Developing a Learning Health System for Primary Care in Thailand

NCT06873243 | Active Not Recruiting DMC

• 2 other identifiers: 0765NIHR156161
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension; Diabetes; Kidney Disease; Primary Care; Primary Care Patients With Chronic Conditions; Quality Improvement

Keywords

Learning Health System; Quality Improvement; Hypertension; Diabetes; Kidney Disease; Primary Care; Non-Communicable Disease

Outcome Measures

Primary Outcomes (3)

• Phase 1: Hypertension

  The proportion of adults with hypertension whose blood pressure meets target levels (\<140/90 mmHg) at 12 months

  12 months

• Phase 2: Type 2 Diabetes

  The proportion of adults with type 2 diabetes whose blood glucose meets target levels (\<6.5%/48 mmol/mol) at 12 months

  12 months

• Phase 3: Chronic Kidney Disease

  The proportion of adults with CKD stages 1-4 who are tested for albuminuria at 12 months.

  12 months

Study Arms (2)

Learning Health System Intervention

EXPERIMENTAL

The intervention is the introduction of a Learning Health System approach to improve the management of hypertension, diabetes, and chronic kidney disease. 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. Primary care units randomized in the intervention will receive monthly data on their performance and patient outcome data from the CMU team. The data produced will be fed-back to practices via regular network-based peer discussions in a visually accessible format and facilitated by the clinical and community champions.

Behavioral: Learning Health System Approach

Routine Care

NO INTERVENTION

This arm encompasses all primary care units not randomized to receive the intervention. Primary care units not randomized to the intervention will deliver routine care for hypertension, type 2 diabetes, and CKD. While we will collect monthly data on practice performance and key outcome metrics, they will not receive feedback or facilitation.

Interventions

Learning Health System Approach BEHAVIORAL

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.

Learning Health System Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any primary care unit in Lampang or Chiang Mai Province

You may not qualify if:

• None

Sponsors & Collaborators

• Queen Mary University of London: lead
• Royal Thai Ministry of Public Health: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Chiang Mai University: collaborator

Study Sites (1)

Chiang Mai University

Chiang Mai, Chiang Mai District, 50200, Thailand

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Kidney Diseases; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rohini Mathur, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

• Chaisiri Angkurawaranon, PhD

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a three-phase open-label stratified cluster randomized controlled trial across two provinces in Thailand. Stratified randomisation will be used to allocate 16 primary care units from 419 total eligible primary care units to receive the intervention. We will generate four strata (the maximum number recommended for stratified cluster randomized trials of this size). Four primary care units in each stratum will be randomly selected to receive the intervention, and the rest will receive routine care (approximately 100 primary care units per stratum).

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)