Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial

Abstract

Background: 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.

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 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.

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 nested trial, the 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.

Keywords: Clinical decision support system; Hypertension; Pragmatic trial.

Conflict of interest statement

In the past three years, Dr. Harlan Krumholz received expenses and/or personal fees from UnitedHealth, Element Science, Aetna, Reality Labs, Tesseract/4Catalyst, F-Prime, the Siegfried and Jensen Law Firm, Arnold and Porter Law Firm, and Martin/Baughman Law Firm. He is a co-founder of Refactor Health and HugoHealth, and is associated with contracts, through Yale New Haven Hospital, from the Centers for Medicare & Medicaid Services and through Yale University from Johnson & Johnson. Dr. Jing Li discloses that she is a recipient of research grants from the government of China, through Fuwai Hospital, for research to improve the management of hypertension and blood lipids, and to improve care quality and patient outcomes of cardiovascular disease; is a recipient of research agreements with Amgen, through National Center for Cardiovascular Diseases (NCCD) and Fuwai Hospital, for a multi-center trial to assess the efficacy and safety of Omecamtiv Mecarbil, and for dyslipidemic patient registration; is a recipient of a research agreement with Sanofi, through Fuwai Hospital, for a multi-center trial on the effects of sotagliflozin; is a recipient of a research agreement with University of Oxford, through Fuwai Hospital, for a multi-center trial of empagliflozin; and was a recipient of a research agreement, through NCCD, from AstraZeneca for clinical research methods training.

© 2022. The Author(s).

Figures

Fig. 1

Infrastructure of the LIGHT and LIGHT-ACD trials

Fig. 2

Schedule of enrollment, intervention allocation and assessment of the LIGHT trial using Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)