ArticleBMJ open2025
Randomised hybrid type 1 pilot trial evaluating preliminary effectiveness and implementation of an emergency care action plan (ECAP) for infants with medical complexity within a rural health network: a study protocol.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06444282 (Optimization and Implementation Trial of a User-Centered Emergency Care Action Plan for Infants with Medical Complexity), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Optimization and Implementation Trial of a User-Centered Emergency Care Action Plan for Infants with Medical Complexity
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10 authors.
Funding
Abstract
introductionChildren 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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