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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06993129
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-19
• Study First Posted: 2025-05-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-06
• Study Start: 2026-04-01
• Primary Completion: 2030-06-01
• Study Completion: 2031-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospitalization	Day 0 (NICU discharge) to Month 12	Dichotomous variable for hospitalization vs. no hospitalization (yes/no)

Secondary Outcome Measures

Name	Time	Method
Number of ED Visits	Day 0 (NICU discharge) to Month 12	Number of ED visits
Usability	Day 0 (NICU discharge) to Month 12	Will assess usability using an adaption of the System Usability Scale (SUS) and qualitative assessment of implementation barriers and facilitators (for intervention group only).
Acceptability	Day 0 (NICU discharge) to Month 12	Will assess acceptability using an adaptation of the Theoretical Framework of Acceptability (TFA), including the following constructs: affective attitude, burden, intervention coherence, self-efficacy, and opportunity costs. Qualitative assessment of implementation barriers and facilitators (for intervention group only) will also elicit perspectives of acceptability.
Feasibility of Intervention	Day 0 (NICU discharge) to Month 12	Will assess feasibility using an adaptation of the Feasibility of Intervention Measure (FIM), as well as a qualitative assessment of implementation barriers and facilitators (for intervention group only).

Trial Locations

Locations (4)

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