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

Abstract

BackgroundComputerized clinical decision support systems (CDSS) are low-cost, scalable tools with the potential to improve guideline-recommended antihypertensive treatment in primary care. Uncertainty remains about the optimal initial antihypertensive therapy in the settings of real practice.MethodsThe Learning Implementation of Guideline-based decision support system for Hypertension Treatment (LIGHT) trial is a pragmatic, cluster-randomized controlled trial of CDSS versus usual care conducted in 100 primary care practices in China. The primary outcome is the proportion of hypertension visits with appropriate (guideline-recommended) antihypertensive treatment. Among patients recruited from primary care practices of the intervention group in the LIGHT trial, we further conducted a sub-study, the LIGHT-ACD trial, to compare the effects of initial antihypertensive therapy by randomizing individual patients to receive different antihypertensive regimens of initial monotherapy or dual therapy. The primary outcome of the sub-study is the absolute change in blood pressure from baseline to 9 months.ResultsWe hypothesize that the use of CDSS will result in a higher proportion of appropriate antihypertensive treatments being prescribed during visits for hypertension control in the LIGHT trial, and that particular choices of monotherapy or combinations of dual therapy lead to greater blood pressure change in the LIGHT-ACD trial.ConclusionThese nested trials will provide reliable evidence on the effectiveness of CDSS for improving adherence to guidelines for hypertension management in primary care, and data on the effectiveness of different initial antihypertensive regimens for blood pressure reduction.Registration numberLIGHT (NCT03636334) and LIGHT-ACD (NCT03587103).