A cluster randomized trial of an mHealth integrated model of hypertension, diabetes and antenatal care in primary care settings in India and Nepal

尽管与怀孕有关的死亡和疾病在印度和尼泊尔仍然构成巨大负担，但自1990年代以来，由于出血等常见死亡原因的减少，孕产妇死亡人数有所下降。与此同时，因妊娠高血压综合征(PIH)和妊娠期糖尿病(GDM)等其他原因造成的死亡和健康不良也有所增加。这两种情况在我们计划进行研究的地区非常常见。高质量的产前护理(ANC)可以有效地预防、检测和治疗这些疾病，但不幸的是，有很好的证据表明，这些建议的干预措施没有在研究环境中常规实施。我们的研究项目旨在解决这一关键差距，并通过使用基于平板的电子决策支持系统(EDSS)来增强ANC。这种药片(A)促使一线卫生工作者提供循证的常规ANC，(B)加强对妊高征和妊娠期糖尿病的检测和管理，(C)促进记录保存和报告，以及(D)联系各级护理人员。我们对使用公共部门保健服务的农村孕妇特别感兴趣。研究问题是：1)向一线卫生工作者提供的mHealth EDSS是否通过改善对国家ANC指南的遵守来加强ANC，并与初级保健环境中的常规护理相比，改善GDM和PIH的筛查、检测、转诊和管理？2)哪些社会经济、卫生系统和政治因素影响增强的ANC的实施？3)与所取得的改善的健康结果的价值相比，加强ANC干预的成本、资源使用的变化以及干预的成本是什么？该项目包括四个部分：1.形成性研究，使用定性方法了解背景，干预开发，开发技术和如何交付，以及试点测试，2.随机分组对照试验(CRCT)，随机选择初级卫生中心来实施和评估干预措施，并将它们与其他提供常规护理的中心进行比较3.持续评估，使用定性方法了解实施过程和4.经济分析，以了解干预措施的成本和成本效益。我们的项目将在印度(特伦加纳)和尼泊尔(加德满都)进行，持续36个月。它将包括一个由印度公共卫生基金会协调的多学科调查小组，并得到(A)印度德里、(B)尼泊尔加德满都和(C)英国伦敦三个地区协调中心的支持。

Although pregnancy-related deaths and diseases still pose a substantial burden in India and Nepal, there has been a decline in maternal deaths since the 1990s, due to a decrease of common causes of mortality such as bleeding. At the same time, there has been an increase in deaths and ill health from other causes such as pregnancy-induced hypertension (PIH) and gestational diabetes (GDM). These two conditions are very frequent in the region where we are planning to conduct the study. Good quality antenatal care (ANC) can prevent, detect and treat these conditions effectively, but unfortunately there is good evidence that these recommended interventions are not being routinely implemented in the study settings. Our research project aims to address this critical gap and enhance ANC, by using a tablet-based electronic decision support system (EDSS). This tablet (a) prompts frontline health workers to provide evidence-based routine ANC, (b) enhances detection and management of PIH and GDM, (c) facilitates record-keeping and reporting, and (d) links across various levels of care providers. We are particularly interested in rural pregnant women using public-sector health services. The research questions are: 1) Does an mHealth EDSS, provided to frontline health workers, enhance ANC by improving adherence to national ANC guidelines, and improve the screening, detection, referral and management of GDM and PIH, compared with usual care in primary healthcare settings?2) What are the socio-economic, health-system and political factors affecting the implementation of the enhanced ANC? 3) What is the cost of the enhanced ANC intervention, the change in resource use, and the costs of the intervention relative to the value of the improved health outcomes achieved? The project has four components: 1. Formative research using qualitative methods to understand the context, intervention development to develop the technology and how to deliver it, and a pilot test, 2. Cluster randomized controlled trial (cRCT) to randomly pick primary health centres to implement and evaluate the intervention and compare them to other centres who give usual care 3. Ongoing evaluation, using qualitative methods to understand the processes of implementation and 4. Economic analysis to see what the intervention costs and how cost effective it is.Our project will take place India (Telangana) and Nepal (Kathmandu) and will last 36 months. It will include a multi-disciplinary team of investigators coordinated by the Public Health Foundation of India, India, with support from three regional co-ordinating centres in (a) Delhi, India, (b) Kathmandu, Nepal and (c) London, UK.