrolling

Conditions: Children With Medical Complexity

Treatments: Other: Usual Care and Enhanced Primary Care; Other: Enhanced Primary Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06216548

TE-2022C3-30607 (Other Identifier)

IRB00102234

Details and patient eligibility

About

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.

Full description

The specific aims of this study are to: compare the effectiveness of Enhanced Primary Care via Telehealth (E-PRIME) verses usual care in improving child-level appointment and outcome measures; compare the effectiveness of (E-PRIME) verses usual care in reducing caregiver stress and improving caregiver satisfaction in primary care and care coordination services; evaluate how acceptable, appropriate, and feasible E-PRIME is from the perspective of practice providers and staff, and 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.

Enrollment: 909 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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909 participants in 2 patient groups

Delayed Enhanced Primary Care (E-PRIME) Group

Active Comparator group

Description:

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

Treatment:

Other: Usual Care and Enhanced Primary Care

Early Enhanced Primary Care (E-PRIME) Group

Experimental group

Description:

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

Treatment:

Other: Enhanced Primary Care