Emergency Care Action Plans for Infants with Medical Complexity

NCT06444282 | Enrolling By Invitation

• 2 other identifiers: 1K23HD109469-01K23HD109469-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Inpatient hospitalization

  Number of inpatient hospital days

  Day 0 (NICU discharge) to Month 12

Secondary Outcomes (6)

• Avoidance of ED visits

  Day 0 (NICU discharge) to Month 12

• Number of ED visits

  Day 0 (NICU discharge) to Month 12

• ED length of stay

  Day 0 (NICU discharge) to Month 12

• Interfacility transfers

  Day 0 (NICU discharge) to Month 12

• Caregiver stress

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

Other Outcomes (2)

• Cost

  Day 0 (NICU discharge)-Month 12

• Implementation outcomes

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

Study Arms (2)

Emergency Care Action Plan

EXPERIMENTAL

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.

Other: Emergency Care Action Plan

Standard Care

NO INTERVENTION

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

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.

Emergency Care Action Plan

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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."

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (6)

• Pulcini CD, Rubin DM. Flipping the Script on Emergency Care for Children With Medical Complexity. Pediatrics. 2019 Sep;144(3):e20183905. doi: 10.1542/peds.2018-3905. No abstract available.

  PMID: 31439622 BACKGROUND

• Pulcini CD, Dubuque A, Lamberson M, Macy ML, Mistry RD, Pruitt CM, Schnadower D, Zorc JJ, Stevens MW. Pediatric Emergency Medicine Physicians' Perspectives on Emergency Care of Children With Medical Complexity: A Multi-institution Mixed-Methods Assessment. Pediatr Emerg Care. 2022 Aug 1;38(8):e1423-e1427. doi: 10.1097/PEC.0000000000002712. Epub 2022 Apr 18.

  PMID: 35436769 BACKGROUND

• Pulcini CD, Belardo Z, Ketterer T, Zorc JJ, Mollen CJ. Improving Emergency Care for Children With Medical Complexity: Parent and Physicians' Perspectives. Acad Pediatr. 2021 Apr;21(3):513-520. doi: 10.1016/j.acap.2020.09.006. Epub 2020 Sep 15.

  PMID: 32947009 BACKGROUND

• Pulcini CD, Coller RJ, Houtrow AJ, Belardo Z, Zorc JJ. Preventing Emergency Department Visits for Children With Medical Complexity Through Ambulatory Care: A Systematic Review. Acad Pediatr. 2021 May-Jun;21(4):605-616. doi: 10.1016/j.acap.2021.01.006. Epub 2021 Jan 21.

  PMID: 33486099 BACKGROUND

• Pulcini CD, Coller RJ, Macy ML, Alpern E, Harris D, Rodean J, Hall M, Chung PJ, Berry JG. Low-Resource Emergency Department Visits for Children With Complex Chronic Conditions. Pediatr Emerg Care. 2022 Feb 1;38(2):e856-e862. doi: 10.1097/PEC.0000000000002437.

  PMID: 34009894 BACKGROUND

• Palaza A, Callas P, Dayan PS, Kuo DZ, Riney L, Spencer SP, Stapleton R, Stevens M, Studts CR, Pulcini CD. Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical complexity within a rural health network: a study protocol. BMJ Open. 2025 Oct 6;15(10):e106842. doi: 10.1136/bmjopen-2025-106842.

  PMID: 41057174 DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care; Emergencies; Chronic Disease

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian D Pulcini, MD, MEd, MPH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): August 8, 2027
• Study Completion (Estimated): August 8, 2028
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 26 months following article publication.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research for individual participant data meta analysis. Proposals may be submitted up to 36 months following article publication. Proposals must be reviewed and approved by an independent review committee identified for this purpose. Proposals should be directed to Christian.Pulcini@uvmhealth.org.

Locations

US (1)