What this study is
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.
What's being tested
- Usual Care and Enhanced Primary Care
Intervention · 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
Intervention · 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
- Official title
- Enhanced Primary Care Via Telehealth for Children With Medical Complexity
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Children With Medical Complexity
- Enrolling
- 909 people
- Starts
- 2024-06-19
- Est. completion
- 2028-04
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWake Forest University Health Sciences
Winston-Salem, North Carolina, United States
- Savithri Nageswaran, MD · Contact336-716-6508snageswa@wakehealth.edu
- Sabina Gesell, PhD · Contact336-713-8738sgesell@wakehealth.edu
Recruiting
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00102234
Principal investigator
Savithri Nageswaran, MD
Wake Forest University Health Sciences
Principal investigator
Sabina Gesell, PhD
Wake Forest University Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.