ENhancing Recovery in CHildren Undergoing Surgery

Summary

Participation Requirements

Description

This application proposes to implement an ERP for pediatric patients with inflammatory bowel disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), and undergoing elective abdominal surgery. They represent an ideal population in which to study the implementation of ERPs becaus...

This application proposes to implement an ERP for pediatric patients with inflammatory bowel disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), and undergoing elective abdominal surgery. They represent an ideal population in which to study the implementation of ERPs because almost one third of patients with CD present before age 20 and up to three-quarters of CD patients require gastrointestinal (GI) surgery for medically refractory disease. A quarter of UC patients present before age 20 and all patients with UC require colectomy to either manage severe disease or mitigate cancer risks. The GI surgical procedures performed in children with IBD are similar to the adult procedures for which ERPs have been well tested and validated. The study team has previously modified existing adult ERPs to meet the needs of pediatric patients undergoing elective GI surgery, primarily for IBD, by conducting (a) a systematic literature review, (b) a national survey to assess readiness for implementation, and (c) an expert panel adjudication of ERP elements. The investigators also conducted a pilot study to assess the feasibility, safety, and preliminary effectiveness of the pediatric ERP in 79 pediatric patients who underwent elective GI surgery. Patient and provider education materials were created, a learning collaborative explored drivers and obstacles to implementation, patient advocates were engaged to enhance the quality improvement process, and data were routinely fed back to the implementation team members. The pilot study demonstrated a 50% decrease in LOS, from 5 to 3 days, near elimination of intraoperative and post-operative opioid use, and a 30% decrease in perioperative fluid administration, without any increase in post-surgical complications or re-hospitalization. Based on these promising results, the investigators propose the ENhancing Recovery In CHildren Undergoing Surgery (ENRICH-US) Study in 18 US hospitals that participate in the Pediatric Surgical Research Collaborative (PedSRC). This multicenter study will use a stepped-wedge, cluster-randomized, pragmatic clinical trial design to evaluate the effectiveness of ENRICH-US while also assessing implementation fidelity, sustainability, and site-specific adaptations. The investigators will optimize implementation using the National Implementation Research Network's five Active Implementation Frameworks (AIFs), which identify competency, organization, and leadership as drivers of implementation and empower team collaboration and facilitate rapid-cycle evaluation.

Tracking Information