A cluster randomised trial of an innovative, low-cost primary care programme for the detection and management of type 2 diabetes in rural Thailand

Diabetes and chronic kidney disease (CKD) were ranked 5th and 7th leading cause of mortality in Thailand by the Global Burden of Disease Study 2015. An estimated 3.2 Thai adults (6.4% of the adult population) had diabetes in 2013, expected to grow to 5.2 million by 2035. Treatment of advanced kidney failure by dialysis is expensive, costing about 3.6% of the Thai healthcare budget in 2011, projected to increase to 6.2% by the year 2018. If detected early, this complication can be prevented in a majority.

Despite the implementation of universal health coverage in Thailand, the health care systems - particularly those serving rural populations - remain poorly equipped to manage diabetes because doctors are in short supply and there are few organised diabetes programmes. This is especially true for diabetes-related kidney disease. Therefore, alternative methods of detecting and managing diabetes in rural areas are urgently required. One potential method is to use a more widely available health care workforce such as village health workers. These workers are not medically qualified but have received health training workers and could potentially be used to deliver more effective care. This study will develop and assess a strategy called 'SMART Health' to use non-physician healthcare workers to identify and manage village residents with diabetes and kidney disease according to best practice. Healthcare workers will be trained to use a simple mobile device (tablet or smartphone) on which they can record patient data such as age, weight, blood pressure, family history and receive immediate advice about how to treat the patient with drugs and/or lifestyle advice generated by an electronic program. This program considers the patient's risk factors and stage of disease and generates recommendations based on national treatment guidelines. The program also links with the patient's personal health record so that they can be followed up or referred to hospitals as appropriate.

The study will have 2 phases. In the first phase, we will develop and test the electronic programmes or 'algorithms' to detect and manage diabetes ensuring that the recommendations are appropriate and in line with the facilities and resources (including affordable medicines) available. In the second phase, we measure the effectiveness of SMART Health Diabetes in a large trial which compares 20 villages who have been trained to use and have access to SMART Health Diabetes ('intervention' villages) with 20 villages who do not have SMART Health Diabetes but will continue their usual practice ('control' villages). We will then compare individuals from intervention and villages in terms important diabetes-related outcomes such as glucose control and kidney damage. In parallel, we will conduct economic assessments and interviews with health workers to determine whether SMART Health Diabetes is cost-effective and acceptable.

We will work with village leaders, government organisations and professional groups to make sure the study is relevant and appropriate. By working with these groups, we will also ensure that SMART Health Diabetes can be used more widely in routine diabetes care if proven to be effective and safe.

The burden of diabetes and diabetic kidney disease is growing rapidly in Thailand but the healthcare systems, particularly in rural areas, are poorly equipped to address this problem. The aim of this project is to evaluate the impact of a bespoke diabetes management program designed for implementation within existing healthcare systems in rural regions of Thailand. The program, called SMART Health Diabetes and Kidney, uses trained non-physician health workers (NPHWs) to deliver evidence-based care to people with, or at risk of, diabetes assisted by an electronic, clinical decision support system.

The study includes 2 phases: a development phase and an evaluation phase.

In Phase 1, we will develop diabetes-specific screening and management algorithms based on national and international guidelines. These algorithms will be deployed using an existing java-based mobile platform which can be accessed directly on low-cost smartphone or tablet devices. Based on entered patient information through the application, output will be generated providing screening and treatment recommendations for frontline NPHWs or doctors. The algorithms will undergo iterative testing and refinement as part of Phase 1. In Phase 2, we will evaluate the effectiveness, cost-effectiveness and SMART Health Diabetes in a large cluster randomised controlled trial of 40 villages in Kamphang Pet province. The unit of randomisation will be the Sub-district (Tambon) health office catering to villages. The co-primary outcomes for the study are HbA1c and progression of albuminuria. We will use household surveys to sample individuals 30 years and older at baseline and at follow-up after 48 months. A parallel qualitative study will assess the scalability of SMART Health diabetes.

In addition to the academic beneficiaries listed above, since this intervention will be integrated into an existing rural community-based healthcare system and will include components directed to health workforce training, there are a number of potential beneficiaries from the research aside from academics, such as the village health workers, nurses and other non-physician health workers.

Diabetes and kidney disease are two important (and rapidly growing) causes of premature death and disability in Thailand, and indeed in most LMIC, and innovative models of care delivery are urgently needed. If found to be effective and cost-effective, the approaches being investigated by this proposed research will have direct implications for health and quality of life of millions of Thais and potentially also large populations in other LMICs. Making a significant contribution towards health and wellbeing of disadvantaged populations will foster economic performance through reduced healthcare costs to the system and enhanced productivity.

The evidence-based technologies developed in this study will potentially have further direct economic and societal impacts through commercial sector engagement. The George Institute has been working on pathways to implementation for the two core technologies of similar interventions for several years and will use the same pathways in this study through collaborations with technology transfer partners.

Through engagement with governments (KT is an advisor to the Thai Government on development of diabetes and kidney disease screening guidelines) and professional societies (VJ is the President-Elect of International Society of Nephrology), this study will help drive the formulation of national guidelines for innovative methods to deliver routine diabetes care and increase the effectiveness of public services. It will also help support the work of local advocacy groups and professional organisations that we have engaged as part of this study. Further, the international role of the investigators will foster implementation of similar approaches in other LMIC settings.

We plan to craft a series of communications to stakeholders, including print, broadcast and digital audiences. We believe that because of the recent changes in policy by the Ministry of Public Health, and emphasis on NCD screening and management in the community, Thai environment will be more receptive to the study's findings and conducive to policy change if we can help promote awareness of projects and its results.

At the beginning of the study, we will issue a traditional announcement and fact sheets. These initial foundation communications pieces will be in Thai. The local team will reach out directly to the media regarding the study for interviews. We will look for opportunities to leverage the study with ongoing topical news, and continue to build interested audiences. Updates on the study will be sent to influential decision makers, the media and interested members of the public through electronic newsletters. We plan to produce a video during the study phase and include this in our digital outreach efforts. We will link to the annual World Diabetes Day and World Kidney Day, and build partnerships with organisations dedicated to fighting diabetes. After a full analysis of the research results, we would leverage the expected publication in a prominent journal for further media coverage. We will conduct multidisciplinary Round Tables and Workshops with healthcare professionals, Technology teams, health economists and policy makers to disseminate the findings and stimulate structural change. Public Policy engagement: We will prepare reports and presentations for the health ministry as well as for municipal government and civil society. Recommendations will be made with the desired outcome of facilitating technology-led healthcare delivery for addressing the NCD prevention needs of the impacted population.