Emergency Care Action Plan for Infant Health

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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+