SMARThealth Pregnancy: A pilot cluster randomised trial in rural India to assess the feasibility and acceptability of a complex intervention using mobile clinical decision support for community health workers to screen, refer and counsel pregnant women at high risk of future cardiometabolic disorders. (Preprint)

BACKGROUND Hypertensive Disorders of Pregnancy (HDP) and Gestational Diabetes Mellitus (GDM) carry independent risks for future cardiometabolic disorders (CMDs), including Type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) - the leading cause of death in women in India. Two-thirds of the population live in rural areas, with limited health service access. Early identification of high-risk women is crucial to reducing CVD deaths. We conducted in-depth contextual work in rural areas of two diverse States in India to design a complex intervention (SMARThealth Pregnancy), using mobile clinical decision support for Community Health Workers (CHWs) to screen, refer and counsel pregnant women at high risk of future CMDs. The intervention was informed by behaviour change theory and embedded 15 behaviour change techniques. OBJECTIVE To assess the intervention’s feasibility and acceptability. METHODS We piloted the intervention in a prospective unblinded cluster randomised controlled trial (cRCT), embedding a qualitative sub-study. Four Primary Health Centres (PHCs): two in Jhajjar district, Haryana, and two in Guntur district, Andhra Pradesh, were randomised to intervention or control (enhanced standard care) groups. CHWs based at the intervention PHCs underwent targeted education and training, focusing on three priority conditions: anaemia in pregnancy, HDP and GDM, identified by key stakeholders within the study districts. RESULTS Two hundred pregnant women, equally randomised to intervention (n=100) and control (enhanced standard care, n=100), were recruited within 5 months across all study sites, with minimal loss to follow-up (2%) at 6 weeks postpartum. A total of 4 primary care doctors and 54 CHWs in the intervention clusters, took part in the study. Fidelity to intervention practices was 100% pre-pandemic. Baseline prevalence of moderate-severe anaemia in both intervention and control groups was high (47% and 58% of women, respectively). Prevalence of HDP (2.5%) and GDM (2%) was low in our study population. CHWs and pregnant/postpartum women found the SMARThealth Pregnancy intervention acceptable, easy to use, and perceived improvements in the quality of antenatal and postnatal care and their self-efficacy. CONCLUSIONS SMARThealth Pregnancy is feasible and acceptable for CHWs to screen, refer and counsel pregnant women at high risk of future CMDs. Mobile clinical decision support for CHWs in rural India is as a useful method of task-sharing and health system strengthening and provides a model of integrated care during the transitions between antenatal, postnatal care and adult health services. Furthermore, the intervention has provided opportunities for home-based care for pregnant and postpartum women during the pandemic. Our experience has informed the decision to initiate a larger scale cRCT. CLINICALTRIAL Trial Registration: ClinicalTrials.gov (NCT03968952). INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.3389/fgwh.2021.620759