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

虽然与怀孕有关的死亡和疾病仍然是印度和尼泊尔的沉重负担，但自1990年代以来，由于出血等常见死亡原因减少，孕产妇死亡率有所下降。与此同时，由于妊娠高血压和妊娠糖尿病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。高质量的产前保健（ANC）可以有效地预防、检测和治疗这些疾病，但不幸的是，有充分的证据表明，这些建议的干预措施在研究环境中没有得到常规实施。我们的研究项目旨在通过使用基于平板电脑的电子决策支持系统（EDSS）来解决这一关键差距并增强ANC。该平板电脑（a）提示一线卫生工作者提供基于证据的常规ANC，（B）加强妊高征和GDM的检测和管理，（c）促进记录保存和报告，以及（d）各级护理提供者之间的联系。我们特别关注农村孕妇利用公共部门保健服务的情况。研究问题是：1）与初级医疗机构的常规护理相比，向一线卫生工作者提供的移动健康EDSS是否通过提高对国家ANC指南的依从性来提高ANC，并改善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到加强的产前护理的实施？3)加强ANC干预的成本是多少，资源使用的变化，以及相对于改善健康结果的价值，干预的成本是多少？该项目有四个组成部分：1。形成性研究使用定性方法来了解背景，干预开发开发技术和如何提供它，以及试点测试，2。群集随机对照试验（cRCT），随机选择初级卫生中心实施和评估干预措施，并将其与提供常规护理的其他中心进行比较3。持续评估，使用定性方法了解实施过程; 4.我们的项目将在印度（特兰加纳）和尼泊尔（加德满都）进行，为期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，并得到以下三个区域协调中心的支持：（a）印度德里;（B）尼泊尔加德满都;（c）英国伦敦。

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.