Clinical Decision Support for Chronic Kidney Disease in Primary Care

Importance: Optimal clinical decision support system (CDSS) implementation for chronic kidney disease (CKD) management in Chinese primary care remains undefined despite the high disease burden. Objective: To examine whether a CDSS for CKD could improve physician behavior and patient outcomes in primary care. Design, Setting, and Participants: This cluster randomized clinical trial is being conducted in Chinese primary care centers. The trial spans a 3-year period (January 1, 2023, to December 31, 2026) and is divided into 2 phases; this phase 1 analysis includes data from the initial 6-month follow-up (June 10 to December 10, 2023). Centers were stratified by size and randomized 1:1 to intervention or control. Participants are adults (aged ≥18 years) with CKD who had 2 visits or more during the 1-year screening period, all enrolled before randomization. Interventions: Both groups received government-supported, nephrologist-delivered training on CKD management. The intervention group was additionally equipped with a CDSS embedded into the electronic health record. Main Outcomes and Measures: The primary outcome was a 36-month composite of kidney-related and cardiovascular hospitalizations (phase 2). This phase 1 analysis evaluated 6-month process measures (ie, CKD diagnosis and renin-angiotensin-aldosterone system inhibitor or sodium-dependent glucose transporter 2 inhibitor use) and clinical outcomes (ie, blood pressure, glycated hemoglobin, and low-density lipoprotein cholesterol control). Results: A total of 3390 patients (mean [SD] age, 72.0 [10.2] years; 1881 [55.5%] female) from 30 primary care centers were included (1912 in the intervention group and 1478 in the control group). Follow-up at 6 months was completed by 3055 patients (90.1%; 1743 [91.2%] in the intervention group and 1312 [88.8%] in the control group). CKD diagnosis rates increased by 21.4 (95% CI, 18.6-24.3) percentage points in the intervention group and by 27.9 (95% CI, 24.4-31.3) percentage points in the control group, with a nonsignificant between-group difference (adjusted odds ratio [AOR], 0.91; 95% CI, 0.72-1.14). Renin-angiotensin-aldosterone system inhibitor use (AOR, 0.96; 95% CI, 0.78-1.19), sodium-dependent glucose transporter 2 inhibitor use (AOR, 1.02; 95% CI, 0.78-1.32), and low-density lipoprotein cholesterol control (AOR, 1.10; 95% CI, 0.83-1.46) showed parallel improvements with no between-group differences. Blood pressure (AOR, 0.88; 95% CI, 0.71-1.09) and glycated hemoglobin (AOR, 1.22; 95% CI, 0.74-2.01) control showed no improvement. Conclusions and Relevance: In this cluster randomized trial of a CDSS for CKD in primary care, both the intervention and control groups demonstrated comparable improvements in 6-month outcomes, with no independent effect of the CDSS detected. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2300070555.