Developing a Learning Health System for Primary Care in Thailand

NCT06873243 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Learning Health System Approach

Our intervention will be informed by the framework for designing LHSs developed by The Health Foundation and the updated framework for developing and evaluating complex evaluations commissioned by the UK Medical Research Council and National Institute for Health Research.The updated framework considers not only if an intervention is effective, but also whether the intervention is acceptable, implementable, cost-effective, scalable, and transferrable across contexts. The trial will encompass three of the four key components of complex intervention design: Development of an intervention Assessment of feasibility of the intervention, and Evaluation of the intervention. . We anticipate that a Plan Do Study Act (PDSA) cycle of quality improvement will be most suited to the Thai context as this approach is currently being promoted by the Thai Ministry of Public Health.

Sponsors & Collaborators

  • Royal Thai Ministry of Public Health

    collaborator UNKNOWN
  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • Chiang Mai University

    collaborator OTHER
  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Rohini Mathur, PhD · Queen Mary University of London

  • Chaisiri Angkurawaranon, PhD · Chiang Mai University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Thailand

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873243 on ClinicalTrials.gov