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: 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
• 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' 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

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.

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.

项目成果

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
• 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

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

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
• 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.

• DOI: 10.1186/s13063-020-04851-9
• 发表时间: 2020-11-16
• 期刊: Trials
• 影响因子: 2.5
• 作者: Raval MV;Wymore E;Ingram ME;Tian Y;Johnson JK;Holl JL
• 通讯作者: Holl JL