Centre of Excellence for Maternal Newborn and Child Health, Department of Health Policy Planning and Management, School of Public Health, Makerere University, Kampala, Uganda.
Department of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
BMC Health Serv Res. 2021 Dec 11;21(1):1324. doi: 10.1186/s12913-021-07155-z.
Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period.
This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial's primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention.
There is evidence that each of the ALERT intervention components improves health providers' practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions.
Pan African Clinical Trial Registry ( www.pactr.org ): PACTR202006793783148. Registered on 17th June 2020.
过去十年中，孕产妇和新生儿死亡以及死产数量的减少并不尽如人意，这对实现可持续发展目标 3 构成了阻碍。大多数死亡发生在分娩期间和产后即刻。克服知识-实践差距，以确保在此期间实施已知的循证干预措施，有可能每年避免至少 250 万孕产妇及其后代的死亡。本文描述了一项研究方案，该方案旨在实施和评估一种多方面的医疗保健系统干预措施，以加强在此关键时期实施循证干预措施和响应性护理。
这是一项在贝宁、马拉维、坦桑尼亚和乌干达 16 家医院进行的集群随机分步楔形试验，嵌套了一个真实的过程评估。ALERT 干预措施将包括四个主要组成部分：i）通过妇女、家庭和助产士提供者的叙述进行最终用户参与，以确保干预措施的共同设计；ii）基于能力的培训；iii）通过临床围产期电子登记册提供的数据支持的质量改进；iv）孕产妇单位领导的赋权和领导力指导，辅以基于区的每半年一次的协调和问责会议。试验的主要结果是院内围产期（死产和早期新生儿）死亡率，我们预计死亡率降低 25%。将实施围产期电子登记册来监测试验。我们嵌套的真实过程评估将有助于了解什么有效、对谁有效以及在什么条件下有效。我们将应用性别视角来探索在这些环境中为提供基于证据的护理的卫生工作者提供服务的限制。经济评估将评估 ALERT 干预措施的可扩展性和成本效益。
有证据表明，ALERT 干预措施的每个组成部分都能改善卫生保健提供者的实践，且具有适度到中度的效果。我们旨在测试这种创新的包装方式，包括解决这些环境中的特定卫生系统限制，是否会产生协同效应，并产生更显著的围产期死亡率降低。
泛非临床试验注册中心（www.pactr.org）：PACTR202006793783148。于 2020 年 6 月 17 日注册。
