What this study is
Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.
What's being tested
- Emergency Care Action Plan
Intervention · 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.
Study details
- Sponsor
- University of Vermont
- Conditions
- Chronic Disease Management · Infants Health · Emergency · Utilization, Health Care · Caregiver Stress
- Enrolling
- 500 people
- Starts
- 2026-04-01
- Est. completion
- 2031-06-01
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 0 Months – 6 MonthsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 0 to 6 months
- Admitted to the University of Vermont Medical Center, Cincinnati Children's Hospital, Children's Hospital of Philadelphia, or Colorado Children's Hospital 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."
- Has three or more documented complex chronic conditions (CCCs)
You can't join 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 the hospital or affiliated sites of which they were recruited from for care during the one-year trial period
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (4)
4 openColorado Children's Hospital
Aurora, Colorado, United States
- Sandra Spencer, MD · Contact720-777-1234sandra.spencer@childrenscolorado.org
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States
- Lauren Riney, DO · Contact513-636-4293lauren.riney@cchmc.org
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
- Joseph Zorc, MD, MSCE · Contact(215) 590-1000zorc@email.chop.edu
University of Vermont Medical Center
Burlington, Vermont, United States
- Christian Pulcini, MD, MEd, MPH · Contact802-324-8368christian.pulcini@uvm.edu
Study team
Sponsor
University of Vermont
Study ID FP00005878
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.