Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial.

BACKGROUND: Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery. METHODS: The multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network's five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. DISCUSSION: The study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts. TRIAL REGISTRATION: ClinicalTrials.gov NCT04060303 . Registered on 07 August 2019.

A Community-Engaged Stroke Preparedness Intervention in Chicago.

Background We evaluated a community-engaged stroke preparedness intervention that aimed to increase early hospital arrival and emergency medical services (EMS) utilization among patients with stroke in the South Side of Chicago, Illinois. Methods and Results We compared change in early hospital arrival (<3 hours from symptom onset) and EMS utilization before and after our intervention among patients with confirmed ischemic stroke at an intervention hospital on the South Side of Chicago with concurrent data from 6 hospitals in nonintervention communities on the North Side of Chicago and 17 hospitals in St Louis, Missouri. We assessed EMS utilization for suspected stroke secondarily, using geospatial information systems analysis of Chicago ambulance transports before and after our intervention. Among 21 497 patients with confirmed ischemic stroke across all sites, early arrival rates at the intervention hospital increased by 0.5% per month (95% CI, -0.2% to 1.2%) after intervention compared with the preintervention period but were not different from North Side Chicago hospitals (difference of -0.3% per month [95% CI, -0.12% to 0.06%]) or St Louis hospitals (difference of 0.7% per month [95% CI, -0.1% to 1.4%]). EMS utilization at the intervention hospital decreased by 0.8% per month (95% CI, -1.7% to 0.2%) but was not different from North Side Chicago hospitals (difference of 0.004% per month [95% CI, -1.1% to 1.1%]) or St Louis hospitals (difference of -0.7% per month [95% CI, -1.7% to 0.3%]). EMS utilization for suspected stroke increased in the areas surrounding the intervention hospital (odds ratio [OR], 1.4; 95% CI, 1.2-1.6) and in the South Side (OR, 1.2; 95% CI, 1.1-1.3), but not in the North Side (OR, 1.0; 95% CI, 0.9-1.1). Conclusions Following a community stroke preparedness intervention, early hospital arrival and EMS utilization for confirmed ischemic stroke did not increase. However, ambulance transports for suspected stroke increased in the intervention community compared with other regions. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02301299.