Status:
NOT_YET_RECRUITING
A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity
Lead Sponsor:
University of Vermont
Conditions:
Chronic Disease Management
Infants Health
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
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 qu...
Detailed Description
The project goal is to optimize and implement an emergency care action plan (ECAP) developed previously by the PI and team (through an NIH K23 award) to improve emergency care for infants with medical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2031
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06993129
Start Date
April 1 2026
End Date
June 1 2031
Last Update
June 6 2025
Active Locations (4)
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1
Colorado Children's Hospital
Aurora, Colorado, United States, 80045
2
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States, 45229
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 05482
4
University of Vermont Medical Center
Burlington, Vermont, United States, 05401