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

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Epidemiology and Population Health

Abstract

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.

Technical Summary

Pregnancy-related deaths and diseases pose a substantial burden to India and Nepal. In India, during 2015, nearly 1.2 million perinatal deaths occurred; in Nepal, with its much smaller population, there were 24,000 deaths. Most of these deaths are preventable with better antenatal care (ANC), but unfortunately there is good evidence that recommended interventions are not routinely implemented in the study settings.

This project attempts to address this critical gap. The ultimate aim of the project is to enhance antenatal care (ANC), by using a tablet-based electronic decision support system (EDSS) that prompts frontline health workers (FHWs) to provide evidence-based routine ANC, enhances detection and management of two increasingly important conditions impacting pregnancy, namely pregnancy-induced hypertension (PIH) and gestational diabetes (GDM), facilitates record-keeping and reporting, and links across levels of care providers.

The research questions are:
-Does an mHealth EDSS, provided to FHWs, 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?
-What are the socio-economic, health-system and political factors affecting the implementation of the enhanced ANC?
-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, taking place in India (Telangana) and Nepal (Kathmandu),will last 36 months. It includes formative research and process evaluation using qualitative methods, and a cluster randomized trial of 88 primary health centres (and those reporting to them). It has 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, (b) Kathmandu and (c) London

Planned Impact

The ultimate aim of this project is to enhance antenatal care (ANC), to address the changing disease burden affecting pregnant women in India and Nepal. The enhancement includes using a tablet-based electronic decision support system (EDSS) tool that prompts frontline health workers (FHWs) to provide evidence-based routine ANC, enhances the detection and management of two increasingly important conditions, namely pregnancy-induced hypertension (PIH) and gestational diabetes (GDM), facilitates efficient record-keeping and reporting, and links across various levels of care providers in the public-sector health services, that are used by most rural women.

We anticipate impact at different levels and among different groups: at the health system level, among pregnant women, among healthcare providers and policymakers.

Health system: The intervention will enhance and improve the quality of ANC services and provide continuity of care by integration of routine ANC with the screening, detection, referral and management of GDM and PIH in the most efficient manner. It will also ease the work flow in the primary care settings and likely increase cost-efficiency.

Pregnant women: The enhanced quality of ANC will lead to improved health outcomes for both mothers and their babies in the near term as well as subsequently during their lifecourse by reducing the risk of hypertension, diabetes and adverse cardiovascular health outcomes. It will also increase women's satisfaction with public sector's health services and boost confidence in the health system and providers.

Healthcare providers: The project offers a unique opportunity for their professional upskilling and delivery of integrated evidence based high quality ANC services, through improved record keeping, reporting, timely prompts, and easier work flow. This will lead to improved outcomes for the women, reduce costs, enhance health system performance and responsiveness to community needs.

Policymakers: They will recieve much needed evidence for implementing better approaches to enhance existing ANC services for improving women's health.

Publications

10 25 50
 
Description We have completed the formative phase of the research in Nepal and in India, with the main questions answered below:

1. What is current care (and likely current care in the control group)?
1.a Health system is well set-up to provide ANC in Nepal; the system in Telangana is complex, with women having many visits with many different providers, at many levels of facilities and different sectors (public and private),
1.b Quality of care needs improvement, particularly communication aspects. Very little GDM testing is currently happening in Nepal
1.c Need sensitizing to non-communicable diseases; GDM yet not included in HMIS
1.d. Need better record keeping to address disjointed nature

2. Who are the right recipients of the EDSS (frontline health workers)?
2.a ANM in Nepal. In India, ANM, but also Medical Officers and Staff Nurses who provide ANC.

3. What is the landscape of EDSS in ANC in Nepal and what can we learn from the existing evidence?
3.a. ANMs in Nepal generally didn't have tablets or Apps. In India, there are several existing apps including the KCR and an NCD app. There are not current EDSS for ANC apps in India (ANMOL has not been rolled out).
3.b. There is a hypertension App that Dhulikhel Hospital had been working on.
3.c. One hospital, supported by another NGO, was trying to develop an ANC App
3.d. WHO App is acceptable to Nepal but we have decided to go with the tailored (less expensive) PHFI App

4. How can the intervention ensure user acceptability AND Better Quality?
4.a Women's concerns around access not just quality of care.
4.b. Previous apps introduced (mainly texting health information to patients) were not sustained because of cost when the funder withdrew.
4.c. Concerns over internet reception, problems with electricity, and not all health workers in rural areas being familiar with technology (not apparent in facility survey). In India, health workers were concerned about additional record keeping, but were interested in learning more about managing high risk pregnancies.
4.d. Some staff in Nepal concerned that given the many problems they face, apps may not be the priority
4.e. Needs extensive piloting of App and supportive training

In preparation for the evaluation research, we have completed trainings with providers in both countries. Providers have said that they appreciate the prompts for clinical information that both apps provide. Anecdotal findings from the piloting of the apps suggests that while the use of the apps during ANC consultations longer, providers are willing to tolerate this if it leads to more complete clinical information.
Exploitation Route We used the finding from the formative phase to design the evaluation phase and they were also be shared with the Ministry of Health in Nepal and the State of Telegana Ministry of Health. We have
Sectors Digital/Communication/Information Technologies (including Software),Healthcare

 
Description Our work has influenced how the WHO is thinking about ANC apps where there are many providers providing care within a specific ANC visit. The Nepal team has sucessfully developed a Nepali version the WHO's digital ANC module- an ANC electronic decision support system. We have changed the focus of the Nepal project to implementation research, where we will evaluate the implementation of both the mIRA and WHO EDSS. This change in focus in Nepal will respond to questions raised by Nepali policy makers in the formative phase, and allow us to better understand the Nepal-specific implementation facilitators and barriers, and will contribute to the WHO's understanding about the use of their EDSS in different contexts. We have also influenced the Telengana state officials in how they may look at quality and continuity of ANC care, and think about routine data collection. We have also communciated formative findings to the Nepal government on health care providers views on use of Apps.
Sector Digital/Communication/Information Technologies (including Software),Healthcare
Impact Types Policy & public services

 
Description (India) Meeting with health officials at Commissionerate of Health and Family Welfare (CHFW)
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Gave evidence to a government review
 
Description (India) Meeting with the Commissioner, Commissionerate of Health and Family Welfare (CHFW)
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Gave evidence to a government review
 
Description (India) Meeting with the Commissionerate of Health and Family Welfare (CHFW)
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Gave evidence to a government review
 
Description Presenation of formative research to the Telengana Ministry of Health
Geographic Reach Asia 
Policy Influence Type Gave evidence to a government review
 
Description Presenation of formative to Nepal Ministry of health stakeholders
Geographic Reach Asia 
Policy Influence Type Gave evidence to a government review
 
Description LSHTM 2019-20 Doctoral Project Travelling Scholarship
Amount £3,950 (GBP)
Funding ID 1402301 
Organisation London School of Hygiene and Tropical Medicine (LSHTM) 
Sector Academic/University
Country United Kingdom
Start 07/2020 
End 07/2021
 
Title Nepal and India: Facility survey dataset 
Description These data sets capture information from a facility survey in the study areas in Nepal (N=10) and India (N=23). This include information on the infrastructure of the facility (e.g. electricity availability and internet access), components of ANC provided and whether they have the drugs/equipment to provide these services. We gained ethical approval for this data collection, and have said that the anonymised Nepal dataset can be shared with other researchers upon request, once data cleaning is finalized. The India Dataset is the property of PHFI 
Type Of Material Database/Collection of data 
Year Produced 2020 
Provided To Others? No  
Impact These data have been of critical importance for informing our team about readiness of facilities to incorporate an electronic decision support system. For example, in Nepal, all facilities surveyed had access to reliable electricity and internet access for at least two hours a day. Higher-level facilities provided more components of ANC than lower-level facilities. We have used this information to suggest primary adn secondary outcomes for the trial. 
 
Title Nepal: ANC observation dataset 
Description This data set captures information from observations of antenatal care (ANC) consultations in the study areas in Nepal (N=10). This include information on the socio-demographics of women accessing ANC, a checklist of components of ANC undertaken during the consultation and the type of healthcare worker which did this, and the record keeping undertaken during the consultation. We gained ethical approval for this data collection, and have said that the anonymised data set can be shared with other researchers upon request. 
Type Of Material Database/Collection of data 
Year Produced 2020 
Provided To Others? No  
Impact These data have been of critical importance for informing our team about the delivery of ANC in our study settings, and therefore informing the development of our intervention. For example, it is clear in India that ANC care is quite fragmented with women seeing multiple different types of healthcare workers in a visit. In Nepal, ANC is generally delivered by the auxiliary nurse midwife. 
 
Description Collaboration with Ona Systems 
Organisation Ona Systems Inc.
Country United States 
Sector Private 
PI Contribution We have collaborated with Ona Systems to develop a Nepali version of the WHO ANC module.
Collaborator Contribution Ona Systems has delivered training and technical support to the Nepali team to develop the ANC module for the Nepal context.
Impact A Nepali version of the WHO ANC module
Start Year 2021
 
Description Collaboration with WHO on creating an electronic decision support tool for antenatal care 
Organisation World Health Organization (WHO)
Country Global 
Sector Public 
PI Contribution This mutually beneficial partnership between our study group and the World Health Organization (WHO) has arisen from a shared interest in using Electronic Decision Support Systems (EDSS) to improve the quality of routine antenatal care (ANC). We are working closely with the team at WHO to critically review an EDSS tool they have developed for use in routine antenatal care. We have shared our formative research on the current ANC set ups in India and Nepal, and the stakeholder interviews on the acceptability and desirability of having an app to support ANC
Collaborator Contribution The WHO are happy for their tool to form the basis of our intervention, and will work with us to adapt it for use in the local contexts and to add on more detailed components for treatment of high-risk women. They have shared the App prototype and linked us with their technical team
Impact We have shared results from our formative phase research with the WHO team to give them a sense of the opportunities and challenges for EDSS use in the areas of Nepal and India in which out trial is being conducted, and they have shared the WHO ANC reference app. This represents a multi-disciplinary collaboration, bringing together IT specialists, clinicians, qualitative researchers and epidemiologists.
Start Year 2019
 
Description Commissionerate of Health and Family Welfare, Government of Telangana collaboration to permit trial, and to increase likelihood of subsequent uptake and scale up 
Organisation Government of Telangana
Department Commissionerate of Health and Family Welfare
Country India 
Sector Public 
PI Contribution We are working in partnerships with the Commissionerate of Health and Family Welfare (CHFW) in Telangana. We have prepared briefings for the the CHFW and shared research findings. We have reviewed the ongoing routine KCR data collection and provided detailed feedback on data quality and suggested improvements.
Collaborator Contribution The CHFW have been supportive in facilitating our work in the State, and have even provided work space within their officers for two researchers employed on our project to facilitate collaborative working between our groups. They have supported our ongoing formative phase research by working closely with our team to assess the current quality of ANC care in the State and to review the current system in which frontline healthcare workers enter data from routine data.
Impact The main outputs to stem from this collaboration thus far are a detailed report from our team to the CHFW including recommendations on they can improve quality and utilisation of the data routinely collected in the State.
Start Year 2019
 
Title Nepali version of the WHO digital ANC module 
Description Working with the WHO and their tech partern, the Nepali team has created a Nepali version of the WHO digital ANC module, which, alongside the mIRA EDSS, we will evaluate during the implementation research phase. The WHO EDSS focusses on facilitating the adoption and adaption of WHO ANC guidelines, 
Type Management of Diseases and Conditions
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2022
Development Status Under active development/distribution
Impact None yet, Final version near ready for implementation. 
 
Title mIRA: an electronic decision support system for frontline health workers to provide quality ANC 
Description The tool is being developed by PHFI, the India DBT partners within this current Newton Fund MRC grant. We are also receiving inputs from the WHO, who have separate funding to develop a similar tool. Our partnership shares lessons, avoids duplication of effort, and strengthens the potential for scale-up. The tool is an electronic decision support system (EDSS) for ANC, to support the management of pregnant women during ANC. It includes prompts for health workers to ensure they provide all elements of evidence based care, and has algorithms to recommend preventive measures, treatment, or referral. 
Type Management of Diseases and Conditions
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2022
Development Status Under active development/distribution
Impact None yet. Final version near ready for implementation. 
 
Description "Please tell them no more apps mam". Formative research for a possible mHealth intervention in Telangana State, India. Poster presenation at Global Health Services Research Conference. Presenter Radha Krishnam 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact "Please tell them no more apps mam". Formative research for a possible mHealth intervention in Telangana State, India. Poster presentation at the Sixth Global Symposium on Health Systems Research, Virtual symposium November 10 - 12, 2020.
Year(s) Of Engagement Activity 2020
 
Description (India) In-person training sessions 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Other audiences
Results and Impact The training of the field workers consisted of the following items:

Study Design, Deliverables for Health Workers, and Timeline
Indian Primary Healthcare System
Routine ANC Guidelines
Record keeping methods (MCP Card in detail)
Study Tools (Facility survey and Audit of record-keeping in detail)
Electronic Decision Support System (EDSS)
Year(s) Of Engagement Activity 2022
 
Description (India) Introduction and orientation of the health workers for the study 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact On the 22nd of Feb 2022, the India team held a virtual meeting to introduce and orient the health workers to the study.
Year(s) Of Engagement Activity 2022
 
Description (India) Virtual practice sessions with Health Workers 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Online sessions were run from the 28 of Feb to the 1st of March with Helath Workers to present specific case scenarios in relation to the mIRA EDSS.
Year(s) Of Engagement Activity 2022
 
Description (Nepal) Local stakeholder meeting 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Other audiences
Results and Impact This meeting with Stakeholders, including governement officials, was on 21st February, 2022 at Dhulikhel Hospital.

Objectives of the meeting were:
• To provide an overview of the mIRA project
• To disseminate findings from formative phase
• To demonstrate mIRA application and WHO application
• To discuss on problems for implementing project and potential strategies for intervention.
• To gather valuable feedback and suggestions for implementing project.
Year(s) Of Engagement Activity 2022
 
Description (Nepal) National stakeholder meeting 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact On May 20 2021, the Nepal team held a virtual National Stakeholder meeting, which included government officials.
Year(s) Of Engagement Activity 2021
 
Description (Nepal) mIRA EDSS training with Auxiliary Nurse Midwives 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact The Nepali team conducted training on the mIRA EDSS training with 10 Auxiliary Nurse Midwives 13-15 March 2022.
Year(s) Of Engagement Activity 2022
 
Description (Nepal) mIRA EDSS training with Field Workers 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Other audiences
Results and Impact The Nepali team conducted training on the mIRA EDSS training with 10 Field Workers 6-8th March 2022.
Year(s) Of Engagement Activity 2022
 
Description Digital health seminar at Dhulikel Hospital Nepal. Rajani Shakya presented on the mIRA trial. 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presenation of trial to clinical colleagues adn to academic researchers. Sparked questions adn discussion.
Year(s) Of Engagement Activity 2021
 
Description From new to routine: how an electronic decision support system changes the quality and process of antenatal care in India and Nepal. 22 June 2020 LSHTM online. Presenter Emma Radovich 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Purpose was to share plans for the process evaluation to a wider group and receive critical feedback. The mIRA cluster randomised trial seeks to test the effectiveness of a tablet-based electronic decision support system to improve the quality of ANC in primary-level health facilities in India and Nepal. The process evaluation of the trial aims to provide insight into how an electronic decision support system contributes to changes in healthcare provider behaviour and the provision of ANC in health facilities.

Many digital health interventions insufficiently interrogate how the technology becomes integrated into systems of health service provision. Drawing from implementation theory and systems thinking, this project will try to better understand the process of implementation, including how a technology becomes part of routine ANC practice, and how a digital health intervention to improve quality of care works (or doesn't work) and why. Multiple statistical approaches will be used in the analysis of primary and secondary trial data to investigate contextual factors and the process of implementation and to explore mechanisms of change.
The main focus of comments was if possible, to think about creating generalizable knowledge: using theory to delineate what hypotheses the theories imply and then use data collection to test hypotheses. The aim is to build bridges by n theory testing and commenting on relevant were the theories. Discussions set up with Carl May afterwards
Year(s) Of Engagement Activity 2020
 
Description National Stakeholder meeting in Nepal 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact The mIRA Nepal National Stakeholder meeting brought together 33 participants including the mIRA research team from Nepal, and individuals the National Planning Commission (NPC), Department of Health Services - Family Welfare Division (FWD), National Health Training Centre (NHTC), Epidemiology and Disease Control Division (EDCD), Integrated Health Information Management Section (IHIMS), Health Insurance Board (HIB), Diabetes Endocrinology Association Nepal (DEAN), Nepal Society of Obstetrics and Gynaecology (NeSOG), Kathmandu Medical College Public Limited (KMC), Maternal and Infant Research Activities (MIRA), Nepal Health Research Council (NHRC), Nepal Chemist and Druggist Association (NCDA), Karuna Foundation, Medic Mobile, Wiseyak, patients with gestational diabetes and Gestational Hypertension along with visitor and Female Community Health Volunteers.
The main objectives of the meeting were:
1. To Inform the meeting participants about the mIRA study
2. Actively involve relevant stakeholders
3. Issues in introduction of Electronic Decision Support System for Antenatal Care
4. Way forward to work collaboratively in future (Public Private Partnership)

After presenting an overview of the study to the participants, there was time for questions and discussions. There was extensive discussion on the challenges, opportunities and a number of recommendations on the intervention from these stakeholders.
Year(s) Of Engagement Activity 2019
 
Description Seminar at Public Health Foundation of India 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact During a collaborative visit for the development of the full proposal for this grant, Oona Campbell delivered a seminar to staff members at the Public Health Foundation of India. This seminar covered a general overview of maternal health, with particular attention to the transition from the Millennium Development Goals to the Sustainable Development Goals. This sparked interesting discussion on the current challenges to improving maternal health in India, and potential solutions including electronic decision support systems.
Year(s) Of Engagement Activity 2018
 
Description Seminar for Maternal and Neonatal Health Group at the London School of Hygiene and Tropical Medicine 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Emma Radovich and Oona Campbell gave a presentation on some of the preliminary results from our formative phase research on the quality of antenatal care to a group of students and academics with expertise in the maternal and neonatal health field. This activity was designed to share some of the methods we have used in this study to try and gain a much deeper understanding on the quality of ANC in the settings in which this study is taking place and identify creative ways of measuring trial outcomes. It generated much discussion on the challenges of measuring quality ANC, and indicators for measuring quality. We got interesting insights from the audience on what they think the most important markers of good quality ANC are. We also gained shared learning, with our team providing an overview of tools that other studies can use and the audience providing valuable input that has been incorporated into our trial design.
Year(s) Of Engagement Activity 2020
 
Description Training to Dhulikhel Hospital and School of Public Health staff, Kathmandu University on qualititive research methods by Loveday Penn-Kekana (LSHTM) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact 35 researchers attended a workshop on use of qualitative analysis methods to understand how auxiliary nurse midwives provide care, and how tablets can be used to improve quality.
Year(s) Of Engagement Activity 2019
 
Description Visit to LSHTM by Rajeev Shrestra, head of the Research and Development Division of the Dhulikhel Hospital to discuss a memorandum of understanding & support for capacity building 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Arranged meetings with Prof Anne Mills (Deputy Director & Provost of LSHTM) ; with Patrick Ng (Research Contracts Office); with mIRA team members (Sylvia Marinova, Clara Calvert, Loveday-Penn Kekana, Oona Campbell); with Anna Kramer (Strategic Research Coordinator/Partnerships)
Year(s) Of Engagement Activity 2019