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Enrolling by Invitation

NCT Number: NCT06444282

Emergency Care Action Plans for Infants with Medical Complexity

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.

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Key information

Conditions

Children with Medical Complexity Behavior Child, Only Chronic Condition Chronic Disease Disease Attributes Emergencies Health Behavior Infant Conditions Infant Morbidity Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Treatment Adherence and Compliance Utilization, Health Care

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Inpatient hospitalization

    Time frame: Day 0 (NICU discharge) to Month 12

    Number of inpatient hospital days

Secondary outcomes

  1. Avoidance of ED visits

    Time frame: Day 0 (NICU discharge) to Month 12

    Caregiver's perceived avoidance of emergency department (ED) visits for their child

  2. Number of ED visits

    Time frame: Day 0 (NICU discharge) to Month 12

    Number of emergency department (ED) visits

  3. ED length of stay

    Time frame: Day 0 (NICU discharge) to Month 12

    Emergency department (ED) length of stay

  4. Interfacility transfers

    Time frame: Day 0 (NICU discharge) to Month 12

    Number of interfacility transfers

  5. Caregiver stress

    Time frame: 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.

  6. Caregiver self-efficacy

    Time frame: 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).

Other outcomes

  1. Cost

    Time frame: Day 0 (NICU discharge)-Month 12

    Costs for healthcare services received

  2. Implementation outcomes

    Time frame: Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)

    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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Optimization and Implementation Trial of a User-Centered Emergency Care Action Plan for Infants with Medical Complexity

Acronym: ECAP

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 5, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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