Effectiveness of a Quality Checklist Intervention in Adult Intensive Care Units: A Cluster Randomized Controlled Trial

BACKGROUND Intensive care units (ICUs) are complex environments where clinicians must simultaneously execute multiple care processes.However, these demands increase the risk of preventable adverse events.Although various structured multi-domain ICU checklists have been tested, their effectiveness remains uncertain, especially in resourceconstrained settings.AIM To evaluate the association between the implementation of a comprehensive, contextspecific ICU quality checklist-based quality improvement intervention and the rate of net adverse events (NAE) among critically ill adult patients admitted to a tertiary care teaching hospital.METHODS A single-centre cluster randomized controlled trial was conducted involving four medical ICUs, with two ICUs allocated to each study group.Adult patients admitted for ≥ 24 hours were considered eligible.The intervention consisted of a locally developed and internally reviewed multi-domain ICU quality checklist-based intervention.The primary outcome was the rate of NAE per 100 patient-days while the secondary outcomes included conventional adverse events (CAE), healthcare associated infections events (HCAIE), administrative/process-related adverse events (AAE), device-associated infections, in hospital mortality, and the ICU length of stay.Adjusted analyses were conducted using negative binomial regression and logistic regression models.The models did not explicitly account for within-ICU correlation; therefore, the findings were interpreted cautiously.4 / 36 RESULTS A total of 221 patients was included (112 checklist group and 109 usual care group), contributing 2718 patient-days.The checklist group demonstrated a lower crude NAE rate than the usual-care group [6.70 events vs 12.42 events per 100 patient-days; adjusted incidence rate ratio (IRR) 0.52, 95% confidence interval (CI): 0.35-0.77;P = 0.001].Furthermore, the adjusted rates were also lower for CAE (IRR 0.55, 95%CI: 0.36-0.87;P = 0.009), HCAIE (IRR 0.47, 95%CI: 0.24-0.93;P = 0.031), and AAE (IRR 0.48, 95%CI: 0.25-0.90;P = 0.023).In the sensitivity analysis excluding administrative/process-related events, the clinical NAE remained lower in the checklist group (adjusted IRR 0.54, 95%CI: 0.36-0.81;P = 0.003).Although some individual adverse events showed lower crude rates in the checklist group, the adjusted analyses did not demonstrate statistically significant differences in ventilator-associated pneumonia, central line-associated bloodstream infection, or catheter-associated urinary tract infection.In-hospital mortality rate did not differ significantly between the groups (adjusted odds ratio 0.74, 95%CI: 0.39-1.41;P = 0.366). CONCLUSIONThe checklist intervention was found to be associated with lower rates of overall and clinical adverse events in this single-centre trial.However, a small number of randomized ICUs and the lack of explicit adjustment for within-ICU correlation warrant cautious interpretation.Larger multicentre cluster-randomized trials with an adequate number of clusters and appropriate methods to account for clustering are needed to confirm these findings.