An Organisational Level Programme of Intervention for AKI: A Pragmatic Stepped-Wedge Cluster Randomised Trial

Background: Variable standards of care may contribute to poor outcomes associated with acute kidney injury (AKI). We evaluated whether a multifaceted intervention (AKI e-alerts, an AKI care bundle and an education programme) would improve delivery of care and patient outcomes.

Methods: A multi-centre, pragmatic, stepped-wedge cluster randomised trial (SWCRT) was performed in five UK hospitals. The intervention was introduced sequentially across fixed three-month periods until all hospitals were exposed. The intervention schedule was randomly determined. All patients with AKI aged ≥18 years were included. The primary outcome was 30-day mortality, with pre-specified secondary endpoints and a nested evaluation of care process delivery. The nature of the intervention precluded blinding, but data collection and analysis were independent of project delivery teams.

Findings: 24,059 AKI episodes were studied. Overall 30-day mortality was 24.5%, with no difference between control and intervention periods (OR 1.04, 95% CI 0.91-1.21). Hospital length of stay (LoS) was reduced with the intervention (-0.2days (95% CI -0.5 to 0.1), -0.7days (-1.3 to -0.2) and -1.3days (-2.5 to -0.2) at the 0.3, 0.5 and 0.7 quantiles respectively). AKI incidence increased (adjusted incidence rate ratio 1.12, 95% CI 1.03-1.22) with a parallel increase in the proportion of patients with a coded diagnosis of AKI. Process measures were assessed in 1048 patients, with improvements seen in several metrics including AKI recognition, medication optimisation and fluid assessment.

Conclusions: A complex, hospital-wide intervention to reduce harm associated with AKI did not alter 30-day AKI mortality but did result in reductions in LoS, accompanied by improvements in in quality of care. AKI incidence increased, likely reflecting improved recognition.