National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital, National Center for Cardiovascular Diseases, 167 Beilishi Road, Beijing, 100037, China.
The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Trials. 2022 May 16;23(1):412. doi: 10.1186/s13063-022-06374-x.
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 to be tested, especially in low- and middle-income countries such as China.
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 sites in China. For each city-based stage, sites are randomly assigned to either implementation of the CDSS for hypertension management (which guides doctors' 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 nested trial 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 changes in blood pressure.
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 nested trial, the LIGHT-ACD trial, will provide data on the effect of different initial antihypertensive regimens for blood pressure management in this setting.
ClinicalTrials.gov, identifier: LIGHT (NCT03636334) and LIGHT-ACD (NCT03587103). Registered on 3 July 2018.
临床决策支持系统（CDSS）是一种低成本、可扩展的工具，具有改善初级保健中基于指南的降压治疗的潜力，但需要对其有效性进行测试，尤其是在中国等中低收入国家。
学习实施基于指南的高血压治疗决策支持系统试验（LIGHT）是在中国 94 个初级保健点进行的一项实用的、四阶段、集群随机试验。对于每个基于城市的阶段，站点被随机分配到高血压管理的 CDSS 实施（根据测量的血压和患者特征指导医生的治疗建议）或常规护理。患者在站点随机化后的头 3 个月内入组，并随访 9 个月。主要结局是提供基于指南的治疗的高血压管理就诊比例。在嵌套于 CDSS 内进行的试验中，以患者为随机单位的 LIGHT-ACD 试验，患者被随机分配接受不同的初始单药或双联降压治疗。LIGHT-ACD 试验的主要结局是血压的变化。
LIGHT 试验将提供在中国初级保健中使用 CDSS 改善高血压管理指南依从性的有效性证据。嵌套试验 LIGHT-ACD 试验将提供关于不同初始降压方案对该环境下血压管理效果的数据。
ClinicalTrials.gov，标识符：LIGHT（NCT03636334）和 LIGHT-ACD（NCT03587103）。于 2018 年 7 月 3 日注册。
