An interventional study of Emergency Care Action Plan in Children with Medical Complexity, Child, Only and Infant Morbidity, sponsored by University of Vermont. Enrolling by invitation at 1 site in United States. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by University of Vermont · Not applicable, Interventional, and Other
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.
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 50 is below the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
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Exclusion Criteria:
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.
Other: Emergency Care Action Plan
The current standard of care does not include emergency care planning.
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.
Inpatient hospitalization
Number of inpatient hospital days
Time frame: Day 0 (NICU discharge) to Month 12
Avoidance of ED visits
Caregiver's perceived avoidance of emergency department (ED) visits for their child
Time frame: Day 0 (NICU discharge) to Month 12
Number of ED visits
Number of emergency department (ED) visits
Time frame: Day 0 (NICU discharge) to Month 12
ED length of stay
Emergency department (ED) length of stay
Time frame: Day 0 (NICU discharge) to Month 12
Interfacility transfers
Number of interfacility transfers
Time frame: Day 0 (NICU discharge) to Month 12
Caregiver stress
Caregiver perceived stress measured using the University of Washington Caregiver Stress Scale 3 item short form for caregivers of children with serious health conditions.
Time frame: Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
Caregiver self-efficacy
Caregiver self-efficacy in health care information or decision making and symptoms identification or management measured using the Parent Measure of Self-Efficacy Managing a Child's Medication and Treatments, adapted from the Patient-Reported Outcomes Measurement Information Systems (PROMIS).
Time frame: Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
Cost
Costs for healthcare services received
Time frame: Day 0 (NICU discharge)-Month 12
Implementation outcomes
Caregiver and provider perspectives on acceptability, adoption, appropriateness, feasibility, useability, and sustainability of Emergency Care Action Plans prior to and throughout implementation will be accessed, in addition to barriers/facilitators to implementation and suggestions for improvement.
Time frame: Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
Plan to share: Yes — Individual participant data that underlie the results reported in this article after de-identification will be shared (text, tables, figures and appendices).
Supporting information: Study protocol
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University of Vermont