E-PRIME For Children With Medical Complexity
- Conditions
- Children With Medical Complexity
- Interventions
- Other: Enhanced Primary CareOther: Usual Care and Enhanced Primary Care
- Registration Number
- NCT06216548
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 909
- Less than 18 years of age
- 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 ≥ 5 sub-specialists/ services OR dependent on ≥ 1 technology (e.g. gastrostomy, tracheostomy, oxygen, ventilator, etc.)
- Children who might turn 18 during the intervention period will be excluded to avoid having to re-consent with adult informed consent form (ICF).
- Children with medical complexity (CMC) who are at a long-term care facility, wards of the state, or whose caregivers do not speak English or Spanish.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early Enhanced Primary Care (E-PRIME) Group Enhanced Primary Care Subjects of this arm will receive E-PRIME intervention at the start of enrollment. Delayed Enhanced Primary Care (E-PRIME) Group Usual Care and Enhanced Primary Care Children will receive usual care before receiving E-PRIME intervention.
- Primary Outcome Measures
Name Time Method Number of Days Outside the Home (DOH) Year 1 Number of hospital days + ER visit days + number of in-person appointments / child year
- Secondary Outcome Measures
Name Time Method Change in Caregiver Burden scores Month 19 Caregiver burden will be measured using the 15-item Impact on Family Scale- Revised which as 15 items and 4 domains - financial, family/social, personal strain, and mastery. Scores will range from 15 to 60. The higher the score the greater the impact.
Change in Caregiver Satisfaction with coordination of care scores Month 19 Caregiver satisfaction with coordination of care will be compared between the two groups and measured by the Family Experiences with Coordination of Care survey. Scores will range from 0 to 100 and each item will be measured independently. Higher scores indicate better care (i.e. care plans, coordination, visit summary content, etc.)
Number of Emergency Room (ER) visits Year 1 Number of ER visits
Number of Hospital Days Year 1 Number of hospital days/observation period in years
Number of Hospitalizations Year 1 Number of hospitalizations/100-child years in the two groups. Number of hospitalizations during the observation period will be counted and the rate will be calculated as: \[Number of hospitalizations/ observation period in years\]\*100. Planned admissions (i.e. elective surgeries, procedures, treatments, etc.) will be excluded.
Appointment Completion Rate Year 1 Proportion of scheduled appointments that were completed
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States