Rationale and design of the Learning Implementation of Guideline-based decision support system for Hypertension Treatment (LIGHT) Trial and LIGHT-ACD Trial

Background Computerized clinical decision support systems (CDSS) are low-cost, scalable tools with the potential to improve guideline-based antihypertensive treatment in primary care, but their effectiveness needs testing in pragmatic trials. Methods The Learning Implementation of Guideline-based decision support system for Hypertension Treatment (LIGHT) trial is a pragmatic, four-stage, cluster-randomized trial conducted in 94 primary care practices in China. For each city-based stage, practices are randomly assigned to either implementation of the CDSS for hypertension management (which guides physicians treatment recommendations based on measured blood pressure and patient characteristics), or usual care. Patients are enrolled during the first 3 months after site randomization and followed for 9 months. The primary outcome is the proportion of hypertension management visits at which guideline-based treatment is provided. In a separate sub-study conducted within the CDSS, with the patient as the unit of randomization, the LIGHT-ACD trial, patients are randomized to receive different initial mono- or dual- antihypertensive therapy. The primary outcome of the LIGHT-ACD trial is the change in blood pressure from the first visit after site randomization to 9 months. Discussion The LIGHT trial will provide evidence on the effectiveness of a CDSS for improving guideline adherence for hypertension management in primary care in China. The sub-study, LIGHT-ACD trial, will provide data on the effect of different initial antihypertensive regimens for blood pressure management in this setting. Trial registration ClinicalTrials.gov, identifier: LIGHT ( NCT03636334 ) and LIGHT-ACD ( NCT03587103 ). Registered on 3 July 2018.