A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Vermont
Study ID
NCT06993129
Status
Not Yet Recruiting

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Conditions

  • Caregiver Stress
  • Chronic Disease Management
  • Emergency
  • Infants Health
  • Utilization, Health Care

Eligibility Criteria

Sex
ALL
Age
0 Months - 6 Months
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Jun 2025
Primary completion
Jun 1, 2030
Completion
Jun 1, 2031

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: 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 the electronic health record.
  • No Intervention: Standard Care
    The current standard of care does not include emergency care planning.

Primary Outcome Measure

Hospitalization [ Time Frame: Day 0 (NICU discharge) to Month 12 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Colorado Children's HospitalAuroraColorado80045
Sandra Spencer, MD
[email protected]
720-777-1234
Cincinnati Children's Hospital and Medical CenterCincinnatiOhio45229
Lauren Riney, DO
[email protected]
513-636-4293
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania05482
Joseph Zorc, MD, MSCE
[email protected]
(215) 590-1000
University of Vermont Medical CenterBurlingtonVermont05401
Christian Pulcini, MD, MEd, MPH
[email protected]
802-324-8368

Find similar trials in Aurora, CO

By research site
Colorado Children's Hospital· Aurora, COCincinnati Children's Hospital and Medical Center· Cincinnati, OHChildren's Hospital of Philadelphia· Philadelphia, PAUniversity of Vermont Medical Center· Burlington, VT

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