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: 9803223
• 负责人: JANE Louise HOLL
• 金额: $ 69.12万
• 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/9803223
• 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; experience; health care service utilization; health related quality of life; high risk population; hospital readmission; 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.

围手术期加速康复方案 (ERP) 始于 20 世纪 90 年代，逐渐受到关注 在广泛的成人外科学科中，导致住院时间（LOS）、住院时间缩短 成本、并发症和显着改善的患者护理体验，减轻了患者的生理压力 手术并加速康复。然而，据估计，证据需要近20年的时间才能得到证实。 进入临床实践，实施复杂创新的失败率在 30% 到 90% 之间。 ERP 在儿科手术中的实施是滞后的，需要共同努力来证明临床 需要有效性并审查实施的障碍。具体来说，儿科患者 接受择期腹部手术的炎症性肠病（IBD）代表了以下人群的理想人群： 研究ERP的实施。近三分之一的克罗恩病 (CD) 患者和 四分之一的溃疡性结肠炎 (UC) 患者在 20 岁之前出现。多达四分之三的 CD 患者 需要胃肠道手术治疗难治性疾病，所有 UC 患者都需要结肠切除术来治疗 严重疾病或降低癌症风险。在过去的四年里，我们的研究团队修改了现有的成人 ERP 满足接受选择性胃肠道手术的儿科患者的需求。基于积极的结果 试点研究，我们建议使用阶梯楔形、聚类进行多中心、前瞻性、务实的研究， 随机对照试验设计，以评估 ERP 的有效性，同时评估实施情况 保真度、可持续性和针对特定地点的适应性。整群随机试验设计非常适合此目的 务实干预实施的类型。国家实施研究网络的五个活跃 实施框架 (AIF)，将能力、组织和领导力确定为驱动因素 实施、增强团队协作并促进快速周期评估，将用于优化 执行。我们建议开展“增强接受手术儿童的康复”项目（ENRICH- 美国）在参与儿科外科研究合作组织 (PedSRC) 的 18 家美国医院进行的研究 在胃肠道手术中实施和评估儿科 ERP 对临床结果的有效性 儿科 IBD 患者，通过测量干预措施的保真度和可持续性，同时确定 改进 ERP 实施和可持续性的组织、领导力和能力驱动因素。