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

• 批准号: 10201700
• 负责人: JANE Louise HOLL
• 金额: $ 64.57万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 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/10201700
• 关键词: Abdomen; Adoption; Adult; Advocate; Age; Back; Child; Childhood; Clinic; Clinical; Clinical Trials; Clinical effectiveness; Cluster randomized trial; Colectomy; Collaborations; Competence; Complex; Crohn' s disease; Data; Discipline; Disease; Education; Effectiveness; Elements; Emergency department visit; Equilibrium; Evaluation; Failure; Future; Gastrointestinal Surgical Procedures; Healthcare; Hospital Costs; Hospitals; 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; Process; Protocols documentation; Provider; Randomized Controlled Trials; Readiness; Recovery; Refractory Disease; Reporting; Resistance; Resources; Review Literature; Safety; Site; Stress; Surgical complication; Surveys; Telephone; Testing; Traction; Training; Ulcerative Colitis; adjudication; base; cancer risk; clinical practice; effective intervention; effectiveness evaluation; experience; health care service utilization; health related quality of life; high risk population; hospital readmission; implementation efforts; implementation fidelity; implementation framework; implementation intervention; implementation research; improved; innovation; member; opioid use; pediatric patients; pragmatic trial; prospective; success; supportive environment; surgical research; trial design

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。