Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444282
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Emergency Care Action Plans for Infants with Medical Complexity
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Optimization and Implementation Trial of a User-Centered Emergency Care Action Plan for Infants with Medical Complexity
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECAP
Brief 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 childs caregivers and kept up by all of those involved in a childs 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
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
Detailed 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 parentlegal 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
Research participants will be assigned by chance to receive an ECAP or standard care Caregivers parentlegal 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HD109469-01 | NIH | None | httpsreporternihgovquickSearchK23HD109469-01 |