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.

CMAJ open Pub Date : 2023-05-01 DOI:10.9778/cmajo.20220177
Ayman Abou Mehrem, Jennifer Toye, Khalid Aziz, Karen Benzies, Belal Alshaikh, David Johnson, Peter Faris, Amuchou Soraisham, Deborah McNeil, Yazid N Al Hamarneh, Karen Foss, Charlotte Foulston, Christine Johns, Gabrielle L Zimmermann, Hussein Zein, Leonora Hendson, Kumar Kumaran, Dana Price, Nalini Singhal, Prakesh S Shah
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Abstract

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.

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艾伯塔省协作质量改进策略以改善中度和晚期早产儿(ABC-QI)试验的结果:一项多中心、楔形步聚类随机试验的方案。
背景:基于证据的质量改进实践(EPIQ)是加拿大新生儿网络采用的一种协作质量改进方法,可降低极早产儿的死亡率和发病率。艾伯塔省改善中度和晚期早产儿结局的协作质量改进策略(ABC-QI)试验旨在评估EPIQ协作质量改进策略对加拿大艾伯塔省中度和晚期早产儿的影响。方法:在一项涉及12个新生儿重症监护病房(nicu)的4年多中心楔形聚类随机试验中,我们将收集第一年采用现行做法的基线数据(对照组所有nicu)。每年年底将有4例新生儿重症监护室转入干预组,最后一组转入干预组后随访1年。首次入住新生儿重症监护病房或产后病房的32 + 0至36 + 6周妊娠新生儿将包括在内。干预措施包括使用EPIQ策略实施呼吸和营养护理包,包括质量改进团队建设、质量改进教育、包的实施、质量改进指导和协作网络。主要结局是住院时间;次要结局包括医疗费用和短期临床结局。新生儿重症监护室工作人员将在第一年完成一项调查,以评估每个单位的质量改进文化,并在每个单位实施1年后进行抽样访谈,以评估实施过程。解释:ABC-QI试验将评估协作质量改进策略是否会影响中度和晚期早产儿的住院时间。它将提供详细的基于人口的数据,以支持未来的研究、基准和质量改进。试验注册:ClinicalTrials.gov,编号:NCT05231200。
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