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

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.

Aims: To adopt a life-course approach to prevention of non-communicable diseases (NCDs) in women through early detection & referral of women at high risk of cardiovascular disease during and after pregnancy, through the development of a complex intervention using a mobile clinical decision support system in rural India.

Objectives: To develop and assess the feasibility and acceptability of a mobile clinical decision support system (SMARThealth Pregnancy) for use by CHWs for improving the detection and follow-up of high-risk pregnancies in rural Andhra Pradesh, India.

Methodology: This will be a mixed methods feasibility study with four stages:
1) Formative research: Exploring the local context using in-depth qualitative interviews & focus groups with key stakeholders to identify barriers & enablers within the health system to providing best practice antenatal and postnatal follow-up for high-risk pregnancies.
2) Development and validation of the SMARThealth Pregnancy Application: Algorithm development using best practice guidelines, and a two-step validation process.
3) Training, content and usability testing with end-users in a series of workshops.
4) Field trial to evaluate the acceptability and feasibility of SMARThealth Pregnancy use by CHWS and Primary care doctors, using a mixed methods approach to generate data to inform a clinical trial.

Scientific & Medical Opportunities:
a) Improved detection, referral and management of high-risk pregnancies in rural India, to improve perinatal & long-term women's health.
b) Education and up-skilling of CHWs and their communities through increased awareness of NCDs.
c) Informing the debate for task-shifting to lower-skilled cadres of health workers in areas where medically-trained professionals are scarce.
d) To help inform the basis of a larger cluster-randomised controlled trial looking at clinical outcomes, process evaluation and cost-effectiveness.

The UN and several multilateral organisations have called for a life-course approach to women's health, but there is limited evidence to support how this can be achieved. This study seeks to contribute to the evidence-base by adopting a life-course approach to the prevention of NCDs in women whilst also addressing major risk factors for maternal and neonatal mortality and morbidity in a resource-poor setting in India, using innovative mobile technology. This study is the formative phase of a proposed large-scale, cluster-randomised trial to address the use of SMARThealth Pregnancy by CHWs to detect and manage GDM and hypertension both antenatally and postnatally.

The research will be of direct benefit to the following groups:
1) Pregnant women and their communities in rural Andhra Pradesh India - through early detection and management of GDM and hypertension in pregnancy, and improved awareness of NCDs through education and engagement with communities.
2) CHWs working in this field - by providing: a) a mobile clinical decision support system (CDSS) to identify and refer women with high-risk pregnancies to primary care physicians; b) training and education relating to the prevention of NCDs in women, and c) the additional advantage of improved morale through engagement and training.
3) Primary Healthcare Physicians working in rural Andhra Pradesh, as a result of ensuring appropriate referral and risk-stratification of pregnant women to primary health centres, and provision of training and support.

Benefits to Society:
This study will address the feasibility and acceptability of integrating SMARThealth Pregnancy into local practice, and help inform both local and national policy, leading to:
1) Strengthened and improved referral pathways and communication between community-level health workers and primary and secondary care in rural Andhra Pradesh, India.
2) Integration within pre-existing Local and National Government schemes, to ensure best use and reduce out-of-pocket expenditure for rural populations.
3) Strengthened human and social capital by educating and screening women earlier in their life course about NCDs and reducing the economic burden associated with NCDs

Global Impact:
Advancing scientific knowledge and technology:
This study will be able to identify whether a CDSS utilised by CHWs can improve the identification and management of high-risk pregnant women. This will be of interest to:
1) WHO, as part of their commitment to the Sustainable Development Goals to reduce maternal mortality.
2) Key policymakers and think-tanks globally as well as governments in other LMICs.
3) NGOs working in maternal-child health in LMICs.
4) International Development agencies such as DFID.
5) m-Health Technology stakeholders by informing an evidence-based approach to the feasibility and acceptability of using m-health technologies in a rural setting.

Economic and Wider Impacts:
SMARThealth Pregnancy is an open source software program, and therefore has the potential to be used worldwide in areas where there are increasing demands on medically trained professionals and subsequent task-shifting to CHWs. SMARThealth Pregnancy, if feasible and acceptable for use by CHWs, may help inform the debate about task-shifting in other contexts, where there are increasing demands on healthcare systems. SMARThealth Pregnancy may also (with further study) have longer-term economic implications with regards to reducing NCDs through adopting a preventative life-course approach to women's health.