Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, SE1 7EH, UK.
Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.
Implement Sci. 2019 Apr 18;14(1):38. doi: 10.1186/s13012-019-0885-3.
Interventions aimed at reducing maternal mortality are increasingly complex. Understanding how complex interventions are delivered, to whom, and how they work is key in ensuring their rapid scale-up. We delivered a vital signs triage intervention into routine maternity care in eight low- and middle-income countries with the aim of reducing a composite outcome of morbidity and mortality. This was a pragmatic, hybrid effectiveness-implementation stepped-wedge randomised controlled trial. In this study, we present the results of the mixed-methods process evaluation. The aim was to describe implementation and local context and integrate results to determine whether differences in the effect of the intervention across sites could be explained.
The duration and content of implementation, uptake of the intervention and its impact on clinical management were recorded. These were integrated with interviews (n = 36) and focus groups (n = 19) at 3 months and 6-9 months after implementation. In order to determine the effect of implementation on effectiveness, measures were ranked and averaged across implementation domains to create a composite implementation strength score and then correlated with the primary outcome.
Overall, 61.1% (n = 2747) of health care providers were trained in the intervention (range 16.5% to 89.2%) over a mean of 10.8 days. Uptake and acceptability of the intervention was good. All clusters demonstrated improved availability of vital signs equipment. There was an increase in the proportion of women having their blood pressure measured in pregnancy following the intervention (79.2% vs. 97.6%; OR 1.30 (1.29-1.31)) and no significant change in referral rates (3.7% vs. 4.4% OR 0.89; (0.39-2.05)). Availability of resources and acceptable, effective referral systems influenced health care provider interaction with the intervention. There was no correlation between process measures within or between domains, or between the composite score and the primary outcome.
This process evaluation has successfully described the quantity and quality of implementation. Variation in implementation and context did not explain differences in the effectiveness of the intervention on maternal mortality and morbidity. We suggest future trials should prioritise in-depth evaluation of local context and clinical pathways.
Trial registration: ISRCTN41244132 . Registered on 2 Feb 2016.
旨在降低孕产妇死亡率的干预措施正变得日益复杂。了解复杂干预措施的实施方式、针对对象以及作用机制是确保其快速推广的关键。我们在 8 个中低收入国家将一种生命体征分诊干预措施纳入常规产科护理，目的是降低发病率和死亡率的综合结局。这是一项务实的、混合方法有效性-实施阶段递增式随机对照试验。本研究介绍了混合方法实施情况评估的结果。目的是描述实施情况和当地环境，并将结果进行整合，以确定干预措施在不同地点的效果差异是否可以得到解释。
记录实施的持续时间和内容、干预措施的采用情况及其对临床管理的影响。在实施后 3 个月和 6-9 个月，进行了 36 次访谈和 19 次焦点小组讨论。为了确定实施对效果的影响，对措施进行了排名，并根据实施领域进行平均，以创建综合实施强度评分，然后与主要结局进行相关性分析。
总体而言，共有 61.1%（n=2747）的卫生保健提供者接受了该干预措施的培训（范围为 16.5%至 89.2%），培训平均持续 10.8 天。干预措施的采用和接受度良好。所有集群均显示生命体征设备的可用性得到改善。干预后，孕妇测血压的比例增加（79.2%对 97.6%；OR 1.30（1.29-1.31）），转诊率无显著变化（3.7%对 4.4%；OR 0.89；（0.39-2.05））。资源的可获得性和可接受的、有效的转诊系统影响了卫生保健提供者与干预措施的互动。在域内或域间、综合评分与主要结局之间均未观察到过程措施之间存在相关性。
该实施情况评估成功描述了实施的数量和质量。实施情况和环境的变化并不能解释干预措施对孕产妇死亡率和发病率的效果差异。我们建议未来的试验应优先深入评估当地环境和临床路径。
试验注册：ISRCTN41244132。于 2016 年 2 月 2 日注册。
