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

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.

• Emergency Care Action Plan (Other): 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.

Primary outcomes

• Hospitalization [Day 0 (NICU discharge) to Month 12]: Dichotomous variable for hospitalization vs. no hospitalization (yes/no)

Secondary outcomes

• 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).

Other outcomes

• Caregiver Stress [Day 0 (NICU discharge) to Month 12]: Will measure caregiver self-perceived stress and compare between the intervention and standard care by using the University of Washington Caregiver Stress Scale 3-Item Short Form.
• Caregiver Self-Efficacy [Day 0 (NICU discharge) to Month 12]: Will measure caregiver self-efficacy and compare between the intervention and standard care by using an adaptation of the Parent Measure of Self-Efficacy Managing a Child's Medications and Treatments, including assessment of self-efficacy in two domains: (1) healthcare information and decision-making, and (2) symptoms identification and management.

Sex: All, ages: 0 Months to 6 Months

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

• 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. PMID 39933576