Clinical Decision Support for Chronic Kidney Disease in Primary Care: A Cluster Randomized Clinical Trial

Optimal clinical decision support system (CDSS) implementation for chronic kidney disease (CKD) management in Chinese primary care remains undefined despite the high disease burden.

To examine whether a CDSS for CKD could improve physician behavior and patient outcomes in primary care.

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.

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.

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).

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.

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.

Chinese Clinical Trial Registry Identifier: ChiCTR2300070555.