Emergency Care Action Plans for Infants with Medical Complexity

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT06444282
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 6 Months
Healthy Volunteers
Not accepted

Interventions

  • Emergency Care Action Plan — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Oct 2024
Primary completion
Aug 8, 2027
Completion
Aug 8, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • No Intervention: Standard Care
    The current standard of care does not include emergency care planning.

Primary Outcome Measure

Inpatient hospitalization [ Time Frame: Day 0 (NICU discharge) to Month 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401-

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