Emergency Care Action Plans for Infants With Medical Complexity

Emergencies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444282
• Other study ID #: 1K23HD109469-01
• Secondary ID: K23HD109469-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: August 8, 2028

Study information

• Verified date: May 2024
• Source: University of Vermont
• Contact: Christian D Pulcini, MD, MEd, MPH
• Phone: 585-615-0381
• Email: christian.pulcini[@]uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 8, 2028
• Est. primary completion date: August 8, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Children With Medical Complexity
• Chronic Disease
• Disease
• Emergencies
• Infant Conditions
• Infant Morbidity
• Utilization, Health Care

Intervention

Other:
• 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 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.

Locations

Country	Name	City	State
United States	University of Vermont Medical Center	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost	Costs for healthcare services received	Day 0 (NICU discharge)-Month 12
Other	Implementation outcomes	Caregiver and provider perspectives on observability, usability, acceptability, feasibility and sustainability of Emergency Care Action Plans as well as barriers/facilitators to implementation and suggestions for improvement. Provider perspectives on workflow, technical infrastructure and available resources to support implementation of Emergency Care Action Plans.	Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
Primary	Inpatient hospitalization	Number of inpatient hospital days	Day 0 (NICU discharge) to Month 12
Secondary	Avoidance of ED visits	Caregiver's perceived avoidance of emergency department (ED) visits for their child	Day 0 (NICU discharge) to Month 12
Secondary	Number of ED visits	Number of emergency department (ED) visits	Day 0 (NICU discharge) to Month 12
Secondary	ED length of stay	Emergency department (ED) length of stay	Day 0 (NICU discharge) to Month 12
Secondary	Interfacility transfers	Number of interfacility transfers	Day 0 (NICU discharge) to Month 12
Secondary	Caregiver stress	Caregiver perceived stress measured using the University of Washington Caregiver Stress Scale 3 item short form for caregivers of children with serious health conditions.	Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)
Secondary	Caregiver self-efficacy	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).	Day 0 (NICU discharge) to Month 12, assessed at quarterly intervals (Month 3, 6, 9, 12)