TY - JOUR
T1 - Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery
T2 - The ENRICH-US Stepped-Wedge Cluster-Randomized Trial
AU - Raval, Mehul V.
AU - Tian, Yao
AU - Schäfer, Willemijn
AU - Balbale, Salva N.
AU - Perez, Mallory N.
AU - Ingram, Martha Conley E.
AU - Lehane, Alison
AU - Smith, Charesa J.
AU - Sullivan, Gwyneth A.
AU - Reiter, Audra J.
AU - Hu, Andrew
AU - Borst, Johanna M.
AU - Blake, Sarah C.
AU - Close, Sharron
AU - Davis, Teaniese L.
AU - Essner, Bonnie S.
AU - Heiss, Kurt F.
AU - Huang, Lynn W.
AU - Wymore, Erin
AU - Paniagua-Perez, Deysi
AU - Engelhardt, Kirsty M.
AU - Graffy, Peter M.
AU - Johnson, Julie K.
AU - Lillehei, Craig W.
AU - Gray, Brian W.
AU - Goldstein, Seth D.
AU - Short, Scott S.
AU - Pandya, Samir R.
AU - Taylor, Janice A.
AU - Gayer, Christopher
AU - Goldin, Adam B.
AU - Boelig, Matthew M.
AU - Rialon, Kristy L.
AU - Jancelewicz, Tim
AU - Lipskar, Aaron M.
AU - Jafri, Mubeen
AU - Tracy, Elisabeth T.
AU - Harting, Matthew T.
AU - Sulkowski, Jason P.
AU - Ham, P. Benson
AU - Vali, Kaveh
AU - Cina, Robert A.
AU - Schindel, David T.
AU - Islam, Saleem
AU - Teeple, Erin A.
AU - Shah, Sohail R.
AU - Gosain, Ankush
AU - Rothstein, David H.
AU - Brockel, Megan A.
AU - Chown, Jillian
AU - Holl, Jane L.
N1 - Publisher Copyright:
© 2026 Raval MV et al.
PY - 2026
Y1 - 2026
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/105039879415
U2 - 10.1001/jamasurg.2026.1382
DO - 10.1001/jamasurg.2026.1382
M3 - Article
C2 - 42126839
AN - SCOPUS:105039879415
SN - 2168-6254
JO - JAMA Surgery
JF - JAMA Surgery
ER -