A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity
1 other identifier
interventional
500
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 28, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
June 6, 2025
June 1, 2025
4.2 years
May 12, 2025
June 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization
Dichotomous variable for hospitalization vs. no hospitalization (yes/no)
Day 0 (NICU discharge) to Month 12
Secondary Outcomes (4)
Number of ED Visits
Day 0 (NICU discharge) to Month 12
Usability
Day 0 (NICU discharge) to Month 12
Acceptability
Day 0 (NICU discharge) to Month 12
Feasibility of Intervention
Day 0 (NICU discharge) to Month 12
Other Outcomes (2)
Caregiver Stress
Day 0 (NICU discharge) to Month 12
Caregiver Self-Efficacy
Day 0 (NICU discharge) to Month 12
Study Arms (2)
Emergency Care Action Plan
EXPERIMENTALAn Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in the electronic health record.
Standard Care
NO INTERVENTIONThe current standard of care does not include emergency care planning.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Colorado Children's Hospital
Aurora, Colorado, 80045, United States
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 05482, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Related Publications (1)
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: 39933576BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Emergency Medicine and Pediatrics
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 28, 2025
Study Start
April 1, 2026
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2031
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 9 months and ending 26 months following article publication.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research for individual participant data meta analysis. Proposals may be submitted up to 36 months following article publication. Proposals must be reviewed and approved by an independent review committee identified for this purpose. Proposals should be directed to Christian.Pulcini@uvm.edu.
Individual participant data that underlie the results reported in this article after de-identification will be shared (text, tables, figures and appendices).