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Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery: The ENRICH-US
Mehul V Raval1,2, Yao Tian1, Willemijn Schäfer1
1Northwestern Quality Improvement, Research & Education in Surgery (NQUIRES), Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Insights
Enhanced recovery protocols (ERPs) in pediatric GI surgery did not significantly reduce length of stay (LOS). However, higher patient-level adherence to ERPs correlated with shorter LOS and fewer complications, improving outcomes.
Area of Science:
- Pediatric Surgery
- Implementation Science
- Clinical Effectiveness
Background:
- Enhanced recovery protocols (ERPs) show promise in adult surgery but have lagged in pediatric adoption.
- Pediatric gastrointestinal (GI) surgery requires tailored evidence-based protocols for improved outcomes.
Purpose of the Study:
- To evaluate the implementation and clinical effectiveness of a consensus-based ERP for pediatric patients undergoing elective GI surgery.
- To assess the impact of ERPs on length of stay, opioid use, complications, and quality of life.
Main Methods:
- A prospective, stepped-wedge, cluster-randomized trial involving 18 US sites and 597 pediatric patients (ages 10-18).
- Implementation utilized a 21-element ERP, a structured toolkit, and a Learning Collaborative curriculum over a 12-24 month sustainment phase.
- Outcomes included length of stay (LOS), opioid use, time to diet, complications, readmission, and health-related quality of life (HRQOL).
Main Results:
- No significant difference in LOS or most secondary outcomes by study phase.
- Patients receiving at least 13 ERP elements showed significantly shorter LOS (-1.14 days) and fewer complications.
- Patient-level adherence to ERPs increased significantly across study phases (P < .001).
Conclusions:
- Multifaceted implementation strategies for a pediatric GI surgery ERP did not significantly reduce overall LOS.
- However, patient-level implementation fidelity was associated with significantly reduced LOS and complications.
- Findings highlight the importance of adherence for ERP effectiveness in pediatric surgical populations.
Importance:
Despite evidence that enhanced recovery protocols (ERPs) improve outcomes in adults undergoing surgery, adoption for pediatric populations has lagged.
Objective:
To assess the implementation and clinical effectiveness of a consensus-based ERP for pediatric patients undergoing elective gastrointestinal (GI) surgery.
Design, Setting, And Participants:
A prospective type 2 hybrid implementation-effectiveness, stepped-wedge, cluster-randomized by entry date into implementation phase, trial of pediatrics patients, 10 to 18 years of age, undergoing elective GI surgery at 18 US sites from September 2019 to June 2024.
Interventions:
Sites were randomized into 3 groups, each spending at least 9 months in a control phase, with usual care, followed by an implementation phase at 6-month intervals that included a 21-element ERP supported by a structured Implementation Toolkit, based on 5 Active Implementation Frameworks (5AIFs), and a sustainment phase (12-24 months). Implementation was facilitated by a 1-year, group-based Learning Collaborative curriculum, a repository of tools, ERP adherence feedback, and implementation report cards.
Main Outcomes And Measures:
Site-level scores were created based on 5AIFs domains. ERP adherence was assessed by ERP elements delivered at patient and site level. The primary effectiveness outcome, postoperative length of stay (LOS), and secondary effectiveness outcomes (including opioid use, time to regular diet, complications, readmission, and patient-reported health-related quality of life [HRQOL]) were evaluated across study phases (baseline, implementation, and sustainability). Correlations between site-level implementation scores and fidelity were estimated.
Results:
Of the 597 enrolled pediatric patients (median [IQR] age, 15 [13-17] years; 274 [45.9%] female; 323 [54.1%] male), 433 (72.5%) had inflammatory bowel disease. No significant differences were found by study phase in LOS or secondary outcomes, except shorter time to regular diet and decreased opioid use during hospitalization. Patients who received at least 13 ERP elements had shorter median LOS (-1.14 days [95% CI -2.01 to -0.27]) and fewer complications (adjusted odds ratio, 0.48 [95% CI, 0.28-0.82]). Patient-level adherence increased by study phase (number of ERPs: 11 [10-13], 14 [12-15], and 14 [13-15], [P < .001]). ERP integration into order sets and site culture were moderately correlated with fidelity.
Conclusions And Relevance:
This stepped-wedge cluster-randomized trial found that despite multifaceted implementation strategies, a pediatric GI surgery ERP did not significantly reduce LOS. However, when accounting for implementation fidelity at the patient level, it resulted in significantly lower LOS and complications.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04060303.
