Clinical Trial of ENhancing Recovery in CHildren Undergoing Surgery - ENRICH-US

促进接受手术的儿童康复的临床试验 - ENRICH-US

基本信息

批准号：
10653087
负责人：
JANE Louise HOLL
金额：
$ 60.87万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-09 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10653087
关键词：
Abdomen Acceleration Adoption Adult Advocate Age Back Child Childhood Clinic Clinical Clinical Trials Clinical effectiveness Cluster randomized trial Colectomy Collaborations Competence Complex Crohn&apos s disease Data Discipline Disease Educational Materials Effectiveness Elements Emergency department visit Evaluation Failure Future Gastrointestinal Surgical Procedures Healthcare Hospital Costs Hospitals Implementation readiness Incentives Inflammatory Bowel Diseases Intervention Leadership Learning Length of Stay Liquid substance Measures Medical Methodology Modeling Operative Surgical Procedures Organizational Change Outcome Parents Patient Care Patient-Focused Outcomes Patients Pediatric Surgical Procedures Perioperative Physiological Pilot Projects Population Postoperative Period Procedures Protocols documentation Provider Randomized, Controlled Trials Recovery Refractory Disease Reporting Resistance Resources Review Literature Safety Site Stress Surveys Telephone Testing Traction Training Ulcerative Colitis adjudication cancer risk clinical practice effective intervention effectiveness evaluation empowerment experience health care service utilization health related quality of life high risk population hospital readmission implementation efforts implementation evaluation implementation fidelity implementation framework implementation intervention implementation research improved innovation member opioid use pediatric patients pragmatic intervention pragmatic trial process improvement prospective success supportive environment surgical research trial design

项目摘要

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.

围手术期增强恢复方案（ERP）于1990年代启动，已逐渐获得关注在广泛的成人手术学科中，导致住院时间降低（LOS），院内成本，并发症以及显着改善了患者护理经验，从而减轻了生理压力手术并加速康复。但是，据估计，证据使它的证据需要将近20年临床实践的方式和实施复杂创新的失败率在30％至90％之间。 ERP在小儿手术中的实施是滞后和共同努力证明这两种临床的努力需要有效性并检查实施障碍。具体而言，儿科患者接受腹部腹部手术的炎症性肠病（IBD）代表了理想人群研究ERP的实施。几乎三分之一的克罗恩病（CD）患者和A 20岁之前出现溃疡性结肠炎（UC）的四分之一。多达四分之三的CD患者需要胃肠道手术治疗医学性难治性疾病，所有UC患者都需要结肠切除术才能管理严重疾病或减轻癌症风险。在过去的四年中，我们的学习团队修改了现有的成人 ERP满足接受选择性胃肠道手术的小儿患者的需求。基于a的积极结果试点研究，我们建议使用阶梯间，群集，，进行多中心，前瞻性，务实的研究随机对照试验设计以评估ERP的有效性，同时评估实施忠诚，可持续性和特定地点适应。群集随机试验设计非常适合此实施实用的类型。国家实施研究网络的五个活跃实施框架（AIFS），将能力，组织和领导才能确定为驱动力实施，使团队合作的能力并促进快速循环评估，将用于优化执行。我们建议进行手术儿童的康复（富集）美国研究的18家美国医院参加了儿科外科研究合作（PEDSRC）的研究实施和评估小儿ERP在胃肠道手术中的有效性小儿IBD患者，并通过识别干预的忠诚度和可持续性来确定改善ERP实施和可持续性的组织，领导和基于能力的驱动因素。

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Pediatric Patient and Caregiver Agreement on Perioperative Expectations and Self-Reported Outcomes.

儿科患者和护理人员关于围手术期期望和自我报告结果的协议。

DOI：
10.1016/j.jss.2022.09.020
发表时间：
2023
期刊：
The Journal of surgical research
影响因子：
0
作者：
Reiter,AudraJ;Sullivan,GwynethA;Hu,Andrew;Tian,Yao;Ingram,Martha-ConleyE;Balbale,SalvaN;Johnson,JulieK;Schäfer,Willemijn;Holl,JaneL;Raval,MehulV
通讯作者：
Raval,MehulV

A qualitative examination of barriers and facilitators of pediatric enhanced recovery protocol implementation among 18 pediatric surgery services.

DOI：
10.1186/s43058-022-00329-8
发表时间：
2022-08-18
期刊：
Implementation science communications
影响因子：
0
作者：
通讯作者：

A mixed-method approach to generate and deliver rapid-cycle evaluation feedback: lessons learned from a multicenter implementation trial in pediatric surgery.

DOI：
10.1186/s43058-023-00463-x
发表时间：
2023-07-18
期刊：
Implementation science communications
影响因子：
0
作者：
通讯作者：

Implementation of Enhanced Recovery Protocols for Gastrointestinal Surgery in Children: Practical Tools From Key Stakeholders.

儿童胃肠手术加速康复方案的实施：来自主要利益相关者的实用工具。

DOI：
10.1016/j.jss.2022.11.071
发表时间：
2023
期刊：
The Journal of surgical research
影响因子：
0
作者：
Close,Sharron;Blake,SarahC;Davis,TeanieseTina;Balbale,SalvaN;Perry,JosephE;Weingard,Reed;Ingram,Martha-Conley;Schäfer,Willemijn;Strople,Jennifer;Raval,MehulV
通讯作者：
Raval,MehulV

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.