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.
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.
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评估接受手术的儿童围手术期加速康复方案的有效性和实施情况：前瞻性、阶梯楔形、集群、随机、对照临床试验的研究方案。
DOI：
10.1186/s13063-020-04851-9
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发表时间：
2020-11-16
期刊：
影响因子：
2.5
通讯作者：
Holl JL
中科院分区：
文献类型：
--
作者：
Raval MV;Wymore E;Ingram ME;Tian Y;Johnson JK;Holl JL
已发现围手术期增强恢复方案（ERP）可减少成人手术人群的住院时间、住院费用和并发症，但缺乏儿科人群的证据。本研究旨在评估适用于儿科手术的21要素ERP的采用、有效性和普遍性。这项多中心研究是一项阶梯楔形、随机分组、实用的临床试验，将评估儿童手术中增强恢复（ENRICH-US）干预的有效性，同时评估特定部位的适应性、实施保真度和可持续性。目标患者人群为10 - 18岁之间接受择期胃肠道手术的儿科患者。18家（N = 18）参与研究中心将被随机分配到三个集群中的一个，每个集群依次被随机分配到一个干预开始阶段（阶梯楔形）。每个集群将参加学习协作，使用国家执行研究网络的五个积极执行框架（AIF）（能力，组织和领导），作为促进快速周期适应和执行的驱动力。主要研究结果是住院时间，实施指标用于评估采用，保真度和可持续性。其他临床结局包括阿片类药物使用、术后并发症和出院后医疗保健利用（门诊/急诊室访视、电话门诊和再次住院），以及评估患者和父母报告的健康相关生活质量结局。该方案符合标准方案项目：干预性试验建议（SPIRIT）检查表。该研究提供了一个独特的机会，以加速在18个美国儿科外科中心采用ERP，并首次评估儿科特定ENRICH-US干预对临床和实施结果的影响。研究设计和方法可以作为未来儿科手术质量改进实施工作的模型。ClinicalTrials.gov NCT 04060303。于2019年8月7日注册。
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.
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DOI：
10.1186/1748-5908-7-64
发表时间：
2012-07-11
期刊：
Implementation science : IS
影响因子：
--
作者：
Cully JA;Armento ME;Mott J;Nadorff MR;Naik AD;Stanley MA;Sorocco KH;Kunik ME;Petersen NJ;Kauth MR
通讯作者：
Kauth MR
影响因子：
3.1
作者：
Fjeldstad, Oystein D.;Johnson, Julie K.;Batalden, Paul B.
通讯作者：
Batalden, Paul B.
影响因子：
2.4
作者：
Feng, Christina;Sidhwa, Feroze;Rangel, Shawn J.
通讯作者：
Rangel, Shawn J.
影响因子：
7.2
作者：
Cook, Karon F.;Jensen, Sally E.;Cella, David
通讯作者：
Cella, David
影响因子：
3.2
作者：
Geltzeiler, Cristina B.;Hart, Kyle D.;Tsikitis, Vassiliki L.
通讯作者：
Tsikitis, Vassiliki L.