Clinical trial NCT06216548: E-PRIME For Children With Medical Complexity
Official title: Enhanced Primary Care Via Telehealth for Children With Medical Complexity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children With Medical Complexity
Keywords: Collaboration
Providers
Telehealth
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-01-22
Enrollment: 909
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Number of Days Outside the Home (DOH)
timeFrame: Baseline
measure: Number of Days Outside the Home (DOH)
timeFrame: Year 1
Secondary outcomes:
measure: Number of Hospitalizations
timeFrame: Year 1
measure: Number of Emergency Room (ER) visits
timeFrame: Year 1
measure: Number of Hospital Days
timeFrame: Year 1
measure: Appointment Completion Rate
timeFrame: Year 1
measure: Change in Caregiver Burden scores
timeFrame: Month 19
measure: Change in Caregiver Satisfaction with coordination of care scores
timeFrame: Month 19
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Savithri Nageswaran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Sabina Gesell, PhD
role: PRINCIPAL_INVESTIGATOR
References: