Child, Only, Children with Medical Complexity, Chronic Condition, Emergencies, Infant Conditions, Infant Morbidity, Utilization, Health Care
Conditions
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.
Detailed 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.
Interventions
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient hospitalization | Day 0 (NICU discharge) to Month 12 | Number of inpatient hospital days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver self-efficacy | 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). |
| Interfacility transfers | Day 0 (NICU discharge) to Month 12 | Number of interfacility transfers |
| Caregiver stress | 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. |
| Avoidance of ED visits | Day 0 (NICU discharge) to Month 12 | Caregiver's perceived avoidance of emergency department (ED) visits for their child |
| Number of ED visits | Day 0 (NICU discharge) to Month 12 | Number of emergency department (ED) visits |
| ED length of stay | Day 0 (NICU discharge) to Month 12 | Emergency department (ED) length of stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implementation outcomes | 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. |
| Cost | Day 0 (NICU discharge)-Month 12 | Costs for healthcare services received |
Countries
United States
Outcome results
None listed