Clinical trial NCT06993129: A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity
Official title: A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Disease Management
Infants Health
Emergency
Utilization, Health Care
Caregiver Stress
Keywords: Children with Medical Complexity
Hybrid Implementation Trial
Health Service Utilization
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

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

Primary outcomes:
measure: Hospitalization
timeFrame: Day 0 (NICU discharge) to Month 12
Secondary outcomes:
measure: Number of ED Visits
timeFrame: Day 0 (NICU discharge) to Month 12
measure: Usability
timeFrame: Day 0 (NICU discharge) to Month 12
measure: Acceptability
timeFrame: Day 0 (NICU discharge) to Month 12
measure: Feasibility of Intervention
timeFrame: Day 0 (NICU discharge) to Month 12
Other outcomes:
measure: Caregiver Stress
timeFrame: Day 0 (NICU discharge) to Month 12
measure: Caregiver Self-Efficacy
timeFrame: Day 0 (NICU discharge) to Month 12
Locations:
city: Aurora
country: United States
facility: Colorado Children's Hospital
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital and Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References:
citation: Pulcini CD, Broder-Fingert S, Callas P, Dayan PS, Drath B, Gravel-Pucillo C, Kuo DZ, Lamberson M, Mistry RD, Palaza A, Stevens M, Yeager J, Stapleton RD. Human-Centered Design to Create an Emergency Care Action Plan for Children With Medical Complexity. Pediatrics. 2025 Feb 12:e2024069125. doi: 10.1542/peds.2024-069125. Online ahead of print.