Although the number of randomized controlled trials (RCTs) published each year involving adult populations is steadily rising, the annual number of RCTs published involving pediatric populations has not changed since 2005. Barriers to the broader utilization of RCTs in pediatrics include a lower prevalence of disease, less available funding, and more complicated regulatory requirements. Although child health researchers have been successful in overcoming these barriers for isolated diseases such as pediatric cancer, common pediatric diseases are underrepresented in RCTs relative to their burden. This article proposes a strategy called High-Efficiency RandOmIzed Controlled (HEROIC) trials to increase RCTs focused on common diseases among hospitalized children. HEROIC trials are multicenter RCTs that pursue the rapid, low-cost accumulation of study participants with minimal burden for individual sites. Five key strategies distinguish HEROIC trials: (1) dispersed low-volume recruitment, in which a large number of sites (50-150 hospitals) enroll a small number of participants per site (2-10 participants per site), (2) incentivizing site leads with authorship, training, education credits, and modest financial support, (3) a focus on pragmatic questions that examine simple, widely used interventions, (4) the use of a single institutional review board, integrated consent, and other efficient solutions to regulatory requirements, and (5) scaling the HEROIC trial strategy to accomplish multiple trials simultaneously. HEROIC trials can boost RCT feasibility and volume to answer fundamental clinical questions and improve care for hospitalized children.

<p><strong>BACKGROUND AND OBJECTIVE: </strong>Pediatric in-hospital cardiac arrest most commonly occurs in the pediatric intensive care unit (PICU) and is frequently preceded by early warning signs of clinical deterioration. In this study, we describe the implementation and evaluation of criteria to identify high-risk patients from a paper-based checklist into a clinical decision support (CDS) tool in the electronic health record (EHR).</p>

<p><strong>MATERIALS AND METHODS: </strong>The validated paper-based tool was first adapted by PICU clinicians and clinical informaticians and then integrated into clinical workflow following best practices for CDS design. A vendor-based rule engine was utilized. Littenberg's assessment framework helped guide the overall evaluation. Preliminary testing took place in EHR development environments with more rigorous evaluation, testing, and feedback completed in the live production environment. To verify data quality of the CDS rule engine, a retrospective Structured Query Language (SQL) data query was also created. As a process metric, preparedness was measured in pre- and postimplementation surveys.</p>

<p><strong>RESULTS: </strong>The system was deployed, evaluating approximately 340 unique patients monthly across 4 clinical teams. The verification against retrospective SQL of 15-minute intervals over a 30-day period revealed no missing triggered intervals and demonstrated 99.3% concordance of positive triggers. Preparedness showed improvements across multiple domains to our a priori goal of 90%.</p>

<p><strong>CONCLUSION: </strong>We describe the successful adaptation and implementation of a real-time CDS tool to identify PICU patients at risk of deterioration. Prospective multicenter evaluation of the tool's effectiveness on clinical outcomes is necessary before broader implementation can be recommended.</p>