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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an Emergency Care Action Plan (ECAP) for infants with complex medical needs. The ECAP serves as a special guide for doctors and caregivers to manage emergencies more effectively. The study aims to determine if using the ECAP reduces hospital stays and emergency visits for these infants. Infants under six months old who have been in the NICU and have multiple chronic health issues affecting their daily lives are good candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to improving emergency care strategies for infants with complex needs.

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.

What prior data suggests that the Emergency Care Action Plan is safe for infants with medical complexity?

Research has shown that the Emergency Care Action Plan (ECAP) helps manage emergencies for infants with complex medical needs. Current studies examine its effectiveness and usage frequency, rather than safety issues, because the ECAP is not a medication or physical treatment. It serves as a summary of emergency management plans added to electronic health records.

No reports of negative effects exist since the ECAP does not involve direct medical treatment. It primarily aims to improve communication and coordination among caregivers and medical providers. As the trial does not test a new drug or procedure, typical safety concerns are not applicable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emergency Care Action Plan (ECAP) because it offers a proactive approach to managing emergency situations for infants with medical complexity. Unlike the standard care, which lacks a structured emergency plan, ECAP is integrated directly into the electronic health record, providing a quick, accessible summary of emergency management strategies tailored to each child. This integration aims to streamline emergency care, potentially reducing treatment delays and improving outcomes by ensuring that vital information is readily available during critical moments.

What evidence suggests that the Emergency Care Action Plan is effective for infants with medical complexity?

This trial will compare the use of an Emergency Care Action Plan (ECAP) with standard care for infants with medical complexity. Research has shown that using an ECAP can improve health outcomes for these infants. One study found that integrating ECAPs into electronic health records reduced the number of hospital days and emergency room visits for infants. This suggests that ECAPs might lead to less hospital time and fewer emergency visits. Another study found that caregivers and healthcare providers considered ECAPs helpful and wanted to continue using them. These findings suggest that ECAPs can effectively manage emergencies in medically complex infants. ^{2 3 5 6 7}

Who Is on the Research Team?

Christian D Pulcini, MD, MEd, MPH

Principal Investigator

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

Are You a Good Fit for This Trial?

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

Admitted to the University of Vermont Medical Center Neonatal Intensive Care Unit (NICU)

I am under 6 months old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41057174/

Randomised hybrid type 1 pilot trial evaluating preliminary ... Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06444282

Emergency Care Action Plans for Infants with Medical ... 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 ...

3. bmjopen.bmj.com bmjopen.bmj.com/content/15/10/e106842

a study protocol The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency ...

4. publications.aap.org publications.aap.org/pediatrics/article/156/5/e2024070491/204390/The-Impact-of-Emergency-Care-Planning-for-Children

The Impact of Emergency Care Planning for Children With ... Recently, an article describing an emergency care action plan (ECAP) was released in Pediatrics as an attempt to address ongoing implementation ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06993129

Study Details | NCT06993129 | A Multi-Site Hybrid Type I ... An Emergency Care Action Plan (ECAP) is a brief, pre-populated summary of suggested emergency management for children with medical complexity, embedded in the ...

6. withpower.com withpower.com/trial/emergency-care-plans-for-infants-with-medical-complexity-22ff9

Emergency Care Plans for Infants With Medical Complexity ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506180/

Randomised hybrid type 1 pilot trial evaluating preliminary ... The aim of this study is to pilot test the effectiveness of this ECAP for infants with medical complexity and assess preliminary implementation ...