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: Evidence-based Practice for Improving Quality (EPIQ) is a collaborative quality improvement method adopted by the Canadian Neonatal Network that led to decreased mortality and morbidity in very preterm neonates. The Alberta Collaborative Quality Improvement Strategies to Improve Outcomes of Moderate and Late Preterm Infants (ABC-QI) Trial aims to evaluate the impact of EPIQ collaborative quality improvement strategies in moderate and late preterm neonates in Alberta, Canada.
Methods: In a 4-year, multicentre, stepped-wedge cluster randomized trial involving 12 neonatal intensive care units (NICUs), we will collect baseline data with the current practices in the first year (all NICUs in the control arm). Four NICUs will transition to the intervention arm at the end of each year, with 1 year of follow-up after the last group transitions to the intervention arm. Neonates born at 32 + 0 to 36 + 6 weeks' gestation with primary admission to NICUs or postpartum units will be included. The intervention includes implementation of respiratory and nutritional care bundles using EPIQ strategies, including quality improvement team building, quality improvement education, bundle implementation, quality improvement mentoring and collaborative networking. The primary outcome is length of hospital stay; secondary outcomes include health care costs and short-term clinical outcomes. Neonatal intensive care unit staff will complete a survey in the first year to assess quality improvement culture in each unit, and a sample will be interviewed 1 year after implementation in each unit to evaluate the implementation process.
Interpretation: The ABC-QI Trial will assess whether collaborative quality improvement strategies affect length of stay in moderate and late preterm neonates. It will provide detailed population-based data to support future research, benchmarking and quality improvement.
Trial Registration: ClinicalTrials.gov, no. NCT05231200.
Competing Interests: Competing interests: Khalid Aziz is a paid facilitator of Evidence-based Practice for Improving Quality (EPIQ) workshops delivered by the University of Alberta and is a volunteer board member of the Canadian Neonatal Foundation. Dr. Aziz reports grants from McGill University for teaching EPIQ for the School of Business. He has received payment from the Canadian Medical Protective Association for legal advice unrelated to this project and was funded by Canadian Institutes of Health Research (CIHR) to attend QI meetings. Charlotte Foulston reports clinical fee-for-service payments from Alberta Health as an Alberta Health Services pediatrician working in the Medicine Hat Regional Hospital neonatal intensive care unit since 2010 (no payment directly related to this manuscript) and payment from Alberta Health Services as clinical pediatrics department lead in Medicine Hat from 2011 to Mar. 1, 2022 (no payment related to this manuscript). Dr. Foulston is a Maternal, Newborn, Child and Youth (MNCY) Strategic Clinical Network (SCN) core committee member in Alberta and has received hourly payment for attending meetings. MNCY SCN has had presentations regarding this study and is aware and supportive of the work; Dr. Foulston has not received payment related to this manuscript. Dr. Foulston is a member of the MNCY SCN Neonatal Intensive Care Unit Steering Committee; she has received a stipend for attending meetings and has not received payment related to this study. Gabrielle Zimmermann and Yazid Al Hamarneh work for the Alberta SPOR [Strategy for Patient-Oriented Research] SUPPORT [Support for People and Patient-Oriented Research and Trials] Unit, which is funded in part by CIHR. Leonora Hendson reports being a member of the Early Hearing Detection and Intervention Program Advisory Committee and the Provincial Perinatal Quality Assurance Committee (neither related to this manuscript or project). No other competing interests were declared.
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