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Not yet recruiting NCT06993129

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

No phase Interventional Chronic Disease Management Infants Health Emergency Utilization, Health Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emergency Care Action Plan.
Who it may be relevant to
Registry conditions: Chronic Disease Management, Infants Health, Emergency, Utilization, Health Care. Basic parameters: 0 months — 6 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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, patie

Primary outcome measures

  • Hospitalization [Time frame: Day 0 (NICU discharge) to Month 12]
Secondary outcome measures (4)
  • Number of ED Visits [Time frame: Day 0 (NICU discharge) to Month 12]
  • Usability [Time frame: Day 0 (NICU discharge) to Month 12]
  • Acceptability [Time frame: Day 0 (NICU discharge) to Month 12]
  • Feasibility of Intervention [Time frame: Day 0 (NICU discharge) to Month 12]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 4 centers
  • Colorado Children's Hospital — Aurora
  • Cincinnati Children's Hospital and Medical Center — Cincinnati
  • Children's Hospital of Philadelphia — Philadelphia
  • University of Vermont Medical Center — Burlington

Publications

  • 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

Identifiers

NCT: NCT06993129 · FP00005878

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗