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

Launched by UNIVERSITY OF VERMONT · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how an Emergency Care Action Plan (ECAP) can help infants with complex medical needs. Infants with medical complexity often need more emergency care than other children, leading to more hospital visits and higher healthcare costs. The goal of the study is to see if this new plan can reduce the number of hospital admissions for these infants and if families and healthcare providers find it helpful and easy to use. The trial will take place at four hospitals across the United States.

To be eligible for this trial, infants need to be between 0 to 6 months old and be admitted to one of the participating hospitals. They must also have multiple significant chronic health problems that require specialized care. It's important that a caregiver agrees to participate in the study and complete follow-up surveys. Families who join the trial can expect to work closely with healthcare providers and will be monitored over a year to see how the ECAP impacts their child's care and health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 0 to 6 months
• • Admitted to the University of Vermont Medical Center, Cincinnati Children's Hospital, Children's Hospital of Philadelphia, or Colorado Children's Hospital Neonatal Intensive Care Unit (NICU),
• • Meets or is expected to meet Children with Medical Complexity status as determined by the treating NICU clinician and defined as "children with multiple significant chronic health problems including multiple organ systems, which result in functional limitations, high health care needs or utilization, and often require need for, or use of, medical technology."
• • Has three or more documented complex chronic conditions (CCCs)
• Exclusion Criteria:
• • Does not have a caregiver participant who agrees to their participation in the study to complete follow-up surveys
• • Does not intend to use the hospital or affiliated sites of which they were recruited from for care during the one-year trial period