E-PRIME For Children With Medical Complexity

Official title

Enhanced Primary Care Via Telehealth for Children With Medical Complexity

Overview

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.

Detailed 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.

Interventions

• Other 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-
• Other 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

Primary outcome measures

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

Secondary outcome measures (6)

• Number of Hospitalizations [Time frame: Year 1]
• Number of Emergency Room (ER) visits [Time frame: Year 1]
• Number of Hospital Days [Time frame: Year 1]
• Appointment Completion Rate [Time frame: Year 1]
• Change in Caregiver Burden scores [Time frame: Month 19]
• Change in Caregiver Satisfaction with coordination of care scores [Time frame: Month 19]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT06216548 · IRB00102234 · TE-2022C3-30607

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗