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

Lead Research Organisation: University of Oxford
Department Name: Women’s & Reproductive Health

Abstract

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.

Technical Summary

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.

Planned Impact

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.

Publications

10 25 50
 
Description The overall goal of this research is to compare management of type 2 diabetes with or without albuminuria between conventional care and that with a health system intervention including electronic CDSS (SMARThealth Diabetes) to be delivered by frontline healthcare workers in rural Thailand. This is to be achieved by adapting and implementing a multicomponent intervention that strengthens the existing primary health care system and addresses known constraints for diabetes management in rural Thailand.

The key finding and outputs till date are:
-A rapid health service appraisal was conducted in Kamphaeng Phet Province in Thailand and multiple factors affecting diabetes and CVD management were identified. They ranged from low community and health worker awareness of diabetes and CVD and its risk factors through to upstream barriers in referral and management in the sub-district health offices
-The SMARThealth (Systematic Medical Appraisal, Referral and Treatment) which is a multifaceted primary healthcare program underpinned by digital technology, including an electronic clinical decision support (CDS) tool was updated with recommendations consistent with local Thai guidelines
-These CDS algorithms were tested and validated for deployment in the field
-The guidelines and workflow were adapted according to the recommendations of the Thai Ministry of Health and the Nursing Council.
-A new workforce training module on diabetes and CKD is developed.
Exploitation Route • Provide evidence-based guidance to health care providers including Village Health Volunteers (VHVs) Community nurses, and doctors at Sub District Health Offices (SHDO)
• Strengthen workforce restructuring and quality of training program thus increase the involvement of physician health workers (NPHWs) and VHVs in routine diabetes care
• New SMARTKidney Thailand screening, referral and management tool with revised CDSS, algorithm and workforce training module
• Continuous performance monitoring and management among all levels of health care workers (HCW)
• Information, Education & communication (IEC) materials developed would help in generating awareness in community and HCWs thus promoting positive behavior
Sectors Communities and Social Services/Policy,Digital/Communication/Information Technologies (including Software),Healthcare

 
Description Clinical Decision Support System (CDSS): -A CDSS based on existing local government guidelines is designed to provide evidence-based guidance to Village Health Volunteers (VHVs) Community nurses, and doctors at Sub District Health Offices (SHDO) -This CDSS would work through an application installed in a 7-inch tablet device. A kit, containing the tablet, blood pressure (BP) monitor, glucometer and other management resources are procured for the health workers. -Induction training is planned in March 2020 for doctors and VHVs and community nurses -Two modules are developed in OpenMRS which will support real time patient tracking: (a) a patient priority module to help community nurses prioritize workload for follow up visits and (b) an alert / reminder module to provide feedback on whether patients were achieving recommended targets SMARThealth: The George Institute's SMARThealth program is a novel primary care platform to support communities and healthcare providers in the prevention and management of common NCDs. -It draws on the principles of "task-sharing" whereby some routine clinical procedures are transferred from doctors to community nurses in an effort to increase access to healthcare and reduce costs. -This is facilitated by a suite of innovative, affordable digital technologies developed to provide evidence-based decision support to both providers and consumers -A SMARTHealth application for the tab has been developed in Thai language and the CDSS algorithm is set as per the Thailand medical management of T2DM -Field testing of the app is being conducted in Kamphaeng Phet Province of Thailand Workforce Training Module: -A SMARThealth Diabetes and CKD training programme module to health workers and doctors consistent with local practice is developed to ensure local relevance. This training package will be delivered in an initial workshop format and continuously reinforced through the program's digital platform.
First Year Of Impact 2019
Sector Communities and Social Services/Policy,Digital/Communication/Information Technologies (including Software),Healthcare
Impact Types Societal,Policy & public services

 
Description Engagement with regional health officials
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Participation in a national consultation
 
Description Thai Govt engagement
Geographic Reach Asia 
Policy Influence Type Membership of a guideline committee
 
Title Questionnaire 
Description A novel questionnaire that helps primary healthcare workers assess the kidney disease and cardiovascular risk of subjects with diabetes using simple checklists is being developed. This will be deployed by village health volunteers and nurses to stratify subjects according to their kidney disease risk, to decide further referral, track treatment compliance and measure quality of care 
Type Of Material Model of mechanisms or symptoms - human 
Year Produced 2019 
Provided To Others? No  
Impact Not yet - but once validated in the study this could become the default tool for risk assessment of individuals with diabetes and kidney disease in the community. 
 
Title SMARTKidney Algorithm 
Description The development and validation of the algorithm followed a three-step process: i. A group of leading Thai and international physicians developed and validated the plain language algorithm on the basis of the ADA, KDIGO and Thai disease management guidelines. The physicians then performed a manual review of the algorithm and assessed the appropriate pharmacological and lifestyle recommendations. ii. A researcher who was not involved with the algorithm development was given the plain language algorithm summary along with mock input data from 200 patients. Output variables were generated using the paper algorithm and were then compared with the output generated by an independent statistical code developed using SAS version 9. iii. The plain language rules were built as a Java-based application into a mobile tablet using the Android operating system. De-identified data from a large cross-sectional study (~1000 patients) was run using the statistical and programming codes. Correlation between the programming code and the statistical code was assessed and inconsistencies were resolved by making changes to the programming code. This continued until 100% consistency was obtained between both the outputs. 
Type Of Material Computer model/algorithm 
Year Produced 2019 
Provided To Others? Yes  
Impact The algorithms have been incorporated into the SMARTKidney Thailand application which will be used by the frontline healthcare workers to screen and refer persons with suspected diabetes and its complications to the Government Healthcare Centres and higher-level hospitals. The effectiveness of this tool will be evaluated in an RCT 
 
Description SMARTKidney 
Organisation Chulalongkorn University
Country Thailand 
Sector Academic/University 
PI Contribution We organised all the collaborations, developed the research proposal, and the protocol. We have developed the study tool, the CDSS and working with the Thai Team to manage the project and data. We will do all analyses.
Collaborator Contribution The Thai Team is providing local intellectual inputs and managing the on-ground implementation of the project. The team is providing local guidelines to help develop the clinical decision tool. The Nursing Council has reviewed the app and the workflow. It has provided important inputs that were considered for the existing version of the application. The project is being implemented in the context of the Thai Ministry of Health. The Indian partners are providing intellectual inputs
Impact The detailed study protocol and the algorithms have been written. The platform to deliver the intervention has been developed. An implementation plan has been decided. Approval has been obtained from the Thai Nursing Council and the Ministry of Thailand.
Start Year 2018
 
Description SMARTKidney 
Organisation Department of Health Government of Khyber Pakhtunkhwa
Country Pakistan 
Sector Public 
PI Contribution We organised all the collaborations, developed the research proposal, and the protocol. We have developed the study tool, the CDSS and working with the Thai Team to manage the project and data. We will do all analyses.
Collaborator Contribution The Thai Team is providing local intellectual inputs and managing the on-ground implementation of the project. The team is providing local guidelines to help develop the clinical decision tool. The Nursing Council has reviewed the app and the workflow. It has provided important inputs that were considered for the existing version of the application. The project is being implemented in the context of the Thai Ministry of Health. The Indian partners are providing intellectual inputs
Impact The detailed study protocol and the algorithms have been written. The platform to deliver the intervention has been developed. An implementation plan has been decided. Approval has been obtained from the Thai Nursing Council and the Ministry of Thailand.
Start Year 2018
 
Description SMARTKidney 
Organisation George Institute for Global Health
Country Australia 
Sector Academic/University 
PI Contribution We organised all the collaborations, developed the research proposal, and the protocol. We have developed the study tool, the CDSS and working with the Thai Team to manage the project and data. We will do all analyses.
Collaborator Contribution The Thai Team is providing local intellectual inputs and managing the on-ground implementation of the project. The team is providing local guidelines to help develop the clinical decision tool. The Nursing Council has reviewed the app and the workflow. It has provided important inputs that were considered for the existing version of the application. The project is being implemented in the context of the Thai Ministry of Health. The Indian partners are providing intellectual inputs
Impact The detailed study protocol and the algorithms have been written. The platform to deliver the intervention has been developed. An implementation plan has been decided. Approval has been obtained from the Thai Nursing Council and the Ministry of Thailand.
Start Year 2018
 
Description SMARTKidney 
Organisation Government of Thailand
Country Thailand 
Sector Public 
PI Contribution We organised all the collaborations, developed the research proposal, and the protocol. We have developed the study tool, the CDSS and working with the Thai Team to manage the project and data. We will do all analyses.
Collaborator Contribution The Thai Team is providing local intellectual inputs and managing the on-ground implementation of the project. The team is providing local guidelines to help develop the clinical decision tool. The Nursing Council has reviewed the app and the workflow. It has provided important inputs that were considered for the existing version of the application. The project is being implemented in the context of the Thai Ministry of Health. The Indian partners are providing intellectual inputs
Impact The detailed study protocol and the algorithms have been written. The platform to deliver the intervention has been developed. An implementation plan has been decided. Approval has been obtained from the Thai Nursing Council and the Ministry of Thailand.
Start Year 2018
 
Description SMARTKidney 
Organisation National Research Council of Thailand
Country Thailand 
Sector Public 
PI Contribution We organised all the collaborations, developed the research proposal, and the protocol. We have developed the study tool, the CDSS and working with the Thai Team to manage the project and data. We will do all analyses.
Collaborator Contribution The Thai Team is providing local intellectual inputs and managing the on-ground implementation of the project. The team is providing local guidelines to help develop the clinical decision tool. The Nursing Council has reviewed the app and the workflow. It has provided important inputs that were considered for the existing version of the application. The project is being implemented in the context of the Thai Ministry of Health. The Indian partners are providing intellectual inputs
Impact The detailed study protocol and the algorithms have been written. The platform to deliver the intervention has been developed. An implementation plan has been decided. Approval has been obtained from the Thai Nursing Council and the Ministry of Thailand.
Start Year 2018
 
Description SMARTKidney 
Organisation Rajamangala Institute of kidney disease
Country Thailand 
Sector Hospitals 
PI Contribution We organised all the collaborations, developed the research proposal, and the protocol. We have developed the study tool, the CDSS and working with the Thai Team to manage the project and data. We will do all analyses.
Collaborator Contribution The Thai Team is providing local intellectual inputs and managing the on-ground implementation of the project. The team is providing local guidelines to help develop the clinical decision tool. The Nursing Council has reviewed the app and the workflow. It has provided important inputs that were considered for the existing version of the application. The project is being implemented in the context of the Thai Ministry of Health. The Indian partners are providing intellectual inputs
Impact The detailed study protocol and the algorithms have been written. The platform to deliver the intervention has been developed. An implementation plan has been decided. Approval has been obtained from the Thai Nursing Council and the Ministry of Thailand.
Start Year 2018
 
Description SMARTKidney 
Organisation Thailand Nursing and Midwifery Council
Country Thailand 
Sector Charity/Non Profit 
PI Contribution We organised all the collaborations, developed the research proposal, and the protocol. We have developed the study tool, the CDSS and working with the Thai Team to manage the project and data. We will do all analyses.
Collaborator Contribution The Thai Team is providing local intellectual inputs and managing the on-ground implementation of the project. The team is providing local guidelines to help develop the clinical decision tool. The Nursing Council has reviewed the app and the workflow. It has provided important inputs that were considered for the existing version of the application. The project is being implemented in the context of the Thai Ministry of Health. The Indian partners are providing intellectual inputs
Impact The detailed study protocol and the algorithms have been written. The platform to deliver the intervention has been developed. An implementation plan has been decided. Approval has been obtained from the Thai Nursing Council and the Ministry of Thailand.
Start Year 2018
 
Title Disease management 
Description An algorithmic approach to management of diabetes, kidney disease and cardiovascular risk factors has been developed, adapted according to the Thai guidelines and deployed on an Android Tablet device. This will be used to guide disease management in the community 
Type Management of Diseases and Conditions
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2019
Development Status Under active development/distribution
Impact This will establish an approach to develop uniform guideline-based care for conditions under study and allow monitoring of quality of care. 
 
Title Lifestyle modification 
Description As part of the intervention we will implement a program of lifestyle modification to improve control of diabetes and prevent or retard the progression of kidney disease. They include weight control, salt restriction, promotion of physical exercise, smoking cessation and adherence to medical treatment. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Initial development
Year Development Stage Completed 2019
Development Status Under active development/distribution
Impact The development process leads to upskilling of nohphysician health workers in their ability to provide integrated domiciliary advice that leads to behaviour modification for improved control of kidney disease progression 
 
Title SHThailand 
Description This software has been developed using the George Institute SMARTHealth platform and will be used for screening and follow up of study subjects by the study team. It has a unique clinical decision support that provides bespoke management advice for each patient. This has been accepted by the stakeholders including the Nursing Council of Thailand. The software has undergone modifications to conform to the current diabetes and kidney disease management gyudelines. 
Type Of Technology Software 
Year Produced 2019 
Impact The tool has been reviewed and accepted by the Nursing Council of Thailand. Once implemented, will influence the way community screening is done in Thai healthcare system. 
URL https://www.georgeinstitute.org/projects/systematic-medical-appraisal-referral-and-treatment-smart-h...
 
Description Facility visit 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact The research team visited the District Hospitals and the Subdistrict health canters in the Kampangpet province where this project will be implemented. A formative health system assessment was done through interactions with stakeholders at all levels. The participants were sensitized to the use of electronic platform for screening and inputs were gathered which would help in developing the intervention. The engagement also helped in finalization of the study design and the protocol
Year(s) Of Engagement Activity 2018
 
Description Field testing of SMARTHealth app 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Professional Practitioners
Results and Impact Field testing of the SMARThealth application among the health care practitioner and Nurses who would use this app for data collection
Year(s) Of Engagement Activity 2019
 
Description Health service assessment 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Patients, carers and/or patient groups
Results and Impact A rapid health service assessment of the primary health care facilities, sub district health offices and district health offices were conducted. Discussions were held with the community members, health care providers and district administrators about the challenges and facilitators existing in the current system for provision of robust NCD care. Inputs were sought for the kind of intervention they thought would be important for them to improve management of NCD conditions in their communities.
Year(s) Of Engagement Activity 2019
 
Description Local Technical group 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 Local working group meeting to seek approval from Nursing council of Thailand. Approval from Nursing council Thailand was obtained for project implementation
Year(s) Of Engagement Activity 2019
 
Description Steering committee 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 A steering committee meeting with 18 steering committee members was held on 03 November 2020 to discuss the progress of the study and plan for the steps forward. The steering committee included members from the Thailand Nursing and Midwifery council, Head of NCD Division - KK provincial health office and Deputy Chief - KPP provincial health office. Many important suggestions related to the implementation of the program, working of the algorithms and evaluation including publication plans were provided to the team.
Year(s) Of Engagement Activity 2020