Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06993129

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Disease Management Behavior Behavioral Symptoms Caregiver Burden Caregiver Stress Disease Attributes Emergencies Emergency Health Behavior Infants Health Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Stress, Psychological Treatment Adherence and Compliance Utilization, Health Care

Age range

0 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Children's Hospital, Aurora, Colorado, United States

Loading trial locations.

About this study

The project goal is to optimize and implement an emergency care action plan (ECAP) developed previously by the PI and team (through an NIH K23 award) to improve emergency care for infants with medical complexity, a particularly challenging subset of CMC with high utilization and unique challenges in the acute care setting. Dr. Pulcini and team will conduct a hybrid type I effectiveness-implementation randomized trial of the ECAP at four sites (Children's Hospital Colorado, Cincinnati Children's Hospital Medical Center, Children's Hospital of Philadelphia, and the University of Vermont), measuring both health care outcomes/effectiveness (primary endpoint: number of hospitalizations) and implementation (endpoints include acceptability, feasibility, and useability). Dr. Pulcini and team will also measure key secondary health service measures (ex. ED visits, caregiver stress and self-efficacy) and monitor facilitators and barriers to implementation throughout the trial at each site.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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 the hospital or affiliated sites of which they were recruited from for care during the one-year trial period

Treatment and study plan

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.

Primary outcomes

  1. Hospitalization

    Time frame: Day 0 (NICU discharge) to Month 12

    Dichotomous variable for hospitalization vs. no hospitalization (yes/no)

Secondary outcomes

  1. Number of ED Visits

    Time frame: Day 0 (NICU discharge) to Month 12

    Number of ED visits

  2. Usability

    Time frame: Day 0 (NICU discharge) to Month 12

    Will assess usability using an adaption of the System Usability Scale (SUS) and qualitative assessment of implementation barriers and facilitators (for intervention group only).

  3. Acceptability

    Time frame: Day 0 (NICU discharge) to Month 12

    Will assess acceptability using an adaptation of the Theoretical Framework of Acceptability (TFA), including the following constructs: affective attitude, burden, intervention coherence, self-efficacy, and opportunity costs. Qualitative assessment of implementation barriers and facilitators (for intervention group only) will also elicit perspectives of acceptability.

  4. Feasibility of Intervention

    Time frame: Day 0 (NICU discharge) to Month 12

    Will assess feasibility using an adaptation of the Feasibility of Intervention Measure (FIM), as well as a qualitative assessment of implementation barriers and facilitators (for intervention group only).

Other outcomes

  1. Caregiver Stress

    Time frame: Day 0 (NICU discharge) to Month 12

    Will measure caregiver self-perceived stress and compare between the intervention and standard care by using the University of Washington Caregiver Stress Scale 3-Item Short Form.

  2. Caregiver Self-Efficacy

    Time frame: Day 0 (NICU discharge) to Month 12

    Will measure caregiver self-efficacy and compare between the intervention and standard care by using an adaptation of the Parent Measure of Self-Efficacy Managing a Child's Medications and Treatments, including assessment of self-efficacy in two domains: (1) healthcare information and decision-making, and (2) symptoms identification and management.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian D Pulcini, MD, MEd, MPH

CONTACT

[email protected]

(802) 847-2434

Roz King, MSN, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
May 28, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.