Alberta Collaborative Quality Improvement Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI) Trial: a protocol for a multicentre, stepped-wedge cluster randomized trial

{"Background": "Preterm birth accounts for 8% of live births in Canada, and 85% of these are moderate and late preterm neonates (32\u201336 weeks' gestation). These neonates face increased risks of serious morbidities, prolonged hospitalizations, and substantial financial and psychosocial burdens on families. Practice variation across NICUs leads to inconsistent outcomes and variable length of stay. Despite representing a large proportion of NICU admissions, moderate and late preterm neonates are underrepresented in research and quality improvement activities. Evidence-based Practice for Improving Quality (EPIQ) is a collaborative quality improvement methodology adopted by the Canadian Neonatal Network that has previously decreased mortality and morbidity in very preterm neonates (<29 weeks). The ABC-QI Trial aims to evaluate whether EPIQ collaborative quality improvement strategies can improve outcomes in moderate and late preterm neonates across Alberta.", "Methods": "This is a 4-year, multicentre, stepped-wedge cluster randomized trial involving 12 NICUs across Alberta (10 level II, 2 perinatal level III). Two surgical NICUs (level III surgical and level IV) are excluded. In the first year, all 12 NICUs are in the control arm collecting baseline data. At the end of each subsequent year, 4 NICUs are randomized to transition to the intervention arm, with 1 year of follow-up after the last group transitions. Randomization is stratified by location (urban v. regional) and level of care, with an algorithm ensuring no step contains both level III NICUs and no step has more than 2 regional NICUs. The study population includes all neonates born at 32+0 to 36+6 weeks' gestation admitted to participating units between Sept. 1, 2022, and Aug. 31, 2026, with a waiver of consent. The anticipated sample size is 9500 neonates. The intervention comprises two care bundles: a respiratory care bundle (5 elements: establishing effective ventilation in delivery room, hypothermia prevention, early diagnosis/management of respiratory distress with CPAP, standardized surfactant indications/administration, standardized early extubation approach) and a nutritional/feeding care bundle (4 elements: early enteral/parenteral nutrition, standardized feeding initiation/progression tables, optimizing breastfeeding/breastmilk use, standardized transition from tube to oral feeds). Implementation uses 5 EPIQ strategies: QI team building (multidisciplinary teams including parent advisors), QI education (6-hour EPIQ workshop delivered within 3 months before transition), care bundle implementation via Plan-Study-Do-Act cycles, mentoring by experienced EPIQ mentors, and collaborative networking (quarterly virtual meetings, quarterly statistical process control chart reports). The primary outcome is length of hospital stay. Power calculations using historic data (2018\u20132019) with an observed intracluster correlation coefficient of 0.034 and design effect of 3.41 provide >99% power at \u03b1=0.05 to detect a 1-day reduction in length of stay (historic mean 14 days). For binary outcomes, the study has 80% power to detect a 10.2% relative reduction if baseline rate is 50%, and 80% power to detect a 19.7% relative reduction if baseline rate is 20%. Analysis will use negative binomial generalized linear mixed models with random intercept for site, fixed effect for period, and indicator for control vs. intervention. Planned subgroup analyses include NICU geographical location, gestational age subgroups (32\u201334 and 35\u201336 weeks), and singleton vs. multiple births. Process measures include number of EPIQ workshops, Plan-Study-Do-Act cycles completed, and adherence to bundle process indicators. Two substudies evaluate organizational culture (QIIS-II survey in year 1) and implementation barriers/facilitators (semistructured interviews using the Consolidated Framework for Implementation Research).", "Key Results": "This is a protocol paper; no results are reported. The trial is registered at ClinicalTrials.gov (NCT05231200) and data collection was planned from Sept. 1, 2022, to Aug. 31, 2026.", "Clinical Implications": "If the EPIQ collaborative quality improvement intervention reduces length of stay and improves clinical outcomes in moderate and late preterm neonates, it would provide a scalable, evidence-based framework for reducing practice variation across NICUs. The study will generate detailed population-based data for this understudied group, supporting future research, benchmarking, and quality improvement initiatives. The economic analysis will determine whether upfront costs of collaborative QI are offset by savings from reduced length of stay and improved outcomes. Knowledge sharing through national/international conferences, media, and peer-reviewed journals using CONSORT extension for stepped-wedge cluster randomized trials will facilitate widespread adoption if results are positive."}