Enhanced Primary Telecare versus Consultative Complex Care for Children with Medical Complexity

Background and Significance: Children with complex chronic medical conditions are characterized by being medically fragile and depending on technology for survival due to health conditions that involve multiple organ systems. These are linked to genetic disorders, extreme prematurity, complications during pregnancy or during/after birth, trauma, infection and cancers, among other disorders. These children need many medical and non-medical services provided by multiple providers at different settings for a long time. The continuing need for complex medical care is a profound burden on parents/caregivers of these patients

While the survival and well-being of children with complex conditions depends on having access to these healthcare services, access to health care is challenging, particularly for children of minority race/ethnicity, living in poverty and in rural areas, and with severe functional limitations. Transporting children to a medical center or hospital for appointments is particularly difficult. Telehealth has long been considered a potential solution to those healthcare access barriers. With the COVID-19 pandemic, telehealth services became widely available, with health insurance covering these services.

However, with the improvement of the pandemic, there is potential for these services to decrease or stop. The project team’s hypothesis is that increased availability of telehealth services can improve access to health care for children with complex conditions. This project aims to answer the following question: what is the effect of telehealth enhanced primary care (E-PRIME) compared to usual care (complex care in a hospital) on health outcomes of children with complex conditions?

Study Aims: In order to achieve the long-term objective of improving healthcare availability and access for children with complex conditions, this project will:

1. Compare the effectiveness of E-PRIME versus usual complex care in improving child-level outcomes—days outside the home, hospitalization rate, emergency room (ER) visit rate, hospital days and appointment outcomes—and investigate impact of minority race/ethnicity status.
2. Compare the effectiveness of E-PRIME versus usual care in reducing caregiver stress and improving caregiver satisfaction in primary care and care coordination services.
3. Evaluate key implementation outcomes associated with E-PRIME, including E-PRIME’s acceptability, appropriateness and feasibility from the perspective of caregivers and practice providers and staff.

Study Description: This is a multicenter randomized controlled trial to examine the comparative effectiveness of E-PRIME versus usual care for children with complex conditions in primary care pediatric practices. E-PRIME consists of:

1. Strengthening telehealth implementation in pediatric practices.
2. Supporting caregivers to use telehealth.
3. Using telehealth to provide clinical support to primary care physicians.

Usual care is coordinated by complex care teams at two children’s hospitals. Primary care pediatric practices (n~35) in western North Carolina will be randomly assigned to early versus delayed implementation of E-PRIME. From these practices, 400 children with complex conditions (<18 years) will be enrolled in the study and will receive E-PRIME for six months (early group). Children in the control practices will receive the intervention after six months (delayed group). Then the study team will compare the total number of days children spend in (a) the hospital, (b) ER and (c) in-person appointments, measured over six months for the two groups. The project team will also measure hospitalization rates; ER visit rates; hospital days; primary appointment outcomes (completion, cancelation and missed rates); and caregiver-level outcomes (caregiver burden and caregiver satisfaction with care coordination). Children will be followed for an additional six months after the end of the intervention.

Stakeholder Engagement: The project team’s existing stakeholder group will grow to larger caregiver and stakeholder advisory groups to include caregivers, primary care physicians, practice leaders, complex care clinicians, telehealth experts, family support organizations and policy makers. The advisory groups will participate in project planning, implementation and dissemination of study results.

Anticipated Impact: The proposed study may provide evidence for telehealth’s effect on essential health indicators of children with complex conditions, and thus help caregivers, providers, leaders and policy makers make decisions about organizing healthcare delivery for children with complex conditions.