Clinical trial NCT06444282: Emergency Care Action Plans for Infants with Medical Complexity
Official title: Optimization and Implementation Trial of a User-Centered Emergency Care Action Plan for Infants with Medical Complexity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Children with Medical Complexity
Child, Only
Infant Morbidity
Infant Conditions
Utilization, Health Care
Emergencies
Chronic Condition
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-06-05
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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."

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

Primary outcomes:
measure: Inpatient hospitalization
timeFrame: Day 0 (NICU discharge) to Month 12
Secondary outcomes:
measure: Avoidance of ED visits
timeFrame: Day 0 (NICU discharge) to Month 12
measure: Number of ED visits
timeFrame: Day 0 (NICU discharge) to Month 12
measure: ED length of stay
timeFrame: Day 0 (NICU discharge) to Month 12
measure: Interfacility transfers
timeFrame: Day 0 (NICU discharge) to Month 12
measure: Caregiver stress
timeFrame: Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
measure: Caregiver self-efficacy
timeFrame: Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
Other outcomes:
measure: Cost
timeFrame: Day 0 (NICU discharge)-Month 12
measure: Implementation outcomes
timeFrame: Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of Vermont Larner College of Medicine, University of Vermont Medical Center
name: Christian D Pulcini, MD, MEd, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pulcini CD, Rubin DM. Flipping the Script on Emergency Care for Children With Medical Complexity. Pediatrics. 2019 Sep;144(3):e20183905. doi: 10.1542/peds.2018-3905. No abstract available.
citation: Pulcini CD, Dubuque A, Lamberson M, Macy ML, Mistry RD, Pruitt CM, Schnadower D, Zorc JJ, Stevens MW. Pediatric Emergency Medicine Physicians' Perspectives on Emergency Care of Children With Medical Complexity: A Multi-institution Mixed-Methods Assessment. Pediatr Emerg Care. 2022 Aug 1;38(8):e1423-e1427. doi: 10.1097/PEC.0000000000002712. Epub 2022 Apr 18.
citation: Pulcini CD, Belardo Z, Ketterer T, Zorc JJ, Mollen CJ. Improving Emergency Care for Children With Medical Complexity: Parent and Physicians' Perspectives. Acad Pediatr. 2021 Apr;21(3):513-520. doi: 10.1016/j.acap.2020.09.006. Epub 2020 Sep 15.
citation: Pulcini CD, Coller RJ, Houtrow AJ, Belardo Z, Zorc JJ. Preventing Emergency Department Visits for Children With Medical Complexity Through Ambulatory Care: A Systematic Review. Acad Pediatr. 2021 May-Jun;21(4):605-616. doi: 10.1016/j.acap.2021.01.006. Epub 2021 Jan 21.
citation: Pulcini CD, Coller RJ, Macy ML, Alpern E, Harris D, Rodean J, Hall M, Chung PJ, Berry JG. Low-Resource Emergency Department Visits for Children With Complex Chronic Conditions. Pediatr Emerg Care. 2022 Feb 1;38(2):e856-e862. doi: 10.1097/PEC.0000000000002437.