[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532725":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":39,"locations":49,"responsibleParty":68,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":32,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":43,"maxAge":81,"enrollmentInfo":82,"targetDuration":43,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":51,"whyStopped":43,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Delayed Enhanced Primary Care (E-PRIME) Group","ACTIVE_COMPARATOR","Children will receive usual care before receiving E-PRIME intervention.",[13],"Other: Usual Care and Enhanced Primary Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Early Enhanced Primary Care (E-PRIME) Group","EXPERIMENTAL","Subjects of this arm will receive E-PRIME intervention at the start of enrollment.",[19],"Other: Enhanced Primary Care",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.\n\nEnhanced 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\u002Fher 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.",[9],[26],"Delayed E-PRIME",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"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\u002Fher 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.",[15],[32],"E-PRIME",[34,37],{"name":35,"affiliation":5,"role":36},"Savithri Nageswaran, MD","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":5,"role":36},"Sabina Gesell, PhD",[40,45],{"name":35,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","336-716-6508",null,"snageswa@wakehealth.edu",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Madeleine Nieto, MPH","336.978.1913","mnieto@wakehealth.edu",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-80.24422,36.09986,{"lat":61,"lon":60},[64,65],{"name":35,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":38,"role":41,"phone":66,"phoneExt":43,"email":67},"336-713-8738","sgesell@wakehealth.edu",{"type":69,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[71],{"name":72,"class":6},"Patient-Centered Outcomes Research Institute","100532725","e-prime-for-children-with-medical-complexity-100532725",false,"NCT06216548","E-PRIME For Children With Medical Complexity","Enhanced Primary Care Via Telehealth for Children With Medical Complexity","Inclusion Criteria:\n\n* Less than 18 years of age on the date of enrollment (date consented)\n* Presence of a chronic condition, defined as a health condition expected to last ≥ 12 months\n* Complexity of the condition, defined as needing ongoing care with 4 sub-specialists\u002F services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)\n\nExclusion Criteria:\n\n* CMC whose permanent address is outside of the state of North Carolina\n* CMC at a long-term care facility\n* CMC who are wards of the state, except when the caregiver is a legal guardian and can consent\n* CMC whose caregivers do not speak English or Spanish","ALL","17 Years",{"count":83,"type":84},909,"ESTIMATED","INTERVENTIONAL",[87],"NA","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.",[90],"Children With Medical Complexity",[92,93,94],"Collaboration","Providers","Telehealth","2026-01-05",{"date":97,"type":98},"2026-01-08","ACTUAL",{"date":100,"type":98},"2024-06-19",{"date":102,"type":84},"2028-04",{"name":5,"class":6},1]