SP228A MULTICENTRE, STEPPED-WEDGE CLUSTER RANDOMISED TRIAL OF A COMPLEX INTERVENTION TO REDUCE HARM ASSOCIATED WITH ACUTE KIDNEY INJURY

Abstract

Background: Acute kidney injury (AKI) is common and associated with poor outcomes. We sought to evaluate the effectiveness, at the hospital level, of a package of measures to reduce harm associated with AKI. Method(s): A multi-centre, pragmatic, stepped-wedge cluster randomised trial (SWCRT) was performed in five UK hospitals. The organisation-wide intervention consisted of AKI alerts, a care bundle and an educational program that was introduced sequentially across fixed three month periods until all hospitals were ultimately exposed to the intervention. The sequence was determined by random number generation. All patients with AKI aged >=18 years hospitalised for >1day were included. Chronic dialysis was the only exclusion criterion. Data were collected in 3 month periods, with a minimum of 2 pre-exposure (control), one transition and a minimum of one exposed periods per site. The primary outcome was 30-day mortality associated with AKI, with pre-specified secondary endpoints and a nested evaluation of care process delivery. Result(s): 24,059 AKI episodes were studied (incidence 7.6 cases/100 admissions); mean age was 72+/-17yrs; 62% had AKI stage 1, 21% AKI stage 2, 17% AKI stage 3. Overall 30d mortality was 24.5%, with no difference between control and intervention periods (OR 1.07, 95% CI 0.93-1.24). Hospital length of stay (LoS) was reduced in the intervention period; -0.2days (95% CI -0.4 to 0.1), -0.7days (-1.3 to -0.1) and -1.3days (-2.7 to 0.1) for tertiles with low, middle and high LoS, respectively. The incidence of AKI increased in the intervention period, likely reflecting improved AKI detection. Process measures were assessed in 1042 patients. In the intervention period, improvements were seen in several metrics including AKI recognition, medication optimization, fluid assessment and urinalysis; care bundle usage was 40% with variation between centres (range 15-68%). The degree of improvement differed between centres, which will be explored in a qualitative analysis. Conclusion(s): A complex, hospital-wide intervention to reduce harm associated with AKI resulted in improvements in delivery of care, improved AKI detection and a modest reduction in LoS, but did not alter AKI mortality.