SMARThealth Pregnancy: Development of a complex intervention using clinical decision support to detect & refer high-risk pregnant women in rural India

研究背景：心脏病是全球女性死亡的主要原因，对低收入和中等收入国家（LMIC）造成的负担最大。心脏病的危险因素包括高血压和糖尿病。这些风险因素可以通过早期发现和使用循证生活方式干预和药物管理来改变。怀孕可能会暴露出对高血压和糖尿病等非传染性疾病（NCD）未来发展的潜在易感性，并可以确定心脏病风险增加的妇女。通过在怀孕期间和怀孕后的头5年内及早发现高危妇女，可以预防或更有效地管理非传染性疾病，并可以减少与怀孕期间高血压和糖尿病有关的严重并发症（影响母亲和婴儿）。这对于根据联合国可持续发展目标减少孕产妇死亡至关重要。循证干预措施包括国际糖尿病联合会的“怀孕期间和怀孕后生活方式改变护理模式”，该模式将怀孕期间及以后与糖尿病相关的风险降低到基线值。这种干预措施可以在社区范围内提供，在印度农村，医生短缺。社区卫生工作者是社区中联系孕妇的主要纽带，为妇女提供基本的产前和产后护理。他们处于筛查和转诊高危妊娠妇女的理想位置，但他们需要适当的培训、支持和监督。这项研究利用移动的技术提供临床决策支持，使社区卫生工作者能够筛查、发现高危妇女，并将她们转介到初级卫生中心，在那里她们可以得到管理和后续护理。干预措施：系统医疗评估、转诊和治疗平台是经过验证的临床决策支持系统，已在印度农村使用。SMARThealth已被用于在印度农村地区筛查精神疾病、糖尿病和结核病，该方案已扩展到中国和印度尼西亚。将对该平台进行调整，以整合关于在常规产前和产后护理中筛查高危妊娠的循证国家和国际准则，从而形成SMARThealth妊娠。总体目标：改善对印度安得拉邦农村地区高危妊娠妇女的筛查、检测、转诊和管理，以便：（a）降低孕产妇和围产期死亡率和发病率，并从长远来看，（B）降低这些妇女与妊娠有关的非传染性疾病的负担。1）进行形成性研究，以确定卫生系统内的障碍和推动因素，并确定证据-实践差距。2）开发和验证临床决策支持系统（SMARThealth Pregnancy），以改善印度农村地区高危妊娠的发现和转诊。3)4）评估社区卫生工作者和初级卫生保健医生使用SMARThealth Pregnancy的可行性和可接受性，以改善高危妊娠的检测、转诊和管理。潜在的应用和益处：SMARThealth妊娠的开发和可行性研究将为采取生命周期方法预防非传染性疾病的证据库提供信息。它还将为关于将生活方式干预措施的筛查和咨询任务转移到类似资源匮乏环境中的较低级别卫生工作者的辩论提供信息。此外，SMARThealth系统使初级保健医生和社区卫生工作者之间能够双向沟通，从而有助于加强现有的卫生系统和转诊途径，改善社区内高危妇女的反馈和后续做法。

Context of Research: Heart disease is the leading cause of death in women worldwide, with the greatest burden affecting low and middle income countries (LMICs). Risk factors for heart disease include high blood pressure (hypertension) and diabetes. These risk factors can be modified through early detection and management using evidence-based lifestyle interventions and medications. Pregnancy may unmask an underlying susceptibility to the future development of non-communicable diseases (NCDs) such as hypertension and diabetes, and can identify women at increased risk of heart disease. Through early detection of high-risk women in pregnancy and in the first 5 years following pregnancy, NCDs may be prevented or more effectively managed, and serious complications associated with high blood pressure and diabetes in pregnancy (affecting mother and baby) may be reduced. This is of great importance in order to reduce maternal deaths in line with the UN's Sustainable Development Goals. Evidence-based interventions include the International Diabetes Federation's Model of Care for lifestyle modification during and after pregnancy, which reduces the risks associated with diabetes in pregnancy and beyond to baseline values. Such interventions may be delivered in a community context.In rural India, there is a shortage of doctors. Community Health Workers (CHWs) represent the main link to pregnant women in the community and provide basic antenatal and postnatal care to women. They are in the ideal position to screen and refer women with high-risk pregnancies, however they need adequate training, support and supervision. This study utilises mobile technology to provide clinical decision support to empower CHWs to screen, detect and refer high-risk women to primary health centres, where they can be managed and receive follow-up care. Intervention: The Systematic Medical Appraisal, Referral and Treatment (SMARThealth) platform is validated clinical decision support system, already in use in rural India. SMARThealth has been adapted to screen for mental health disorders, diabetes and TB in rural India, and the programme has been extended to China and Indonesia. This platform will be adapted to integrate evidence-based national and international guidelines on screening for high-risk pregnancies during routine antenatal and postnatal care to form SMARThealth Pregnancy. Overall Aim:To improve screening, detection, referral and management of women with high-risk pregnancies in rural Andhra Pradesh, India, so as to reduce: a) maternal and perinatal mortality and morbidity, and in the longer term, b) the burden of pregnancy-associated, non-communicable diseases for these women.Specific Objectives:1) Conduct formative research to identify the barriers and enablers within the health system and identify the evidence-practice gap.2) Develop and validate a clinical decision support system (SMARThealth Pregnancy) to improve detection and referral of high-risk pregnancies in rural India. 3) Conduct training, content and usability testing of SMARThealth Pregnancy with end-users.4) Evaluate the feasibility and acceptability of SMARThealth Pregnancy for use by Community Health Workers and Primary Health Care doctors to improve detection, referral and management of high-risk pregnancies. Potential Applications & Benefits:The development and feasibility study of SMARThealth Pregnancy will inform the evidence base on taking a life-course approach to women's health to prevent NCDs. It will also inform the debate on task-shifting of screening and counselling for lifestyle interventions to lower cadres of health workers in similar resource-poor settings. Additionally, the SMARThealth system enables bidirectional communication between primary care doctor and CHWs, thus helping to strengthen existing health systems and referral pathways, improve feedback and follow-up practices of high-risk women within the community.