Emergency Care Action Plans for Infants with Medical Complexity (ECAP)

University of Vermont

Status: Invitation-only

Conditions: Emergencies; Child, Only; Chronic Condition; Utilization, Health Care; Infant Conditions; Children with Medical Complexity; Infant Morbidity

Treatments: Other: Emergency Care Action Plan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06444282

1K23HD109469-01 (U.S. NIH Grant/Contract)

K23HD109469-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Emergency Care Action Plan

Experimental group

Description:

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.

Treatment:

Other: Emergency Care Action Plan

Standard Care

No Intervention group

Description:

The current standard of care does not include emergency care planning.