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Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care
Abigail Palaza1, Peter Callas2, Peter S Dayan3
1Department of Emergency Medicine, University of Vermont Larner College of Medicine, Burlington, Vermont, USA.
Insights
This pilot study evaluates an emergency care action plan (ECAP) for infants with medical complexity. The goal is to improve care quality and reduce hospitalizations for these vulnerable children.
Area of Science:
- Pediatric Healthcare
- Medical Complexity
- Health Services Research
Background:
- Children with Medical Complexity (CMC) face challenges in emergency care, including poor quality of care and high caregiver burden.
- Existing emergency care planning tools lack evidence for effectiveness and implementation.
- An optimized Emergency Care Action Plan (ECAP) was developed using a human-centered design approach for infants with medical complexity.
Purpose of the Study:
- To evaluate the effectiveness and implementation of an ECAP for infants with medical complexity.
- To assess the impact of ECAP on inpatient hospital days, emergency department visits, healthcare costs, and caregiver outcomes.
- To identify barriers and facilitators for the adoption and implementation of ECAP.
Main Methods:
- A pilot type 1 hybrid effectiveness-implementation randomized controlled trial (RCT) involving infants with medical complexity and their caregivers.
- Participants are randomized to either the ECAP intervention group or a standard care control group.
- Outcomes include inpatient hospital days, perceived avoidance of ED visits, healthcare costs, caregiver stress, self-efficacy, and implementation metrics (acceptability, feasibility, appropriateness, usability).
Main Results:
- This section describes the study protocol and does not contain results yet.
- The study is designed to collect data on effectiveness and implementation outcomes.
- Key partners, including caregivers and healthcare providers, will be engaged throughout the trial.
Conclusions:
- This pilot RCT protocol outlines a rigorous approach to evaluate the ECAP for infants with medical complexity.
- Findings will inform the effectiveness and implementation strategies for ECAP in this population.
- The study aims to improve emergency care for children with medical complexity and reduce healthcare utilization and caregiver burden.
Introduction:
Children with medical complexity (CMC) are a subset of children with special healthcare needs, defined by high healthcare utilisation, severe single or multisystem organ dysfunction, and in many cases, reliance on medical technology. In the emergency care setting, known challenges for this population include poor quality of care, avoidable admissions and high caregiver and provider burden. While experts and professional societies recommend emergency care planning tools to address these concerns, evidence to support effectiveness and implementation of such tools is lacking. Through a human-centred design approach, we recently engaged key partners to create and optimise an emergency care action plan (ECAP) for infants with medical complexity. Here, we describe the protocol for a pilot type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) for infants with medical complexity aimed to evaluate ECAP effectiveness and implementation.
Methods And Analysis:
Infants with medical complexity and their caregivers will be randomly assigned to the intervention group (ECAP) or control group (standard care) in a pilot type 1 hybrid effectiveness-implementation RCT. The primary outcome is number of inpatient hospital days for infant participants. Additional effectiveness outcomes include perceived avoidance of emergency department (ED) visits, healthcare costs, caregiver stress and self-efficacy. Preliminary implementation outcomes include acceptability, feasibility, appropriateness and usability, as well as contextual barriers and facilitators to reach, adoption and implementation. Key partners, including caregivers of CMC and healthcare providers, will be engaged throughout the implementation of the ECAP and execution of the trial.
Ethics And Dissemination:
This study was approved by the University of Vermont Institutional Review Board (STUDY00002937). Findings will be disseminated through peer-reviewed publications, conference presentations, and focus groups and interviews with key stakeholders.
Trial Registration Number:
NCT06444282.
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