NCT06993129

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 0 Months – 6 Months
• Healthy volunteers: Not accepted

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 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.

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 complexity, a particularly challenging subset of CMC with high utilization and unique challenges in the acute care setting. Dr. Pulcini and team will conduct a hybrid type I effectiveness-implementation randomized trial of the ECAP at four sites (Children's Hospital Colorado, Cincinnati Children's Hospital Medical Center, Children's Hospital of Philadelphia, and the University of Vermont), measuring both health care outcomes/effectiveness (primary endpoint: number of hospitalizations) and implementation (endpoints include acceptability, feasibility, and useability). Dr. Pulcini and team will also measure key secondary health service measures (ex. ED visits, caregiver stress and self-efficacy) and monitor facilitators and barriers to implementation throughout the trial at each site.

Conditions

• Chronic Disease Management
• Infants Health
• Emergency
• Utilization, Health Care
• Caregiver Stress

Interventions

Type	Name	Description
OTHER	Emergency Care Action Plan	An Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in a patient's electronic health record for access by providers in an emergency. Patients/families will have digital access to the ECAP and be given a paper copy. The patient's care team and caregiver(s) (parent/legal guardian) will collaborate to create an individualized ECAP containing the following content: caregiver contact information, patient summary, anticipated emergency presentations with suggested management, problem list (emergency relevant only), medication list, technology dependence, baseline important physical exam findings, baseline vital signs, allergies, advance directive information, contact information for established care providers, and other important information.

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-06-01
• Completion: 2031-06-01
• First posted: 2025-05-28
• Last updated: 2025-06-06

Locations

4 sites across 1 country: United States