Clinical Trial of ENhancing Recovery in CHildren Undergoing Surgery - ENRICH-US - Initiated in the 1990s, perioperative Enhanced Recovery Protocols (ERPs) have progressively gained traction
in a wide range of adult surgical disciplines and resulted in decreased hospital length of stay (LOS), in-hospital
costs, complications, and markedly improved patient care experience that mitigates the physiologic stress of
surgery and hastens recovery. However, it is estimated that it takes nearly 20 years for evidence to make its
way into clinical practice, and failure rates for implementing complex innovations range from 30% to 90%.
Implementation of ERPs in pediatric surgery is lagging and concerted efforts to demonstrate both clinical
effectiveness and to examine obstacles to implementation are needed. Specifically, pediatric patients with
inflammatory bowel disease (IBD) undergoing elective abdominal surgery represent an ideal population in
which to study the implementation of ERPs. Almost one third of patients with Crohn's disease (CD) and a
quarter of patients with Ulcerative Colitis (UC) present before age 20. Up to three-quarters of CD patients
require GI surgery for medically refractory disease and all patients with UC require colectomy to either manage
severe disease or to mitigate cancer risks. Over the past four years, our study team modified existing adult
ERPs to meet the needs of pediatric patients undergoing elective GI surgery. Based on the positive results of a
pilot study, we propose to conduct a multicenter, prospective, pragmatic, study using a stepped-wedge, cluster,
randomized controlled trial design to evaluate the effectiveness of ERPs while assessing implementation
fidelity, sustainability, and site-specific adaptations. The cluster randomized trial design is ideally suited for this
type of pragmatic intervention implementation. The National Implementation Research Network's five Active
Implementation Frameworks (AIFs), which identifies competency, organization, and leadership as drivers of
implementation, empowers team collaboration, and facilitates rapid-cycle evaluation, will be used to optimize
implementation. We propose to conduct the ENhancing Recovery In CHildren Undergoing Surgery (ENRICH-
US) Study in 18 US hospitals participating in the Pediatric Surgical Research Collaborative (PedSRC) by
implementing and evaluating the effectiveness of the Pediatric ERP in GI Surgery on clinical outcomes for
pediatric IBD patients and by measuring by fidelity and sustainability of the intervention while identifying
organizational, leadership, and competency-based drivers of improved ERP implementation and sustainability.
