Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery: The ENRICH-US Stepped-Wedge Cluster-Randomized Trial.
Publication/Presentation Date
5-13-2026
Abstract
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.
ISSN
2168-6262
Published In/Presented At
Raval MV, Tian Y, Schäfer W, Balbale SN, Perez MN, Ingram ME, Lehane A, Smith CJ, Sullivan GA, Reiter AJ, Hu A, Borst JM, Blake SC, Close S, Davis TL, Essner BS, Heiss KF, Huang LW, Wymore E, Paniagua-Perez D, Engelhardt KM, Graffy PM, Johnson JK, Lillehei CW, Gray BW, Goldstein SD, Short SS, Pandya SR, Taylor JA, Gayer C, Goldin AB, Boelig MM, Rialon KL, Jancelewicz T, Lipskar AM, Jafri M, Tracy ET, Harting MT, Sulkowski JP, Ham PB 3rd, Vali K, Cina RA, Schindel DT, Islam S, Teeple EA, Shah SR, Gosain A, Rothstein DH, Brockel MA, Chown J, Holl JL. Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery: The ENRICH-US Stepped-Wedge Cluster-Randomized Trial. JAMA Surg. 2026 May 13:e261382. doi: 10.1001/jamasurg.2026.1382. Epub ahead of print. PMID: 42126839; PMCID: PMC13173425.
Disciplines
Medicine and Health Sciences | Pediatrics
PubMedID
42126839
Department(s)
Department of Pediatrics
Document Type
Article