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

Project: Research project

Project Details

Description

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. The specific aims are to: Aim 1: Conduct a multicenter, prospective, pragmatic trial of ENRICH-US for elective GI surgery at 18 US hospitals to establish its effectiveness and generalizability. Aim 1a: Establish the effectiveness of ENRICH-US by measuring clinical outcomes including LOS, opioid use, and balancing measures such as post-surgical complications and healthcare utilization (clinic/ED visits, telephone calls, re-hospitalizations). Aim 1b: Conduct difference in differences analyses of patient and parent reported health-related quality of life (HRQoL) outcomes for children who receive standard postsurgical recovery management compared to children who receive ENRICH-US postsurgical recovery management. Aim 2: Assess implementation fidelity, sustainability, and site-specific adaptations of ENRICH-US for GI Surgery. Aim 2a: Assess quantitative and qualitative measures of ERP adoption, fidelity, and sustainability. Aim 2b: Identify organizational, leadership, and competency-based drivers of improved ERP implementation and sustainability, using qualitative methodologies. The ENRICH-US Study of children undergoing elective GI surgery for IBD, provides an opportunity to accelerate adoption of ERP elements to pediatric healthcare, thus improving care for this high-risk population. Incorporating ERPs into practice using the five AIFs will serve as a model for future implementation efforts.
StatusActive
Effective start/end date9/9/196/30/25

Funding

  • National Institute of Child Health and Human Development (5R01HD099344-05)

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