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

Starting soon · Not applicable

Conditions studied: Chronic Disease Management, Infants Health, Emergency, Utilization, Health Care, Caregiver Stress

In brief

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.

Key facts

Study ID

NCT06993129

Run by

University of Vermont

People needed

500

Starts

2026-04-01

Expected to finish

2031-06-01

Last updated by the study team

2025-06-06

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Colorado Children's Hospital — Aurora, Colorado, United States
• Cincinnati Children's Hospital and Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Vermont Medical Center — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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