Emergency Care Action Plans for Infants with Medical Complexity

Not Applicable

• Conditions: Children with Medical Complexity; Child, Only; Infant Morbidity; Infant Conditions; Utilization, Health Care; Emergencies; Chronic Condition
• Interventions: Other: Emergency Care Action Plan

• Registration Number: NCT06444282
• Lead Sponsor: University of Vermont

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 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.

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 (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 Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-05
• Study Start: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2027-08-08
• Study Completion: 2028-08-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age 0 to 6 months
• Admitted to the University of Vermont Medical Center 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."

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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 University of Vermont Health Network and affiliated sites for care during the one-year trial period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emergency Care Action Plan	Emergency Care Action Plan	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.

Primary Outcome Measures

Name	Time	Method
Inpatient hospitalization	Day 0 (NICU discharge) to Month 12	Number of inpatient hospital days

Secondary Outcome Measures

Name	Time	Method
Caregiver self-efficacy	Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)	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).
Avoidance of ED visits	Day 0 (NICU discharge) to Month 12	Caregiver's perceived avoidance of emergency department (ED) visits for their child
Number of ED visits	Day 0 (NICU discharge) to Month 12	Number of emergency department (ED) visits
ED length of stay	Day 0 (NICU discharge) to Month 12	Emergency department (ED) length of stay
Interfacility transfers	Day 0 (NICU discharge) to Month 12	Number of interfacility transfers
Caregiver stress	Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)	Caregiver perceived stress measured using the University of Washington Caregiver Stress Scale 3 item short form for caregivers of children with serious health conditions.

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States