Trial Outcomes & Findings for ENhanced Recovery in CHildren Undergoing Surgery (NCT NCT04060303)

This was a stepped-wedge, cluster-randomized trial with 18 clinical sites assigned to 3 randomized sequences (6 sites per seq.). Each sequence progressed through Baseline (usual care), Implementation and Sustainability phases at different calendar times according to the prespecified roll-out. Participants reported by the phase active at their site at time of surgery. Learning Collaborative personnel were not research participants and do not contribute to Participant Flow, Outcome Measures or AEs

Sites (clusters) were randomized into 3 sequences (6 sites/sequence) and crossed from Baseline to Implementation to Sustainability per the prespecified roll-out. Participants were enrolled continuously according to surgery dates.

Unit of analysis: Site / Hospital

ENhanced Recovery in CHildren Undergoing Surgery

Measured in days from surgery to discharge

Binary variable derived from LOS; \> 6 days = Yes.

Days from surgery until first documented tolerance of regular diet in EHR

Total volume of intraoperative crystalloid fluid administered, as abstracted from the anesthesia record.

Average daily opioid use during hospitalization, converted to morphine milligram equivalents (MME/day).

Number of participants who were prescribed an opioid medication at the time of hospital discharge.

Composite of surgical, infectious, pulmonary, vascular, neurologic, and renal complications; each participant counted once per category.

Participants experiencing \> 1 distinct postoperative complication.

Any unplanned hospital readmission within 30 days of discharge after index surgery. Events were abstracted from medical records and categorized as yes/no. Values are reported by study phase as number and percentage of participants readmitted.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health T-score before surgery. The PROMIS Pediatric Global Health Scale (PGH-7) is a validated, standardized patient-reported outcome measure assessing overall physical, mental, and social health in children and adolescents. Scores are reported as T-scores standardized to the U.S. pediatric population, with a mean of 50 and standard deviation of 10. Possible scores typically range from approximately 20 to 80. Higher T-scores indicate better global health. The PROMIS Pediatric Global Health T-score was assessed preoperatively within 30 days prior to surgery and summarized by study phase.

The PROMIS Pediatric Global Health Scale (PGH-7) is a validated, standardized patient-reported outcome measure assessing overall physical, mental, and social health in children and adolescents. Scores are reported as T-scores standardized to the U.S. pediatric population, with a mean of 50 and standard deviation of 10, and a typical range of approximately 20 to 80. Higher T-scores indicate better global health. The PROMIS Pediatric Global Health T-score was assessed postoperatively at 2-4 weeks after surgery and summarized by study phase.

The PROMIS Pediatric Pain Interference Scale is a validated patient-reported outcome measure assessing the extent to which pain interferes with physical, emotional, and social functioning in children and adolescents. Scores are reported as standardized T-scores with a mean of 50 and standard deviation of 10, with a typical range of approximately 30 to 80. Higher T-scores indicate greater pain interference (worse outcome). Pain interference T-scores were assessed preoperatively within 30 days prior to surgery and summarized by study phase.

The PROMIS® Pediatric Pain Interference Scale is a validated patient-reported outcome measure assessing the extent to which pain interferes with physical, emotional, and social functioning in children and adolescents. Scores are reported as standardized T-scores with a mean of 50 and standard deviation of 10, with a typical range of approximately 30 to 80. Higher T-scores indicate greater pain interference (worse outcome). Pain interference T-scores were assessed postoperatively at 2-4 weeks after surgery and summarized by study phase.