This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 51 primary care sites are randomized to three groups, with 17 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 17 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 17 sites to the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,160
Group A (CG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG) and machine learning (ML) approach.
Group B (CG+ICG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG), hemodynamic parameters measured by impedance cardiograph (ICG), and machine learning (ML) approach.
Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.
Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences
Shenzhen, Shenzhen, China
RECRUITINGhierarchical composite outcome
The primary outcome of the trial is a hierarchical composite outcome, evaluated using the Win-ratio method in the following order: 1. Office blood pressure control rate (\<130/80 mmHg) at 3 months after randomization. 2. The duration from baseline to the first occurrence of controlled blood pressure achievement (\<130/80 mmHg) within 3 months after randomization. 3. The composite index of the number and dosage of antihypertensive drugs among participants achieved controlled blood pressure at 3 months after randomization.
Time frame: Baseline; 3 months
Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months
Time frame: Baseline; 3 months
Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months
Time frame: Baseline; 1 month; 3 months
Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months
Time frame: 3 months
Changes in hemodynamic parameters measured by ICG from baseline to 3 months
Including dynamic parameters (heart rate and cardiac index), resistance parameters (arterial stiffness index and systemic vascular resistance index), and volume parameters (thoracic blood volume saturation)
Time frame: Baseline; 3 months
Differences in the three-tier hierarchical composite primary outcomes and each component of the three-tier hierarchical composite primary outcome among intervention groups at 3 months
Time frame: Baseline; 3 months
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