A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity

Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.

NCT Number	NCT06993129
Lead Sponsor	University of Vermont
Conditions	Chronic Disease Management, Infants Health, Emergency, Utilization, Health Care, Caregiver Stress
Enrollment	500 participants
Start Date	2026-04-01
Primary Completion	2030-06-01 (estimated)
Study Completion	2031-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-06