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.

在20世纪90年代开始，围手术期增强恢复协议（ERP）逐渐获得牵引力 在广泛的成人外科学科，并导致减少住院时间（LOS），在医院 成本、并发症和显著改善的患者护理体验， 手术和加速恢复。然而，据估计，需要近20年的证据，使其 在临床实践中，实施复杂创新的失败率从30%到90%不等。 ERP在小儿外科的实施是滞后的，并共同努力，以证明临床 需要提高效率，并审查执行的障碍。具体来说， 接受选择性腹部手术炎性肠病（IBD）代表了 研究ERP的实施。几乎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 对于医学难治性疾病需要GI手术，所有UC患者都需要结肠切除术， 严重疾病或减轻癌症风险。在过去的四年里，我们的研究小组修改了现有的成人 ERP，以满足接受择期胃肠道手术的儿科患者的需求。基于一项积极的结果 初步研究，我们建议进行一项多中心，前瞻性，务实，研究使用阶梯楔形，集群， 随机对照试验设计，以评估ERP的有效性，同时评估实施情况 忠诚度、可持续性和特定地点的适应性。整群随机试验设计非常适合于此 务实的干预措施。国家执行研究网络的五个活跃的 实施框架（AIF），将能力、组织和领导力确定为 实施，授权团队协作，并促进快速周期评估，将用于优化 实施.我们建议在进行手术的儿童中进行增强恢复（ENRICH- 美国）在参与儿科外科研究协作组织（PedSRC）的18家美国医院进行的研究， 实施和评价小儿胃肠道手术ERP对临床结局的有效性， 儿童IBD患者，并通过测量干预的保真度和可持续性，同时确定 组织、领导和基于能力的驱动因素，改善企业资源规划系统的实施和可持续性。