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

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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.