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Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing
Mehul V Raval1,2, Erin Wymore3, Martha-Conley E Ingram3,4
1Surgical Outcomes Quality Improvement Center, Northwestern University Feinberg School of Medicine, 633 N. St. Clair, 20th Floor, Chicago, IL, 60611, USA. mraval@luriechildrens.org.
Insights
This study evaluates a pediatric enhanced recovery protocol (ERP) to improve surgical outcomes for children. The ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention aims to reduce hospital stays and complications.
Area of Science:
- Pediatric Surgery
- Implementation Science
- Clinical Trials
Background:
- Enhanced Recovery Protocols (ERPs) are established for adults, reducing hospital stay, costs, and complications.
- Evidence for pediatric populations is limited, necessitating tailored interventions.
- A 21-element ERP adapted for pediatric surgery will be evaluated.
Purpose of the Study:
- To evaluate the adoption, effectiveness, and generalizability of a pediatric-specific ERP.
- To assess the impact of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention.
- To provide a model for future pediatric surgical quality improvement initiatives.
Main Methods:
- A multicenter, stepped-wedge, cluster-randomized pragmatic clinical trial involving 18 sites.
- The ENRICH-US intervention will be implemented using Active Implementation Frameworks (AIFs).
- Primary outcome: hospital length of stay. Secondary outcomes: opioid use, complications, healthcare utilization, and quality of life.
Main Results:
- The study will provide the first evaluation of a pediatric-specific ERP's clinical and implementation outcomes.
- Data on adoption, fidelity, and sustainability of the ERP will be collected.
- Effectiveness will be measured by changes in hospital length of stay and other clinical outcomes.
Conclusions:
- This study accelerates ERP adoption in pediatric surgery across 18 US centers.
- It offers a novel evaluation of a pediatric-specific ERP (ENRICH-US).
- The findings will inform future pediatric surgical quality improvement efforts.
Background:
Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery.
Methods:
The multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network's five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
Discussion:
The study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts.
Trial Registration:
ClinicalTrials.gov NCT04060303 . Registered on 07 August 2019.
