Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)a stepped wedge cluster randomized controlled trial in public hospitals
Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)a stepped wedge cluster randomized controlled trial in public hospitals
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DOI：
10.1186/s13012-019-0917-z
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发表时间：
2019-06-19
影响因子：
7.2
通讯作者：
Ashish, K. C.
中科院分区：
文献类型：
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作者：
Gurung, Rejina;Jha, Anjani Kumar;Ashish, K. C.
背景每年全球发生220万例产中相关死亡(产中死产和第一天新生儿死亡)，其中99%发生在低收入和中等收入国家。尽管在这些环境中的保健机构分娩的比例加速上升，但死产和新生儿死亡率并没有相应地降低。这些死亡中有三分之二归因于卫生设施护理质量差。改善分娩期间的护理质量需要在循证干预方面进行投资。我们的目标是评估尼泊尔公立医院的质量改进包通过质量改进在尼泊尔(持续)扩大更安全的捆绑包，以提高尼泊尔公立医院的产中护理和产中相关死亡率。方法我们将在8家公立医院进行阶梯式楔形整群随机对照试验，每家医院每年至少提供3000次分娩。每个医院代表一个集群，每个集群有2个月的干预过渡期。以95%的显著性水平，90%的统计能力和0.00015的组内相关性，19个月的研究周期应该能检测到产中相关死亡率至少15%的变化。将根据每家医院的瓶颈分析，建立质量改进培训、指导、系统反馈和持续改进周期。所有有关的卫生工作者都将接受标准的基本新生儿复苏和基本新生儿护理方面的培训。这些医院将引入便携式胎儿心跳监测器(Moyo(R))和新生儿心率监测器(NeoBeats(R))，以识别分娩过程中胎儿的窘迫，并改进新生儿复苏。独立研究小组将通过审查记录、进行观察和访谈，在每家医院收集关于干预输入、过程和结果的数据。剂量-反应效应将通过过程评估来评估。讨论随着全球改善产中护理质量的势头，更好地理解卫生设施背景下的QI包是重要的。拟议的一揽子方案是基于以前在尼泊尔进行的一项类似的扩大试验的经验。拟议的评估将提供关于QI包和技术的证据，以便在类似的环境中实施和扩大规模。试验注册号为ISRCTN16741720。注册日期为2019年3月2日。
BackgroundEach year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement packageScaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)on intrapartum care and intrapartum-related mortality in public hospitals of Nepal.MethodsWe will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo (R)) and neonatal heart rate monitors (Neobeat (R)) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations.DiscussionWith the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings.Trial registration numberISRCTN16741720. Registered on 2 March 2019.