Clinical Trial

Developing a Learning Health System for Primary Care in Thailand

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Summary
Research question: Can a Learning Health System (LHS) approach improve delivery of care and reduce inequalities in outcomes for people with hypertension and related non-communicable diseases (NCDs) compared to routine care in primary care settings in Thailand? Background: NCDs account for 74% of all deaths in Thailand. Electronic health record data is used in Thailand to monitor how well whole regions deliver care, but is not directly available to healthcare teams in an actionable format which allows them to identify individuals in need of earlier, or more active management. LHS' are an effective framework for empowering healthcare teams to drive quality improvement (QI), reduce inequalities, and translate electronic health record data into actionable clinical insight. Aims and objectives: The investigators will conduct a stratified cluster randomized controlled trial to compare the LHS approach to routine care in two Thai provinces. The investigators will randomize 16 primary care units to the intervention over three phases: targeting management of people with hypertension in phase 1, type 2 diabetes in phase 2 and chronic kidney disease (CKD) in phase 3. In each phase, the investigators will: 1. Co-design a LHS with healthcare teams, policymakers, researchers and the public 2. Train healthcare and analytic teams to deliver the LHS and establish local champions to support it 3. Trial the LHS approach for 12 months 4. Compare performance between intervention and control practices and evaluate the benefits and costs of implementing the LHS 5. Identify provider and patient barriers and facilitators to inform long-term QI for NCDs Methods: The investigators will create four strata of primary care units according to practice size and case-mix. Within each stratum, the investigators will randomize four practices to the intervention arm. In each of the three phases of the intervention, the investigators will hold a series of stakeholder workshops to co-design quality improvement pathways, training materials, and computerised decision support tools (Aim 1); train multidisciplinary healthcare, analytic and research teams to implement the LHS and establish clinical and community champions to support it (Aim 2). The investigators will trial the LHS for 12 months. Monthly data on key metrics will be used to monitor progress and iterate the LHS based on data analytics and shared learning across healthcare teams (Aim 3). The investigators will conduct formal statistical comparisons between intervention and control arms, undertake health economic and mixed-methods realist evaluations to understand what works in promoting change and associated costs and benefits. (Aims 4 \& 5). Timeline: Trial setup (months 0-6), Hypertension (months 3-21), Diabetes (months 15-33), CKD (months 24-45), Evaluation (months 24-48) Impact and dissemination: Results will be disseminated via publication in high-impact journals, conference presentations, stakeholder meetings, and the media. The investigators will co-produce locally relevant educational materials and clinical guidelines. Impact will include the generation of longitudinal epidemiological data on management and outcomes of NCDs, including factors which facilitate continuous QI, and associated costs and benefits. The decision support tools, training resources, and economic evaluative frameworks will be made freely available by the Thai Ministry of Health and the regional WHO office. Capacity building will ensure the next generation of clinical, community, and research leaders promulgate this way of working across the region.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-06.
Trial Details
NCT Number NCT06873243
Lead Sponsor Queen Mary University of London
Collaborators: Royal Thai Ministry of Public Health, London School of Hygiene and Tropical Medicine, Chiang Mai University
Conditions Hypertension, Diabetes, Kidney Disease, Primary Care, Primary Care Patients With Chronic Conditions, Quality Improvement
Enrollment 419 participants
Start Date 2024-11-01
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-15