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Clinical Trial Summary

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. Once created, ECAPs are added to the Electronic Health Record (EHR), shared with the child's caregiver(s), and kept up by all of those involved in a child's care. 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 discharged from the Neonatal Intensive Care Unit (NICU). This study will also measure other real-time potential challenges related to the use of the ECAP including, but not limited to, if it is being used, if providers and caregivers want to use it, and if they keep using it over a long period of time.


Clinical Trial Description

National expert recommendations and human-centered design principles were used to optimize an Emergency Care Action Plan (ECAP) for infants with medical complexity. This study will implement and monitor the effectiveness and feasibility of the optimized Emergency Care Action Plan for infants with medical complexity. The primary objective is to determine the effectiveness of a user-centered Emergency Care Action Plan for infants with medical complexity on emergency health care utilization and cost metrics. The secondary objective is to monitor and evaluate barriers and facilitators to the current and widespread implementation of a user-centered Emergency Care Action Plan for infants with medical complexity. Research participants will be assigned by chance to receive an ECAP or standard care. Caregivers (parent/legal guardian) of infant participants will be asked to complete periodic surveys during a one-year feasibility trial period. If assigned, caregivers will be asked to help with the process of creating an ECAP for their child. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06444282
Study type Interventional
Source University of Vermont
Contact Christian D Pulcini, MD, MEd, MPH
Phone 585-615-0381
Email christian.pulcini@uvm.edu
Status Not yet recruiting
Phase N/A
Start date August 1, 2024
Completion date August 8, 2028

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