Raval Mehul V, Wymore Erin, Ingram Martha-Conley E, Tian Yao, Johnson Julie K, Holl Jane L
Surgical Outcomes Quality Improvement Center, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 20th Floor, Chicago, IL, 60611, USA.
Division of Pediatric Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Ann & Robert H. Lurie Children's Hospital, 225 E. Chicago Ave, Chicago, IL, 60611, USA.
Trials. 2020 Nov 16;21(1):926. doi: 10.1186/s13063-020-04851-9.
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.
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.
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.
ClinicalTrials.gov NCT04060303 . Registered on 07 August 2019.
围手术期强化康复方案（ERPs）已被发现可缩短成年手术患者的住院时间、降低住院费用并减少并发症，但儿科患者的相关证据尚缺。本研究旨在评估一项适用于小儿外科手术的包含21项内容的ERP方案的采用情况、有效性和可推广性。
这项多中心研究是一项阶梯式楔形整群随机实用临床试验，将评估儿童手术强化康复（ENRICH-US）干预措施的有效性，同时评估特定地点的调整、实施的保真度和可持续性。目标患者群体为10至18岁接受择期胃肠手术的儿科患者。18个参与地点将被随机分配到三个整群之一，每个整群又将被随机分配到一个干预启动期（阶梯式楔形）。每个整群将参与一个学习协作项目，使用国家实施研究网络的五个积极实施框架（AIFs）（能力、组织和领导力），作为促进快速循环调整和实施的驱动力。主要研究结局为住院时间，实施指标用于评估采用情况、保真度和可持续性。其他临床结局包括阿片类药物使用情况、术后并发症以及出院后医疗保健利用情况（门诊/急诊就诊、致电门诊以及再次住院），同时评估患者及家长报告的与健康相关的生活质量结局。该方案遵循标准方案项目：干预试验推荐（SPIRIT）清单。
本研究提供了一个独特的机会，可加速美国18个儿科手术中心采用ERPs，并首次评估针对儿科的ENRICH-US干预措施对临床和实施结局的影响。该研究设计和方法可作为未来儿科手术质量改进实施工作的典范。
ClinicalTrials.gov NCT04060303。于2019年8月7日注册。
