Abstract
INTRODUCTION: Variability in implementation of enhanced recovery protocols (ERPs) often reduces the effects of an intervention on clinical outcomes. This study aimed to evaluate hospital-level implementation fidelity to a pediatric gastrointestinal surgery ERP by assessing site-specific implementation materials. METHODS: This document analysis study operationalized implementation fidelity as adherence to the creation of specified materials at each study site. During the 12-mo implementation phase within the stepped-wedge cluster randomized control trial, ENhanced Recovery In CHildren Undergoing Surgery, study sites were provided with materials (e.g., order sets), access to peer-counseling, and given key ERP elements spanning multiple phases of care. Sixteen of the 18 total study sites submitted implementation materials, including 14 anesthesia protocols, 11 order sets, and 16 sets of patient/family education materials. These materials were assessed and graded for fidelity using prespecified criteria. Hospital-level fidelity scores could range from 0 to a maximum score of 18, and were categorized as either high or low, based on whether the score was above or below/equal to the median. Descriptive statistics and Wilcoxon rank sum test were used for analysis. RESULTS: The overall hospital-level median fidelity score for inclusion of ERP elements in the implementation materials was 10.5. The median score was 12.8 at nine high-fidelity sites and was 5.6 at nine low-fidelity sites (P < 0.01). Higher adherence was noted for avoiding prolonged fasting (n = 16/18 hospitals; 89%) and preventing nausea and vomiting (n = 16/18 hospitals; 89%) in anesthesia protocols and/or order sets. Lower adherence was noted for incorporation of minimally invasive surgical techniques (n = 2/18 hospitals, 11%) and of preoperative optimization of medical comorbidities (n = 0/18 hospitals, 0%) in implementation materials. CONCLUSIONS: Despite substantial resources to promote ERP elements, there was wide variation in fidelity for incorporating ERPs into implementation materials among hospital sites. Development of high-fidelity implementation materials for complex ERPs for gastrointestinal surgery in children may require longer than 12 months. Additional implementation strategies, resources, and modification of implementation-focused materials may be needed.