Emergency Care Plans for Infants With Medical Complexity

(ECAP Trial)

Overseen By Christian D Pulcini, MD, MEd, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Disqualifiers: No caregiver consent, Non-UVM care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

50 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Emergency Care Plan for Infants With Medical Complexity safe?

The research highlights that emergency departments can be high-risk environments for children, with potential for unintended harm. However, specific safety data for Emergency Care Plans for Infants With Medical Complexity is not provided in the available studies. ^{1 2 3 4 5}

How is the Emergency Care Action Plan treatment different from other treatments for infants with medical complexity?

The Emergency Care Action Plan is unique because it involves creating a personalized emergency care plan for infants with medical complexity, which includes standardized forms and data sets completed by healthcare professionals. This approach focuses on preparing families and healthcare providers to manage emergency situations effectively, unlike other treatments that may not offer such tailored and comprehensive planning. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Christian D Pulcini, MD, MEd, MPH

Principal Investigator

University of Vermont Larner College of Medicine, University of Vermont Medical Center

Eligibility Criteria

This trial is for infants with complex medical needs who have been discharged from the Neonatal Intensive Care Unit (NICU). It aims to help caregivers and providers manage emergencies by using a tool called an Emergency Care Action Plan.

Inclusion Criteria

I am under 6 months old.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Emergency Care Action Plan (ECAP) for infants with medical complexity

12 months

Quarterly assessments (Month 3, 6, 9, 12)

Follow-up

Participants are monitored for health outcomes such as inpatient days and emergency department visits

12 months

Treatment Details

Interventions

• Emergency Care Action Plan

Trial Overview The study tests if having an Emergency Care Action Plan (ECAP) in a child's Electronic Health Record helps reduce hospital stays and emergency visits. The ECAP's usage, acceptance, and long-term adoption are also evaluated.

Participant Groups

Group I: Emergency Care Action Plan Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

In a study of 1367 children treated in a pediatric emergency department, 2.5% experienced adverse events related to their care, highlighting a significant risk of harm in this setting.

Most of these adverse events (87.9%) were deemed preventable, with management and diagnostic issues being the most common types, indicating areas where patient safety can be improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the paediatric emergency department: a prospective cohort study. Plint, AC., Stang, A., Newton, AS., et al.[2021]

A retrospective analysis of 144 adverse events in Veterans Health Administration emergency departments revealed that the most common issues included delays in care (26.4%), elopements (14.6%), and suicide attempts (10.4%).

The primary root causes identified were knowledge deficits (11.4%), inadequate policies and procedures (11.1%), and a lack of standardized practices (9.4%), highlighting areas for improvement to enhance patient safety in emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Adverse Event Reports From Emergency Departments in the Veterans Health Administration. Gill, S., Mills, PD., Watts, BV., et al.[2023]

In a study of 6,376 children treated in pediatric emergency departments, 3.0% experienced at least one adverse event related to their care, highlighting a significant safety risk in this setting.

Most of these adverse events (76.5%) were deemed preventable, primarily due to management and diagnostic issues, indicating that there are clear opportunities for improving patient safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe are paediatric emergency departments? A national prospective cohort study. Plint, AC., Newton, AS., Stang, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Adverse events in the paediatric emergency department: a prospective cohort study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

How safe are our paediatric emergency departments? Protocol for a national prospective cohort study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Review of Adverse Event Reports From Emergency Departments in the Veterans Health Administration. [2023]

4. England pubmed.ncbi.nlm.nih.gov

How safe are paediatric emergency departments? A national prospective cohort study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of clinically significant adverse events in patients discharged from a tertiary-care emergency department in Taiwan. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Preventing Emergency Department Visits for Children With Medical Complexity Through Ambulatory Care: A Systematic Review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Pediatric Emergency Medicine Physicians' Perspectives on Emergency Care of Children With Medical Complexity: A Multi-institution Mixed-Methods Assessment. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Primary Care Preparation for Children with Medical Complexity for Emergency Encounters in the Community. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Which urgent care services do febrile children use and why? [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Emergency preparedness for children with special health care needs. Committee on Pediatric Emergency Medicine. American Academy of Pediatrics. [2019]