Emergency Care Action Plan for Infant Health

Not yet recruiting at 3 trial locations

Overseen By Roz King, MSN, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Disqualifiers: No caregiver consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an Emergency Care Action Plan (ECAP) can reduce hospital visits for infants with complex medical needs. The plan, a summary tool added to the electronic health record, helps doctors and families manage emergency care more effectively. The study will occur at four U.S. hospitals and will assess the ECAP's practicality and user-friendliness. Families with infants aged 0-6 months who have multiple chronic health issues and are currently in specific neonatal intensive care units (NICUs) may be suitable for this trial. As an unphased study, this trial allows families to contribute to innovative care strategies that could enhance emergency care management for infants with complex medical needs.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this emergency care action plan is safe for infants with medical complexity?

Research shows that the Emergency Care Action Plan (ECAP) assists healthcare providers in caring for infants with complex medical needs during emergencies. Previous studies have examined how this tool functions in real-life situations. Although specific safety data for the ECAP itself is lacking, it is crucial to recognize that it is a tool, not a medication or procedure. As such, it generally poses no direct physical risks to patients. Instead, it aims to make emergency care more efficient and personalized, potentially reducing hospital visits for these infants. Since this trial is in the "Not Applicable" phase, the study focuses on using the tool effectively rather than testing its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emergency Care Action Plan (ECAP) because it introduces a proactive approach to managing emergencies for children with medical complexities. Unlike the current standard care, which lacks pre-planned emergency protocols, ECAP provides a detailed, pre-populated guide embedded directly into the electronic health record. This new method aims to streamline emergency management, potentially reducing response times and improving outcomes by ensuring that healthcare providers have immediate access to tailored emergency instructions. By having this information at their fingertips, medical teams can make quicker, more informed decisions during critical situations, which could significantly enhance the care and safety of these vulnerable children.

What evidence suggests that the Emergency Care Action Plan is effective for infants with medical complexity?

Research has shown that Emergency Care Action Plans (ECAPs), which participants in this trial may receive, can improve health outcomes for infants with complex medical needs. Studies have found that using an ECAP reduces emergency room visits and hospital days for these infants. An ECAP, included in electronic health records, provides healthcare providers with a quick summary of emergency care steps. Early findings suggest that this tool is effective and easy to use, helping families and medical teams manage emergencies better. By customizing care plans to fit each child's needs, the ECAP aims to reduce hospital stays and enhance emergency care for these vulnerable children. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for infants with complex medical needs who often require emergency care. It aims to help these children receive better quality healthcare and reduce hospital visits. To participate, infants must meet certain health criteria that will be specified by the researchers.

Inclusion Criteria

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.

I have three or more complex chronic conditions.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Emergency Care Action Plan (ECAP) for infants with medical complexity across four US hospitals

12 months

Regular monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after implementation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Emergency Care Action Plan

Trial Overview The study is testing an Emergency Care Action Plan (ECAP) designed for infants with complex medical issues. The plan will be implemented across four US hospitals to see if it can lower hospitalizations and improve emergency healthcare over a one-year period.

How Is the Trial Designed?

Group I: Emergency Care Action Plan Experimental Treatment 1 Intervention

An 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.

Group II: Standard Care Active Control 1 Intervention

The current standard of care does not include emergency care planning.

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06444282

Emergency Care Action Plans for Infants with Medical ... The goal of this study is to measure important health outcomes (ex. inpatient days, emergency department visits) in terms of the use of the ECAP for infants ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41057174/

Randomised hybrid type 1 pilot trial evaluating preliminary ... Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/10/e106842

Main menu This study tests an optimised, human-centred designed Emergency Care Action Plan for infants with medical complexity, assessing both effectiveness and ...

4. publications.aap.org publications.aap.org/pediatrics/article/155/3/e2024069125/200950/Human-Centered-Design-to-Create-an-Emergency-Care

Human-Centered Design: Emergency Care Plan for Children Comparison of emergency care delivered to children and young adults with complex chronic conditions between pediatric and general emergency departments.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06993129

Study Details | NCT06993129 | A Multi-Site Hybrid Type I ... An Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506180/

Randomised hybrid type 1 pilot trial evaluating preliminary ... The aim of this study is to pilot test the effectiveness of this ECAP for infants with medical complexity and assess preliminary implementation ...

7. publications.aap.org publications.aap.org/pediatrics/article/156/5/e2024070491/204390/The-Impact-of-Emergency-Care-Planning-for-Children

The Impact of Emergency Care Planning for Children With ... Extending beyond, yet paralleling the role of advanced emergency care planning is the importance of pediatric readiness across our emergency ...

8. withpower.com withpower.com/trial/emergency-care-plans-for-infants-with-medical-complexity-22ff9

Emergency Care Plans for Infants With Medical Complexity ... An Emergency Care Action Plan (ECAP) is a tool intended to be helpful to providers when treating a child with complex medical needs during an emergency.